Fact Sheet No. 162 (Jänner 2024)
Idecabtagene vicleucel (Abecma®) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies
Fact Sheet No. 163 (Jänner 2024)
Selpercatinib (Retsevmo®) as monotherapy is indicated for the treatment of adults and adolescents with advanced RET fusion-positive thyroid cancer
New (pharmaceutical) products are getting increasingly more expensive. As a result of this trend accessibility of pharmaceuticals decreases. However, not all innovation can be attributed to private companies. Subsequently, the role of public institutions like universities, university spin-offs, and publicly funded biotech start-ups is largely being disregarded at the price negotiations. Public funding in the form of research grants, tax incentives, utilisation of clinical infrastructure or regulatory measures make a major contribution.
Article 57 of the proposed Pharmaceutical Legislation (PL, Directive) will require market authorization applicants to publicly declare any direct financial support for R&D received from public authorities. The aim of our research (funded by EU Horizon Europe Grant Agreement Number 101095593) is to increase transparency in (pharmaceutical) R&D to mitigate the risk of market failure associated with information asymmetry by analyzing pharmaceutical R&D expenditures of bringing a new medicine to the market and which factors influence these expenditures and to identify the categories needed to capture direct or indirect public contributions to R&D, to provide a framework for standardized reporting of public contributions and to reduce ambiguity in the interpretation of “direct” and “indirect” public contributions.
The report is the first output of the project HI-PRIX (WP2, sub-deliverable 2.2).
Publication: HTA Project Report No. 158: https://eprints.aihta.at/1499/
Contact: Claudia Wild
Fact Sheet No. 157 (November 2023)
Avapritinib (Ayvakyt®) for the treatment of indolent systemic mastocytosis (ISM)
Fact Sheet No. 158 (November 2023)
Pembrolizumab (Keytruda®) with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma (BTC)
Fact Sheet No. 159 (November 2023)
Adagrasib (Krazati®) as monotherapy for the treatment of advanced non-small cell lung cancer (NSCLC)
Fact Sheet No. 160 (November 2023)
Momelotinib (Omjjara®) for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis (PMF), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis
Fact Sheet No. 161 (November 2023)
Talazoparib (Talzenna®) in combination with enzalutamide for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
Registries are systems for collecting observational data on patients in a database. They can be used by decision-makers to improve healthcare. However, the number and type of existing registries in Austria are unknown. Therefore, the aim of this report was to provide an overview of the Austrian registry landscape and to present the quality and characteristics of selected registries. Furthermore, it was a goal to examine the utilisation of Austrian registries and whether some areas need further development.
Publication: HTA Project Report No. 157: https://eprints.aihta.at/1489/
Contact: Christoph Strohmaier
]]>
For children, adolescents and adults with overweight or grade 1 obesity, group programmes are offered which include content on nutrition, exercise and behaviour. However, it is a challenge to reach the respective target groups and to retain the participants in the programme for the entire duration. Based on the reviewed literature, numerous strategies for recruiting target groups and improving programme adherence were identified. In addition, an overview of existing programmes in German-speaking countries was provided.
Publication: HTA Project Report No. 155: https://eprints.aihta.at/1486/
Contact: Inanna Reinsperger
Since 2017, three therapies have been approved by the FDA and EMA for the treatment of SMA patients: The results show clinically relevant improvements in motor skills in SMA type 1 patients, especially in patients with early treatment initiation and >=2 SMN2 copies, as well as stabilisation of health status in SMA type 2 to 4 patients. In all studies reporting these outcomes, no significant improvements in respiratory and nutritional function were recorded regardless of SMA type and therapy used, with most studies reporting no change or an increase in the need for ventilation and nutritional support.
20 observational studies and 1 RCT were included in the synthesis, reporting on a total of 1,374 patients. 15 studies investigated nusinersen in 948 patients, one study was identified on onasmenogene abeparvovec and investigated 12 patients, and two studies investigated risdiplam in 221 patients. 193 patients received combination therapy.
Publication: Policy Brief Nr. 001, 2. Update: https://eprints.aihta.at/1485/
Contact: Claudia Wild
Fact Sheet No. 151 (October 2023)
Zanubrutinib (Brukinsa®) with obinutuzumab for the treatment of refractory or relapsed follicular lymphoma (FL)
Fact Sheet No. 152 (October 2023)
Elranatamab (Elrexfio®) as monotherapy for the treatment of relapsed and refractory multiple myeloma (MM)
Fact Sheet No. 153 (October 2023)
Durvalumab (Imfinzi®) as monotherapy for the first line treatment of advanced or unresectable hepatocellular carcinoma (HCC)
Fact Sheet No. 154 (October 2023)
Dostarlimab (Jemperli®) with carboplatin and paclitaxel for the treatment of mismatch repair deficient (dMMR)/ microsatellite instability high (MSI-H) primary advanced or recurrent endometrial cancer (EC)
Fact Sheet No. 155 (October 2023)
Pembrolizumab (Keytruda®) with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma
Fact Sheet No. 156 (October 2023)
Rucaparib (Rubraca®) as monotherapy for the maintenance treatment of advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
We performed a guideline synopsis to identify indications for the use of image-guided interventions and summarise the subsequent recommendations. We also considered potential organisational or social aspects.
Ten clinical guidelines fulfilled our eligibility criteria. Seven were related to epidural injections in four indications (axial discogenic pain, disc herniation, spinal stenosis, post-surgery syndrome) and five clinical guidelines on facet joint injections in one indication (axial facet joint pain). The majority are related to the lumbar spine. Only three guidelines on epidural injections and four on facet joint injections provided recommendations on imaging modalities.The synopsis of recommendation for epidural injections is inconsistent in two clinical indications, axial discogenic pain and spinal stenosis, with con-flicting recommendations across CGs. The same is true for facet joint injections, for both nerve block and intraarticular injections. The other two clinical indications for epidural injections, disc herniation and post-surgery syndrome, included both strong and weak recommendations for using epidural injections.
Publication: HTA Project Report No. 156: https://eprints.aihta.at/1477/
Contact: Gregor Goetz
Fact Sheet No. 146 (September 2023)
Brentuximab vedotin (Adcetris®) in combination with doxorubicin, vinblastine and dacarbazine for previously untreated CD30+ Stage III or IV Hodgkin lymphoma
Fact Sheet No. 147 (September 2023)
Trastuzumab deruxtecan (Enhertu®) as monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation
Fact Sheet No. 148 (September 2023)
Pembrolizumab (Keytruda®) as monotherapy for the adjuvant treatment of non-small cell lung carcinoma (NSCLC)
Fact Sheet No. 149 (September 2023)
Melphalan flufenamide (Pepaxti®) in combination with dexamethasone for the treatment of multiple myeloma (MM)
Fact Sheet No. 150 (September 2023)
Quizartinib (Vanflyta®) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by single-agent maintenance therapy for patients with newly diagnosed acute myeloid leukaemia (AML)
Community Nursing is a new model of care in Austria to strengthen the health of the elderly population. The literature review examines the cost-effectiveness of the concept and methods for presenting it. The results are inconclusive. The use of community nursing tends not to be cost-effective in the eleven identified studies, but methodological limitations may have biased the results. The studies are also older and largely not from Europe. Further research using more recent methodological findings from research on complex interventions and evaluation of public health interventions is needed.
Publication: HTA Project Report No. 153: https://eprints.aihta.at/1470/
Contact: Ingrid Zechmeister-Koss
]]>
Fact Sheet No. 138 (August 2023)
Crisantaspase (Enrylaze®) for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL)
Fact Sheet No. 139 (August 2023)
Cedazuridine/decitabine (Inaqovi®) for the treatment of newly diagnosed acute myeloid leukaemia (AML)
Fact Sheet No. 140 (August 2023)
Elacestrant (Orserdu®) monotherapy for the treatment of oestrogen receptor (ER)?positive, HER2-negative, locally advanced or metastatic breast cancer
Fact Sheet No. 141 (August 2023)
Talquetamab (Talvey®) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM)
Fact Sheet No. 142 (August 2023)
Epcoritamab (Tepkinly®) as monotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Fact Sheet No. 143 (August 2023)
Tislelizumab (Tevimbra®) as monotherapy for the treatment of unresectable, locally advanced, or metastatic oesophageal squamous cell carcinoma (OSCC)
Fact Sheet No. 144 (August 2023)
Nivolumab (Opdivo®) as monotherapy for the adjuvant treatment of Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease
Fact Sheet No. 145 (August 2023)
Pembrolizumab (Keytruda®) with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction (GEJ) adenocarcinoma
Robotic-assisted surgery represents a technically advanced form of a minimally invasive procedure that claims to improve clinical outcomes as well as healthcare resource utilization. This report is an update of a systematic review from 2019, which examined the effectiveness and safety of robotic-assisted surgery in thoracic and visceral indications, compared to open surgery and conventional laparoscopy. In total, 14 indications were investigated, with no evidence identified for five indications. Due to the heterogeneous results and lack of evidence for some study endpoints, a general statement on the effectiveness and safety of robotic-assisted surgery is not possible.
Publication: HTA Project Report No. 108: https://eprints.aihta.at/1461
Contact : Nicole Grössmann-Waniek
]]>
Fact Sheet No. 135 (July 2023)
Tremelimumab (Imjudo®) with durvalumab (Imfinzi®) and platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC)
Fact Sheet No. 136 (July 2023)
Trifluridine / tipiracil (Lonsurf®, TAS-02) with bevacizumab for the treatment of metastatic colorectal cancer (CRC)
Fact Sheet No. 137 (July 2023)
Sacituzumab govitecan (Trodelvy®) for the treatment of unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer
]]>
+ 3 Updates
Fact Sheet No. 130 (May 2023)
Glofitamab (Columvi®) as monotherapy for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)
Fact Sheet No. 131 (May 2023)
Pirtobrutinib (JaypircaTM) as monotherapy for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL)
Fact Sheet No. 132 (May 2023)
Futibatinib (Lytgobi®) for the treatment of locally advanced or metastatic cholangiocarcinoma
Fact Sheet No. 133 (May 2023)
Nivolumab (Opdivo®) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC)
Fact Sheet No. 134 (May 2023)
Piflufolastat (18F) (Pylclari®) for the diagnosis of prostate cancer
Fact Sheet No. 129 (April 2023)
Lisocabtagene maraleucel (Breyanzi®) for the treatment of diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B)
Publication: Policy Brief No. 007/5. Update: https://eprints.aihta.at/1443/
Contakt: Claudia Wild
Preexposure prophylaxis (PrEP) is an antiretroviral therapy-based HIV prevention strategy to prevent HIV infection in people who have not been infected with the virus but are at high risk of infection. The report aimed to provide an update evidence synthesis based on a systematic literature search regarding the effectiveness and safety of in the EU and/ or US approved oral and parenteral PrEP pharmaceutical to prevent HIV infection in populations at risk. Additionally, the report addressed organisational, economic, patient/social, ethical and legal aspects to support evidence-based decision-making process on PrEP in Austria.
Publication: HTA Project Report No. 152: https://eprints.aihta.at/1436/
Contact: Inanna Reinsperger
This report is based on that of the LBI-HTA of 2015 and the updates of 2018 and 2020. Various guideline databases and policies were searched to identify the recommended oncological indications for the use of PET/PET-CT applications. In addition to guideline databases, recommendations and non-recommendations from professional societies were considered.
The guideline search identified a total of 122 recommendations regarding the use of PET. The majority of the recommendations (n=112) resulted from the guideline search and database search of national professional societies. The search in supranational professional societies resulted in 10 recommendations. A further 36 recommendations were directed against the use of PET ("inappropriate" cancer indications).
The overall recommendations of the present 2023 update (as in the previous year's 2015 & 2018 reports, as well as the 2020 update) indicate little benefit from PET as a primary or standard diagnostic (not least because of radiation exposure). The summarised evidence from guidelines can be used as a guideline for investment decisions.
Publication: Policy Brief No. 003/3. Update: https://eprints.aihta.at/1442/
Contact: Claudia Wild
Fact Sheet No. 125 (April 2023)
Niraparib/abiraterone acetate (Akeega®) for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
Fact Sheet No. 126 (April 2023)
Ivosidenib (Tibsovo®, Tidhesco®) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukaemia (AML)
Fact Sheet No. 127 (April 2023)
Ivosidenib (Tibsovo®) monotherapy for the treatment of locally advanced or metastatic cholangiocarcinoma
Fact Sheet No. 128 (April 2023)
Cemiplimab (Libtayo®) in combination with platinum-based chemotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)
Up to 20% of women and 10% of men experience a mental illness during pregnancy and in the first year after birth. Due to the potentially severe effects on parents and child, there is an urgent need for rapid and effective care. This report provides a mapping of current care structures in Austria. The report is part of the FWF-funded research project "Co-designing perinatal mental health care in Tyrol". The report is to seen in connection with another report which has recently been published as part of the project and which describes the international recommendations on perinatal and infant mental health care (https://eprints.aihta.at/1420/1/HTA-Projektbericht_Nr.148.pdf).
Publication: HTA Projektbericht No. 151: https://eprints.aihta.at/1437/
Contact: Ingrid Zechmeister-Koss
Fact Sheet No. 124 (February 2023)
Cipaglucosidase alfa (Pombiliti®) in combination with Miglustat for the treatment of adults with late-onset Pompe disease (acid alpha-glucosidase [GAA] deficiency)
Fact Sheet No. 123 (February 2023)
Darolutamide (Nubeqa®) in combination with docetaxel and androgen deprivation therapy (ADT) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC)
Fact Sheet No. 121 (February 2023)
Nadofaragen Firadenovec (Adstiladrin®) for Bladder cancer
Fact Sheet No. 122 (February 2023)
Oportuzumab monatox (Vicineum®) for Bladder cancer
Fact Sheet No. 117 (February 2023)
Olaparib (Lynparza®) for mCRPC
Fact Sheet No. 118 (February 2023)
Tremelimumab (Imjudo®) + Durvalumab (Imfinzi®) for HCC
Fact Sheet No. 119 (February 2023)
Tremelimumab (Tremelimumab AstraZeneca®) + Durvalumab (Imfinzi®) + Chemotherapy for NSCLC
Fact Sheet No. 120 (February 2023)
Trastuzumab deruxtecan (Enhertu®) for HER2-low breast cancer
Fact Sheet No. 115 (December 2022)
Trastuzumab deruxtecan (Enhertu®) for Gastric or gastroesophageal junction (GEJ) adenocarcinoma
Fact Sheet No. 116 (December2022)
Durvalumab (Imfinzi®) for Biliary tract cancer
Up to 20% of women and 10% of men suffer from mental health problems during pregnancy and in the first year after the birth of the child. Due to the potentially severe impact on parents and child, there is an urgent need for rapid and effective care. This scoping review provides an overview of international models for the prevention and care of perinatal mental health problems and describes their similarities and differences. The review is part of the FWF funded research project ‘Co-designing perinatal mental health support in Tyrol’.
Publication: HTA Project Report No. 148: https://eprints.aihta.at/1420/
Contact: Inanna Reinsperger
QRs in dementia care are systems to support decision-makers and healthcare planners in developing optimal dementia care pathways while improving the quality of dementia care services and patient outcomes. The aim of the report was to analyse dementia QRs and to provide an overview of the quality indicators used including the underlying evidence. In addition, the empirical results from the identified dementia QRs, in combination with good registry practice from the literature, were embedded into a good practice framework.
Publication: HTA Project Report No. 150: https://eprints.aihta.at/1419/
Contact: Christoph Strohmaier
Mental disorders in children and adolescents are among the most common illnesses with a high burden of disease. The increasing need for care with simultaneous bottlenecks in health services leads to considerations for other care and prevention models. In this context, in this research report international models for prevention and care for child and adolescent mental health were analysed. In addition, an overview of relevant indicators specifically for this population was compiled. Based on these international recommendations, possibilities for the further development of the current Austrian care structures were identified.
Publication: HTA Project Report No. 149: https://eprints.aihta.at/1418/
Contact: Reinhard Jeindl
Osteopathy aims to holistically improve and support all aspects of health. Osteopathic treatments are often applied for pain in the musculoskeletal system. In Austria, there is no legal regulation for the practice, education and training of osteopaths, while other countries have already introduced regulations. The report aims to summarise evidence on the effectiveness and safety of osteopathy in the treatment of musculoskeletal pain and to provide an overview of the training and quality requirements and regulations for the osteopathic profession in Europe.
Publication: HTA Project Report No. 144: https://eprints.aihta.at/1416
Contact: Lucia Gassner
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>The two CAR-T cell therapies Kymriah® and Yescarta® were approved by the EMA in 2018 for patients with B-cell acute lymphoblastic leukaemia (B-ALL), diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL) in third line. Treatment is often associated with high expectations, but the evidence on efficacy and safety of these novel therapies is still uncertain. The aim of this systematic review was to contrast the results of patient characteristics as well as selected efficacy and safety endpoints from the pivotal trials with those from real-world evidence studies. In addition, the results and conclusions of other HTA reports were summarised regarding the available evidence on efficacy and safety.
Publication: HTA Project Report No. 146: https://eprints.aihta.at/1415/
Contact: Claudia Wild
Fact Sheet No. 112 (November 2022)
Zanubrutinib (Brukinsa®) as monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)
Fact Sheet No. 113 (November 2022)
Cemiplimab (Libtayo®) as monotherapy for the treatment of recurrent or metastatic cervical cancer
Fact Sheet No. 114 (November 2022)
Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
Fact Sheet No. 109 (October 2022)
Loncastuximab tesirine (Zynlonta®) as monotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL)
Fact Sheet No. 110 (October 2022)
Zanubrutinib (Brukinsa®) as monotherapy for the treatment of marginal zone lymphoma (MZL)
Fact Sheet No. 111 (October 2022)
Axicabtagene ciloleucel (Yescarta®) for the treatment of patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL)
Publication: HTA Project Report No. 135b Update: https://eprints.aihta.at/1408/
Contact: Sarah Wolf
]]>The wearable cardioverter defibrillator (WCD) is intended to provide protection against sudden cardiac death in high-risk patients. In 2018, the first RCT was available (VEST/ Prevention of Early Sudden Death Trial), showing no reduction in sudden cardiac death when compared to medical therapy alone. Due to the fact that VEST was limited by poor compliance, it is still unclear whether anticipated patient-relevant benefits of using the WCD is supported by scientific evidence.
The project at hand aimed at synthesising the current available evidence regarding the use of the WCD: An update systematic review regarding the effectiveness and safety of the WCD was performed. The best available RCT evidence still consists of VEST solely. Low certainty evidence derived from one RCT (n=2,348) indicated that WCD therapy might not be associated with a clinical benefit in arrhythmic mortality in post-myocardial infarction (MI) patients with an ejection fraction of ?35%.
Six new observational studies were identified, yielding to 11 observational studies meeting our inclusion criteria (range of enrolled patients: 102-2,000). New observational studies indicate that compliance with WCD is well above 20 hours per day, with poor compliance being a major limitation of the only available randomised evidence for WCD use. Most of the evidence is, however, observational and consists of studies including mixed-populations in the analysis, leading to the inability to draw firm conclusions on indication-specific utility of the WCD.
In the absence of comparative effectiveness evidence, more RCT data are needed to justify continuing or expanding the use of WCD therapy in Austria.
Publication: Decision Support Document No. 103/2. Update 2022: https://eprints.aihta.at/1407/
Contact: Gregor Götz
]]>All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>
Fact Sheet No. 105 (August 2022)
Relatlimab/nivolumab (Opdualag®) for the first line treatment of advanced melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%
Fact Sheet No. 106 (August 2022)
Fact Sheet No. 107 (August 2022)
Teclistamab (Tecvayli®) as monotherapy for the treatment of patients with relapsed and refractory multiple myeloma (MM) who have received at least three prior therapies
Fact Sheet No. 108 (August 2022)
Selpercatinib (Retsevmo®) as monotherapy for the treatment of adults and adolescents 12 years and older with advanced RET mutant medullary thyroid cancer (MTC)
Breast cancer screening programs aim to diagnose cancer earlier and reduce surgical therapies (e.g. mastectomy) or breast cancer deaths. However, screening (mammography) also carries risks, such as false-negative results or false-positive suspected breast cancer cases, which can result in unnecessary diagnostic procedures (biopsies) and therapies that are burdensome for patients. Risk-based screening considers multiple risk factors compared to traditional age-based breast cancer screening. Breast cancer should thus be detected equally well or earlier, and possible disadvantages of age-based screening should be reduced, for example, through risk-based screening recommendations – less frequent mammographies in women with a low risk of breast cancer. Against this background, the objective of this report was to investigate the risk prediction quality of identified risk prediction models and their effectiveness in a risk-based screening program. In addition, organisational requirements for implementing a risk-based screening program were summarised.
Publication: HTA Project Report No. 145: https://eprints.aihta.at/1402/
Contact: Ingrid Zechmeister-Koss
]]>
Fact Sheet No. 65 (July 2022)
Degarelix (Firmagon®) as a neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone-dependent prostate cancer
Fact Sheet No. 66 (July 2022)
Degarelix (Firmagon®) as a neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone-dependent prostate cancer
Fact Sheet No. 100 (July 2022)
Melphalan flufenamide (Pepaxti®) with dexamethasone for the treatment of multiple myeloma (MM)
Fact Sheet No. 101 (July 2022)
Asciminib (Scemblix®) for the treatment of Philadelphia chromosome?positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase (CP)
Fact Sheet No. 102 (July 2022)
Trastuzumab deruxtecan (Enhertu®) as monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer
Fact Sheet No. 103 (July 2022)
Ibrutinib (Imbruvica®) in combination with venetoclax for the treatment of previously untreated chronic lymphocytic leukaemia (CLL)
Fact Sheet No 104 (July 2022)
Olaparib (Lynparza®) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer
Decision Support Documents 2022:
+ 4 Updates:
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>
Fact Sheet No. 98 (June 2022)
Selinexor (Nexpovio®) in and dexamethasone for the treatment of multiple myeloma (MM)
Fact Sheet No. 99 (June 2022)
Pembrolizumab (Keytruda) as monotherapy for the adjuvant treatment of stage IIb IIc III melanoma
This report is an update of a previous Horizon Scanning report from 2020, which identified 32 ATMPs. Since August 2020, six of these new ATMPs have been approved by the EMA and five more will be decided by 2023. According to market analyses, 535 ATMPs will be investigated in phase 1 to 3 in 2022, with a further 1,451 in preclinical stages. Coagulation factor VIII (haemophilia A) remains the most common target for non-oncology indications and coagulation factor IX (haemophilia B) has risen to become the second most common indication.
To answer the questions, a systematic search of trial registries was conducted to identify gene therapies and ATMPs in development, followed by extraction of data on identified ongoing clinical trials (limited to phase 2/3 and 3), complemented by a search of the EMA database of medicines under assessment to identify those therapies that are close to approval. Published information on the products and the current development/regulatory status was then collected and subsequently converted into short "vignettes".
Publication: Policy Brief No. 006b: https://eprints.aihta.at/1383
Contact: Ozren Sehic
]]>All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>
Fact Sheet No. 86 (April 2022)
Ciltacabtagene autoleucel (Carvykti®) for the treatment of multiple myeloma (MM)
Fact Sheet No. 87 (April 2022)
Cabozantinib (Cabometyx®) as monotherapy for the treatment of thyroid carcinoma (DTC)
Fact Sheet No. 88 (April 2022)
Tisagenlecleucel (Kymriah®) for the treatment of follicular lymphoma (FL) after two or more lines of systemic therapy
Fact Sheet No. 89 (April 2022)
Polatuzumab vedotin (Polivy®) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of B-cell lymphoma (DLBCL)
Fact Sheet No. 90 (April 2022)
Pembrolizumab (Keytruda®) as monotherapy in adults with colorectal cancer
Fact Sheet No. 91 (April 2022)
Pembrolizumab (Keytruda®) in combination with chemotherapy with or without bevacizumab for cervical cancer
The treatment of diabetes mellitus is individually tailored to achieve freedom from symptoms and avoid acute complications and serious secondary diseases. Telemedical diabetes care programs can be supported by digital health applications and may be beneficial to improve diabetes care. This report provides an overview of Austrian telemedicine activities and a systematic review of evaluation methods and evidence of potential health care effects.
Publication: HTA Project Report No. 143: https://eprints.aihta.at/1370/
Contact: Gregor Goetz
]]>Prenatal screening and diagnostic tests include First Trimester Screening/Combined Test, non-invasive prenatal test (NIPT), invasive (diagnostic) tests and ultrasound screening for fetal anomalies in the second trimester. Whether and in what form these tests are offered and financed to pregnant women varies considerably between countries. This policy brief provides an overview of country strategies for integrating the tests into antenatal care and their (public) financing in 6 selected European countries (DE, CH, NL, UK, NO, IT).
Publication: Policy Brief No. 12: https://eprints.aihta.at/1369/
Contact: Inanna Reinsperger
]]>CAR-T cell-therapies are commonly indicated as „transformative“ therapies referring to the huge expectations associated with them since their market approval in 2017 (USA) and 2018 (Europe). Due to the hope, but also the enormous prices a horizon scanning (HS) document was first published in 2020 to support budget planning in hospitals. In 2020 13 CAR-T cell-therapies in advanced stages were identified. Of these, in addition to Yescarta® and Kymriah®, that were already approved at that time, three further therapies have since been approved by the European Medicines Agency (EMA) between 8/ 2020 and 03/2022: Tecartus® (2020), Abcema® (2021) and Breyanzi® (2022).
This HS document updates the earlier report by surveying the status of the ten therapies already described in 2020 and adding additional therapies that have since then reached a later phase of clinical testing. Within the next year 2023 one new CAR-T cell-Therapy for multiple myeloma will eventually be approved, but further development can be expected with the extension of the approved CAR-T cell-therapies towards earlier lines of therapy and new indications.
Publication: Policy Brief No. 6a, 1. Update: https://eprints.aihta.at/1368
Contakt: Ozren Sehic
]]>
Fact Sheet No. 79 (March 2022)
Tebentafusp (Kimmtrak®) bei Uveal melanoma
Fact Sheet No. 80 (March 2022)
Relugolix (Orgovyx®) bei Prostate Cancer
Fact Sheet No. 81 (March 2022)
Nivolumab (Opdivo®) bei MIUC
Fact Sheet No. 82 (March 2022)
Ipilimumab (Yervoy®) + Nivolumab (Opdivo®) bei OSCC
Fact Sheet No. 83 (March 2022)
Nivolumab (Opdivo®) + chemotherapy bei OSCC
Fact Sheet No. 84 (March 2022)
Abemaciclib (Verzenios®) bei early breast cancer
Fact Sheet No. 85 (March 2022)
Enfortumab vedotin (Padcev®) Urothelial cancer
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>
Fact Sheet No. 77 (February 2022)
Lisocabtagene maraleucel (Breyanzi) for the treatment of relapsed or refractory DLBCL
Fact Sheet No. 78 (February 2022)
Avapritinib (Ayvakyt®) for the treatment of advanced systemic mastocytosis (AdvSM)
Fact Sheet No. 72 (January 2022)
Enfortumab vedotin (Padcev®) as monotherapy for the treatment of patients with locally advanced or metastatic urothelial cancer
Fact Sheet No. 73 (January 2022)
Tepotinib (Tepmetko®) as monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC)
Fact Sheet No. 74 (January 2022)
Pembrolizumab (Keytruda®) as monotherapy for the adjuvant treatment of renal cell carcinoma (RCC)
Fact Sheet Nr. 75 (January 2022)
Lorlatinib (Lorviqua®) as monotherapy for the treatment of anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC)
Fact Sheet No. 76 (January 2022)
Tegafur/gimeracil/oteracil (Teysuno®) for the treatment of metastatic colorectal cancer
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>Since 2017, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved three drugs for the treatment of SMA. Results of the pivotal trials showed clinically meaningful improvements (MCID) in motor skills in SMA type 1 (especially those with early treatment initiation and >=2 SMN2 copies), as well as a stabilisation of health status in SMA type 2 to 4 patients. In SMA type 1 patients, while motor skills improved, no changes (sometimes even a deterioration) in the need for ventilation and nutritional support could be observed. The present report aims to synthesize the evidence on mid- and long-term (>= 12 months) follow-up of the approved drugs as monotherapies or as combination therapies.
Twenty-two observational studies were included for analysing mid- and long-term outcomes. The included studies reported on 840 SMA patients, of which 289 SMA type 1 patients and 521 SMA type 2 to 4 patients were treated with nusinersen, only 12 SMA type 1 patients with onasemnogene abeparvovec and 18 SMA type 1 patients received a combination therapy.
Publication: Policy Brief No. 001, 1. Update: https://eprints.aihta.at/1352
Contact: Judit Erdös, Claudia Wild
Children and adolescents from so-called ‘parents with a mental illness’ have a potentially increased risk of developing negative (health) consequences on the way to their adulthood. One option to mitigate or even prevent negative consequences are family-oriented intervention programmes with social support systems. Gaps in health economic knowledge is a barrier to grasp the overall benefit of these programmes. The report is intended to serve as a source for researchers in order to conduct sound impact assessments of family-oriented intervention programmes and to raise awareness in policy makers about the economic and societal dimensions of mental illness in families.
Publication: HTA Project Report No. 142: https://eprints.aihta.at/1351/
Contact: Christoph Strohmaier
Non-communicable diseases (NCDs) are the leading cause of death worldwide and are responsible for a high burden of disease. Many countries have developed national strategies for the management and prevention of NCDs in order to improve the care of chronically ill people or to prevent NCDs. This report aims to provide an overview of national NCD strategies from selected countries and their implementation as well as to summarise evaluation findings on specific programmes. The focus was on chronic respiratory and cardiovascular diseases, diabetes and depression.
Publication: HTA Project Report No. 139: https://eprints.aihta.at/1349/
Contact: Lucia Gassner, Inanna Reinsperger
Digital health applications (DiGAs) are increasingly using diagnostic and therapeutic algorithms. However, for the majority of currently available DiGAs, there is limited evidence on the medical or organizational benefit. Based on a suggested evaluation process for DiGAs outlined by AIHTA (Project report 2020: “Framework for reimbursement decisions of digital health technologies”), the proposed process for an evidence-based evaluation has been further refined and applied in a sample evaluation of a DiGA from the group of the so-called “symptom-checkers”.
Publication: HTA Projekt Report No. 141: https://eprints.aihta.at/1348/
Contact: Reinhard Jeindl
Fact Sheet No. 71
Sotorasib (Lumykras®): Sotorasib (Lumykras®) as monotherapy for the treatment of advanced NSCLC with KRAS G12C mutation
Fact Sheet No. 67
Pembrolizumab (Keytruda) in combination with Lenvatinib (Kisplyx) for the firstline treatment of advanced renal cell carcinoma (RCC)
Fact Sheet No. 68
Pembrolizumab (Keytruda) in combination with Lenvatinib (Kisplyx) for the treatment of advanced or recurrent endometrial carcinoma (EC)
Fact Sheet No. 69
Amivantamab (Rybrevant) as monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC)
Fact Sheet No. 70
Sacituzumab govitecan (Trodelvy) as monotherapy for the treatment of patients with unresectable or metastatic triple-negative breast cancer (mTNBC)
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>Due to the expected growing number of long COVID cases and the associated increasing average sick leave durations, it not only places a burden on the patients and their families but also the wider economy, in particular, the workforce. The present systematic review aimed to support preparations and adjustments in the long COVID care planning in Austria by giving (1) an overview of recommendations about long COVID care pathways for adult patients as well as (2) examples of already existing care structures in selected European countries.
Publlication: HTA Project Report No. 135b: https://eprints.aihta.at/1342
Contact: Sarah Wolf
Publication: HTA Project report No. 140: https://eprints.aihta.at/1341
Contact: Claudia Wild
Fact Sheet No. 60
Zanubrutinib (Brukinsa®) as monotherapy for the treatment of patients with waldenström’s macroglobulinaemia (WM)
Fact Sheet No. 62
Ripretinib (Qinlock®) for the treatment of patients with advanced gastrointestinal stromal tumour (GIST)
Fact Sheet No. 64
Pembrolizumab (Keytruda®) in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC)
Colorectal Carcinoma (CRC) is the third most frequent cancer type, with an incidence and prevalence of approximately 4,800 and 40,000 cases respectively each year in Austria. Multi-target stool DNA (MT-sDNA) testing is a novel non-invasive screening test that may be able to supplement or replace established stool tests by analysing (stool-based) tumour DNA. In this policy brief, the latest available evidence with regard to the clinical benefits and harms of MT-sDNA tests is summarized.
Publication: Policy Brief No. 011: https://eprints.aihta.at/1335
Contact: Gregor Goetz
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>Real World Evidence (RWE) complements the data of randomised clinical trials, that are based on selected, homogeneous patient collectives and a limited study duration, with long-term data from clinical practice. As there has been no evaluation of immunotherapy in everyday care in Austria to date, a retrospective pilot study was conducted in six Austrian hospitals on the efficacy and safety of anti-PD-1/PDL1 monotherapy in patients with NSCLC using routine data.
Publication: HTA Project report No. 126: https://eprints.aihta.at/1227
Contact: claudia.wild@aihta.at; sabine.geiger-gritsch@tirol-kliniken.at
Publication: Policy Brief Nr. 010: https://eprints.aihta.at/1333/
Contact: Ozren Sehic
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>
Fact Sheet No. 57 (July 2021)
Idecabtagene vicleucel (Abecma®) for the treatment of patients with relapsed and refractory multiple myeloma (MM)
Fact Sheet No. 58 (July 2021)
Tafasitamab (Minjuvi®; Monjuvi®) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Fact Sheet No. 59 (July 2021)
Adjuvant nivolumab (Opdivo®) as monotherapy for the treatment of patients with oesophageal (OC) or gastro-oesophageal junction cancer (GEJC)
The growing market entry of high-cost medicines threatens the financial sustainability of healthcare systems. Limited data available on the benefit of therapies at the time of approval poses a challenge for payers. Outcome-based Managed-entry agreements (OBMEAs) present a reimbursement tool for payers to fund therapies and enable patient access - under conditions. The study aimed to design a generic organizational model for OBMEAs for highly-priced therapies, providing conditional funding while simultaneously generating publicly accessible data on the real-world evidence of treatment effects.
Publication: HTA Project report No. 138: https://eprints.aihta.at/1329
Contact: Claudia Wild
Decision Support Documents 2021:
+1 Update:
Due to the expected increase in long COVID cases, social consequences have to be considered in addition to the impairments in daily life for the affected persons and their families. For this reason, an overview of the epidemiology of long COVID, possible risk factors, as well as of the consequences on everyday life, was given in the present review within the cooperation with the Belgian HTA institute, KCE.
Publication: HTA Projektbericht No. 135a: https://eprints.aihta.at/1321
Contact: Sarah Wolf
Fact Sheet No. 51 (Mai 2021)
Nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) for the treatment of patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer
Fact Sheet No. 52 (Mai 2021)
Cemiplimab (Libtayo®) as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC)
Fact Sheet No. 53 (Mai 2021)
Cemiplimab (Libtayo®) as monotherapy for the treatment of locally advanced or metastatic basal cell carcinoma (laBCC or mBCC)
Fact Sheet No. 54 (Mai 2021)
Pembrolizumab (Keytruda®) in combination with platinum and fluoropyrimidine based chemotherapyfor the treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus
Fact Sheet No. 55 (Mai 2021)
Daratumumab (Darzalex®) in combination with pomalidomide and dexamethasone for the treatment of multiple myeloma (MM)
Fact Sheet No. 56 (Mai 2021)
Daratumumab (Darzalex®) in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of newly diagnosed systemic light chain (AL) amyloidosis
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>The clinical evidence for bamlanivimab as monotherapy and in combination with etesevimab consists of a published 5-arm RCT with an adaptive study design (part of the patient population from phase 2 of BLAZE-1) with final results from 592 patients with mild-to-moderate SARS-CoV2 disease in an ambulant setting. In addition, unpublished results are available from the 3-arm phase 3 part of BLAZE-1 in high-risk patients with mild to moderate SARS-CoV2 disease. There are currently several registered ongoing clinical trials evaluating bamlanivimab as monotherapy and in combination with etesevimab compared to standard of care or other investigational neutralising monoclonal antibodies in the outpatient setting. The unpublished results must be interpreted with caution until a peer-reviewed publication is available. A conclusive assessment is not possible based on the current data.
Publication: Policy Brief No. 009: http://eprints.aihta.at/1314/
Contact: Claudia Wild
The clinical evidence for a combination therapy with casirivimab plus imdevimab (REGN-COV2) consists of a published RCT with an adaptive trial design (part of the phase 1/ 2 patient population) with preliminary results in 275 patients with mild-to-moderate SARS-CoV2 disease and the unpublished phase 3 part of the same RCT in 4,567 non-hospitalised high-risk adults with mild-to-moderate SARS-CoV2 disease. Both studies suggest that REGN-COV2 can reduce follow-up treatment, which is particularly relevant for patients at high risk of disease progression, and that REGN-COV2 has a favourable safety profile. However, a final assessment is not possible based on the current data.
Publication: Policy Brief No. 008: http://eprints.aihta.at/1313/
Contact: Claudia Wild
In 2019, only 39 out of a total of 115 PHARMIG member companies disclosed financial contributions to patient initiatives. Compared to 2018, the disclosure rate dropped from 43 to 34 per cent, while at the same time there was a significant increase in the amount of money declared by 37 per cent to around 2.3 million euros. In 2019, the areas of haemato-oncology (around 16 per cent of the total) and haemophilia (around 13 per cent) received the largest share, followed by lung diseases, diabetes and metabolic diseases.
Publication: Policy Brief No. 007: https://eprints.aihta.at/1308
Contact: Ozren Sehic
Fact Sheet No. 47 (April 2021)
Azacitidine (Onureg®) for the maintenance treatment of patients with acute myeloid leukaemia (AML)
Fact Sheet No. 48 (April 2021)
Osimertinib (Tagrisso®) as monotherapy for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC)
Fact Sheet No. 49 (April 2021)
Venetoclax (Venclyxto®) in combination with a hypomethylating agent for the treatment of patients with newly diagnosed acute myeloid leukaemia (AML)
Fact Sheet No. 50 (April 2021)
Nivolumab (Opdivo®) in combination with ipilimumab for the first-line treatment of patients with unresectable malignant pleural mesothelioma
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>Publication: HTA Project Report No. 143: https://eprints.aihta.at/1370/
]]>
Fact Sheet No. 44 (March 2021)
Duvelisib (Copiktra®) for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) and refractory follicular lymphoma (FL)
Fact Sheet No. 45 (March 2021)
Atezolizumab (Tecentriq®) as monotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC)
Fact Sheet No. 46 (March 2021)
Enzalutamide (Xtandi®) for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT)
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>Several previous reports researched and summarised screening recommendations from evidence-based guidelines for pregnant women and children. The aim of this update was to review the guideline recommendations for mental health, nutrition, and social competence from previous reports to ensure they were current and to provide an update. The total of 52 included guidelines recommend screening and/or counselling for the majority of the topics addressed. The update report can subsequently be used as a decision support for an updated screening program for pregnant women and children.
Publication: Policy Brief Nr. 005: http://eprints.aihta.at/1303/
Contact: Inanna Reinsperger
Robotic assisted rehabilitation (RAR) and functional electrostimulation (FES) can, among others, be used as a supplement to conventional rehabili-tation in post-stroke patients. The use of RAR could have the advantage of allowing more intensive and frequent therapy (by increasing the motiva-tion to train), which at the same time reduces the effort of the physiotherapist. FES is a targeted application of electrical stimulation inducing muscle contractions supporting motor activities. The electrical stimulation takes place during a functional movement and may, inter alia, strengthen the muscle and improve blood circulation or blood flow.
This report aimed at evaluating the additional clinical benefit of RAR and FES. Systematic reviews of effectiveness and safety were conducted in cooperation with a working group (ReMoS/ Rehabilitation of Mobility after Stroke - AG) of the Association of the Scientific Medical Societies in Germany (AWMF)
Publication: LBI-HTA Project Report No.: 128: https://eprints.aihta.at/1302
Contact: Gregor Goetz
Fact Sheet No. 42 (February 2021)
Nivolumab (Opdivo®) in combination with cabozantinib (Cabometyx®) for the first-line treatment of patients with advanced renal cell carcinoma (RCC)
Fact Sheet No. 43 (February 2021)
Isatuximab (Sarclisa®) in combination with carfilzomib and dexamethasone for the treatment of patients with multiple myeloma (MM)
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>
Fact Sheet No. 38 (January 2021)
Pembrolizumab (Keytruda®) is indicated for the treatment of adult and paediatric patients with relapsed or refractory classical Hodgkin lymphoma (cHL)
Fact Sheet No. 39 (January 2021)
Selinexor (Nexpovio®) in combination with dexamethasone for the treatment of relapsed and refractory multiple myeloma (MM)
Fact Sheet No. 40 (January2021)
Pemigatinib (Pemazyre®) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>
Fact Sheet No. 31 (Dezember 2020)
Avelumab (Bavencio®) as monotherapy for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma
Fact Sheet No. 32 (Dezember 2020)
Trastuzumab deruxtecan (Enhertu®) in patients with previously treated HER2-positive breast cancer
Fact Sheet No. 33 (Dezember 2020)
Fedratinib (Inrebic®) for the treatment of primary and secondary myelofibrosis
Fact Sheet No. 34 (Dezember 2020)
Pembrolizumab (Keytruda®) as monotherapy for the first-line treatment of MSI H or dMMR colorectal cancer
Fact Sheet No. 35 (Dezember 2020)
Moxetumomab pasudotox (Lumoxiti®) for the treatment of patients with relapsed or refractory hairy cell leukaemia (HCL)
Fact Sheet No. 36 (Dezember 2020)
Selpercatinib (Retsevmo®) for the treatment of RET-fusion positive NSCLC, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer
Fact Sheet No. 37 (Dezember 2020)
Tucatinib (Tukysa®) with trastuzumab and capecitabine for the treatment of HER2-positive locally advanced or metastatic breast cancer
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>
Fact Sheet No. 28 (November 2020)
Tagraxofusp (Elzonris®) in blastic plasmacytoid dendritic-cell neoplasm (BPDCN)
Fact Sheet No. 29 (November 2020)
Carfilzomib (Kyprolis®) with daratumumab and dexamethasone for the treatment of adult patients with multiple myeloma (MM)
Fact Sheet No. 30 ((November 2020)
A fixed-dose combination of pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) for the treatment of early and metastatic breast cancer
Recent evidence on the effectiveness of lung cancer screening with low dose computed tomography (LDCT), such as the National Lung Screening Trial (NLST) or the Dutch-Belgian Randomized Lung Cancer Screening Trial (NELSON), seems to confirm a potential relative lung cancer mortality reduction (although not in overall mortality) from the LDCT-screening. Since then, a considerable body of new evidence also emerged on the cost-effectiveness of LDCT-screening for lung cancer. In this context, the present systematic review aimed to provide an update of the evidence on the cost-effectiveness, cost-utility and budget impact of LDCT lung cancer screening in adult persons without confirmed or suspected lung cancer but at elevated risk, with a special focus on the health economic methodologies.
Publication: HTA Project Report No. 132b: https://eprints.aihta.at/1283
Contact: Christian Ernst Heinrich Boehler, Sarah Wolf
Lung cancer is the fourth most frequently diagnosed cancer in the European Union. Risk factors for lung cancer include smoking in particular, family history, idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), and occupational or environmental exposure to radon, asbestos or fine particles. Low-dose computed tomography (LDCT) can be used for lung cancer screening, which is increasingly offered in routine clinical practice. Current evidence shows that screening for lung cancer with LDCT in (former) heavy smokers probably reduces lung cancer mortality, but results in little or no difference in overall mortality, compared with no screening.
Publication: HTA Project report No. 132a: http://eprints.aihta.at/1282/
Contact: Claudia Wild
Molecular genetic diagnostics (GDx) is an increasingly important tool in the so-called "precision medicine" and personalised health care, including organised screening programs. For a structured and controlled implementation of GDx, organisational-regulatory and ethical aspects, as well as far-reaching economic effects have to be considered in addition to efficacy and safety concerns.
The aim of the present report was to illustrate the general complexity of such (predictive) diagnostic tests and systematic test strategies using the example of familial hypercholesterolemia (FH).
Publication: HTA Project report No. 130: http://eprints.aihta.at/1281/
Contact: Melanie Walter, Christoph Strohmaier
In Vienna, in 1958, for the very first time in Europe, the institutionalisation process started with founding the Austrian Society for the Promotion of Music Medical Science. One year later, the first training course in Europe was established. Today, music therapy is understood as an expression promoting, scientific-artistic-creative and independent form of treatment using active and receptive music therapeutic methods. In an update of Cochrane Reviews, the effectiveness and applied methods of music therapy in autism, dementia, depression, sleep disorder and schizophrenia were examined. The results suggest that music therapy can help patients in terms of physical and psychosocial aspects.
Publication: HTA Projektbericht No. 133: http://eprints.aihta.at/1280/
Contact: Lucia Gassner
Digital health applications have the potential to improve disease monitoring and management. For the majority of available digital health applications, however, there is little evidence of (medical, organizational or economic) benefit. The thorough evaluation of a digital health application requires additional technology-specific domains. Decision-makers are thus faced with new challenges in the evaluation of these applications.
The aim of this report was to provide guidance to funding institutions and manufacturers as to what evidence is expected for which type of digital health application. For this purpose, the applicability of currently available assessment frameworks for digital health applications was examined.
Publication: HTA Projektbericht No. 134: https://eprints.aihta.at/1279
Contact: Reinhard Jeindl, Claudia Wild
Fact Sheet No. 25 (October 2020)
Blinatumomab (Blincyto®) for the treatment of patients with Philadelphia chromosome positive B-precursor acute lymphoblastic leukaemia (ALL)
Fact Sheet No. 26 (October 2020)
Nivolumab (Opdivo®) as monotherapy for the treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OESCC)
Fact Sheet No. 27 (October 2020)
Autologous anti-CD19-transduced CD3+ cells (Tecartus®) for the treatment of relapsed or refractory mantle cell lymphoma (MCL)
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
]]>Publication: AIHTA Project report No. 129: http://eprints.aihta.at/1275/
Contact: Sarah Wolf, Nicole Grössmann
]]>
Fact Sheet No. 20 (September 2020)
Atezolizumab (Tecentriq®) plus bevacizumab for the treatment of advanced or unresectable hepatocellular carcinoma (HCC)
Fact Sheet No. 21 (September 2020)
Nivolumab (Opdivo®) plus ipilimumab (Yervoy®) and chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC)
Fact Sheet No. 22 (September 2020)
Niraparib (Zejula®) in patients with newly diagnosed advanced ovarian cancer
Fact Sheet No. 23 (September 2020)
Olaparib (Lynparza®) for metastatic castration-resistant prostate cancer (mCRPC)
Fact Sheet No. 24 (September 2020)
Olaparib (Lynparza®) plus bevacizumab as first-line maintenance treatment in patients with ovarian cancer
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
All work steps are conducted in close international (European) cooperation.
Publications:
Contact: Claudia Wild
It is predicted that by 2022 there will be about 16 "Advanced Therapies Medicinal Products" (ATMPs) on the market, about 2-4 new therapies per year. There are currently 11 ATMPs approved. According to the annual report of the "Alliance of Regenerative Medicine (ARM)", by the end of 2019 more than 1,000 clinical trials worldwide are investigating regenerative/ advanced therapies for various diseases, 94 of which are in phase 3, 591 in phase 2, 60% in oncological indications alone. Among the best known already approved are the CAR-T cell therapies (2 approved in Europe, 1 in the approval process) and gene therapies for spinal muscular atrophy (also 2 approved in Europe, 1 in the approval process). Two Horizon Scanning reports – a cooperation project of AIHTA and Tirol Kliniken - dealt with a look into the near future of further gene therapies.
The European Medicines Agency (EMA) classifies ATMPs into three main types: Gene therapeutics and somatic cell therapeutic drugs and tissue engineering products. The two reports should address the questions for which indications CAR-T cell therapies and other ATMPs/gene therapies are in development and by when a marketing authorization is expected. To answer the questions, a systematic search of study registries was performed to identify gene therapies in development and ATMPs, followed by the extraction of data on the identified ongoing clinical trials, complemented by a search of the EMA database of drugs under evaluation to identify those therapies that are expected to be approved soon. Finally, published information on the products, their indication and patient population was collected. The search identified 32 ATMPs in 8 broad indication areas and 13 CAR-T cell therapies in haematological malignancies at an advanced stage of development.
Publications:
Contact: Claudia Wild
]]>
Fact Sheet No. 14 (ad April 2020)
Carmustine (Carmustine Obvius®) as conditioning treatment before transplantation in patients with Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphomas (NHL)
Fact Sheet No. 15 (Juli 2020)
Acalabrutinib (Calquence®) for the treatment of chronic lymphocytic leukaemia (CLL)
Fact Sheet No. 16 (Juli 2020)
Avapritinib (Ayvakyt®) for the treatment of gastrointestinal stromal tumours (GIST)
Fact Sheet No. 17 (Juli 2020)
Belantamab mafodotin (Blenrep®) as monotherapy for the treatment of relapsed or refractory multiple myeloma (MM)
Fact Sheet No. 18 (Juli 2020)
Durvalumab (Imfinzi®) in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC)
Fact Sheet No. 19 (Juli 2020)
Ibrutinib (Imbruvica®) as a single agent or in combination with rituximab or obinutuzumab for the treatment of previously untreated chronic lymphocytic leukaemia (CLL)
All work steps are conducted in close international (European) cooperation.
Publication: Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Decision Support Documents 2020:
+2 Updates:
All work steps are conducted in close international (European) cooperation.
Publication: Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Publication: AIHTA Policy Brief No.: 003: http://eprints.aihta.at/1249/
Contact: Nicole Grössmann
Fact Sheet No. 11 (Mai 2020)
Maintenance olaparib (Lynparza®) for the treatment of patients with germline BRCA-mutated metastatic pancreatic cancer
Fact Sheet No. 12 (Mai 2020)
Alpelisib (Piqray®) plus fulvestrant for PIK3CA-mutated, hormone receptor–positive advanced breast cancer
Fact Sheet No. 13 (Mai 2020)
Entrectinib (Rozlytrek®) for the treatment of patients whose solid tumours have a NTRK gene fusion, or patients with ROS1-positive advanced NSCLC
Publication: HTA Projektbericht No. 133: http://eprints.aihta.at/1280/
]]>All work steps are conducted in close international (European) cooperation.
Publication: Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Worldwide, 82 particle therapy facilities are currently in clinical operation; further 37 centers are under construction or in planning. This means that the number of centres worldwide has more than doubled since 2013. In Europe alone, 27 centres are currently operational (2013: 14). With such a large number of treatment centers, it should be assumed that the underlying clinical evidence on patient benefit is convincing. The update of the LBI-HTA report 2013 has the task to give an overview of secured indications as well as indications that are only recommended under clinical research. Only a hand search for HTA reviews and systematic reviews was conducted. The identified reviews articulate in unison that the available - mostly retrospective - studies are of low quality and insufficient to make conclusive statements on the added value of proton or carbon ion therapy. Only a few indications are recommended for proton or carbon ion therapy (chordomas and chondrosarcomas, uveamelanoma, pediatric tumors in the base of the skull, brain and head and neck tumors) to avoid secondary tumors. Further indications, with curative intention and non-metastatic, are only recommended under conditions of prospective clinical studies.
Publication: AIHTA Policy Brief No.: 004: http://eprints.aihta.at/1245/
Contact: Claudia Wild
Fact Sheet No. 7 (April 2020)
Encorafenib (Braftovi®) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation
Fact Sheet No. 8 (April 2020)
Cabazitaxel Accord for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel containing regimen
Fact Sheet Nr. 9 (April 2020)
Daratumumab (Darzalex®) in a new pharmaceutical form associated with a new strength and a new route of administration for the treatment of multiple myeloma
Fact Sheet No. 10 (April 2020)
Glasdegib (Daurismo®) with low-dose cytarabine (LDAC) in patients with newly diagnosed acute myeloid leukaemia (AML)
Publication: HTA Project report No. 134: https://eprints.aihta.at/1279
]]>All work steps are conducted in close international (European) cooperation.
Publication: Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Publications:
HTA Project report No. 132a: http://eprints.aihta.at/1282/ (part 1)
HTA Projektbericht Nro 132b: https://eprints.aihta.at/1283 (part 2)
Publication: DSD No. 129: https://eprints.aihta.at/1328/
]]>Publication: HTA Project report No. 130: http://eprints.aihta.at/1281/
]]>Publication: HTA Project report No. 129: http://eprints.aihta.at/1275/
]]>Publication: LBI-HTA Project Report No.: 128: https://eprints.aihta.at/1302
]]>
The establishment of a HSS/ Horizon Scanning System for Covid19 interventions has the intentions of informing health policy makers at an early stage which interventions (vaccinations and drugs) are currently undergoing clinical trials and to monitor them over the next few months in order to support evidence-based purchasing if necessary.
Based on international sources (information gathered by the WHO, preliminary work by other international institutions, publications) first selective searches by means of searches in study registries are carried out for information on clinical studies in humans and the state of research. Thereafter “vignettes” (short descriptions) are developed for those products that are already in an "advanced" stage. Subsequently, the products are monitored with regard to the status of the clinical studies up to approval and finally evaluated for their benefit and harm.
All work steps are conducted in close international (European) cooperation.
Publication: Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Real-world data can provide information on the quality of health care and can inform health care system decisions. The present data analysis was focusing on the health care at the end of life of cancer patients, based on Austrian data (2012 to 2016) from all nine federal states. In the period under review, 283,228 persons with cancer diagnoses were admitted to a publicly financed hospital. Of these, about 29% (80,818) persons died. The proportion of patients who died in the inpatient sector was homogeneous across Austria (~61%) with the exception of Vienna. About 13% of deceased patients were admitted to the hospital two days before their death. With regard to the analysis of special oncological treatments (radiotherapy, chemotherapy and monoclonal antibodies) within 30 days before death, slight variabilities could be observed across the Austrian federal states.
Publication: LBI-HTA Project report No. 127: http://eprints.aihta.at/1233
Contact: Nicole Grössmann
In June 2017, Nusinersen (Spinraza®) was approved broadly – for all SMA Typologies (despite lack of evidence) – by the European Medicines Agency (EMA) for the treatment of chromosome 5q13 (5q)-associated SMA. The question of the update presented here is which scientific evidence from clinical intervention or observational studies for the medium (or long-term) benefit of Nusinersen (Spinraza®) in children and adolescents > 6 years with SMA "late onset" (SMA 2 + 3) is available. Three publications on the question (SMA 2 + 3 with a total of 40 patients) were identified. The available evidence for medium-term (> 12 months) follow-up data comes from a single prospective sponsor-funded ISIS CS12 study, as well as from a small retrospective study (of poor quality). Even after more than two years after the approval of Nusinersen, the evidence for this patient population is of extremely low quality, lacking validity.
Publication: Policy Brief No. 1: http://eprints.aihta.at/1228/
Contact: Claudia Wild
Experience in routine clinical practice may differ from that seen in a controlled clinical trial. Although randomised clinical trials (RCTs) are considered to be the standard for generating clinical evidence, they lack generalisability to real-world evidence due to selected patient populations (strict and complex enrolment criteria). Therefore, the use of real-world evidence (RWE) to evaluate the effectiveness and safety of medical interventions is gaining interest. As there is limited evidence regarding the real-world effectiveness of immunotherapy in Austria, we conducted a retrospective pilot study in six Austrian hospitals to present data on patient characteristics, effectiveness and safety from real-world practice in an NSCLC population treated with anti-PD-1/PD-L1 monotherapy.
Publication: LBI-HTA Projektbericht Nr. 126: to be published soon
Contact: Claudia Wild
A possible measure for quality assurance in day surgery is minimum volume standards (MVSs). While the majority of research in this context observes a positive relationship between volume and outcome in the form of statistical correlation, the data availability on surgery specific and evidence-based minimum volume thresholds is low. Aims of the present report were to show the fundamentals of the MVSs theory, to illustrate possible internationally implemented MVSs frameworks in day surgery, and (in the course of a systematic review) to examine whether MVVs for specific day surgeries lead to better results in terms of efficacy and safety.
Publication: LBI-HTA Project report No. 125: https://eprints.aihta.at/1225/
Contact: Michal Stanak, Christoph Strohmaier
]]>
Troponin and D-dimer point of care tests can be used to aid the diagnosis of patients with symptoms suggestive of suspected acute coronary syndrome and venous thromboembolism respectively. Potential advantages of point of care tests include faster turnaround time, reduced length of stay and reduced unnecessary hospitalisation/further testing. This report aimed at evaluating the clinical benefit of these two point of care diagnostics in various settings. Two overview of reviews, two guideline synopsis and interviews with experts were hereby carried out.
Publication: LBI-HTA Project report 124: https://eprints.aihta.at/1224/
Contact: Gregor Goetz
Cervical cancer screening has been revolutionized by the discovery that nearly all cervical cancer diseases are caused by persistent infection with human (high-risk) papillomaviruses (HPV). Along with this, the development of new HPV-based test systems internationally led to a change in existing cervical carcinoma screening strategies. The purpose of this report was to provide a basis for the decision to implement the HPV test in cervical carcinoma screening in Austria.
Publication: LBI-HTA Project report No. 121: https://eprints.aihta.at/1223/
Contact: Eva Fuchs, Sarah Wolf
This LBI-HTA report focuses on children and adolescents from 6 to 18 years and deals with 9 international screening services, 4 Austrian screening programmes and with screening and counselling recommendations from 59 evidence-based guidelines on a total of 25 diseases and risk profiles. Based on the guidelines, the report involves positive screening recommendations for 11 health threats. The country programmes resulted in consistent screenings with regard to body weight, height, dental diseases, visual and hearing disorders and mental disorders. In summary, thematic similarities between the guideline recommendations, the international practice examples and the 4 Austrian programmes were found.
Publication: LBI-HTA Project report No. 123 + Addendum report: https://eprints.aihta.at/1221
Contact: Roman Winkler / Inanna Reinsperger
Until a few years ago, there were no specially designed rehabilitation centres for children and adolescents in Austria, which differ from adult rehabilitation programmes with regard to the supply structure (e.g.; structural requirements or rehabilitation measures). In 2010, a need for a total of 343 beds for 11 indicator groups and an additional 50 beds for the relatives was indicated within the scope of the planning phase of the child and adolescent rehabilitation centres in four Austrian supply zones by 2020. The six newly built centres will now be evaluated on a regular basis. Therefore, the present report provides an overview of international evaluation methods and (standardised) evaluation instruments that can be used for future evaluations.
Publication: LBI-HTA Projektbericht No. 122: https://eprints.aihta.at/1222
Contact: Sarah Wolf, Roman Winkler
]]>DSD HSO No. 91
]]>In recent years, payments made by the pharmaceutical industry to doctors and medical institutions have increasingly been questioned critically. In a systematic analysis, the websites of all PHARMIG member companies (113) were once again searched for information on financial contributions to Austrian healthcare professionals and institutions in 2018. In 2018, a total of 138.3 million euros flowed from PHARMIG member companies to doctors and medical institutions as well as to clinical research and observational studies in Austria. In 2015, the total amounted to 104.1 million euros.
Although the number of Pharmig member companies declaring grants increased only slightly compared to 2015 (2015: 69/113, 2018: 76/115), in 2018 almost one third (32.8%) more grants were made - an increase of 34.2 million euros. In 2018, the share of donations to physicians in the total amount was 7% lower than in 2015. Since this figure corresponds exactly to the increase in the category research and development, a re-declaration can be assumed here. The actual willingness to disclose financial contributions, especially from doctors, is still low - the individual disclosure rate (by name) averaged only 21.1% (2015: 21.9%), which corresponds to 18.5% (2015: 17%) of the amounts paid out. In contrast, the willingness to disclose payments to medical institutions by name (institution) was still significantly higher on average at 49.4% (2015: 50.2%).
Publication: Rapid Assessment No. 7d/ 1. Update 2019: https://eprints.aihta.at/1218/
Contact: Ozren Sehic
Information on the year 2018 was found from 49 out of 113 PHARMIG member companies.
In 2018, a total of € 1,657,087 as financial support to patient initiatives were reported. Most grants (around 85% of all financial contributions) were given to initiatives in the nine fields of Oncology & Hematology, Neurology, Hemophilia, Pulmonology, Rare Diseases, Dermatology, Gastroenterology, Rheumatology, and HIV/AIDS. After a significant decline in 2016, the total sum declared represents an increase of +45%. The number of disclosures doubled compared to 2014 (2014: 24/115 PHARMIG companies declared contributions to patient initiatives, 2018: 49/113).
Consistent monitoring by a critical public is still required in order to observe the implementation of the voluntary commitment to more transparency.
Publication: Rapid Assessment No. 7b 3. Update: https://eprints.aihta.at/1217/
Contact: Ozren Sehic
DSD HSO No. 90
Enzalutamide (Xtandi®) in addition to standard first-line therapy in men with metastatic hormone-sensitive prostate cancer (mHSPC)
Publication: Rapid Assessment No. 14: https://eprints.aihta.at/1215/
Contact: Claudia Wild
Diabetes mellitus is a rapidly increasing disease worldwide. In the Austrian Diabetes Report 2017, the number of people with diabetes mellitus in Austria is estimated at about 7 to 11%, with an assumed 30-35% not diagnosed. The—individually adapted—treatment of diabetes mellitus therefore aims to achieve freedom from symptoms and to prevent acute complications and serious secondary diseases. This project report examines whether screening in the general population is recommended in guidelines and, if so, what methods are used to recommend screening in subpopulations.
Publication: LBI-HTA Project report No. 118: https://eprints.aihta.at/1213/
Contact: Claudia Wild
]]>
Part I: Overview of screening and prevention programmes in other countries
Part II: Recommendations from evidence-based guidelines (guideline synopsis)
In Austria, the "Mutter-Kind-Pass” (the “mother-child pass") is a screening instrument for children up to the age of 5 years. There are currently no (universal) routine screenings in Austria for children and adolescents older than 6 years. In the present two-part report we researched and presented screening programmes in 9 countries and we identified evidence-based guidelines in guideline databases and via websites of relevant institutions and summarised their recommendations.
Publication: LBI-HTA Project report No. 106: https://eprints.aihta.at/1212/
Contact: Roman Winkler, Inanna Reinsperger
]]>In the process for the further development of the Austrian screening tool for pregnant women and children (“Mother-Child-Pass”), initiated by the Ministry of Health in 2014, after several reports conducted by the LBI-HTA, an interdisciplinary and multiprofessional expert working group formulated comprehensive (screening) recommendations for pregnancy, puerperium and childhood (0-6 years). The transparent and participatory process was finished in May 2018. The final report includes all protocols of the expert working group meetings as well as all submitted formal statements. Additionally, the recommendations were thematically structured by screening methods and by time.
Publication: LBI-HTA Project report No. 92: https://eprints.aihta.at/1163/
Contact: Inanna Reinsperger
]]>Irreversible electroporation (IRE) is a non-thermal ablative process in which short but strong electric fields are generated using precisely placed needles and computer-controlled potential differences between these needles. In this way, pancreatic and liver tumors located near large blood vessels or other sensitive structures can be removed without damaging them.
There is insufficient evidence that IRE is more effective/safe or at least as effective/safe as the conventional standard of care (chemotherapy, chemoradiotherapy or palliative therapy) in the treatment of inoperable LAPC or that IRE is more effective/safe or at least as effective/safe as the conventional standard of care (TACE, sorafenib or palliative therapy) in the treatment of primary or secondary inoperable liver cancer that is not suitable for thermal ablation.
Publication: LBI-HTA Project report No. 119: https://eprints.aihta.at/1211/)
Contact: Eva Fuchs
]]>
DSD HSO No. 89
Brentuximab vedotin (Adcetris®) in combination with chemotherapy for CD30-positive peripheral T-cell lymphoma (PTCLs)
3D printed custom-made or customisable implants and cutting guides are currently most frequently applied in knee, maxillofacial, and cranial surgery. Evidence of very low or low quality shows significant differences in precision in terms of malalignment and deviation between 3D printed technology and standard instrumentation in knee arthroplasty. Evidence of higher quality is needed to validate these significant results and draw final conclusions. No firm conclusions can be made in mandibular reconstruction and cranioplasty, since no outcomes were significant in favour of either technology. No statements regarding long-term safety outcomes can be made.
Publication: LBI-HTA Projektbericht Nr. 117: https://eprints.aihta.at/1209/
Contact: Sabine Ettinger
]]>Decision Support Documents 2019:
+4 Updates:
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DSD HSO No. 88
Darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC)
In robot-assisted surgery, the surgeons control the surgical instruments with a telemanipulator. The aim of our report was to investigate the efficacy and safety of robotic surgery compared to open surgery as well as conventional laparoscopy in thoracic and visceral indications. A total of 13 indications were investigated. There was insufficient evidence for the evaluation of efficacy in nine indications. Statements on effect were possible only for some of the outcomes in only four of the procedures (oesophagectomy, gastrectomy, rectal resection,cholecystectomy), for which the quality of the evidence was rated low to moderate. Since the current evidence is not sufficient to determine the added value of robot-assisted surgery compared to conventional surgical procedures, results of ongoing studies are awaited.
Publication: LBI-HTA Project report No. 108: https://eprints.aihta.at/1198/
Contact: Louise Schmidt
]]>Advanced Therapy Medicinal Products" (ATMP) is the umbrella term for three classes of medicinal products: somatic cell therapy medicinal products, gene therapy medicinal products and biotechnologically processed tissue preparations [also known as tissue engineering products (TEP)], as well as combination products. These drugs contain or mostly consist of living cells or tissues and are therefore highly complex. The cells used are often taken from a patient, processed in the laboratory (e.g. increased or genetically modified) and then administered again to the same patient.
The review of the LBI-HTA (published only as an English publication, not as a report) gives an overview of applications of ATMP products shortly before or after their market launch.
Publication: Article
Contact: Claudia Wild
]]>Vulnerable groups, such as homeless and non-insured people, have a poorer physical and mental health status than comparable populations and usually have no or difficult access to standard health care. Social organisations provide basic health and social care services for these groups of people. Against this background, we searched for evaluation methods for the benefit assessment of easily accessible, outpatient health centers and described the methods, indicators, and instruments used in evaluation studies and reports of comparable services.
Publication: LBI-HTA Project report No. 114: https://eprints.aihta.at/1195/
Contact: Roman Winkler, Inanna Reinsperger
]]>Publication: LBI-HTA Project report No. 116: https://eprints.aihta.at/1194/
Contact: Sabine Ettinger
]]>
DSD HSO No. 86
Olaparib (Lynparza®) as first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer
DSD HSO No. 87
Atezolizumab (Tecentriq®) with nab-paclitaxel (Abraxane®) for the treatment of advanced triple-negative breast cancer (aTNBC)
CAD is a disease defined as the manifestation of arteriosclerosis in the coronary arteries and is the leading cause of death in Europe. This systematic review evaluates the current evidence on the efficacy and safety of bioresorbable stents, the latest generation of stents in percutaneous coronary intervention (PCI) in the treatment of CAD, compared to traditional revascularisation strategies (PCI with permanent metal stents or coronary artery bypass graft surgery).
Based on evidence from eight RCTs, the fully bioresorbable everolimus-eluting stent Absorb® BVS is considered to be less effective and to have a worse safety profile compared with everolimus- or biolimus-eluting permanent metal stents. There is insufficient evidence to determine whether Absorb® BVS is considered less effective or less safe than other revascularisation strategies. There is insufficient evidence to determine whether the other four currently CE-certificated fully bioresorbable sent systems [DESolve®, Magmaris (Dreams 2G), Art Pure or Fantom®] are more effective than (or at least as effective as) and/or have better (or at least similar) safety profiles compared with drug-eluting permanent metal stents or other revascularisation strategies.
Publication: Decision Support Document No. 81/1.Update: https://eprints.aihta.at/1191/
Contact: Judit Erdos
]]>Since 2006, natalizumab is used for the treatment of relapsing-remitting multiple sclerosis. Assessing seven studies, which met the inclusion criteria, the present project report investigated the clinical efficacy and safety of natalizumab compared to alternative immunomodulating drugs for a treatment period of at least 36 months.
Publication: LBI-HTA Project report No. 112: https://eprints.aihta.at/1190/
Contact: Eva Fuchs
]]>Transcatheter aortic valve implantation (TAVI, also called percutaneous aortic valve replacement) is the insertion of a bioprosthesis into the aortic valve using a catheter. Since the introduction of TAVI in 2007 for patients at high surgical risk, TAVI is being used more and more frequently. The EUnetHTA report with a German summary analyzes the results from 2 RCTs on patients with moderate operative risk.
Publication: LBI-HTA Projektbericht No.115: https://eprints.aihta.at/1188/
Contact: Claudia Wild
]]>Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. In Europe, there are about 350 000 out of hospital SCAs per year. Mostly, ventricular tachycardia and ventricular fibrillation are the underlying aetiology of SCA. The wearable cardioverter defibrillator (WCD) – a novel defibrillation therapy – claims to prevent sudden cardiac deaths that may result from SCA. To date, it is unclear whether the plausible and promising theoretical benefits can be translated into clinically relevant benefits.
Therefore, the project at hand aimed at synthesising the current available evidence regarding the use of the WCD: A systematic review regarding the effectiveness and safety of the WCD was hereby performed.
In total, 11 studies were identified: 1 RCT was eligible for the evidence synthesis of the effectiveness of the WCD and further 10 observational studies were additionally included for the evaluation of safety of the device. The scientific evidence from 1 RCT indicates the WCD in combination with guideline-directed medical therapy (GDMT) is not proven to be more effective than GDMT alone based on the endpoint arrhythmic mortality. The studies included in the evaluation of safety of the device suggest that the WCD could be a relatively safe device.
To date, the comparative effectiveness of the WCD could not be established – it is unclear if and especially for whom the plausible theoretical advantages of using the WCD can be translated into clinically relevant benefits. Further research is needed in this context.
Publication: Decision Support Document No. 103/Update 2018: https://eprints.aihta.at/1186
Contact: Gregor Götz
]]>
DSD HSO No. 85
Ibrutinib (Imbruvica®) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia
DSD HSO No. 84
Enzalutamide (Xtandi®) in patients with nonmetastatic, castration-resistant prostate cancer (CRPC)
On the one hand, reimbursement decisions on medicines in Austria are divided into outpatient and inpatient sector, on the other hand, decisions are made regionally in the inpatient sector (on a federal state level). Both can result in an unequal availability in particular of high-priced drugs. In favour of equal access to medical services, often there are deliberative decision-making processes that seek to make public (health policy) decisions fairly, transparently, and evidence-based. The present HTA report provides a basis for discussion of an Austria-wide standardised and transparent reimbursement process for high-priced hospital drugs taking into account deliberative processes.
Publication: LBI-HTA Projektbericht No. 109: https://eprints.aihta.at/1183/
Contact: Sarah Wolf, Claudia Wild
]]>In the care of patients with fears of dental treatment, inhalation sedation with nitrous oxide (N2O) in the context of anxiety and behavioural management in dentistry is of central importance. The administration of inhalation sedation with N2O in dentistry serves the minimal or conscious sedation of the patient. Against this background, the report focuses on organizational and professional aspects as well as the systematic analysis of the efficacy and safety of inhalation sedation with N2O.
Publication: LBI-HTA Project report No. 105: https://eprints.aihta.at/1182/
Contact: Katharina Rosian
]]>A recently started 4-year research project aims at improving the situation of children who have mentally ill parents in Tyrol. Different approaches can be followed for early identifying and supporting these children. One is to get into contact with the children via the parents in the adult mental health care settings. To explore this strategy further, we analysed the prevalence of mental disorders and the use of mental health benefits that are provided within the health care sector in Tyrol. Our data sources were published literature and administrative data from the Tyrolean health insurance.
Publication: LBI-HTA Project report No. 113b: https://eprints.aihta.at/1181/
Contact: Ingrid Zechmeister-Koss
]]>Publication: LBI-HTA Project report No. 103a: https://eprints.aihta.at/1180/
Contact: Ingrid Zechmeister-Koss
]]>Hardly any other medical technology has been evaluated as often in the western countries as positron emission tomography (PET/PET-CT): this is an expression of uncertainty about the value of PET diagnostics in the care of patients. The present HTA report updates the evidence on oncological indications and adds neurological indications and inflammatory diseases to the LBI-HTA report from 2015. The report was conducted in cooperation between the TU Berlin and the LBI-HTA to provide an updated decision support for evidence-based PET/PET-CT planning in Germany and Austria.
Publication: LBI-HTA Project report No. 77/ Update: https://eprints.aihta.at/1178/
Contact: Claudia Wild & Nicole Grössmann
]]>External trigeminal nerve stimulation (e-TNS) device produced by the manufacturer Cefaly is the intervention at stake. The mechanism of action is that e-TNS produces a micro-pulse on the upper branch of the trigeminal nerve (suborbital nerve) through an adhesive electrode that is placed on the forehead. The aim of the project is to perform a synthesis of evidence on the basis of a systematic literature search regarding effectiveness and safety of the e-TNS for the prevention and treatment of episodic and chronic migraine.
Publication: Decision Support Document No. 114: https://eprints.aihta.at/1177/
Contact: Michal Stanak
]]>
DSD HSO No. 83
Pembrolizumab (Keytruda®) in combination with chemotherapy for the treatment of metastatic non-small-cell lung cancer (NSCLC)
DSD HSO No. 82
Nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) for the first-line treatment of patients with advanced RCC
The project aimed at elaborating possible cancer types, being an indication for carbon ion radiotherapy (CIRT). As such, clinical studies, analysing the use of CIRT for specific cancer types, were identified through a systematic literature search and were reviewed and reported in this project.
Furthermore, a systematic review on the effectiveness (mortality, morbidity) and safety of CIRT for 54 oncologic indications in 12 regions (i.e., skull base, eye, brain, ear-nose-throat, lung, gastrointestinal, bone and soft tissue, prostate, breast, kidney, nervous system, hematologic cancer) was conducted.
Publication: LBI-HTA Project report No. 101: https://eprints.aihta.at/1174/
Contact: Gregor Goetz
]]>Decison Support Documents 2018
+ 3 Updates
Irreversible electroporation (IRE, NanoKnife®) is a type of focal therapy which has been suggested as an alternative to radical treatment. It typically uses 3 to 5 electrodes which deliver short repetitive electrical pulses to destroy the cancer cells. Stereotactic radiotherapy (stereotactic body radiation therapy or SBRT) is a type of external radiation in which a higher radiation dose is delivered in a reduced number of fractions as is the case with conventional or moderately fractionated radiation therapy. Proton therapy (PT) is a further type of external radiation therapy which uses high doses of ionizing rays directed at the tumour. There is at present inadequate and insufficient evidence to show that IRE, SBRT and PT have either a positive impact on survival and quality of life or the ability to prevent or delay prostatectomy.
Publication: LBI-HTA Project report No. 107: https://eprints.aihta.at/1165/
Contact: Claudia Wild
]]>
DSD HSO No. 81
Daratumumab (Darzalex®) in combination with bortezomib, melphalan and prednisone for untreated myeloma
DSD HSO No. 80
Osimertinib (Tagrisso®) for the initial treatment of EGFR-mutated advanced non–small-cell lung cancer (NSCLC)
The intention of the present MRI report, part 3, is to identify methods for the identification of inappropriate care. In addition, relations between MRI of lower extremities and subsequent (surgical) interventions are evaluated.
In total, we were able to identify 8 methodological approaches to detect in-appropriate care. All methods have certain strengths and weaknesses. The analysis of the relations of MRI to subsequent interventions showed that more knee replacements were in OECD in countries with higher MRI utilization rates. Finally, we were able to identify a series of refunding policies that could exert an influence on MRI utilization.
Publication: LBI-HTA Project report No. 80c: https://eprints.aihta.at/1159/
Contact: Robert Emprechtinger
]]>Aim of the report at hand is to describe the use of echocardiography in Austria and set it into context with the international literature on the appropriateness of echocardiography.
Repeated echocardiographic exams within one year are often related to inappropriate use. Some districts had notable differences in the ratio of over-all exams to repeated exams. With an increase in the number of overall exams there is a tendency for a higher percentage of repeated exams, especially for regions with very high rates of the use of echocardiography. Since the aim is to improve medical care, a discussion with the stakeholders should be conducted.
Publication: LBI-HTA Project report No. 98: https://eprints.aihta.at/1158/
Contact: Robert Emprechtinger
]]>Part I: Predictors, theories and models to explain and recommend courses of action to avoid discontinuation of therapy
Part II: "Overview of Reviews" on dropouts in psychotherapy
The project dealt in two parts with dropouts in psychotherapies. The first part of the report focused on definitions, parameters for describing psychotherapy dropouts and explanatory models. In addition, dropout predictors were identified at a meta-level, which were further empirically recorded in the second report part by an "Overview of systematic reviews". In this context, evidence synthesis (including 14 systematic reviews/meta-analyses) showed that a (young) age of psychotherapy patients and certain mental disorders (such as personality disorders) can represent relevant risk factors for an unplanned termination of psychotherapy. Dropout predictors, which are more likely to be attributed to psychotherapists, are currently only partially researched. With regard to suitable prevention strategies, eight measures were proposed in the report which, among other things, aimed at organisational aspects (e.g. clarification of therapy goals, possibilities and limits of psychotherapy) and interpersonal factors (e.g. strengthening the therapeutic alliance between patient and psychotherapist).
Publication: LBI-HTA Project report No. 100: https://eprints.aihta.at/1157/
Contact: Roman Winkler
]]>
DSD HSO No. 79
Rituximab (MabThera®) after autologous stem-cell transplantation (ASCT) in mantle cell lymphoma (MCL)
Gesellschaft der Ärzte
Frankgasse 8, 1090 Vienna
By invitation only
]]>Since several years, numerous new non-invasive prenatal tests (NIPTs) have been available to identify common chromosomal anomalies. Most NIPTs are available for trisomies 21, 18 and 13 and sex chromosome aneuploidies, but many laboratories have expanded their range of analysis to include other trisomies and common microdeletions. The main advantage of NIPT compared to the conventional screening approach is the ease of implementation and non-invasiveness of the assay, as well as the potential reduction in false-positive [FP] results. An introduction of non-invasive genetic testing has ethical, social and organizational implications that need to be considered.
Publication: LBI-HTA Project report No. 103: https://eprints.aihta.at/1153/
Contact: Claudia Wild
]]>
DSD HSO No. 77
Alectinib as monotherapy for the first-line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC)
MammaPrint® is a test that measures the activity of certain genes within the tumour cells to estimate the likelihood of the tumour to return and spread to other organs, where it becomes incurable. Based on the outcome of MammaPrint®, depending whether the tumour has a low or high risk of returning, and in consultation with the clinician, it can be determined whether or not additional chemotherapy is needed after surgery. This 'gene expression test' is analysing the activity of 70 genes in the breast tumour and claims to be a tumour fingerprint.
Publication: LBI-HTA Project report No.102: https://eprints.aihta.at/1147
Contact: Claudia Wild
]]>Due to the medical advances in neonatal intensive care medicine, the survival rate of premature infants has increased over the last two decades with babies born after 22 weeks of gestation now having a chance of survival. Based on interviews with five heads of Austrian perinatal care centers and a clinical ethicist, this literature review outlines the current evidence on decision-making practices (guidelines, good practice models, and communication strategies) and ethical challenges at the limit of viability.
Publication: LBI-HTA Projekt report No. 97b: https://eprints.aihta.at/1148/
Contact: Michal Stanak
]]>Due to the medical advances in neonatal intensive care medicine, the survival rate of premature infants has increased over the last two decades, with babies born after 22 weeks of gestation now having a chance of survival. In a systematic review, recent data on survival and survival without impairment for extremely preterm infants was collected, as well as literature on resource needs in neonatal intensive care units (NICUs). In addition, interviews with five heads of Austrian perinatal care centers provide insights into the current supply situation in Austrian NICUs.
Publication: LBI-HTA Project report No. 97a: https://eprints.aihta.at/1146/
Contact : Katharina Hawlik
]]>
DSD HSO No. 76
Durvalumab (Imfinzi™) for the treatment of patients with stage III non-small-cell lung cancer after prior chemoradiotherapy
Psychotherapy developed on the basis of various sciences (e.g., medicine or psychology) and became an independent scientific discipline with specific methods. Against this background, the report is based on concepts used in German-speaking countries as well as general and specific effect factors in psychotherapy. Furthermore, differences in the German-speaking area are presented in the legally recognized psychotherapeutic methods for the outpatient sector as well as the legal framework conditions for the recognition of new psychotherapeutic methods, vocational training and professional practice in psychotherapy.
Publication: LBI-HTA Project report No. 93: https://eprints.aihta.at/1143/
Contact: Katharina Rosian
]]>Social Return On Investment measures the social „value for money“ of an intervention. In our project, though, we are providing an overview of studies measuring the return on investment of 15 health-related interventions from the societal perspective. The studies have shown that all interventions are worth the investment. Thus, the savings are higher than the costs of the interventions. The highest returns can be expected in the areas of “crime” and “income”.
Publication: LBI-HTA Project report No. 96: https://eprints.aihta.at/1142/
Contact: Stefan Fischer
]]>A secondary analysis of reimbursement data (DRG-data) from public hospitals was conducted in order to determine how the Aortic Valve Replacement was implemented 2009-2016, either percutaneously (TAVI) or surgically (SAVR), in the Austrian healthcare system. For the period 2009 and 2016, in total 4,338 TAVI and 16,439 surgical aortic valve replacements (SAVR) were carried out. During this period the data show a constant rise in TAVI and a slight fall in SAVR use. The analysed data show a rate of 107 TAVI per million inhabitants in Austria.
Publication: LBI-HTA Project report No. 95b: https://eprints.aihta.at/1141/
Contact: Martin Robausch
]]>
DSD HSO No. 74
Midostaurin with standard chemotherapy in FLT3-Positive Acute Myeloid Leukaemia
For several years, the high-cost Transcatheter Aortic Valve Implantation (TAVI) has been a less invasive alternative to surgery for patients. The aim of the present work was to evaluate the health-economic evaluations of TAVI for inoperable patients and operable patients with high or intermediate surgical risk within a systematic review. The results showed that, TAVI was cost-effective compared to Medical Management in inoperable patients, whereas TAVI compared to Standard Management in inoperable patients and to Surgical Aortic Valve Replacement in patients with high surgical risk resulted in controversial results.
Publication: LBI-HTA Project report No. 95: https://eprints.aihta.at/1139
Contact: Sarah Wolf
]]>
DSD HSO No. 72
Abemaciclib (Verzenio®) in combination with fulvestrant for treatment of HR-positive, HER2-negative advanced breast cancer (ABC)
DSD HSO No. 71
Olaparib (Lynparza®) in patients with BRCA-mutated metastatic breast cancer
As part of the professionalization of patients organizations and the expansion of their activities (eg. awareness campaigns, advisory services for patients and their relatives, etc.) the need for financial resources is also increasing. This need is often covered by pharmaceutical and medical device manufacturers. This update analyzed the extent of financial support for patient organizations from pharmaceutical companies in Austria in 2016. 40 of 118 PHARMIG member companies have declared donations to patient organization for the year 2016. A total sum of € 1.435.059 in grants to patient initiatives were reported by the PHARMIG member companies. Most grants (72%) were given to initiatives in the field of Oncology & Hematology, Neurology, Lung, Hemophilia, and Rheumatology.
Altogether the increase in disclosure in comparison to 2015 was much lower. The total sum of contributions even decreased by almost 20% compared to 2015.
Publication: Rapid Assessment Nr. 7b/2. Update 2017: https://eprints.aihta.at/1132
Contact: Philipp Petersen
]]>Decison Support Documents 2017
+2 Updates:
As part of the professionalization of patients organizations and the expansion of their activities (eg. awareness campaigns, advisory services for patients and their relatives, etc.) the need for financial resources is also increasing. This need is often covered by pharmaceutical and medical device manufacturers. This update analyzed the extent of financial support for patient organizations from pharmaceutical companies in Austria in 2015. 36 of 116 PHARMIG member companies have declared donations to patient organization for the year 2015. A total sum of € 1.724.683 in grants to patient initiatives were reported by the PHARMIG member companies. Most grants (68%) were given to initiatives in the field of Oncology & Hematology, Neurology, Lung, Hepatitis, and Rheumatology.
Altogether there was a significant increase in disclosure in comparison to 2014. Both the number of pharmaceutical companies that declared financial contributions and the total sum of contributions has risen by 50%.
Publication: Rapid Assessment No. 7b/1. Update 2017: https://eprints.aihta.at/1125/
Contact: Philipp Petersen
]]>
DSD HSO No. 70
Pembrolizumab (Keytruda®) as second-line treatment for patients with advanced urothelial carcinoma (UC)
DSD HSO No. 69
Ceritinib (Zykadia®) as first-line therapy for patients with advanced ALK-positive non-small cell lung cancer
The study questions of non-interventional studies (NIS) in Austria were evaluated again two years after the first report. NIS evaluate pharmaceuticals and medical devices after their marketing authorization for the approved indication in routine clinical settings. By law NIS do not have to be approved in Austria but need to be registered. A public database of NIS has to be made available to the interested public. On Aug. 7th, 2015, the initial reference date, LBI-HTA had evaluated the then 33 available summaries of final reports from the database from a total of then 251 registered NIS. On April 3rd, 2017 – the reference date of this update – already 72 summaries (plus 39) were available for evaluation from a total of now 325 (plus 74) registered NIS. So this update shows that over time more and more summaries of final reports are included in the public database. Most summaries are still formally incomplete. The most common research questions NIS addressed were effectiveness in practice and drug safety. The summaries of final reports answer their respective research questions with mostly exclusively positive results, only 2 of 72 NIS for which summaries are in the database also report negative results. 21 of 72 NIS are also registered in international trial registries and for 13 of 72 NIS scientific publications could be identified via Pubmed. The poor quality of the database (maintenance and control of content) has not improved in the almost two years since our initial report.
Publication: Rapid Assessment No. 7c Update: https://eprints.aihta.at/1122/
Contact: Claudia Wild
]]>
]]>
DSD HSO No. 68
Atezolizumab (Tecentriq®) in previously treated non-small cell lung cancer (NSCLC)
DSD HSO No. 67
Ipilimumab (Yervoy®) in the adjuvant therapy for high-risk stage III cutaneous melanoma
DSD HSO No. 65
Ribociclib in combination with letrozole for the first-line therapy of HR-positive, HER2-negative recurrent or metastatic breast cancer
DSD HSO No. 66
Neratinib for the treatment of patients with HER2-positive breast cancer after trastuzumab-based adjuvant therapy
In this report, we conducted an economic analysis of three screenings during pregnancy: testing of TSH as screening for hypothyroidism, urine culture as screening for asymptomatic bacteriuria and ultrasound screening for foetal anomalies.
Over a three years period, the screening for hypothyroidism would save 2 million euros due to prevented preterm births. The costs for the screening for bacteriuria using urine culture are 1.17 million euros and the costs for the ultrasound screening would cost 337,800 euros, when 5 % of all pregnant women would be screened.
Publlication: LBI-HTA Project report No. 91: https://eprints.aihta.at/1112/
Contact: Stefan Fischer
]]>
DSD HSO No. 63
Ixazomib (Ninlaro®) in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma (MM)
The definition of the “Best point of service (BPoS)” for all healthcare settings is a primary goal and shall be re-thought and set by the Austrian health reform. Against this background, part I of this report is based on definitions, models and approaches towards the potential content of a BPoS. The BPoS for the outpatient area at the conceptual level is discussed. In Part II, two concrete health interventions are presented alongside the evidence of the effectiveness and safety. Furthermore, the analysis shall involve organisational information regarding the service provision of a BPoS (using the “organisational domain” of the EUnetHTA core model).
Publication: LBI-HTA Project report No. 88: https://eprints.aihta.at/1110/
Contact: Brigitte Piso
]]>Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. In Europe, there are about 350 000 out of hospital SCAs per year. Mostly, ventricular tachycardia and ventricular fibrillation are the underlying aetiology of SCA, which is claimed to be successfully treated by a novel defibrillation therapy, a wearable cardioverter defibrillator (WCD).
This assessment, performed within the „European Network for Health Technology Assessment“ (EUnetHTA) Joint Action 3, aimed to provide valid data on clinical effectiveness and safety of the WCD. Furthermore, the project intended to elicit patients’ views on aspects regarding their cardiac disease and the WCD therapy as well as to identify neglected outcomes.
According to the published data, no statement can be made about the device effectiveness – further research is needed. Studies suggest that the WCD could be a relatively safe intervention in the short to medium term. However, more data and more adequate reporting of (serious) adverse events are needed in order to establish the device safety. In particular, more data is needed for specific risk stratification of high risk patients in order to further narrow down the wide range of indications for WCD use.
Publication: Decision Support Document No. 103: https://eprints.aihta.at/1109/
Contact: Sabine Ettinger
]]>In addition to the results of the prospective multicentre cohort study on the effectiveness of the outpatient cardiac phase III rehabilitation programme (see part VI), the aim of this report was to compare the costs that occur due to the treatment of cardiovascular diseases of patients who underwent an outpatient cardiac phase III rehabilitation programme (intervention group) and patients who did not receive this phase III (control group).
The data of a total of 164 patients was analysed for this report. On average, the total costs that occurred for patients in the control group were 2,900 euros per patient and 5,099 euros per patient in the intervention group.
Publication: LBI-HTA Project report No. 89: https://eprints.aihta.at/1102/
Contact: Stefan Fischer
]]>The issues discussed in the recent literature can be summarized in five major critical points. The analyses of HTA reports on 10 selected high-risk medical devices revealed the amount of the redundancies in European HTA production: the number of reports per technology ranged between 5 and 22 reports over a time-span of 10-12 years; ranging between 1-6 reports of the same technology within the same year, sometimes even within the same country (language).
The results strongly support the assumption that the resources of HTA institutes can be used more efficiently. The knowledge gained contributes to the conclusion that there is a need not only to collaborate across borders within the same year but also to build on each other´s assessments of the same technologies over years by using the same format, method, language.
Publication: Rapid Assessment No. 12: https://eprints.aihta.at/1108/
Contact: Claudia Wild
]]>In the last few years, payments from the pharmaceutical industry to physicians and medical institutions are increasingly critically questioned, since evidence suggests that those payments are influencing the the medical profession (e.g. in prescribing). To promote trust, the European Federation of Pharmaceutical Industries and Associations (EFPIA) responded with directives and regulations. The "Transparency Initiative" calls on member companies to disclose "monetary benefits to members of the professional circles and institutions" in year 2015. This information should be accessible to the general public at the respective websites of the pharmaceutical companies. The question that underlies this project report is the following: To what extent were Austrian physicians and medical institutions supported by pharmaceutical companies in 2015 and how transparent are they in the disclosure of the financial benefits? In a systematic analysis, the websites of all PHARMIG member companies (115) were searched for information on financial allocations to Austrian physicians and medical institutions in 2015. For a total of 69 out of 115 PHARMIG member companies, cash-based benefits were found in 2015. 20 pharmaceutical companies stated that they had not made any financial contributions; the rest of the companies did not provide feedback on request. A total of 104.1 million euros from PHARMIG member companies to doctors and medical institutions as well as to clinical research and application observations were made in Austria in 2015. Of this, clinical and post-marketing studies were financed with around 54 million euros (52% of the total financial expenditures), medical institutions and organizations received 27 million euros (26%) and medical doctors 22 million euros (22%). The results also show that Austrian pharmaceutical companies invested approximately 30 million euros in events (conferences, meetings), including the support of the events themselves, conference and participation fees as well as travel and accommodation costs. A total of 14 million euros was spent on services and advisory fees (e.g. lectures from doctors) and about 6 million euros for donations and funding. The disclosure of payments by pharmaceutical companies to doctors and medical institutions in Austria is an important step towards greater transparency, but is still at an initial stage. The evaluation of the data from 2015 shows that the actual willingness to disclose financial grants, especially from physicians, is low and the individual disclosure rate (name of the nominee) was only at an average of 21.9%. In contrast, the willingness to disclose payments from medical institutions by name (institutional) was significantly higher at 50.2%.
Publication: Rapid Assessment No. 7d: http://eprints.aihta.at/1107/
Contact: Philipp Petersen
]]>
DSD HSO No. 61
Atezolizumab (TecentriqTM) for the treatment of locally advanced and metastatic urothelial carcinoma
DSD HSO No. 62
Venetoclax (VenclextaTM) for the treatment of relapsed or refractory chronic lymphocytic leukaemia (CLL) with chromosome 17p deletion
Health care personnel regularly carrying out invasive procedures have a higher risk for exposure with HCV positive blood through needle stick injuries The aim of this study was to analyse the appropriateness of preoperative/preinterventional HCV testing in patients using available data on the prevalence and transmission risk and in comparison to international guideline recommendations.
Recent national and international reports were retrieved for estimates of HCV prevalence and incidence in Austria. Data on hepatitis C as an occupational disease were provided by the AUVA. We defined the factors influencing the patient- provider transmission risk and systematically searched the literature for studies on transmission risk and guidelines with recommendations on HCV screening or transmission prevention.
The effectiveness of HCV-tests in patients to prevent infections in HCW or even reduced needle-stick injuries is not supported by evidence. Current guidelines recommend to universally apply precautions to minimise needle stick injuries. Recommendations on preoperative HCV screening prior to elective surgeries are based on expert consensus: no clinical studies could be identified that analysed the effectiveness of the testing on infection prevention.
Publication: Decision Support Document No. 102: https://eprints.aihta.at/1103/
Contact: Agnes Kisser
]]>In 2012, we published the study protocol of a prospective multi-centre cohort study (https://eprints.aihta.at/971/) that aimed at comparing patients who attended an outpatient phase III cardiac rehabilitation after phase II with patients who did not. We defined the mean between group difference of risk factors out of the target range at the end of the observation period as the primary outcome. Now, we report on the results: 16 months after Phase II Rehabilitation, this (adjusted) mean difference was -0,06 [-0.7; 0.6] (non-significant). Roughly spoken, about one out of twenty IG patients (6 of 100) of the sample showed one risk factor out of the target range less than a KG patient. In secondary endpoints, only the change in the exercise stress test (percental increase) and the frequency of inpatient re-rehabilitation showed a statistically significant group difference in favour of the intervention. The higher than expected drop-out should be considered when interpreting the results.
Publication: LBI-HTA Project report No. 90: https://eprints.aihta.at/1101/
Contact: Brigitte Piso
]]>
DSD HSO No. 60
Obinutuzumab (Gazyvaro®) in combination with bendamustine for the treatment of relapsed/refractory follicular lymphoma (FL)
Publication: LBI-HTA Project report No. 62 - Update 2016: https://eprints.aihta.at/996/
Contact: Brigitte Piso
]]>Decision Support Documents 2016:
+1 Update:
Percutaneous transluminal coronary angioplasty (PTCA) with drug-eluting balloon (DEB)
https://eprints.aihta.at/1093/
]]>
Developmental Coordination Disorder (DCD) is characterized by a severe developmental impairment of the motor coordination, which is not solely caused by mental retardation or specific neurological damage. DCD approximately affects 5 to 6% of school children. It may cause significant difficulties in activities of daily living and lead to consequences in adulthood. Children and adolescents with DCD are primarily referred to paediatric occupational therapists and physiotherapists. The report addresses the research questions, which recommendations on DCD (for screening, diagnostic testing, indication and form of therapy) are provided in evidence-based guidelines, which differentiation criteria between occupational therapy and other forms of treatment are discussed and which of the recommended tools can be introduced in Austria with regard to language (German) and standardization/ adaption (central Europe). Depending on the research question, literature was identified by a systematic and/ or manual search. A population based screening for DCD is not recommended due to the lack of sufficiently sensitive screening tools. For DCD diagnosis, all information sources recommend the use of standardized assessment tools. However, currently there is no gold standard available. Of 85 identified assessment tools, 12 have been translated into German and standardised/ adapted for Central Europe. Recommended interventions for children and adolescents with DCD should target the individual activity- and participation-level of the affected person. Differentiation criteria for various forms of therapy could not be identified.
Publication: Decision Support Document No. 96: https://eprints.aihta.at/1092/
Contact: Brigitte Piso
]]>Austria belongs to those countries that adopt new cancer drugs not only early and fast, but use them also widely. In 2009, the LBI-HTA launched the program “Horizon Scanning in Oncology” (HSO) in order to enable evidence based decisions on the use of cancer drugs and estimations on implications for the health care budget in Austria. Since then numerous (n=59) early assessments of new cancer drugs were published. This review shall provide an overview of all approved cancer drugs 2009–2015 by the European Medicines Agency (EMA) and the knowledge on patient-benefit at time of approval and will analyse which policies for high-prized cancer drugs are applied in other (European) countries.
At the time of approval by EMA, for 26 (23%) of 73 cancer drugs between 2009 and 2015 no information about the two endpoints overall survival (OS) and progression free survival (PFS) was available. For 37 (45%) of cancer drugs, OS was increased up to 3 months, and for 14 (13%) up to 5.8 months in relation to the comparator. The benefit assessments in various countries (Germany, England, Norway, Belgium, Netherlands, Canada) differ in the point in time carried out (before/ after approval), in methods used (only clinical benefit assessment or additional cost-effectiveness analysis), the publication of results (degree of transparency) and the binding character of recommendations (from purely informational to binding). In a comparison of national benefit assessments of cancer drugs 14 drugs in 15 indications, including also some drugs that are in the Austrian MEL-catalogue, have been assessed consistently negative (not recommended). 16 drugs in 22 indications have been assessed consistently positive (recommended). Assessments with (binding) recommendations, health economical evaluations, “Managed-Entry Agreements” and “Value-based pricing” are approaches identifying cancer drugs with the highest benefit and acceptable costs with transparent and traceable methods.
Publication: Rapid Assessment No. 8: https://eprints.aihta.at/1091/
Contact: Nicole Grössmann, Claudia Wild
]]>Publication: LBI-HTA Project report No. 80b: https://eprints.aihta.at/1090/
Contact: Agnes Kisser
]]>There is consensus among HTA-experts that the involvement of patient and citizen perspectives can valuably complement health technology assessment (HTA) processes. Since the 1990s, scientific papers about different forms and models of participation have been published. Until now sound (cost-) benefit assessments are missing.
The project aims to summarize internationally published models, methods and experiences in a systematic overview. Furthermore it intends to identify and describe obstacles, facilitating factors and learnings for HTA in Austria by using examples of selected countries and models of good practice.
Publication: LBI-HTA Project report No. 86: https://eprints.aihta.at/1088/
Contact: Claudia Wild
]]>
DSD HSO No. 57
Ofatumumab (Arzerra®) as maintenance therapy in patients with relapsed chronic lymphocytic leukaemia (CLL)
DSD HSO No. 58
Pembrolizumab (Keytruda®) in previously treated advanced non-small cell lung cancer (NSCLC)
Publication: Decision Support Document No. 95: https://eprints.aihta.at/1084/
Contact: Robert Emprechtinger
]]>Publication: Decision Support Document No. 94: https://eprints.aihta.at/1081/
Contact: Claudia Wild
]]>This project includes a theoretical part explaining concepts and models and potential mechanisms of incentives on health behaviour. The empirical part is based on an overview of systematic reviews (SRs), which examined the evidence of incentive effects for smoking, alcohol, nutrition and physical activity.
In general, there was a focus on material/ tangible incentives in the SRs. There is a considerable body of evidence for ‘smoking and incentives‘ (primarily for cessation and abstinence) (17 SRs) with clear evidence of a medium-term effectiveness (especially for pregnant women and women post partum). Regarding ‘alcohol and incentives’ (4 SRs), we found an insufficient evidence base, which does not allow putting forward statements about the effectiveness of incentives. Minor, positive effects could be detected regarding an improved nutritional behaviour due to incentives (14 SRs). Conflicting results have been reported for ‘incentives and physical activity’ (7 SRs).
Overall, the project shows that effects decrease once incentives were suspended. Bascially, incentives should be considered as part of an overall strategy seeking to influence health behaviour. Against the backdrop of social (and health) justice, the consideration of the policy-design of people’s social environments is of particular importance.
Additionally, an addendum provides a theoretical discussion of an issue that is closely linked to incentives: Nudging – stratgies (which can be primarily found on the policy-level) attempting to influence the health behavior of people by changing settings, (health) standards etc.
Publication: LBI-HTA Project report No. 83: https://eprints.aihta.at/1078/
Contact: Roman Winkler
]]>
DSD HSO No. 56
Bevacizumab (Avastin®) in addition to standard chemotherapy for the first-line treatment of ovarian cancer
By law NIS need to be registered. The research question underlying this systematic analysis was primarily to learn about the scientific objectives of these. On the cutoff date (Aug. 7th, 2015) information available through the public database was systematically evaluated. It comprised 251 NIS on 581 pharmaceuticals with a total planned patient enrollment of 406,831. Of 33 final reports available only 8 conformed to the formal requirements. For at least 14 (and possibly up to 31) additional NIS such reports should already have been posted online. The most common research questions a NIS addressed were effectiveness in practice (efficacy) and drug safety. The addressed pharmaceuticals were mostly patented me-too drugs and generic drugs/biosimilars. In 31 of the 33 reports the respective research questions were answered with a positive result for the NIS. Due to deficits in reporting requirements for the public database and due to modest reporting morale and accountability the informed public is in no position to make well-founded statements on completed and ongoing NIS.
Publication: Rapid Assessment No. 7c: https://eprints.aihta.at/1080
Contact: Claudia Wild
]]>
Robot-assisted surgery is already performed in many disciplines, especially in urology and gynaecology.
The report assessed the efficacy and safety of robot-assisted surgery, compared to laparoscopic and open surgery for partial nephrectomy, adrenalectomy, radical prostatectomy, radical cystectomy, hysterectomy and ovariectomy.
Furthermore, the costs (acquisition, maintenance, instruments) of robot-assisted surgery from the perspective of hospitals were calculated and the future of robotic surgery was evaluated.
Publication: LBI-HTA Project report No. 84: https://eprints.aihta.at/1077/
Contact: Stefan Fischer
]]>
DSD HSO No. 55
Pembrolizumab (Keytruda®) for the treatment of advanced melanoma
Mitral valve regurgitation (MR) or mitral insufficiency is a common disease esp. among the elderly. MR may be acute or chronic, depending on the underlying pathology: accordingly, it must be distinguished between primary (degenerative) MR (DMR) and secondary (functional) MR (FMR). Since recent years new minimally invasive procedures are available for inoperable or high-risk patients. This assessment examines the question of efficacy and safety of mitral valve repair using minimally invasive procedures such Mitraclip® for inoperable patients with DMR or FMR; Carillon® inoperable patients with FMR; NeoChord DS 1000 for operable patients with DMR to answer.
Two of the evaluated medical devices, NeoChord DS1000 and CARILLON® are still at an early stage of development. The MitraClip® however, was already implanted worldwide in around 23,000 patients before results of a comparative study has been published.
Publication: Decision Support Document No. 93: https://eprints.aihta.at/1075/
Contact: Claudia Wild
]]>Balloon Eustachian Tuboplasty (BET) is a minimally invasive treatment option for patients with chronic tube dysfunction which involves passing a balloon catheter into the Eustachian tube. Currently, there are 2 CE marked products on the market for BET: the Bielefelder Ballonkatheter/TubaVent® produced by Spiggle & Theis and the AERATM produced by Acclarent Inc./Johnson & Johnson.
This report, which is based on a EUnetHTA assessment published in February 2015, aims to compare the effectiveness and safety of BET in patients aged >12 years with tympanostomy and medication.
Publication: Decision Support Document No. 91: https://eprints.aihta.at/1073/
Contact: Julia Mayer
]]>As part of the professionalization of patients organizations and the expansion of their activities (eg. awareness campaigns, advisory services for patients and their relatives, etc.) the need for financial resources is also increasing. This need is often covered by pharmaceutical and medical device manufacturers. This report analysed the extent of financial support for patient organizations from pharmaceutical companies in Austria. 24 of 115 PHARMIG member companies have declared donations to patient organization for the year 2014. A total of € 1,145.718.- grants were given. Most grants (63%) were given to four fields of diseases: neurology, haemato-oncology, rheumatology and haemophilia.
Publication: Rapid Assessment No 7b: https://eprints.aihta.at/1072
Contact: Claudia Wild
]]>Publication: Decision Support Document No. 92: https://eprints.aihta.at/1071
Contact: Brigitte Piso
]]>
DSD HSO No. 52
Carfilzomib (Kyprolis®) for patients with relapsed multiple myeloma who have received one to three prior lines of therapy
DSD HSO No. 53
Nivolumab (Nivolumab BMS®) for the second-line therapy of metastatic squamous non-small cell lung cancer
Part 3: Sponsoring of non-interventional (NIS) post-marketing studies
Part 4: Pharma: Disclosure of payments to doctors in Austria 2015
Project team:
Part 1: Roland Küllinger, Claudia Wild, Katharina Hintringer
Part 2: Ozren Sehic, Aamna Khan, Judit Erdos, Claudia Wild
Part 3: Nikolaus Gregor-Patera, Marlene Schader, Claudia Wild
Part 4: Stefanie Mantsch, Philipp Petersen, Claudia Wild
Publication: Decision Support Document Nr. 89: https://eprints.aihta.at/1067/
Contact: Claudia Wild
]]>Health policy goals in Lithuania until 2020 include increasing transparency, cost-effectiveness and rational use of resources. Despite repeated initiatives, a systematic application of HTA is so far not in place in Lithuania. In the context of a EU funded project we formulated a HTA-Strategy for Lithuania (https://eprints.aihta.at/1064). For this we undertook a background analysis of the Lithuanian healthcare system, together with local partners. We locally conducted 19 expert interviews with stakeholders. In addition a systematic search of the literature was made for HTA strategy papers, complemented by hand searches. The recommendations developed for Lithuania (and activities proposed) based on this analytical report are published in a separate document, the HTA-Strategy for Lithuania (https://eprints.aihta.at/1064).
More generally it was found that the regulatory environment is essential for the role of HTA. HTA’s impact is greatest, when conducted for supporting concrete decisions. Timely HTAs of good quality with clear messages are important. Not only HTA products themselves require transparency, also the entire HTA process (from topic selection to implementation) demands it for ultimate acceptability of the method. HTA needs to be independent from health policy and from providers (professions, industry) in order to be respected, which also requires a stable funding-basis for HTA.
Publication: Decision Support Document No. 90: https://eprints.aihta.at/1063
Contact: Claudia Wild
]]>The HTA-Strategy for Lithuania was formulated based on a thorough analysis of the Lithuanian health care system (“Background Analysis for National HTA Strategy for Lithuania - Focus on Medical Devices”: https://eprints.aihta.at/1063). It aims to boost the use of HTA-information in Lithuania. Its goals are to support the establishment of both a framework to promote, enforce and facilitate the uptake of HTA and of the necessary organizational structures for the timely, efficient and good-quality provision of HTA-information.
Recommendations and short/ medium/ long terms suggestions for implementation activities are presented for four strategic objectives: regulatory embedding and ensuring legitimacy of HTA; organization of HTA; quality assurance of HTA; capacity building for HTA.
A change of culture (in decision making) takes time. The ultimate success of the HTA-Strategy for Lithuania will be for its health sector stakeholders to increasingly take ownership of the HTA process. In the meantime the HTA-Strategy for Lithuania proposes that raising awareness for HTA works best by successfully realizing “flagship projects” that increase the quality of patient services, decrease inappropriate or even harmful interventions or create savings that can be reinvested for other services.
Publication: Decision Support Document No. 90a: https://eprints.aihta.at/1064
Contact: Claudia Wild
]]>Decision Support Documents 2015:
+2 Updates:
In recent years, the sponsorship of CME/ continuing medical education for physicians by the pharmaceutical and medical device industry is increasingly scrutinized. The question in this project was the scope of sponsoring in the Austrian CME-training. From the CME database of the Austrian Academy of doctors 13 medical fields (from a total of 56) were selected with the aim to analyse the number of events that were financially supported by manufacturer. The investigation shows that a sponsorship of at least 14.3% and at most 67.2% of the events took place. The sponsors are, as might be expected, pharmaceutical and medical product suppliers in the respective subject, mainly from "high-cost and / or high-volume" products.
Publication: Rapid Assessment 7a: https://eprints.aihta.at/1053
Contact: Claudia Wild
]]>Publication: Decision Support Document No. 79: https://eprints.aihta.at/1050
Contact: Brigitte Piso
]]>
DSD HSO No. 50
Nivolumab (Opdivo®) as single-agent first-line therapy for unresectable or metastatic melanoma
A Belgian KCE-Assessment analysed – as an update of the 2007 report – the evidence for hadron therapy (proton and carbon ions) in 15 paediatric indications. Since 2015 the Austrian MedAustron started operating and the first patients are treated, the LBI -HTA has been involved in the Belgian report as external expert. Now the LBI -HTA wrote – due to the regional relevance – a German summary of the Belgian report.
In the assessment 21 clinical studies (non-randomized, non-controlled and mostly retrospective) were found. All studies showed serious methodological flaws. The conclusion therefore is that to date clinical data on PBT in all paediatric cancers under study are lacking as well as critical information on long-term effectiveness and harms.
Prospective comparative clinical trials in the field are urgently needed.
Publication: Decision Support Document Nr. 88: https://eprints.aihta.at/1049
Contact: Claudia Wild
]]>The systematic review assessed the efficacy and safety of a treatment of chronic venous insufficiency (CVI) and haemorrhoidal diseases (HD) with capillary stabilising agents that are listed in the Austrian Code of Reimbursement.
A total of 56 studies were included for a data synthesis.
The majority of studies have shown that the symptoms and signs of CVI and HD can be reduced slightly with the agents (mostly when compared to placebo). Only minor side effects occurred.
However, the strength of the evidence of nearly all identified studies is low. Therefore, we cannot draw a final conclusion on the efficacy of capillary stabilising agents for the treatment of CVI and HD.
Publication: LBI-HTA Project report No. 79: https://eprints.aihta.at/1047
Contact: Stefan Fischer
]]>
Publication: LBI-HTA Project report No. 77: https://eprints.aihta.at/1045
Contact: Claudia Wild
]]>
Tuesday, March 3, 2015, 4:00 p.m. to 6:00 p.m.
Library of the Medical Society
DSD HSO No. 49
Idelalisib (Zydelig®) in addition to rituximab for the treatment of relapsed chronic lymphocytic leukaemia
Publication: LBI-HTA Project report No. 78: https://eprints.aihta.at/1042
Contact: Brigitte Piso
]]>Publication: Decision Support Document No. 80: https://eprints.aihta.at/1043
Contact: Agnes Kisser
]]>The usefulness of a biomarker test requires the demonstration of its diagnostic accuracy together with the demonstration of its clinical utility. The methodology for evidence-based evaluation of biomarkers is not yet fully established. In this project we reviewed current methodological approaches and synthesised them into a procedural guidance.
Publication: Decision Support Document No. 77: https://eprints.aihta.at/1041
Contact: Agnes Kisser
]]>For the planned appraisal process in the context of the further development of the mother-child-pass, the LBI-HTA worked on the following preparatory reports on behalf of the Austrian Ministry of Health: In Part Xa of the project “Re-orientation of the Austrian parent-child preventive care programme”, we analysed and compared national and international practice examples for the appraisal and contextualization of evidence. The identified similarities served as the basis for the development of an appraisal process for the further development of the mother-child-pass. The main features of this process were summarised in Part Xb. Additionally, we updated the guideline synthesis (Part IX) with screening recommendations from recent evidence-based guidelines for pregnancy. This update can be used as evidence basis for the appraisal process.
Publications:
Decision Support Document No. 78a and 78b: https://eprints.aihta.at/1039
LBI-HTA Project report No. 62 - Update 2014: https://eprints.aihta.at/996
Contact: Inanna Reinsperger
]]>
DSD HSO No. 47
Ibrutinib (Imbruvica®) for relapsed or refractory chronic lymphocytic leukaemia
DSD HSO No. 48
Bevacizumab (Avastin®) for platinum-resistant recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer
Health Technology Assessment HTA has in many countries become an integral part of health policy decision-making. After the assessment (the synthesis of available research evidence) some countries undertake an appraisal of the evidence’s impact and applicability for a specific context. Appraisal committees, sometimes called policy committees, work where research and policy meet. Appraisal committees facilitate the life of decision makers in health policy by translating research results into political recommendations. This working paper presents 11 appraisal committees from 7 countries and condenses their experience into recommendations. An appraisal committee set up in line with these examples of good-practice may serve as an important building block for transparent and evidence-based decision making in health policy.
Publication: Decision Support Document Nr. 72: https://eprints.aihta.at/1036
Contact: Claudia Wild
]]>The report contains an analysis of data and methods to calculate the costs of day surgery and inpatient treatment in Austria. Thus, varicose vein surgery was chosen as an example to proof several data sources for their applicability. Beside the calculation by using Austrian meta data and international costs from the UK, we used costs from individual hospitals. The calculated costs differed between 859 and 4,664 Euros for day surgery and 1,720-2,330 Euros for an inpatient treatment.
Publication: LBI-HTA Project report No. 71: https://eprints.aihta.at/1035
Contact: Stefan Fischer
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DSD HSO No. 46
Bevacizumab (Avastin®) as maintenance therapy after first progression on bevacizumab for patients with advanced colorectal carcinoma
Fehleinschätzung der Renalen Denervation
Perkutaner Vorhofohr-Verschluss
Stereotaktische, roboterunterstützte Radiofrequenzablation (SRFA)
Medikamentenfreisetzende Stents
Endobronchiale Ventilimplantation
HIPEC
September 16th 2014/4-5 pm
Jugendstilhoersaal, MUV, BT 88, Level 2
Spitalgasse 23, 1090 Vienna, Austria
Decision Support Documents 2014:
+2 Updates:
DSD HSO No. 45
Obinutuzumab (Gazyva®) for previously untreated patients with chronic lymphocytic leukaemia (CLL)
Overall, included studies (1 meta-analysis, 4 RCTs, 2 pre-post studies with, and 14 without a control group) showed similar trends: the improvement between admission and discharge deteriorated to varying degrees during the catamnestic period. Nevertheless, results remained better than at admission, though. In studies on specific aftercare we observed a trend towards an improved stabilization of treatment effects.
Publication: LBI-HTA Project report No.75: https://eprints.aihta.at/1025
Contact: Brigitte Piso
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DSD HSO No. 43
Nab-Paclitaxel (Abraxane®) as first-line therapy for metastatic adenocarcinoma of the pancreas
Publication: LBI-HTA Project report No. 69a: https://eprints.aihta.at/1018
Contact: Nikolaus Patera
Publication: LBI-HTA Project report No. 69b: https://eprints.aihta.at/1019
Contact: Inanna Reinsperger
Publication: LBI-HTA Project report No. 72: https://eprints.aihta.at/1021
Contact: Claudia Wild
]]>Publication: LBI-HTA Project report No. 73: https://eprints.aihta.at/1017
Contact: Claudia Wild
]]>The results show that among many other indication areas CNS-disorders, developmental delays and ADHD were mentioned most often. Detailed, indication-specific information concerning prescription of OT for children and young people cannot be found.
Publication: LBI-HTA Project report No. 70: https://eprints.aihta.at/1016
Contact: Johanna Breuer
]]>This systematic analysis of 8 already implemented models for the identification of ineffective interventions and technologies highlights existing commonalities between these models as well as general challenges that arise from the development and implementation of such models.
Publication: LBI-HTA Projektbericht Nr. 68: https://eprints.aihta.at/1014
Contakt: Julia Mayer
]]>9:00-21:00
Haus der Industrie, Schwarzenberg Platz 4
]]>Herpes Zoster (Shingles) primarily occurs in people over 50 years old. The disease is hardly lethal, however, it is often associated with long-term pain (postherpetic neuralgia) and decreased quality of life. Since 2006, a vaccine against Herpes Zoster (Zostavax®) has been licensed for persons aged 50+. Completed studies so far have shown that vaccination decreases Herpes Zoster incidence, however, the benefit for patients in terms of quality of life or long-term pain is unclear. Moreover, the vaccine’s efficacy in terms of Herpes Zoster incidence decreases substantially with age. Overall mortality and hospital admissions on a population level won’t be reduced with vaccination. Because safety data have indicated an increased risk for severe adverse events in people over 80 years of age after vaccination, members of this age group should rigorously weigh benefit against risks.
Publication: Decision Support Document Nr. 73: https://eprints.aihta.at/1013/
Contact: Ingrid Zechmeister-Koss
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DSD HSO No. 39
Pomalidomide (Pomalyst®) for the ? 3rd-line therapy of patients with relapsed and refractory multiple myeloma
DSD HSO No. 40
Regorafenib (Stivarga®) for heavily pretreated patients with metastatic colorectal cancer (mCRC)
Publication: LBI-HTA Project report No. 72: https://eprints.aihta.at/1009/
Contact: Agnes Kisser
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