EUnetHTA Guidelines The primary aim of the guidelines is to help the assessors of evidence to process, analyse and interpret the data. The links to all published EUnetHTA methodological guidelines can be found below: Read more Tools EunetHTA has developed several tools to support the conduciton of Joint Assessments, but […]
Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard cataract surgery The publication of the final project plan of the assessment on “Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard cataract surgery” and the comments provided by one manufacturer during fact check of […]
This is the assessment of the relative effectiveness of “Screening of fetal trisomies 21, 18 and 13 by non invasive prenatal testing”. We are pleased to announce that the CA of JA3 WP4 on “Screening of fetal trisomies 21, 18 and 13 by non invasive prenatal testing.” is now available. […]
WP1 Lead Partner, in its function as the EUnetHTA Directorate, acknowledges the recent publication of the proposed Regulation on HTA in Europe. The EUnetHTA JA3 Directorate looks forward to constructive dialogue vis-à-vis the proposed Regulation and continues to actively support HTA collaboration in Europe through Joint Action 3.
The revised ATMP guideline on safety and efficacy follow-up and risk management has been released for a 3-month public consultation (deadline of 30th April). EMA would be pleased to receive any HTA comments in respect of the post-authorisation safety and efficacy studies’ endpoints. Please see the links below. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/02/news_detail_002897.jsp&mid=WC0b01ac058004d5c1 Guideline […]
This is the assessment of the relative effectiveness of “Alectinib (Alecensa©) as monotherapy for the first line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC). We are pleased to announce that the pharmaceutical Joint Rapid Assessment on “Alectinib (Alecensa©) as monotherapy for the first line treatment […]
2018 – PDF . Final Assessment Report, External Comments/Answers and Project Plan for Other Technologies CA MammaPrint® This is the assessment of the relative effectiveness of MammaPrint® – Added value of using the gene expression signature test MammaPrint® for adjuvant chemotherapy decision-making in early breast cancer. Find the documentation provided […]
Interview with Menno Aarnout/AIM, Partner Profiles: Portugal, Impact: Croatia and Italy, A Patient’s Perspective: Dr. Cees Smit, EMA-EUnetHTA Finalise Joint Work Plan, 2017-2020 winter_2017_magazine_final.pdf
An analysis of HTA and reimbursement procedures in EUnetHTA partner countries: final report Background Health technology assessment (HTA) is the systematic evaluation of properties, effects, and/or impacts of health technologies. HTA aims to respond to decisionmakers’ information needs regarding the introduction, coverage, use or disinvestment of health technologies. Information needs […]
Medicines regulator and network of Health Technology Assessment (HTA) bodies continue to strengthen their collaboration The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have published a joint work plan outlining key areas of collaboration for the next three years. The EMA-EUnetHTA collaboration, which began […]
Final project plan for Other Technologies CA on MammaPrint® – Added value of using gene-expression signature for adjuvant chemotherapy decisions in early breast cancer assessment (OTCA04) This is the final project plan of the Other Technologies CA on MammaPrint® – Added value of using gene-expression signature for adjuvant chemotherapy decisions […]
We are pleased to announce that the pharmaceutical Joint Rapid Assessment on “Midostaurin (Rydapt©) with standard chemotherapy in FLT3 positive Acute Myeloid Leukaemia” is now available. The final assessment report was published in November 2017. Find the documentation provided by the authoring team here.
Final Assessment Report, External Comments/Answers and Project Plan for pharma JA on Regorafenib (Stivarga©) We are pleased to announce that the pharmaceutical Joint Rapid Assessment on “Regorafenib (Stivarga©) indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib” is now […]