The participants already have invested resources and expertise in Health Technology Assessment on a national level. Building on this, we will invest in further collaboration in this field. Our overall goals are to collaborate on a supranational level, leading to joint Health Technology Assessments, and to explore new mechanisms. For example, the mutual recognition of national assessments. This would also reduce the workload of national HTA-organizations.
We will continue to actively participate and coordinate efforts within EUnetHTA to facilitate international collaboration on Health Technology Assessment.
We aim to achieve:
- Insight in the timelines of ongoing and future assessments;
- Health Technology Assessment reports that are suitable for international use, by optimizing and harmonizing current reporting standards;
- Joint assessments, both bilateral as well as within EUnetHTA;
- The adoption of ‘non-national’ HTA-reports in national reimbursement decisions, by investigating and tackling the legislative hurdles.
Four types of collaboration are being studied in the Beneluxa initiative:
- Re-use of Health Technology Assessment (HTA) reports
In this case, countries use parts of HTA-reports of other countries - Joint writing of an HTA report
Authors of several countries join forces in order to write one report. This report can be used in all countries involved. - Mutual recognition of HTA reports
In this case, large parts of, or even a full, HTA-report of one country are adopted by others in a parallel process. The results of the assessments are then published at the same time. This has not been carried out yet. - External referee
HTA institutes of the various countries can also act as each other’s external referees in national procedures. It does not involve active work in a Health Technology Assessment itself.
First results
This table shows the first actual joint HTA procedures that were carried out. They were performed according to national legislation and based on actual submission files from the companies.
HTA activities in the year 2018:
1) Joint writing
The joint writing of the report on OCALIVA obeticholic acid (indication: primary biliary cholangitis) was broken up prematurely, at the request of the company, in 2017. Both ZIN (Netherlands) and RIZIV-INAMI (Belgium) completed the assessment of OCALIVA (i.e. national HTA report) in 2018 based on the initial draft joint assessment.
2) Re-use
In collaboration with the pharmaceutical company, a re-use of an existing report was carried out: RIZIV-INAMI used ZIN’s assessment report for the reimbursement procedure in Belgium. It concerned SPINRAZA nusinersen (indication: spinal muscular atrophy). The assessment report was shared with the other HTA organisations after publication of the final report. Following this re-use a joint negotiation on Spinraza was conducted with Belgium and the Netherlands.
Other re-use of (parts of) assessments was also done, these without the involvement of the pharmaceutical company for the following products: XERMELO telotristat; RAVICTI phenylbutyrate (ZIN-reports used by RIZIV-INAMI) as well as TAGRISSO osimertinib; VERZENIOS abemaciclib (LBI-reports used by RIZIV-INAMI).
3) Exchange
Informal exchange of national HTAs was done during the year 2018.
Update 2019:
Adoption of HTA reports
In The Hague, delegates of Beneluxa countries discussed on Nov 25th 2019 the current status of HTA collaboration. In the annex of the Letter of Intent (2018), “mutual recognition of work” is mentioned as an element of collaboration. Till now, no adoption of HTA reports has been carried out because of legal constraints. Nevertheless, partial re-use of HTA reports of other Member States was done in accordance with national legislations.
In this way, we have benefited from each other’s expertise, learned from the different approaches and taken a step further towards adoption of full HTA reports in the future.
Update 2021:
Joint HTA assessment of ZYNTEGLO
ZYNTEGLO betibeglogene autotemcel (shorter name: beti-cel) was jointly assessed as a Beneluxa pilot, which led to a successful publication of this joint effort in July 2021. The pharmacotherapeutic assessment was written by RIZIV-INAMI; the pharmaco-economic assessment was written by ZIN as well as the budget impact for the Netherlands and Belgium. The National Centre for Pharmaco-Economics (Dublin) was the external reviewer in the Belgian procedure.
End September 2021, the manufacturer Bluebird bio has withdrawn its application for reimbursement of ZYNTEGLO in the Netherlands and Belgium. Bluebird bio announced to “wind down” its operations in Europe and to focus on the business in the United States. Apparently, the company has tried to find a partner who can market their gene therapies in Europe, but they have not yet succeeded. The Beneluxa initiative regrets the company’s decision to exit the European market.
The HTA report can be found here: https://www.zorginstituutnederland.nl/publicaties/adviezen/2021/07/21/pakketadvies-sluisgeneesmiddel-betibeglogene-autotemcel-zynteglo
Website written in Dutch; HTA report written in English