In its comments on the European Commission’s draft regulation, the GKV-Spitzenverband (National Association of Health Insurance Funds) has put forward its own proposals for stronger European cooperation between EU members when undertaking Health Technology Assessment (HTA). Instead of focusing on binding guidelines, as Brussels wants, the statutory health insurance funds are strongly in favour of continued cooperation and a gradual expansion.
‘Improving the exchange of national HTA assessments is basically the right way forward. All patients in the European Union should be able to benefit from scientifically-based, independent information on the benefits of medicinal products and medical devices’, said Dr Doris Pfeiffer, Chair of the Board of the GKV-Spitzenverband. ‘However, there is an issue with how the EU Commission has proposed doing this. The procedure set out in the draft regulation would mean taking the second step before the first one. Although methodological evaluation criteria are to remain open for the time being, implementation is to become obligatory immediately. This would have serious, unwanted side effects. The better way forward is European cooperation, with the HTA organisations of the Member States taking on a stronger role.’
Currently, Member States take different methodological approaches to assessing medicinal products. This is due to different national assessment goals and the different ways that healthcare is organised in each country.
The GKV-Spitzenverband is of the opinion that the planned mandatory harmonisation of HTA would lead to healthcare cuts (time and cost of setting up institutions, staff and procedures), even in those EU states whose national laws are yet to provide for HTA. It is possible that national health systems will be overwhelmed. ‘And this would be the exact opposite of what the EU Commission wants to achieve with its proposal. Joint clinical evaluations must remain voluntary as long as there is no agreement on methodology, presentation of results and the transparency of the data. Only when national decision-making systems and joint HTA reports are meaningfully interlinked, does it make sense to make this mandatory in all EU Member States.’ This also applies to Germany, where there is a statutory requirement to provide immediate market access and the health insurance funds are obliged to reimburse all authorised medicinal products. This relies heavily on an HTA procedure that is transparent and in line with healthcare regulations.
The GKV-Spitzenverband argues that instead of harmonising and centralising HTA in the Member States, cooperation should be the priority. Therefore, it is better to build on the initial successes of the clinical evaluation in the EUnetHTA project. ‘If EUnetHTA can be used as a springboard for further developments, then cooperation on the independent assessment of health technologies can become significantly more binding without renouncing national control’, stated Pfeiffer.
The EU Commission's proposal means that, in the future, HTA experts from the Member States will work together in a coordination group to jointly assess whether or not a medicinal product has added value compared to the standard therapy. The result will be binding for all Member States. The EU member states will no longer carry out their own clinical evaluations. The European Commission believes that market access to innovative drugs, medical devices and diagnostics is hampered by the different national HTA procedures and methods. This results in higher costs for companies, duplicated work by the national HTA organisations, and delayed access to innovations for patients. It wants to change that with its legislative proposal.