After years of preparation the European Commission published a proposal for ‘Health Technology Assessment and amending the Directive 2011/24/EU’, in an attempt to harmonise the process of which HTA is conducted across Europe[i].
The proposal looks ambitious and is EU Commission’s response to 3 identified problems:
- “Impeded and distorted market access”
- “Duplication of work for national HTA bodies”
- “Unsustainability of HTA cooperation”
The proposal, apart from the obvious (accelerated access and cost-savings), intends to introduce a level of transparency and consistency into the different HTA procedures across Europe. This is good news for both the industry and the patients;
Are member states ready to accept a centralised HTA process?
Since its publication, the proposal has received the praise of EU Health Commissioner Vytenis Andriukaitis[ii] and has been welcomed by EFPIA[iii] and European patient organisations. However, despite the hype, negotiations for its finalisation and implementation will be challenging, as the scope of a centralised EU HTA has already divided the member states.
Countries with well-established HTA bodies, such as Germany, did not see the centralised approach in a positive light. This was illustrated by the reaction of Germany’s Federal Joint Committee (G-BA) which warned of the potential pitfalls of a “one-size-fits-all” approach and the risk of failing to meet the differing needs of each country[iv]. Similarly, Greece is creating its own HTA mechanism as part of the bailout deal and has expressed its intention that the opinion of the EU HTA will not be more than advisory[v]. If the opinion of the EU HTA is not obligatory, to what extent will it achieve its objectives?
Conversely, member states with non-fully developed HTA bodies, such as Croatia, will probably warmly welcome the proposed bill. Equally, the Netherlands is known to be more in favour of more EU-wide coordination on pharmaceutical access and pricing.
It is important to remember that HTA is inextricably linked with pricing and reimbursement and therefore significantly affected by budget constraints and the economic health of each country. In this context, how easy will it be to harmonise P&R processes across members-states?
Responding to those concerns, an EU spokesperson highlighted that “the joint work would focus on clinical aspects of health technology assessment and leave member states to decide on economic (“cost-effectiveness”) or ethical parts, which are more country-specific”[v].
Brexit makes the whole story even more interesting. NICE is widely considered to be the world’s most advanced HTA body. Due to Brexit it will be excluded from the mix, which is rather ironic.
A step forward
It is too early to speculate; a proposal which aims at faster, better, more equitable access to medicines across Europe and that promotes innovation and transparency, is unarguably a step towards the right direction. The proposal itself is one of the many important milestones that need to take place before single HTA becomes a reality. Despite the concerns, many key stakeholders are convinced that the potential advantages will outweigh any likely disadvantages, therefore the future of HTA and P&R across Europe looks very interesting.
Nick Delimpaltadakis, Associate Consultant, Cello Health Consulting
We are proposing a regulatory framework that will bring benefits to patients all over Europe, whilst encouraging innovation, helping the take-up of high-quality medtech innovations and improving the sustainability of health systems across the EU