While harmonised regulatory approval processes have created synergies that decrease the workload of European payers and institutional stakeholders, the same may not be said for the case of health technology assessment (HTA). Public reimbursement stakeholders have produced a diverse range of national and local HTA processes and cost-benefit perspectives on new drug entrants and, as a result, a great need exists for HTA harmonisation across most European healthcare systems.
The variety of European healthcare systems and HTA processes translate into increasing trial burdens for pharmaceutical developers and increasing demand for skilled personnel, health economics and outcomes research (HEOR) expertise, and economic-modelling power for manufacturers and payers. The wide variety of HTA processes also has a significant influence on the increasing gap between pricing and reimbursement of medical therapies, creating an additional cost burden for healthcare systems in Europe.
Current efforts
Despite interest in HTA harmonisation, the discussion remains at an academic level, focused on the challenge of harmonisation and the current state of HTA across Europe, rather than on providing ideas as to how harmonisation could be achieved and what it ultimately will mean. But growing evidence is emerging that suggests the individual markets will start to move toward harmonisation for their own benefit in the decade ahead.
Today, the few efforts underway to promote the idea of harmonisation are mainly focused on establishing shared HTA tools, standardised reporting, and discussion platforms.
Attempts to standardise the methodological tools used by HTA stakeholders include the efforts of international societies like Health Technology Assessment international (HTAi) and the International Network of Agencies for Health Technology Assessment (INAHTA). The European network for Health Technology Assessment (EUnetHTA) was established by the European Commission to create an effective and sustainable network for HTA across Europe.
Challenges of alignment
Because of differences in decision processes, legal conditions, and cultural understanding, HTA agencies need to suit the national and local conditions in which they reside. The challenge is making these agencies fulfil international standards across Europe as well. The issue becomes more complicated in that harmonisation does not just concern Europe as a union of countries; individual countries need to work on harmonisation efforts at the regional and local levels.
The issue of relative effectiveness of products also comes into play in Europe. While European law would allow common criteria for determining the relative effectiveness of drugs to be established, cultural differences among countries could make it challenging for a consensus to be reached as to the most effective treatment among available options.
The right fit
Campbell Alliance has identified several layers of future HTA harmonisation across Europe, all of which face different challenges for implementation and require various groups of stakeholders to be involved.
1. HTA Process and value dossier format requirements
Creating harmonisation around HTA processes and value dossier format requirements is only loosely dependent on local legislation, being predominantly driven by national and regional HTA stakeholders. As a result, the group of relevant stakeholders is reasonably small, making potential harmonisation realistically achievable in the next few years. For such harmonisation to happen, a well-respected HTA body, such as the National Institute for Health and Care Excellence (NICE) in the UK, would need to step in as an unofficial leader in the endeavour.
2. HEOR modelling methodology platform
Reaching an agreement regarding an HEOR modelling methodology platform would most likely be more challenging than establishing a common format for value dossiers. And while such an agreement would not represent true harmonisation, it would pave the way to harmonise on the methodological level later.
By agreeing on the algorithms and data used to model cost-effectiveness, budget impact and patient outcomes (without a formal assessment), a first big leap toward harmonisation could be achieved. Driven by their rather scientific nature, HEOR modelling algorithms may be the most likely first step toward harmonisation, providing a strong basis for further efforts for harmonisation.
3. Mutual recognition of HTA assessment opinions
A successful reference case for the mutual recognition of HTA assessment opinions across Europe already exists in the form of the centralised regulatory approval process used by the European Medicines Agency (EMA). While the mutual recognition process is hardly used anymore for new drug applications, the way that the mutual recognition process started to drive regulatory harmonisation provides some useful parallels and analogies that can serve as a blueprint for HTA harmonisation.
With central political back-up, driven by industry lobbying, the European authorities would seem to be well-positioned to force countries under one umbrella and establish the first step toward full harmonisation. The chances of this happening are likely very high, given the political momentum being initiated on the EU level.
4. Centralised European HTA agency
A centralised European HTA agency is the logical evolution from a mutual recognition process on access. Again, the role model for this comes from the regulatory arena, in which we saw the implementation of the centralised approval process about 10 years ago. Today it is the standard go-to-market route for new market entries in Europe.
This level of harmonisation requires considerably more momentum at the political and payer levels than mutual recognition, which is why implementation of this ultimate evolution is still likely a decade away.
5. HTA methodology, assessment criteria, and data requirements
Alignment of HTA methodology, assessment criteria, and data requirements is the ultimate goal of HTA harmonisation.
However, due to the heterogeneous socioeconomic perspectives and heritage of the countries of Europe, this fully integrated HTA harmonisation has the lowest likelihood of coming to fruition in the near to mid-term, unless a strong central authority leads the process in the political arena.
Future goal
Despite the unlikelihood of harmonisation happening in the near future, the general expectation seems to be that HTA will continue to spread due to the potential cost savings it could offer countries struggling with tight budgets.
Creation of a single pricing and reimbursement market is also not likely in the near term. However, the drug industry in Europe does have a framework in place that makes it more favourable to the creation of a single pricing market. The growth of European wholesalers, parallel importing, and the network of international reference pricing are the mechanisms through which harmonisation could take place.
