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23 Aug 2024
In the ever-evolving pricing, reimbursement, and market access (PRMA) environment, European healthcare systems continue to face growing cost pressures and explore avenues for relief. At a recent advisory board meeting, we asked European payers/advisors to discuss these critical developments in their health systems, and the implications on the near-term and longer-term future state of PRMA.
This session was the latest in a continuing series of meetings to discuss key pharma market access challenges and the future of PRMA within, and across, Europe. Participants included ex-CEPS (Comité économique des produits de santé) and ex-TC (Transparency Committee) payers from France, an ex-head of the Department of Medicines at a large sickness fund and KV (Kassenärztliche Vereinigung) payers from Germany, an ex-regional payer from Italy, and an ex-SMC (Scottish Medicines Consortium) advisor from the UK.
This blog post is the latest in a 3-part series covering insights from our EU Advisory board meeting. Post 1 spoke about the cost pressures and relief efforts across European health systems, and post 2 shares perspectives on the European healthcare gross-to-net pricing gap manifestations. This post focuses on the payers’ outlook on the future of market access in Europe: the impact of the evolving EU-wide joint Health Technology Assessment (HTA) process and AI’s potential role in market access.
How will the evolving EU-wide Joint HTA impact market access?
The EU HTA Regulation was adopted in 2021 by the European Commission with its rollout expected to happen over the balance of this decade. The main goal is to accelerate patient access to treatments across the EU and harmonize pharmaceutical review processes, currently conducted individually, as well as the resulting access to therapies. Once fully adopted, in theory, all pharmaceutical products will have their clinical evidence evaluated by a single, joint HTA body at the European Union level, however non-clinical evidence evaluation will remain the responsibility of the member states.
Overall, our payer advisors were skeptical about the initiative and saw it as a bureaucratic imposition likely to slow market access, especially due to the many implementation steps required. They expect no short-term benefit to their countries and highlight logistical/administrative difficulties rectifying current market differences in HTA standards and processes. For example: How many clinical comparators are appropriate (up to 57 according to a recent report1)?; which clinical trial endpoints are most important?; how/where should we require quantifiable benefit(s)? Given the choice, our EU payers would prefer to preserve the autonomy and flexibility of their current systems.
I think there is zero convergence on the European-level when it comes to HTA… they just added every country to build a whole package and then [are] redistributing to every country out of that package… [larger countries see this as a] delay of time to market.
– KV member, Germany
DESCRIPTION
We are very, very far from having a kind of European HTA.
– Ex-AIFA advisor, Italy
DESCRIPTION
The regulation is expected to be more beneficial for smaller member states that lack the resources to independently conduct HTA and rely on external sources to support access decisions.
Maybe Hungary and Bulgaria asked for it, [but] no [larger countries] asked for it… It's imposed by bureaucrats with one intention without thinking it through, without any idea of how it's going to work. And it will have the opposite intention, because if you actually adhere to it… Companies are [saying] it might actually slow things down.
– UK ex-SMC advisor
DESCRIPTION
Despite the skepticism from the payer advisors, implementation of EU-wide joint HTA has already begun. In March, the European Commission released its first of six “implementing acts” scheduled for 2024 to jumpstart the regulation’s enactment. Manufacturers should monitor adoption steps in the coming years and how they may impact their product pipelines to improve launch strategies. Likewise, healthcare systems should prepare to adapt to new processes with unique challenges to support market access and, ultimately, the patients and caregivers within their countries.
Where does AI fit in European healthcare market access?
Another area of uncertainty about the future discussed by the advisor panel was the application of Artificial Intelligence (AI) to market access. Although unsure of exactly where it fits and how it will be applied, payers were open to AI’s potential usefulness, especially as cost pressures continue to rise. Payers highlighted some areas where AI may prove more and less useful.
On the positive side, some payers believed AI could benefit manufacturers in the drug discovery and evidence generation processes by enhancing their ability to synthesize complex datasets for a potential new product/molecule. Others cited potential use by healthcare systems in analyzing structured data and automating mundane tasks (e.g., tender processing). There was also some discussion of AI’s use alongside digital therapeutics to potentially mitigate the negative effects of staffing shortages and assist with administrative tasks (e.g., scheduling patient visits).
[The] Main [benefit I see] is from the manufacturer perspective, I think could be easier to find molecules using calculations, big data and calculation… If this results in a faster approach, we have to wait for the future [to know for sure]. Other [benefit] is [for] diagnostic processes to have again big data easily processed in order to help physicians make good diagnoses.
– Ex-AIFA advisor, Italy
DESCRIPTION
Points of payer skepticism included the feeling that present-day AI is significantly more error-prone than its human counterparts. For example, AI-synthesized product evidence/data submission by manufacturers would likely have more errors and therefore lengthen the process compared to existing methods. On the health system side, important tasks like pricing calculations & non-mundane analyses for tenders’ management could not be trusted to AI – and are already handled well by current methods.
[When] it comes to tenders, it's based on billing data [which is] very structured [and] easy to analyze these data [via] ancient methods like excel. So I think there it is not helpful.
– Ex-head of the Department of Medicines at a large sickness fund, in Germany
DESCRIPTION
Given the need for specialized modeling, evaluation, and experience in the market access process, advisors are skeptical that AI technology has progressed far enough for manufacturers or health systems to benefit significantly from its use – at least in the near-term. It will likely be up to industry to innovate and educate payers on where AI’s usefulness lies if it is to grow and become widely adopted in market access.
It reminds me a bit like the introduction of microsurgery in the 1980s. They started somewhere and suddenly everybody used it for everything. And then ten years later, we learned that it is helpful in some indications, but it's not helpful in other indications. And I think that is exactly currently what we have [with] AI. [We currently think] helps us everywhere. But this is not the case. There are definitely fields where it is helpful, but there are also fields where is absolutely not helpful.
– Ex-head of the Department of Medicines at a large sickness fund, In Germany
DESCRIPTION
Emerging initiatives and new waves of technology may have a major impact on market access in Europe, though the path forward remains unclear.
This blog post is the latest in a 3-part series following our EU Advisory board. Be sure to check out our previous blog posts as well:
3. Current Blog - Emerging Role of HTA Regulation and AI in European Healthcare Systems
If you enjoyed this post and are interested in any of these topics, please get in touch. We plan to discuss monitor and report back on these in future blogs/whitepapers and at conferences.
Contact us to learn more!
*Abbreviations: TC: Transparency Committee; CEPS: Comité économique des produits de santé, KV: Kassenärztliche Vereinigung, AIFA: Agenzia Italiana del Farmaco (Italian Medicines Agency), SMC: Scottish Medicines Consortium
References:
1. EU HTA Regulation for Oncology Medicines: Learnings from a Simulation on the Impact of Proposed EUnetHTA21 Methods. EFPIA, 2024.
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