Rachel Howard, Tania Rodrigues, and Rebeca Nana Barrantes recently joined over a thousand delegates in attending the 2022 World EPA Congress in person in Amsterdam.
All eyes on the EU’s joint HTA
After two years of virtual events, it was inspiring to be able to network with one another in person again. Especially as we were able to make the most of the unseasonably warm weather to stretch our legs and explore the city after busy days attending plenary sessions, roundtable discussions and special interest tracks.
This year’s three-day congress covered a whole host of topics, including evidence generation and collection, the increasing involvement of patients in access decisions and how this can be facilitated, and the impact of big data, AI and other digital solutions on the healthcare ecosystem – not to mention numerous sessions dedicated to country-specific updates. We’ll be diving into some of the advanced therapy (ATMP)-related updates in more detail in an upcoming future article. For now, in this round up we focus on the topic of the moment, which came up time and time again over the course of the event, namely, the imminent prospect of a joint HTA in Europe.
Hot off the press
The European Union’s joint Health Technology Assessment, which is finally due to launch in 2025, was a major talking point throughout the congress. The location of the congress seemed to be spot on to discuss this topic considering the Netherlands is home to the EMA and a major driver of the cross-border initiative Beneluxai, which also conducts joint HTA.
We attended a series of sessions and roundtable discussions presenting the EUnetHTA concept, process and timelines as well as the impact on innovative drug evaluations. The first phase will include oncology treatments and ATMPs, followed by orphan drugs in 2028 with a view to covering all new treatments by 2030.
EUnetHTA aims to consolidate the clinical assessment of new pharmaceutical products across EU countries. This will involve a Coordinator Group that includes different committees such as the Clinical Assessment group, who together with the “stakeholder network”, which includes experts from national and subnational organizations and patient advocacy groups (PAGs) across all EU countries, will conduct their joint clinical assessment of the new product.
Potential and promise
Proponents of EUnetHTA focused on advantages such as a reduction in timings (assessments will be available 30 days after the marketing approval) and the potential to allow launches across multiple EU countries simultaneously. However, some challenges have also been raised, including a lack of harmonization of standard of care (SoC) across countries. The difficulty in aligning on an appropriate clinical comparator given current country differences in treatment approach is also an immediate issue that received a lot of attention.
EUnetHTA expert, Anne Willemsen from the Dutch Zorginstituut Nederland (ZIN), reassured the audience that all potential SoCs will be considered through their PICO (Population, Intervention, Comparator(s), Outcomes) framework. Moreover, EUnetHTA’s joint HTA assessments will not be legally binding, which means individual EU member states have the option to not consider the assessment and conduct their own HTA. This in turn comes with its own challenges, as it could increase bureaucracy for manufacturers seeking to navigate what could essentially be an additional layer of HTA.
Small pharma companies with limited resources were particularly concerned about the impact, as there is pressure for manufacturers to prepare and submit a dossier to EUnetHTA 45 days before the Committee for Medicinal Products for Human Use (CHMP) publishes its opinion. This is also risky as it means the European Public Assessment Report (EPAR), which is the basis for the HTA evaluation, would not yet be available.
Does one size fit all?
As mentioned, oncology, orphan drugs, and ATMPs are expected to be the first treatments prioritized to go through this new process. While the aim is to improve equity of access across EU markets, some commentators question how suited the “one size fits all” joint assessment is to evaluate such therapies considering their complexity.
Recent feedback we have received from EU payers in response a recent poll we conducted mirror this uncertainty. As we’ll be diving into in more detail in an upcoming article, some anticipate the EU’s joint clinical assessment will have a moderate impact on helping the cross-border healthcare framework for ATMPs to realise its full potential, allowing patients to cross borders to receive these highly specialised therapies in another country. Others, however, expect minimal change, given the assessments will only form the basis of countries’ individual decisions and those decisions do not equate to access, which is more related to the individual health care organization.
Time will tell
As the concept of EU joint HTA moves from a theoretical conceptual ideal to something more tangible, it is clear from the lively debates we heard throughout the congress that stakeholders from all perspectives are grappling with unresolved questions relating to how it will work on a practical level. The many questions raised by participants of the roundtable led by Dr. Filippo Drago on the topic of ‘harmonisation of regulation across Europe’, gave a flavour of these concerns.
- How will the joint HTA consider the unmet needs and treatment pathways of all countries?
- Should post-launch real-world data generation and collection methods/requirements be established in the joint assessment? If so, how?
- How willing will payers from the individual EU member states be to accept the joint clinical assessment?
- How will the interpretation of the assessment differ between member states and how will this ultimately play out in terms of market access?
As far as that last question is concerned, only time will tell – but we will certainly be keeping a close eye on these ongoing developments.
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