Panel explores insights and implications of the game-changing EU JCA

Shifting the HTA responsibility

Currently, at most large pharma companies, submission for the HTA is handled at the local level, but under the JCA the advice is that global and regional should handle the EU submissions. As Jurgen Huismans, Global Director Access & HTA Strategy, MSD, noted, the challenge really lies in shifting responsibilities and establishing new ways of working. Besides, the JCA is only one part of the reimbursement process, so there is a risk of some duplication, additional analysis and timeline changes. 

“We’re really exploring the potential impact at the local level, which requires close and regular engagement with local teams,” he said.
Amid these shifting responsibilities, Herbert Altmann, Head Commercialization and Access Solutions Europe, PharmaLex, said the HTA process is becoming more tightly connected with the regulatory process, with submission timelines and the clinical research question, or PICO scoping phase (Population, Intervention, Comparator(s), Outcomes)ⁱⁱⁱ, overlapping.

“Global cross-functional teams in matrix organizations will require a lot of education to understand the kind of evidence, structure and format needed.”

Herbert Altmann, Head Commercialization and Access Solutions Europe, PharmaLex

With the JCA, regional teams will need to play a stronger role in the HTA submission, said Casper Paardekooper, Partner, Vintura. He added that local teams should focus on engaging with the relevant HTA bodies to shape the JCA and the research question, while making sure that the JCA report is adopted at a local level to avoid duplication.

Another challenge will be addressing the concerns of the national HTA bodies, which will want to ensure their policy questions will still be included, said Mihai Rotaru, Senior Manager Market Access, EFPIA (European Federation of Pharmaceutical Industries and Associations).

“There's a risk that we will end up with an amalgamation of the existing 27 different requirements at European level,” Mihai said. There should ideally be something like a European PICO that can answer the policy questions of as many countries as possible.

Addressing concerns in the lead-up to 2025

The Member State Coordination Group on HTA (HTACG), put in place by the European Commission to implement the JCA methodologies, and whose members are designated in accordance to Article 3(2) of the Regulation (EU) 2021/2282, is reviewing the EUnetHTA21 consortium developed suggestions. This joint consortium of 13 member organizations was created as the successor of EUnetHTA Joint Action 3 with the aim of further developing HTA methodology. It is hoped that a clear procedural guidance will be published within six months, giving companies affected by the 2025 implementation at least a year to prepare^iv.

However, there are already concerns that the approaches will not be fit-for-purpose for novel ATMPs, Casper noted. He pointed to a recent publication from the Alliance for Regenerative Medicine, which says nearly 90% of ATMPs currently approved in the EU would never have been approved under the anticipated JCA methodologies^v.

Timelines are also a cause for some concern, with companies having very little time to respond to questions, Casper said.
While there has been some opportunity to learn from pilots already conducted, Herbert, who took part in the EUnetHTA Joint Action 3 pilot, which ran between 2016 and 2021, pointed to the importance of sharing those learnings and insights across industry. 

Much remains to be done, and Mihai noted that, with EUnetHTA 21 wrapping up its role in September^vi, and processes expected to be in place by January 2025, there’s very little time for local HTA authorities to prepare. “We haven't seen a single HTA body in Europe publish new procedures or new regulations where the HTA regulation has officially been implemented or has been absorbed,” Mihai said. “This is worrying, as the regulation is designed to increase efficiency and avoid duplication of clinical assessment at the local level.” 

However, from September 2023 until the end of 2024, Germany’s central HTA coordination contact, the G-BA, will coordinate requests for parallel scientific advice from the national HTA bodies and the EMA during the transition period^vii. The objective will be to offer advice to manufacturers with regards to pivotal studies.

Collaboration is the way forward
All panelists agreed that companies will need to engage with local HTA authorities to ensure local procedures reflect JCA reports.

“Local affiliates will need to sit down with local HTA bodies to discuss what the process will look like and how they can work together to align on the research question,” Casper said. “It’s really discussing a new local operating model.”

Given the short timelines, Mihai advised working with the coordination group to fully understand the requirements coming from the PICO survey, used to frame and answer a clinical question in order to discuss data availability and determine what can be done in a complementary assessment.

There remains some uncertainty as to whether companies will have input into the PICO phase. Mihai suggested that if manufacturers aren’t included in the discussion, the best alternative route is to have their affiliates involved in national discussions, which will require ensuring a unified company view channeled through the national level.

Companies and their local affiliates should also find other ways to remain informed, the panel noted. “I would recommend local affiliates connect to the scientific bodies and patient advocacy groups, because an HTA body will also consult with those stakeholders,” Jurgen said.

The JCA process should also ensure involvement of patient groups and medical societies, the panel noted. Mihai added that during a recent HTA stakeholder network meeting, patients voiced their interest in being more involved, both in defining the rules of the process as well as in the assessments themselves.

Envisioning the long-term for the JCA

As with any new process, there will be a learning curve with the JCA, with potentially some redundancy at a local level to start with.

“There are opportunities to achieve significant efficiency gains in the long term by having HTA bodies specialize in different disease types and thus carrying out respective assessments in those disease areas on behalf of everyone else.”
Mihai Rotaru, Senior Manager Market Access, EFPIA

The panel noted that there needs to be a commitment to limit the number of PICOs that end up at the final JCA to ensure the process runs smoothly.

“PICOs should reflect the broader European clinical practice, so I would hope European organizations and medical sites collaborate to make sure there's consensus around clinical practice.”
Jurgen Huismans, Global Director Access & HTA Strategy, MSD

Mihai added that the JCA, coupled with Joint Scientific Consultations (JSC), has the potential to give Europe more say in the design of clinical development plans. The core objective of the JSC is to generate “robust evidence that satisfies the needs of both regulators and HTA bodies.”^viii

“There is that opportunity to use the JCA and JSC frameworks to build a stronger voice for Europe when it comes to how companies develop products,” he said.

Listen to the webinar to learn more about the JCA and what it will mean for industry.