EU HTAR – Achieving broad access fast
Herbert Altmann, Vice President, Market Access and Healthcare Consulting for Europe at Cencora, recently moderated a panel discussion about the essential healthcare system requirements and policies for accelerating patient access to groundbreaking medicines under the EU HTAR, in a webinar hosted by The Evidence Base.
Panelists Iga Lipska, Chairwoman of the Board, Health Policy Institute Poland; François Meyer, Independent Consultant; and Oriol Solà-Morales CEO, Fundació HiTT joined Altmann in discussing how innovative medicines can succeed under the new EU HTAR.
Excerpts from their discussion are below. To learn more, listen to the full webinar here: "EU HTA - Achieving broad access fast! What will it take for innovative medicines to succeed?".
Moderator
Speaker
Speaker
François Meyer
Independent Consultant
Speaker
Successfully managing the EU HTAR
The EU HTAR was created to speed equal patient access to innovative products while adhering to the utmost quality standards. Key objectives include efficiently using resources, strengthening HTA, and improving transparency and inclusiveness.
“All stakeholders need to be prepared, including pharmaceutical companies, patients, clinicians, and regulatory bodies. People also need to be open to collaboration and learning from others,” Lipska said.
In terms of resources, managing the EU HTAR frame successfully may be just as hard for big pharma as it is for small and midsized companies. Although big companies may have more resources, including local affiliates with insights into each country, they may not be able to adapt as quickly as smaller, nimbler companies, Solà-Morales noted.
For pharma manufacturers, success largely depends on early engagement in the Joint Scientific Consultation (JSC) phase, preparing for the JSC process, getting internally equipped for potential PICOs (Population, Intervention, Comparator, Outcome) component, and working through the national “delta dossier” and pricing and reimbursement processes, which are still in the member states' responsibility.
"To have the opportunity for a joint scientific consultation (JSC) should make the work much easier for everybody, including the HTA bodies and the edge health technology developers, since the pharma companies will get useful insight on what the PICOs will be when they submit the dossier a couple of years later.," Meyer said.
Altmann said, “The JSC process should be done before phase 3 clinical trials start. With that the internal clinical team better understands the external requests and requirements for successfully going through the marketing authorization and JCA processes, which will start at a certain point of time in parallel. After finishing the EMA approval, a JCA report should be received from EU HTA CG (Coordination Group) no more than 30 days later, which will be included in all member states’ national ‘delta dossier’ process."
Leveraging JCA reports
National differences in healthcare systems and treatment guidelines could eventually lead to extensive PICO criteria within the JCA process, for example. Adapting from one country to the next can help a manufacturer enter multiple markets more quickly.
“There will be a lot of method harmonization, which for most countries will be welcomed. It's not only beneficial for the countries but also for the manufacturers because they will be able to anticipate what they need to prepare,” he continued.
Collaboration boosts efficiency for manufacturers, member states, healthcare systems, and industry stakeholders.” If it's only a top-down process, it will be perceived as an imposed process. But with a bottom-up approach people can feel empowered to collaborate and discuss issues with their peers and the broader establishment,” Solà-Morales said, pointing to the consistencies that conversations between manufacturers and HTA agencies can create between countries, for example.
The EU HTAR has been designed to get innovative medicines to patients faster and more equitably—and could well do so. "The HTA is moving forward rapidly. So it's very important to be active in all the processes," Lipska said.
Pharma manufacturers can help more patients sooner if they adapt to the evolving regulatory landscape. That starts with understanding the transformative shift in how medicines are evaluated and approved that the EU HTAR has brought about.
For more information on how to achieve broad access to innovative medicines, listen to the full webinar here: "EU HTA - Achieving broad access fast! What will it take for innovative medicines to succeed?".
Sources
1Joint Clinical Assessments. European Commission Public Health. Available online at https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en
2Walker, Joanne. European Union ushers in new era in health technology assessment as new regulation comes into force. 13 January 2025. Available online at https://becarispublishing.com/digital-content/blog-post/european-union-ushers-new-era-health-technology-assessment-new-regulation-comes-into
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