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Focus:HTA alignment, pricing and reimbursement impact, regulatory mechanics, and what "market readiness" really means under the EU HTA Regulation.
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How are recent policy developments influencing pricing dynamics and launch sequencing?
Are companies becoming more selective in where and when they launch, and how does this differ for rare & specialty products vs mass-market therapies?
How do you manage pricing risk across interconnected markets without compromising long-term value?
Real-world evidence has become central to the market access conversation — but does more evidence actually change what payers cover, or what they pay? Drawing on a career spanning federal health policy, healthcare cost research, and now leading data and analytics for a major US health plan, Niall Brennan offers a candid view from the other side of the table. He'll unpack which real-world evidence payers genuinely use and trust, where it moves coverage decisions and where it doesn't, and why — even in an era of abundant data and AI — the binding constraint on access remains price, not proof. Expect a frank, occasionally contrarian take on the limits of evidence as a substitute for structural reform, and what manufacturers routinely misread about how payers actually decide.
A 60-minute moderated roundtable begins with a short presentation of the Vaccines Europe study, followed by a discussion exploring:
· Why do vaccine assessment and access pathways differ from those for other medicinal products?
· Which differences are necessary to reflect the specific nature and value of vaccination, and which may contribute to avoidable delays?
· What should be done now to ensure implementation of the EU HTA Regulation is fit for purpose for vaccines?
· What can vaccine assessors learn from HTA of other medicinal products - and what should be approached differently?
· How should NITAG and HTA processes interact as vaccines move towards JCA scope in 2030?