Pharmaceutical/Biotech, Market Access & HEOR, Global (non-specific)
- Health technology assessment challenges in assessing clinical and cost effectiveness of cell / gene therapies.
- Who pays? Healthcare system determinants of funding/reimbursement paradigm.
- Affordability: Pricing and budget impact challenges
W. Neil Palmer
President & Principal Consultant
PDCI Market Access Inc.
Pharmaceutical/Biotech, MedTech, Europe, Market Access & HEOR, Central Eastern Europe
- Regional diversities in approaches to public funding decision making.
- Comparative measures to enable informed allocation of company strategic efforts.
- Analysis of public funding decision making practice as a tool to identify risks and opportunities and to provide unbeatable arguments to CEE decision makers
Director, Market Access Consulting
Arcana Institute, Poland
Pharmaceutical/Biotech, Market Access & HEOR, Biosimilars
- Is differentiation possible or even necessary in the biosimilars market? Although the impetus for a biosimilar development originally might have been solely economic, we argue thatmmanufacturers should devise a value proposition for biosimilars that moves beyond price, demonstrating value to payers, physicians, and patients.
- Presenting a unifying value framework as a guiding tool for biosimilar manufacturers supporting internal processes - for example: Building internal business cases for differentiating concepts with the end goal to develop a value-enhancing strategy.
Boston Healthcare, USA
Pharmaceutical/Biotech, USA, Market Access & HEOR, Biosimilars
- The US is essentially a “secondary” market for biosimilars; as such, what can be learned from other markets?
- The business model for biosimilars, neither branded or generic products, is likely to be different in the US than in other markets, especially when it comes to pricing. How will business models be structured and operate?
- With only 5 applications and 1 approval to date, there isn’t yet a clear regulatory pathway for biosimilars in the US. What might that pathway look like when more fully developed?
- With originators of branded products making more defensive manoeuvres in the US than in other countries, lifecycle management of biosimilars is likely to be different in the US than elsewhere. What differences will there be?
Kathleen E. Hughes
Vice President, Avalere Health, USA
Pharmaceutical/Biotech, Europe, Market Access & HEOR
An interactive session exploring the lifecycle of a drug including:
- Comparison of regulatory and HTA agency clinical trial evaluations
- Impact of the label indications on the HTA review process
- HTA opinion on submitted evidence
Context Matters Inc., USA