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Market Access Challenges for Rare Diseases

April 14, 2016 @ 10:00 - 11:00 UTC+0


Webinar Topic:

Market Access Challenges for Rare Diseases

Webinar Date/Time:

Thursday, April 14, 2016 at

10:00 am EDT (NYC, USA)

3:00 pm BST (London, UK)

4:00 pm CEST (Paris, FR)

Webinar Host:


Charles Makin, BSPharm, MS, MBA, MM - Vice President, Mapi Real World Strategy & Analytics (RWSA), Mapi Group

Charles has served as Principal Investigator on a large number of global retrospective database studies, registries, patient/physician surveys, systematic literature reviews, economic models, and value strategy development in many therapeutic areas, including cardiovascular, central nervous system, oncology, diabetes, respiratory, rheumatology, dermatology, infectious diseases and others. He has authored over 60 peer-reviewed manuscripts and scientific presentations.

Webinar Content:

  • 30 Minute PowerPoint Presentation
  • 30 Minute Question & Answer (Q&A) Session about Topic / Presentation

Webinar Description:

Orphan drugs often represent a problem for reimbursement decision-making, as they rarely meet the criteria of cost-effectiveness and evidence quality. The lack of an HTA process suitable to respond to the specificities of orphan drugs can result in restricted or delayed access to patients. Many national pricing and reimbursement systems have been criticized for not adapting their processes to address the specific challenges associated with orphan drugs. However, in recent years there has been a focus on a more fit-for-purpose approach involving amendments to existing processes and/or the creation of alternative processes in several European countries.

This webinar will provide an overview of some of the special considerations made in the HTA and reimbursement processes for orphan drugs in Europe.

Key Discussion Points:

  • Opportunities for early engagement with stakeholders, including clinical and economic evidence generation advice
  • The current reimbursement environment across the globe, including the US, EU, Japan, Korea and Taiwan
  • Country-specific orphan drug programs and information requirements
  • Existing challenges to reimbursement
  • Demonstrating cost-effectiveness/budget impact
  • Innovative schemes for reimbursement of orphan drugs

Limited Seats Available, Don't Delay! Register now:



April 14, 2016
10:00 - 11:00
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