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ISPOR 11th Annual International Meeting
May 15-18,
2005, Marriott Wardman Park Hotel, Washington, DC
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ISSUE PANEL PROPOSAL EXAMPLE |
SHOULD MANUFACTURERS CONSULT WITH CMS STAFF ON THE PHASE III STUDY DESIGN, AS CMS IS NOW REQUESTING?
MODERATOR: Diane Simison PhD, Executive Director, MEDTAP Center for
Pricing and Reimbursement, Arlington, VA USA
PANELISTS: Steve Phurrough MD, MPA, Director, Coverage
Analysis Group, Centers for Medicare and Medicaid Services, Baltimore, MD
USA; Beth A. Hahn PhD, Managing Director, MEDTAP Center for Pricing
and Reimbursement, Arlington, VA USA
ISSUES: Should manufacturers consult with CMS staff on the Phase
III study design, as CMS is now requesting?
OVERVIEW: For those new technologies for which the manufacturer
wishes Medicare coverage, CMS has requested that manufacturers meet with
CMS officials to discuss the Phase III trial design. This will ensure that
CMS requirements can be considered in various aspects of design, such as
patient inclusion and exclusion criteria, and other design elements.
Technology sponsors may resist this request for a variety of reasons
including increased timelines, possible conflicting opinions with FDA, and
increased resource requirements. This issue panel is to debate the reasons
behind both perspectives. |
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11th Annual International Meeting
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