Industry Seeks CMS Guidance On Preclinical Meetings, Trial Design
This article was originally published in The Pink Sheet Daily
Guidance on trial designs and communications between industry and CMS in the early stages of product development would clarify what evidence will be needed for national coverage decisions, Amgen and Guidant reps say. Such meetings may need to occur as early as the preclinical stage.
You may also be interested in...
The council will establish two working groups: the "Better Evidence" group will focus on improving clinical data available for coverage decisions and the "Effective Innovation" group will develop ways to improve the efficiency of the coverage decision process. CMS' Herbert Kuhn and Sean Tunis will co-chair the council.
The cardiologist panel calls for use of the congestive heart failure therapy to be "strictly limited" to patients that present with symptoms in the hospital setting. The expert panel also recommends that Scios "immediately undertake" a professional educational campaign about Natrecor's appropriate uses.
Following the June 6 bid submission deadline, CMS expects to have multiple drug plans in every region. Administrator McClellan declines to provide exact number of Part D bids.