Teenage Wasteland: Paying for New Drugs and Other "Adolescent" Technologies
This article was originally published in RPM Report
Executive Summary
The debate over comparative effectiveness research has focused heavily on standards of evidence to judge the relative value of different therapies and standards for when and how conclusions should drive coverage policy. Less attention has been paid to a more fundamental question: when should the value determination be made. CMS’ top coverage official has an idea that would radically change that process.
You may also be interested in...
CMS Takes A Look At Alzheimer’s With Lilly's Amyvid In Mind
The Alzheimer’s drug Amyvid received FDA approval for a narrower indication than the sponsors originally wanted. The limited indication got the imaging agent to market, but now Amyvid faces another challenge on the reimbursement front.
Carving-In Innovation: Payment Reform and Biopharma
When it comes to health care reform, Democrats and Republicans don’t appear to agree on very much. But during a BIO annual meeting session, three key policymakers representing both sides of the aisle in the Senate and the Obama Administration did agree on one thing: it is time for industry to stop asking to be “carved out” of new payment systems, and to start proving the value of its products.
Accelerated Withdrawal in Action: The Avastin Hearing Process
The June hearing on the status of Genentech’s metastatic breast cancer indication for Avastin will focus on a long list of substantive disagreements about the data. But any sponsor interested in the future of the accelerated approval process should study the back-and-forth in the hearing process itself.