Medicare Expands Options for Off-Label Use

Press

A portion of the quote below, provided to Ron Piana at Oncology News International, was used in this story and can be found here at Medicare Expands Options for Off-Label Use

The CMS action has garnered plaudits not only from major cancer organizations but also from watch-dog groups like Accelerate Progress, who view FDA’s ultraconservative drug approval process as a barrier to cancer care for desperately ill people, according to Scott Riccio, Accelerate Progress executive director.

Mr. Riccio told Oncology News International that “we believe that expanding the meaningful and effective use of off -label drugs is driven, in part, by appropriate reimbursement from CMS. Appropriate off -label use of cancer drugs will be fostered by more, not less, communication of clear actionable information.”

For additional context, the full quote provided read as follows:

“Accelerate Progress believes that expanding the meaningful and effective use of off-labels drugs is driven, in part, by appropriate reimbursement from CMS.  A great deal of our learning about what drugs work for which patients and which dosing schedule and multi-drug combinations are most effective for each individual takes place after drugs are approved by FDA and available to oncologists.  These oncologists are a well-networked group and, as health IT improves, they are increasingly effective at communicating their learnings to colleagues to help quickly inform new treatment paradigms for particular patients or patient groups.  Appropriate off-label use that informs improvements in individual patient care will be fostered by more, not less, communication of clear, truthful, and actionable information.

Our analysis of the entire drug-to-patient system indicates that accelerating this post-approval learning while enhancing the IT infrastructure and tissue-banking initiatives necessary to support sharing of learning and communication of both safety and efficacy data is one key component of driving meaningful progress to patients more quickly and effectively.  This important step, however, is limited in its effectiveness by the number of safe and effective options available to oncologists for use which means that we also need to be addressing the poor output (the so-called “Valley of Death") from the development and regulatory pipeline that delivers such limited options to oncologists.”

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