Medicare looking for health benefits in reimbursing off-label use

The Centers for Medicare and Medicaid Services announced last week that it will begin reimbursement for an off-label use of Visudyne (verteporfin for injection, Novartis) photodynamic therapy for treatment of age-related macular degeneration.

According to an article in the Boston Globe, this move may signify a change of direction for the agency, which previously covered off-label prescriptions based solely on a physician’s judgment. CMS is now beginning to look at clinical trial data itself, in addition to the physician’s judgment, and is not necessarily agreeing with the Food and Drug Administration regarding use of drugs, the article said.

In this instance, the FDA has not yet approved the use of Visudyne to treat subfoveal occult with no classic or minimally classic choroidal neovascularization, but CMS has agreed to pay doctors for this indication.

CMS is also beginning to scrutinize coverage for off-label uses of several cancer drugs, the paper reported, to determine whether payment for those non-approved uses should continue. According to interviews with CMS employees reported in the Globe, the agency began reviewing physician prescribing habits based on “non-clinical concerns.”

Head-to-head trials within similar classes of drugs to determine which is the most cost-effective are also supported by CMS, according to the article.