AMA delegates vote for coverage of off-label drug use

Chicago -- Third-party payers, including Medicare, should be required to cover off-label uses of drugs that are supported by peer-reviewed literature, according to policy adopted by the American Medical Association at its Annual Meeting last month. The move came in reaction to reports that insurance companies were using Food and Drug Administration approvals to determine reimbursement -- despite the fact that off-label prescribing is legal and common.

"We do this all the time," said AMA Trustee Kevin C. Reilly Sr., MD. "It's very proper, and we need to be able get reimbursement for ourselves and our patients when we do use medicines appropriately."

The AMA also encouraged health plans to allow more choices in their formularies and called for protocols that would allow the use of non-formulary drugs, if the physician determines it appropriate. In addition, patients should not be switched to various drugs because of changes in the formulary, particularly if they are stable on one regimen.

"We want everyone to be safe and at the same time [medicines to be] cost-effective, and a proper functioning formulary system can do that," said Michael S. Ellis, MD, an otolaryngologist and delegate from Chalmette, La.

On the access side, the AMA will monitor drug patent issues to ensure that they do not interfere with the availability of cheaper alternatives. But the organization does not want to take away the financial incentive to develop new drugs that patent protection provides.

"In light of recent reforms to current legislation, it seems that it would be better for us to continue to monitor the situation rather than seek new legislation," said AMA Trustee Joseph M. Heyman, MD.

Also, to ease a patient's access to cheaper or even free medications, the AMA will urge pharmaceutical companies to create a uniform application process for their drug assistance programs. At the moment, the Pharmaceutical Researchers and Manufacturers of America runs a Web site to help patients and physicians find such programs, but it includes only the group's 48 member companies. The AMA called for an expanded version that would include all drug manufacturers as well as provide one application form for all.

"It seems that pharmaceutical companies want to have as many barriers to these programs as possible," said Charles F. Wilson, MD, a pediatrician and delegate from Greenville, N.C.

Safety first

To improve safety, the AMA reaffirmed its opposition to illegal drug sales, such as those involving counterfeiting or importation. The AMA also recommends that herbal supplements be labeled with any known adverse interactions with prescription products as well as a warning that as-yet-unknown reactions can occur.

"We know that some patients end up in emergency departments when they get some of these substances and have no idea of the interactions with prescribed medications," said Melvyn L. Sterling, MD, an internist and delegate from Orange, Calif. "Patients deserve to have this information."

In terms of supply issues, delegates directed the Association to seek laws requiring pharmaceutical companies to provide notification of any supply interruptions.

"There are a lot of drug shortages, and there's no advance warning," said Roy G. Soto, MD, an alternate delegate from the American Society of Anesthesiologists. "It's very difficult for us to know what drugs are going to be available at what time."

The FDA monitors drug supply issues and makes note of any shortages on its Web site. Participation by manufacturers is currently voluntary.