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Medicare expands options for use of off-label drugs

Medicare expands options for use of off-label drugs

ABSTRACT: Coverage parameters triple as Centers for Medicare & Medicaid Services sanctions three more compendia as acceptable for off-label use. Critics say that more choices may not lead to the best decision-making.

In the first of what will become an annual review process, the nation’s largest cancer-care payer has added three new formularies to its drug coverage policy, giving oncologists even greater ability to prescribe off -label cancer drugs.

Compendia changes are significant because at least 50% of all cancer treatments are off -label. Moreover, Medicare coverage decisions affect the behavior of private payers who frequently follow Centers for Medicare & Medicaid Services’ lead in crafting their own coverage policies.

“Th e expanded number of compendia by Medicare is welcome and provides evidence- based recommendations for cancer care,” said Joseph S. Bailes, MD, liaison for ASCO’s government relations council (see Table 1).

However, health economists worry that broadening coverage parameters will add to the dramatically rising costs of Medicare spending on Part B drugs, a category dominated by cancer drugs.

“The U.S. market appears to be able to tolerate virtually any price for the smallest of benefits, largely because everyone is paying with third-party dollars and because the pricing system is set up to reward doctors financially for using the most expensive therapies,” said Leonard Saltz, MD, professor of medicine at The New York Hospital- Cornell Medical Center and an attending physician at Memorial Sloan-Kettering Cancer Center, both in New York.

Fifteen-year struggle
Advocacy for expanded use of off-label drugs began 15 years ago when ASCO petitioned for passage of the 1993 Omnibus Budget Reconciliation Act requirement. Th e latter mandated that Medicare provide coverage for off -label cancer drugs if their use is supported by designated compendia.

Prior to the 1993 statute, Medicare did not cover drugs unless they were on FDA labeling for a specific indication, even if clinical trials had found them effective, Dr. Bailes told Oncology News International. “We spent a lot of time and energy to make sure people got access to cancer drugs that otherwise wouldn’t have been available,” he said.

Th e 1993 statute listed three compendia and gave the U.S. Department of Health and Human Services (HHS) authority to update the list. Since the statute was passed, only one of the original compendia, the American Hospital Formulary Service- Drug Information (AHFS-DI), is still in publication. Concerned that limiting coverage to a single compendium might constrain access to off -label drugs, ASCO and other groups lobbied CMS to recognize additional sources.


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