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Coalition of patient and consumer groups calls for Legislative action to ensure access to 'Off-Label' drug treatment

WASHINGTON, Nov. 20 /PRNewswire-USNewswire/ -- Twenty-six patient, family caregiver and health professional organizations are calling upon Congress to pass legislation to require Medicare prescription drug plans to provide access to all medically accepted uses for the drugs they cover.

Medicare regulations exclude Part D coverage of a medication if it is prescribed for a use that is not on the Food and Drug Administration (FDA) label or supported by a citation in one of three specific medical compendia. In a sign-on letter to the Senate, the organizations wrote that the "exclusive reliance on FDA indications and a limited number of compendia prevents access to medically necessary, life-sustaining prescriptions."

Over 20 percent of the 500 most commonly prescribed drugs are used for off-label treatments. According to the letter, "People with cancer, HIV/AIDS, lupus, multiple sclerosis, debilitating pain, and mental health conditions, and other rare and serious conditions are routinely prescribed drugs off-label to manage disease symptoms and progression." The letter is available at http://www.medicarerights.org/maprxlettertobaucus.pdf

"We know of a number of people who have been hospitalized or been required to take other more expensive treatments because they did not have access to their prescribed medicines," said Andrew Sperling, Director of Legislative Advocacy, National Alliance on Mental Illness.

For specific cases and more information, see the Medicare Rights Center's report, "Off-Base: The Exclusion of Off-Label Prescriptions from Medicare Part D Coverage," available at http://www.medicarerights.org/Off-label_PartD_Coverage.pdf

Medicare's Part D regulations on off-label use are inconsistent with the more expansive Part B regulations, which allow for consideration of evidence of effectiveness in peer-reviewed literature in addition to the FDA label and the compendia. Part B's prescription drug coverage includes certain injectable cancer drugs and immunosuppressive drugs.

"As HIV clinicians, we are asking for the ability to present published data during the exceptions process that would demonstrate compelling evidence that an individual patient would benefit from treatments that cannot be covered by Medicare Part D programs under the current rules," said Bruce Williams, MD, MPH, a member of the HIV Medicine Association.

"Often the debilitating effects of HIV or its treatments are best treated with medications that may not have been approved specifically for people with HIV/AIDS or for a specific condition, despite strong evidentiary support for the use in the medical literature."

The sign-on letter specifically urges Congress to amend the Medicare statutes to make Part D coverage of off-label uses consistent with Part B, allowing for consideration of peer-reviewed literature in determining coverage.

Medical Access for Patients Rx (MAPRx), a coalition of patient, family caregiver and health professional organizations, is working with other allied groups to build support for a Congressional action on this issue.

 MAPRx is a coalition of patient, family caregiver and health professional organizations committed to safeguarding the well-being of patients with chronic diseases and disabilities under Medicare Prescription Drug Coverage. MAPRx member organizations collaborate with national and state policymakers to ensure that beneficiaries have the access to the medication therapies they need and deserve.