Pharmacy Times, Volume 0, 0

Medicare rules giving Part D drug plansthe right to deny coverage for off-labelprescription drugs are unfairly limiting thetreatment options for millions of olderAmericans, critics of the program havecharged.

In opening fire on those restrictions,officials at the Medicare Rights Centersaid that many seniors are able to obtainrelief from pain or treat rare diseases bysecuring prescriptions for medicinesapproved by the FDA for other uses.Although this type of off-label drug use iswidely accepted by patients and theirphysicians, the Medicare rules close thedoor on this practice, the critics maintain.

According to officials at the MedicareRights Center, the off-label drugs mostcommonly denied by Part D insurersinclude painkillers such as oral transmucosalfentanyl citrate (Actiq) and fentanylbuccal tablet (Fentora), which have beenapproved for cancer-related pain but notfor other types; ondansetron HCl (Zofran),an antinausea medication approved forchemotherapy patients; and alosetron HCl(Lotronex), a bowel-syndrome drug thatthe FDA has approved for women but thatsome men also have found useful.

Critics of the Part D restrictions contendthat these rules have widespreadimplications for health care. According tothe Medicare Rights Center, of all US prescriptionswritten for the 500 most commonlyused prescription drugs, 1 in 5today is for off-label use.