Medicare has expanded patient access to cancer treatments to include automatic coverage for a broader range of off-label uses for the drugs. The new policy, which took effect in November and was reported by The New York Times on Tuesday, increased the number of compendia that Medicare consults to determine which off-label drug uses should be covered from one guide to four.

The new policy obliges Medicare to pay for a cancer treatment as long as at least one compendium recommends its use, though the agency would not be required to cover a particular cancer drug if other guides specifically advised against it. Peter Ashkenaz, a spokesman for Medicare, stated that a drug’s inclusion in the compendia does not mean it will automatically be covered; doctors will be required to show that the prescribed drug is both “reasonable and necessary.”

However, a draft report commissioned by Medicare last year criticises the new rules for taking decisions about off-label use of medications out of Medicare’s purview and allowing compendium recommendations to become “the final word.” A final version of the draft document is expected to be released shortly.

Among the treatments most likely to benefit from the changes is Roche’s and Genentech’s Avastin (bevacizumab), which is expected to be routinely covered for ovarian cancer, as well as brain and kidney cancer. Eli Lilly’s Gemzar (gemcitabine), approved by the FDA for four types of cancer, is now expected to be covered by Medicare for use in nearly a dozen other forms, including cervical cancer.

Commenting on the Medicare policy changes, a spokesperson for PhRMA said the new rules ensure “that cancer patients have access to the treatments they need.” The American Society of Clinical Oncology also welcomed the new rules, saying the group will ensure that off-label prescribing will be done appropriately.

Source: FirstWord

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