11 March 2010

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Oncology Final Determinations

Section 1861 of the Social Security Act established AHFS DI as an official compendium for determining medically accepted indications of drugs and biologics used in anti-cancer chemotherapeutic regimens under Medicare Part B.

A formal determination process has been developed to supplement the long-standing evidence-based process by AHFS for evaluation of off-label cancer uses of drugs and biologics.

A Final Determination Report for each off-label use will be published on the AHFS website and will reflect the consensus vote of the members of the AHFS Oncology Expert Committee.

  • Azacitidine (use in AML with multilineage dysplasia; elderly AML patients intolerant of induction therapy)
  • Bendamustine (use as first-line and salvage therapy for indolent non-Hodgkin's lymphoma and mantle cell lymphoma)
  • Bortezomib (use as first-line therapy for previously untreated multiple myeloma)
  • Cetuximab (use as first-line therapy in advanced-stage non-small cell lung cancer)
  • Lenalidomide (use in transfusion-dependent, low-or intermediate-1 risk MDS without the deletion 5q abnormality)
  • Levoleucovorin (use as first-line therapy for advanced-stage colorectal cancer)
  • Zoledronic Acid (use in preventing aromatase inhibitor-induced bone loss)