Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Imatinib Mesylate. Our Physician Reviewer determined that criteria for coverage were met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that the requested drug is not being prescribed to treat a medically accepted indication. We reopened this case to address the Plan's argument.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Imatinib mesylate 400 mg tablet. Imatinib mesylate is requested to treat chronic graft vs host disease (cGVHD). The enrollee is a 57-year-old man with cGVHD after matched unrelated donor stem cell transplant to treat lymphoma. He has been treated with Tacrolimus, Prednisone, Ibrutinib, Ruxolitinib, Cellcept, Sirolimus, light therapy and artificial tears. He continues to have progression of the disease affecting his eyes and sclerodermatoid skin changes. His right fingers are swollen and uncomfortable. They will not fully flex or extend. His ankles are also worse and inhibit stretching but not walking. The prescriber requests Imatinib mesylate to treat him. The enrollee is taking steroids.The prescriber states he has tried multiple drugs. The use of this drug is for a treatment of a disease directly related to his cancer treatment. Therefore, this reviewer used the CMS compendia for cancer treatments. The NCCN compendium lists Imatinib mesylate for use in cGVHD: For chronic graft-versus-host disease (GVHD) as additional therapy in conjunction with systemic corticosteroids following no response (steroid-refractory disease) to first-line therapy options. The enrollee has had progressive cGVHD despite multiple immunosuppressants. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee does not satisfy the Plan's coverage criteria. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Plan is required to cover Imatinib Mesylate.This decision affirms our previous favorable decision.