Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Imatinib Mesylate, 100 mg tablet, 30 per 30 days. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Imatinib, 100 mg tablet, 30/30.The drug is requested to treat graft vs host disease (GVHD) or myelodysplastic syndrome (MDS) in remission and without a PDGFR rearrangement, which is an off-label (non-FDA approved) use. The enrollee is a 70 year old man with MDS treated in 2017 with a matched unrelated donor marrow transplant and then with Vidaza. He is currently in complete remission. His blood counts on 7/15/20: white blood count 7,400, hemoglobin 13.5 and platelets 494,000. He developed GVHD due to the transplant. It has been treated with Prograf, Triamcinolone cream, Sirolimus, Cellcept and PUVA therapy. He now has sclerodermatous involvement. He has erythematous, hyperkeratotic lesions of palms and soles, tightening of skin with erythema along the abdomen and lateral chest wall. The prescriber first requested Imatinib to treat the GVHD in combination with Rituxan. On appeal the prescriber stated the diagnosis is MDS. An article from a non-CMS journal reporting 2 cases of Imatinib for GVHD was submitted and reviewed. The use of Imatinib is not FDA approved or supported in any of the compendia for GVHD. The use for MDS is FDA approved for adult patients with myelodysplastic/myeloproliferative diseases associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test. There is no information that the enrollee has active MDS or that his MDS has the required genetic changes. And the FDA use for MDS does not include Rituxan. Therefore, in the opinion of this reviewer the requested use is not a medically accepted use for either of the enrollee's diagnoses.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia or peer-reviewed medical literature in CMS-approved journals or publications. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Imatinib Mesylate, 100 mg tablet, 30 per 30 days for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Imatinib Mesylate, 100 mg tablet, 30 per 30 days. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.