Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Iclusig 15 mg tablet. 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 Iclusig 15 mg, 30 tablets per 30 days. The drug is requested to treat Philadelphia chromosome positive acute lymphoblastic leukemia (ALL).The enrollee is a 71-year-old woman with ALL that has been treated with Vincristine, Dexamethasone, Dasatinib (Sprycel), intrathecal ARA-C and Methotrexate and with Imatinib. She did not tolerate the Imatinib (Gleevec) due to terrible diarrhea alternating with constipation and worsening of her chronic nausea. After achieving remission, she now has low lever BCR ABL positivity. Her leukemia is not T3151-positive. The prescriber requests Iclusig to treat her. In response to inquiry, the prescriber states she could not be treated with Nilotinib or Bosutinib as they have not been adequately studied in Philadelphia chromosome positive ALL.Per the FDA website, Iclusig is indicated for treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated. The enrollee has been treated with two (2) TKI agents: Dasatinib and Imatinib. The prescriber states other TKIs are not indicated. Therefore, she meets the Plan's prior authorization criteria.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 satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. 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. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Iclusig 15 mg tablet for the diagnosed condition. As a result, Iclusig 15 mg tablet is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Iclusig 15 mg tablet.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.