Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Imatinib Mesylate 100 mg. 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 Mesylate 100 mg, 30/30. The drug is requested to treat chronic phase chronic myelogenous leukemia (CML).The enrollee is a 64-year-old man with multiple comorbidities and CML. He was diagnosed with CML in 2012. He has been treated with Imatinib mesylate which was not tolerated at full doses, so he was treated with Dasatinib which caused what sounds like pleural effusions. Nilotinib was intolerable. He has also been treated with 200 mg of Imatinib Mesylate for about a year. His bone marrow in 2017 showed 1% BCR-ABL and conventional cytogenetics showed a 1 of 20 metaphases with an isolated t(9;22). BCR-ABL testing was negative in 2017. Bosutinib caused nausea, vomiting and diarrhea requiring hospitalization. The prescriber requests Imatinib mesylate to treat him. He will get reduced dosage due to renal insufficiency. He submitted page CML-2 from the NCCN Guidelines Version 3.2020 in support of the request.Per the FDA website, the drug is indicated for newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.The enrollee's CML is positive for BCR-ABL, the Philadelphia chromosome. The documentation does not indicate he has had failure of response to Imatinib nor progression of the CML. There have been multiple drug changes in an attempt to find a regimen he will tolerate. Therefore, in this reviewer's opinion, the request is to treat the enrollee for chronic phase, Philadelphia chromosome positive as continued effort to treat newly diagnosed CML.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 Imatinib Mesylate 100 mg for the diagnosed condition. As a result, Imatinib Mesylate 100 mg 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 Imatinib Mesylate 100 mg.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.