Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Venclexta. 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 Venclexta.Venclexta is requested to treat acute myeloid leukemia (AML). The enrollee is a 73 year old woman with a history of breast cancers, carcinoid tumor of lung and thyroid cancer, retinitis pigmentosa and morbid obesity. She presented with fatigue and cytopenias and was diagnosed with myelodysplastic syndrome (MDS). The marrow report indicates it is evolving to AML. Your prescriber's note indicates that flow showed 25% blasts. There are multiple chromosomal abnormalities including deletions of chromosomes 5,7 and 20 and abnormalities of chromosomes 17 and 22. There is no history of severe cardiac or pulmonary comorbidity. She has no history of moderate hepatic impairment or creatinine clearance less than 45 ml/min. There are two copies of an office note of June 8, 2020. One was signed June 15, 2020 and states her ECOG performance status is 1. The other was signed June 22, 2020 and states her ECOG performance status is 2. The appeal indicates her ECOG performance status is 2 due to blindness. She has been treated with transfusions of red cells and platelets and has had a cycle of Vidaza. You request Venclexta to be given with Vidaza to treat her.Per NCCN recommends Venclexta for patients age 60 years and older in combination with Decitabine, Azacitidine, or low-dose Cytarabine for treatment induction in candidates for intensive remission induction therapy with unfavorable-risk cytogenetics (exclusive of AML-MRC) and treatment induction in patients who are not a candidate for intensive remission induction therapy or decline intensive therapy (preferred option in patients who have AML without actionable mutations). Therefore the enrollee has a medically accepted indication for the use of the drug.The enrollee does not meet the Plan's prior authorization criteria. There is a discrepancy of the ECOG performance status that was changed at the time of denial of the drug. 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. You have not sufficiently addressed the Plan's coverage criteria and/or have not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor 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 not met. Therefore, the Plan is not required to cover Venclexta.