Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Cresemba. 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 Cresemba 186 mg capsule. Cresemba is requested to treat the enrollee's condition. A reopening was requested by the Plan, challenging Maximus' decision. The enrollee is a 69-year-old woman with acute myelogenous leukemia (AML) who has had prolonged neutropenia due to chemotherapy which includes Gilteritinb. She has had fevers and a left lung infiltrate. She has been treated with antibiotics and Fluconazole, an anti-fungal. She has a history of mucocutaneous Candidiasis and documented GI Candida albicans colonization. The lung infiltrate was brushed and washed on bronchoscopy with no specific findings. The infectious disease consultant states she has presumptive Candida pneumonia that did not respond to Fluconazole. She was started on Cresemba in the hospital with stabilization of the lung findings and improvement in clinical status.She will be able to be discharged. Other antifungals would have a drug-drug interaction with her chemotherapy putting her at high risk for atrial fibrillation. The prescriber requests Cresemba to continue to treat her. Per Drug-dex, Cresemba has an orphan drug designation for treatment of invasive candidiasis/candidemia. Orphan drug designation is considered a medically accepted use by CMS. In the opinion of this reviewer, the diagnosis of Candida pneumonia is clinically justified based on the clinical course of illness including known colonization of the GI tract. The prescriber has adequately indicated why alternative drugs have a risk of toxicity due to drug-drug interactions. 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 Cresemba.This decision affirms our previous favorable decision.