Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Pomalyst. 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 Pomalyst. Pomalyst is requested to treat multiple myeloma in combination with Dexamethasone, Ixazomib and Clarithromycin.The enrollee with chronic lymphocytic leukemia and multiple myeloma. The enrollee has multiple myeloma progressing with a rising M protein, from 0.9 in 7/19, to 1.2 in 12/19 to 1.7 in 2/20. The multiple myeloma has been treated with Revlimid, Biaxin and Dexamethasone. The enrollee has had two autologous stem cell transplants. The enrollee did not tolerate Revlimid maintenance and it was stopped. He has also had Cytoxan, Bortezomib, and Velcade. The submitted records do not indicate The enrollee has been on treatment within the last 60 days. The prescriber requests Pomalyst to be given on a clinical trial at the clinical. That institution is an NCI designated cancer center. Therefore, the study is sponsored by a federally qualified agency. The prescriber states the drug is standard of care. Alternative treatment would include Daratumumab which would require an infusion port and would potentially cause unnecessary morbidity to the enrollee. An all oral combination is preferred.The use of Pomalyst is FDA approved for use, in combination with Dexamethasone, is indicated for patients with multiple myeloma who have received at least two prior therapies including Lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. The other CMS compendia also support the use only if the patient has had progression of disease during treatment or within 60 days of completion of most recent treatment.The enrollee has not had any treatment within the last 60 days. Therefore, the requested use does not meet the FDA use required by the Plan.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 not sufficiently addressed the Plan's coverage criteria and/or has 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 Pomalyst.