Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Promacta 75 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 Promacta 75 mg tablet. Promacta 75 mg tablet is requested to treat thrombocytopenia in this enrollee with acute myeloid leukemia who is status post bone marrow transplant with delayed engraftment. Extensive medical records were submitted to the Plan; the Plan denied coverage of Promacta because they concluded that it is not being prescribed for a medically accepted indication as defined by Medicare for this enrollee.The documentation indicates that the enrollee has had pancytopenia following bone marrow transplant treated with multiple transfusions and double growth factor (Leukine and Granix). A bone marrow biopsy on day 23 following transplant revealed marked hypocellular bone marrow (5%), trace trilineage hematopoiesis, increased iron stores, and no malignancy. You have indicated that the enrollee's marrow is presenting like aplastic anemia; therefore has prescribed the requested drug. Aplastic anemia refers to pancytopenia in association with bone marrow hypoplasia/aplasia in the absence of an abnormal infiltrate or marrow fibrosis. Aplastic anemia can be a temporary side effect of chemotherapy/radiation therapy. 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. DRUGDEX notes the following in the Adult Dosing section for the requested drug (quick answers view only): Orphan drug designation: Treatment of aplastic anemia. The orphan drug designation is not limited to a particular cause of aplastic anemia, nor is it limited to use in combination with or after failure of immunosuppressive therapy. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. You have 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 Promacta 75 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.