Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Abiraterone Acetate 250 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 Abiraterone acetate 250 mg. Abiraterone is requested to treat castration sensitive, non-metastatic prostate cancer.The enrollee is an 86-year-old man with very high risk, high-grade non-metastatic prostate cancer. The tumor is stage T3-T4 and Gleason's grade 9. Bone scan was negative in 10/19. MRI showed extra-prostatic extension and no involved nodes. He has been started on Lupron and Bicalutamide and has completed radiation therapy. The prescriber requests Abiraterone to treat him per the STAMPEDE trial results cited in the NEJM 2017; 377: 338-51. The prescriber requests Abiraterone acetate to be given with Prednisone and Lupron. In response to inquiry, the prescriber states the enrollee has an estimated life expectancy of 5.5 years by life expectancy tables. He has symptoms of bothersome lower urinary tract symptoms of nocturia. The prescriber states the requested treatment is the only documented treatment of improved overall survival and failure free survival for him.Per the NCCN compendium, Abiraterone acetate is used in combination with Prednisone or Methylprednisolone* and an LHRH agonist or LHRH antagonist with or without external beam radiation therapy (EBRT) as initial therapy for patients in the regional risk group if life expectancy >5 years or symptomatic.In this reviewer's opinion, the requested use is part of initial therapy. The prescriber states the enrollee has symptoms and an expected survival of over 5 years. Therefore, the requested use meets a medically accepted use. The prescriber has indicated it is the only treatment with the efficacy to improve overall and freedom from recurrence.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. However, 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 Abiraterone Acetate 250 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.