Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Zytiga. 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 Zytiga 500 mg; 60/30. The drug is requested to treat metastatic castration resistant prostate cancer (CRPC). The enrollee is a 75 year old man with metastatic prostate cancer involving bones. He has been treated with Lupron, Docetaxel and bilateral orchiectomy. His PSA is rising and bone scan shows progression of the cancer. He signed consent to participate in the CHAARTED-2 clinical trial which includes treatment with Zytiga, Prednisone and randomization to add Cabazitaxel or no additional drug. The prescriber requests Zytiga to be given with Prednisone to treat him. The prescriber states this is standard of care. Per the FDA website, Zytiga is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). Therefore the drug is being used for a medically accepted indication. There are no FDA contraindications to the use of the drug. The enrollee has tried and failed first line treatment with Docetaxel. The requested use is supported by the NCCN compendium. The enrollee is participating in a clinical trial sponsored by ECOG-ACRIN Cancer Research Group in collaboration with the National Cancer Institute. Therefore the trial meets the CMS rules for eligible coverage for drugs.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 satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Zytiga.We are dismissing the request for Prednisone. You requested an appeal of the Plan's unfavorable determination for coverage of Prednisone. Medicare rules do not allow us to review this case until you have completed all levels of appeal with the Plan.Medicare rules set forth the steps you must take when appealing a Part D plan's denial of coverage. If you do not agree with a coverage decision from the Plan, you must request that the Plan review this decision, and the Plan must issue a Coverage Determination. If you do not agree with the Plan's Coverage Determination, the next step is for you to request a Redetermination appeal from the Plan. The request for a Redetermination asks the Plan to reconsider the initial Coverage Determination. Both levels of appeal with the Plan must be completed before you can appeal to us. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination for Prednisone.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.