Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Xtandi. 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 Xtandi 40 mg; 120 per 30 days. The drug is requested to treat prostate cancer. The enrollee is a 68 year old man with recurrent prostate cancer. He was treated with surgery. Due to rising PSA he had salvage radiation. He was then treated with intermittent Casodex and unspecified LH-RH analogs. His PSA continued to rise and he was started on Xtandi with a drop in the PSA to <0.03. You are requesting continuation of Xtandi to be given with ongoing Leuprolide. The drug was denied due to the drug being supplied on a patient assistance program. You stated the enrollee is no longer receiving the drug through a patient assistance program.Per the FDA website, Xtandi is indicated for the treatment of patients with: - castration-resistant prostate cancer (CRPC). The enrollee had rising PSA on anti-androgen therapy with Casodex and LH-RH analogs. Therefore he has castration resistant disease. He will continue to receive Leuprolide, a type of androgen deprivation therapy, every 3 months.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.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Xtandi for the diagnosed condition. As a result, Xtandi is being prescribed for a medically accepted indication as defined by Medicare law.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 Xtandi.Please note, the Part D Plan has indicated that the enrollee is currently receiving coverage under a Pharmaceutical Assistance Program (PAP). Beginning when a beneficiary's assistance under a PAP is effective (and for as long as the beneficiary remains eligible for PAP assistance), a claim for a drug for which a PAP has provided assistance will never be submitted to a beneficiary's Part D plan. Prospective coverage of a Part D drug is a separate and distinct issue from coordination of benefit with a PAP (which is considered a retrospective or reimbursement issue). The Part D Plan has agreed to provide prospective coverage for the requested drug according to Plan rules. There is no indication that the enrollee has purchased the requested drug. Therefore, coordination with a PAP in this case will not be addressed by MAXIMUS.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.