Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Azathioprine and Astagraf XL as prescribed. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the transplant was paid for by Medicare Part A. The case record indicates that Azathioprine and Astagraf XL are needed for a kidney transplant performed February 10, 2014. In this case, we requested additional information from the Part D Plan. We requested the evidence the Plan used to determine that the transplant was paid for by Medicare. We received a response from the Part D Plan; however, there is insufficient information to show that the transplant was paid for by Medicare. Based on the available information we cannot verify that coverage for the requested drugs would be available for coverage under Medicare Part B. Therefore, it appears that Azathioprine and Astagraf XL may be eligible for Part D coverage. We asked our Physician Reviewer to determine if other Part D coverage criteria are met.Azathioprine is requested for prophylaxis of renal transplant rejection. The enrollee satisfies the Plan's coverage criteria.Our Physician Reviewer's opinion is that prior authorization criteria for Azathioprine are met.Astagraf XL is requested for prophylaxis of renal transplant rejection. The prescriber sent a statement dated 3/18/2020 clarifying the medical history. The prescriber states that the enrollee requires a Tacrolimus-based therapy. The enrollee has tried and failed immediate release Tacrolimus, including Tacrolimus 0.5 mg, 1 mg, and 5 mg capsules. The prescriber states the enrollee must receive an extended release product to ensure adherence and consistent drug levels. The enrollee's trough tacrolimus levels are consistent and stable on his current regimen of extended-release Tacrolimus. His tacrolimus levels on immediate release product were inconsistent. 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 formulary exception criteria for Astagraf XL are met.Regarding the request for Azathioprine: 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 Azathioprine. Regarding the request for Astagraf XL: A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore, the Plan is required to cover Astagraf XL.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.