Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Nulojix 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 Nulojix 250 mg. Nulojix 250 mg, for intravenous administration at home, is requested for prevention of renal transplant rejection. It is noted that the enrollee developed acute tubular necrosis of her transplanted kidney related to Tacrolimus toxicity; therefore, her regimen for immunosuppression was changed to include the requested drug and Sirolimus. The Plan denied coverage because they determined that the requested drug is eligible for coverage under Medicare Part B; however per the Medicare Part B coverage guidelines, the requested drug is not eligible for coverage under Medicare Part B when administered at home. 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, a Medicare approved compendium, has noted in its Adult Dosing Section for the requested drug (Quick Answers view only) that there is an Orphan Drug Designation for prophylaxis of organ rejection in renal allograft recipients without stipulation of any other conditions. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee satisfies the Plan's coverage criteria which only requires Medicare Part B vs D determination. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant. Medicare Part B will not provide coverage for Nulojix (Belatacept) for at home administration. In this case, Nulojix is being administered at home. Therefore, it is not eligible for coverage under Medicare Part B and we sent the request to our physician reviewer to review for coverage under Medicare Part D.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 Nulojix for the diagnosed condition. As a result, Nulojix 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 Nulojix.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.