Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nulojix. 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 Nulojix is needed for a kidney transplant performed April 9, 2020. 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 are unable to verify that coverage for the requested drug would be available for coverage under Medicare Part B. Therefore, it appears that Nulojix may be eligible for Part D coverage. We asked our Physician Reviewer to determine if other Part D coverage criteria are met.Our Physician Reviewer thoroughly reviewed the case record to determine whether the Part D Plan was correct in denying the request for Nulojix 250 mg.The drug is requested to treat kidney transplant in the absence of Basiliximab induction, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the formulary alternatives and to clarify the enrollee's transplant regimen. The prescriber states that the enrollee did not receive Basiliximab induction. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.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 no citations in the Medicare approved compendia that support the use of Nulojix for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Nulojix. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.