Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sirolimus. 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 Sirolimus. The drug is requested for a 41 year old female with acute myeloid leukemia, status post allogenic hematopoietic stem cell transplantation (HSCT) (performed December 22, 2017) with chronic graft versus host disease (GVHD), which is an off-label (non-FDA approved) use. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the diagnoses and previous medications tried and failed.  The prescriber statement was returned.  The prescriber documented that the enrollee has significant ongoing GVHD with joints not responding to Tacrolimus and Prednisone.  The prescriber stated that the enrollee did not tolerate Tacrolimus (December 20, 2017-August 21, 2019) due to high blood pressure and cannot be on long-term Prednisone due to side effects. However, the Medicare-approved compendia do not contain any citations to support the use of the requested drug with Prednisone 15 mg daily, as prescribed, for treatment of the noted condition. 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.  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. In this case, the transplant was performed December 22, 2017. The enrollee's Part A entitlement was not effective until 2020. 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 no citations in the Medicare approved compendia that support the use of Sirolimus 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 Sirolimus.  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.