Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tacrolimus . 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 Tacrolimus 1 mg.The drug is requested to treat red cell aplasia and large granular lymphocytic leukemia, which is an off-label (non-FDA approved) use.The enrollee is a 70 year old woman with a history of breast cancer. She was diagnosed in 2019 with T cell large lymphocytic leukemia with red cell aplasia. She has been treated with Aranesp, Prednisone, transfusions and Cyclosporine. She experienced severe side effects from Prednisone so she was tapered from it. Cyclosporine was titrated by blood levels. She continues to require weekly transfusions. Blood counts on 1/6/20 were white count 13,200, hemoglobin 7.9, hematocrit 24% and platelets 325,000. The prescriber requests Tacrolimus to treat her. Articles from non-CMS approved journals were submitted in support of the request and were reviewed. The article by Balasubramanian et al reflects a heterogeneous treatment group and does not isolate patients treated with Tacrolimus from those treated with Cyclosporine. The article by Yabe et al does not reflect the enrollee's clinical situation.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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Tacrolimus 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 Tacrolimus. 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.