Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Jakafi. 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 Jakafi 10 mg.   The drug is requested to treat large cell non-Hodgkin's lymphoma (NHL) and hemaphagocytic lymphohistiocytosis, which is an off-label (non-FDA approved) use.  The enrollee is a 72 year old woman with comorbidities and a history of large cell NHL of the lung.  She was treated with Rituximab, Cytoxan, Vincristine, and Prednisone.  PET scan on 6/17/20 showed evidence of worsening of the lymphoma in the spleen.   She developed fevers, splenomegaly, elevated ferritin, elevated triglycerides and elevated liver enzymes, low fibrinogen, elevated soluble interleukin-2 and -6 and pancytopenia. She was diagnosed with hemophagocytic lymphohistiocytosis. She was treated with IVIG and high dose Prednisone. She initially improved and then had recurrence.  Laboratory on 8/18: ferritin 926 (normal 13-150), LDH 285 (normal 135-214), AST 76 (normal 15-46), ALT 112 (normal 9-52), platelets 76,000 (normal 140,000-400,000).  The prescriber requests Jakafi to be given with Prednisone to treat her. Journal articles were submitted in support of the request and were reviewed.  The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 Jakafi 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 Jakafi.  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.