Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tafinlar. 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 Tafinlar. The drug is requested to treat hairy cell leukemia (HCL), which is an off-label (non-FDA approved) use.The enrollee is a 58-year-old man with hairy cell leukemia with multiple relapses. He also has a history of osteosarcoma treated with surgery, Doxorubicin, Cisplatin, Etoposide and Ifosfamide. He has had multiple infections His HCL has been treated with Chlorambucil, splenectomy, Interferon, Caldribine, Vemurafenib, Rituximab, transfusions, GCSF, and Moxetumumab. Vemurafenib had to be stopped due to severe rash. He did appear to respond to the drug despite a short time on it. Bone marrow on 1/2/20 showed 95% involvement. Treatment options were discussed including Interferon, Ibrutinib, Pentostatin and Caldribine. Due to cytopenias and previous infections there is concern about those treatments. The prescriber states that over 95% of HCL has BRAF V600E mutation. The prescriber requests Tafinlar to treat him. Citations from the medical literature were submitted in support of the request. The citation from the New England J of Medicine relates to a different drug. The other 2 were case reports which Medicare rules do not permit to be used to determine medically accepted 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. 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 Tafinlar 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 Tafinlar. 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.