Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tibsovo. 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 Tibsovo 250 mg. The drug is requested to treat oligodendroglioma, which is an off-label (non-FDA approved) use.The enrollee is a 32-year-old woman with recurrent oligodendroglioma. She has been treated with surgery, radiation, Dexamethasone, Gleostine and Temozolomide. Her MRI on 1/7/20 showed 1.A new focus of suspicious nodular enhancement at the right anterior frontal cerebral convexity. Additional suspicious nodular enhancement at the posterior-inferior aspect of the right frontal resection cavity. 2. New large fluid and blood containing collection within the right frontal resection cavity. Her tumor has an IDH1 mutation by Caris testing which suggests possible response to Tibsovo. The prescriber requests Tibsovo to treat her. A press release was submitted in support of the request. The press release describes a meeting abstract of early results of an ongoing clinical trial.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. This reviewer did not find any supporting citations in a PubMed search. 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 Tibsovo 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 Tibsovo. 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.