Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Balversa, 5 mg tablet. 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 Balversa 5 mg; 30/30.The drug is requested to treat prostate cancer, which is an off-label (non-FDA approved) use. The enrollee is a 73 year old man with prostate cancer. He has progressed on hormonal therapy including Enzalutamide and Leuprolide and Docetaxel and radiation. The prescriber states he has progressed through all standard treatments for prostate cancer. His tumor has a BRCA2 mutation. It also has a FGFR1 amplification by Guardant 360 testing, which is not an FDA approved test for this drug. The prescriber requests Balversa to treat him based on the FGFR1 mutation.The submitted documents indicate that Lynparza was approved for the enrollee. There are prescriptions in the submitted documents for both 5 mg and 3 mg Balversa to be given together. The dose planned does not affect the determination of not a medically accepted use for this enrollee.Balversa is approved and supported for urothelial cancer with susceptible FGFR3 or FGFR2 mutations. The enrollee has prostate cancer and an FGFR1 mutation. Therefore the requested use is not a medically accepted indication. 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 Balversa, 5 mg tablet 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 Balversa, 5 mg tablet. 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.