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. The drug is requested to treat chondrosarcoma, which is an off-label (non-FDA approved) use.The enrollee is a 95-year-old man with metastatic dedifferentiated chondrosarcoma. He has had progression on Pazopanib. The tumor has an IDH-1 mutation on Tempus testing suggesting possible response to Tibsovo (Ivosidenib). The prescriber states that chemotherapy is not being given due to the enrollee's age. The prescriber states there are few options due to the rarity of the disease. The prescriber requests Tibsovo to treat him. An article from the Journal of Clinical Oncology was submitted for review. The study cited was a phase I trial, and the conclusion states the drug showed durable control in patients with conventional chondrosarcoma. It states the development of the drug has potential. Per the NCCN Guidelines Version 1.2021 Chondrosarcoma page BONE-B 1 of 5, dedifferentiated chondrosarcoma is not conventional chondrosarcoma and should be treated as osteosarcoma. In the opinion of this reviewer, this phase I report does not meet the Medicare guidelines for adequate support for the requested use of Tibsovo.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 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.