Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mekotvi and Braftovi. 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 Braftovi and Mektovi. The drugs are requested to treat lung cancer, which are off-label (non-FDA approved) uses.The enrollee is a 79 year old woman with metastatic adenocarcinoma of lung involving bones and nodes. Her cancer has a BRAF V600E mutation by Guardant360. She has been treated with surgery to a hip metastasis, radiation and Keytruda. She received Dabrafenib and Trametinib but stopped due to severe toxicity of fever, chills, rigors, arthralgias, rash and nausea and vomiting. You request Braftovi and Mektovi to treat her. At the office visit, options of reduced dose chemotherapy with Platinum/Pemetrexed, reduced doses of the Dabrafenib and Trametinib or comfort measures due to age and comorbidites were discussed. You state the requested combination may be better tolerated. A letter to the editor with a case report from a non-CMS approved journal was submitted in support of the request. You stated that an ongoing Phase 2 clinical trial, NCT03915951, is studying the combination in lung cancer. Therefore the requested use is investigational.The Medicare-approved compendia reviewed do not contain any citations to support the use of the requested drugs, 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 a PubMed search and found no supporting citations. Therefore, the requested drugs are 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 drugs, as prescribed, do not meet the definition of a Medicare Part D drug. Therefore, the requested drugs are not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drugs 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 Mekotvi and Braftovi for the diagnosed condition. As a result, the drugs are not being prescribed for a medically accepted indication as defined by Medicare law. As such, they cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because these drugs, as prescribed, do not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Mekotvi or Braftovi.This decision does not concern the medical necessity of the requested drugs. It only establishes if payment can be made under the Medicare Part D benefit.