Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Matulane. The Plan did not grant this request. We received this case to conductan independent review.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Medicare Part B coverage includes oral anti-cancer drugs thatare prescribed as anti-cancer chemotherapeutic agents providing they have the same active ingredients andare used for the same indications as anti-cancer chemotherapeutic agents which would be covered if theywere not self-administered and they were furnished incident to a physician's service as drugs andbiologicals. This coverage includes FDA approved prodrugs used as anti-cancer drugs. The oral anti-cancerdrug must be used for the same anti-cancer chemotherapeutic indications, including unlabeled or offlabeluses, as the non-self-administrable form of the drug. A claim denied for the reason that the diagnosisdoes not fall in the covered diagnosis section of the Policy Article, titled ICD-10 Codes that are Covered,will receive a statutory denial as non-covered, but may be covered at appeal if used for a medicallyaccepted indication, as defined by Medicare law for oral anti-cancer chemotherapeutic agents. In this case,Matulane is not a Part B eligible drug under the Oral Anti-Cancer rules. Therefore, it is not eligible forcoverage under Medicare Part B and we sent the request to our physician reviewer to review for coverageunder Medicare Part D.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Matulane. The drug is requested to treat anaplastic oligodendroglioma in combination with Lomustine,which is an off-label (non-FDA approved) use. The enrollee is a 38 year old man with anaplasticoligodendroglioma. He has been treated with alternative medical regimens, surgery, radiation andTemozolomide. He has had recurrence and had surgery in 10/2019 with subsequent radiation. Theprescriber requests Matulane to be given with Procarbazine to treat him. The prescriber states he hasexhausted all other approved treatment options. The prescriber cites the NCCN guidelines in support of therequest. The guidelines cited include Vincristine in the recommended combination. The combination ofMatulane, Lomustine and Vincristine is the combination supported in the CMS approved compendia. Therequested combination does not include Vincristine and there is no explanation that Vincristine is notmedically appropriate. Therefore the requested use is not a medically accepted use.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medicalliterature from an approved journal submitted to support this appeal. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically acceptedindication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals orpublications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia and there was no peer-reviewed literature from an approved journal submitted tosupport the use of Matulane for the diagnosed condition. As a result, the drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit for this condition. An exceptions request based on medical necessity cannot beconsidered 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 Matulane.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.