Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe.If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Jakafi, 10 mg tablet. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Jakafi, 10 mg tablet; 60/30.The drug is requested to treat chronic myeloproliferative disease, which is an off-label (non-FDAapproved) use. The enrollee is a 76 year old woman with a history of elevated white blood count andplatelets. She has been treated for years with Hydrea which is no longer effective. On 6/12/20 her whiteblood count was 51,200 with no reported blasts or immature white blood cells reported. Her platelets were902,000. Her bone marrow in 5/2016 was hypercellular with atypical megakaryocytes suggestive of chronicmyeloproliferative disorder. Her bone marrow cells were positive for Jak2 mutation. The prescriberrequests Jakafi to treat her.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 Jakafi, 10 mg tablet for the diagnosed condition. As a result, the drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be coveredunder the Medicare Part D benefit for this condition. An exceptions request based on medical necessitycannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, our decision is that the Plan is not required to provide coverage for Jakafi, 10 mg tablet.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.