Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Darzalex. The Plan did not grant this request. We received this case to conduct an independent review.DarzalexWe asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Darzalex. The drug is requested to treat newly diagnosed multiple myeloma with Velcade, Dexamethasone and adding Melphalan later, which is an off-label (non-FDA approved) use. The patient is 80 years old with untreated multiple myeloma with low blood counts, and pain related to bone involvement. Bone marrow was consistent with multiple myeloma. The prescriber states the patient is not a candidate for stem cell transplant. The prescriber requests Darzalex to be given with Velcade and Dexamethasone with a plan to add Melphalan at cycle 2 if the patient can tolerate the treatment. The submitted documents indicate that Velcade has been approved.The FDA label and all compendia state the steroid to be used is Prednisone, not Dexamethasone.Therefore, the requested use is not supported as medically accepted use. 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 Darzalex 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 Darzalex. 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.VelcadeWe are dismissing the request for Velcade. The Part D Plan provided documentation that the request for coverage or payment for Velcade was approved as requested. Since the Plan has agreed to provide coverage or payment, there is no need for a reconsideration review.Contact the Part D Plan to learn more about how and when coverage or payment will be provided for Velcade.MelphalanWe are dismissing the request for Melphalan. We received your letter asking for an appeal of the Plan's unfavorable determination for Melphalan. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination. You may wish to submit this request to the Plan at this time.