Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Arikayce. 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 Arikayce. Arikayce is requested for ongoing treatment of the mycobacterium avium complex disease. The plan denied coverage of the requested drug because they concluded there was insufficient documentation that the requested drug is being prescribed for a medically accepted indication. Arikayce/Amikacin liposome inhalation suspension is indicated for the treatment of Mycobacterium avium complex (MAC) lung disease in adults who have limited or no alternative treatment options, as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. There is insufficient documentation that the enrollee meets the approved indication for the use of the requested drug. Extensive records have been submitted and reviewed - None of the following have been sufficiently documented: refractory ongoing infection, previous multidrug background treatment for 6 months, or current combination antibacterial regimen. Based on the information provided, there is insufficient documentation that the requested drug is 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 DOf note, salient points from the records are as follows: it is stated in numerous notes that 4/2016 positive for AFB, but he does not want treatment, in a note dated 5/17/17, there is discrepant information regarding the results of a therapeutic brochoscopy performed 4/2017 - it is noted in one place in the note, bronch was positive for gram negative organisms and Strep Pneumoniae. MAI infection while later in the same note it is stated that Acid fast - negative, and it was specifically stated that special stains negative for acid fast and fungal organisms on the surgical path report from the specimen 4/18/2017. Culture for AFB negative on 7/14/19 - preliminary result. Regarding treatment, it is noted that the enrollee was treated with Azithromycin for a period of time; however it is noted that the drug was stopped due to insurance reasons.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. 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.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Arikayce 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 Arikayce. 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.