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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Nucala 100 mg/mL. 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 Nucala.Nucala is requested for treatment of the enrollee's condition. The stated diagnosis is R76.8 - Other specified abnormal immunological findings in serum. The prescriber has indicated that the enrollee does not have a diagnosis of severe asthma, or hypereosinophilic syndrome. It is noted that the enrollee has had persistent eosinophilia with an eosinophil count over 1000, and an elevated IgE level - 1073.5 on October 6, 2020. Comprehensive medical records have been provided from patient encounters from September 8, 2020 to October 27, 2020. Initial cardio/pulmonary diagnoses noted by the prescriber included interstitial lung disease, restrictive lung disease, pulmonary hypertension due to left heart disease, history of tobacco abuse, history of asbestos exposure, pleural calcification, dyspnea on exertion felt to be out of proportion to the enrollee's pulmonary function testing. It was later noted that the enrollee had a history of COVID-19. The medical records indicate that the enrollee was started on Proair HFA and Trelegy Ellipta for a diagnosis of pulmonary hypertension due to left heart disease on September 8, 2020. The Trelegy Ellipta was noted to be discontinued for unclear reasons on October 6, 2020. The enrollee was started on supplemental oxygen at that time due to oxygen desaturation overnight. The enrollee was seen on October 27, 2020 for follow up of interstitial lung disease: it is documented that patient states his breathing is good. It was noted that the patient had no complaints - no cough, wheezing, dyspnea - There was no indication that the enrollee was requiring his rescue medication, and it was stated that ProAir and nocturnal oxygen were discontinued. Physical examination was noted to be unremarkable. The diagnosis of eosinophilic asthma was added to the assessment on the October 27, 2020 visit, and it is stated that he has tried and failed inhaler therapy. I believe he is a candidate for biologic therapy.Nucala is indicated for the add-on maintenance treatment of patients with severe asthma aged 6 years and older, and with an eosinophilic phenotype. There is insufficient documentation that the enrollee has severe asthma, that he is currently on maintenance therapy for treatment of asthma, or that the eosinophilia/increased IgE level are related to asthma. Based on the information submitted, there is insufficient documentation that the enrollee has a medically accepted indication for the use of the requested drug. 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. 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 Nucala 100 mg/mL 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 Nucala 100 mg/mL. 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.