Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Nucala auto-injector 100 mg/mL subcutaneously. According to the U.S. Food and Drug Administration (FDA), Nucala is approved for use as add-on maintenance treatment of adult and pediatric patients aged six years and older with severe asthma and with an eosinophilic phenotype. There is a lack of report of recent hospitalizations, nighttime awakenings, or emergency department evaluations to determine the severity of patients asthma. According to the Global Initiative for Asthma (GINA), severe asthma is a subset of difficult-to-treat asthma that is defined as asthma that is uncontrollable despite medium or high-dose inhaled corticosteroids with a second controller, such as a long-acting beta agonist or maintenance oral corticosteroid therapy, to maintain symptom control. GINA has estimated that only about 3-10% of the population of asthmatics have symptoms that meet the definition of severe asthma. Overall, there is inadequate evidence of severe asthma attacks, as described above, or a need to reduce use of treatment with inhaled corticosteroids. In this case, the diagnosis of eosinophilic asthma has not been firmly established based on the available information. The patient has a peripheral eosinophil count of 198 cells/uL. Although there is no guideline standard consensus on a hard cutoff criterion for peripheral eosinophil count to aid in the diagnosis of eosinophilic asthma, typically, a threshold of greater than 300 cells/uL is used in practice. However, treating providers also need to establish the diagnosis of asthma is associated with inflammation in the Th2 pathway. It is this pathway of inflammation, which is mediated by secretion of interleukin-5, which is targeted by Nucala. Testing such as sputum or bronchoalveolar lavage eosinophil counts, exhaled nitric oxide results, and a history of atopy help provide additional support for this diagnosis. The records do not include documentation of a peripheral eosinophil count above 300 cells/uL, elevated exhaled nitric oxide, and additional testing to support a firm diagnosis of eosinophilic asthma and, therefore, an indication for treatment with Nucala. Furthermore, a record was provided for additional review. This record provided conflicting evidence and indicated a final diagnosis of only mild persistent asthma, with exacerbation, that required a short burst of oral prednisone for treatment. No other details were provided for review to substantiate diagnoses of either severe asthma or eosinophilic asthma. All told, the requested Nucala auto-injector 100 mg/mL subcutaneously is is not medically necessary for treatment of this patient.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in internal medicine with subspecialty certifications in pulmonary diseases and critical care medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.