Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the medication Afrezza for treatment of the enrollees type I diabetes. Findings:  The physician reviewer found that According to the guidelines distributed by the American Diabetes Association: A patient-centered approach should be used to guide the choice of pharmacologic agents. Considerations include efficacy, hypoglycemia risk, impact on weight, potential side effects, cost, and patient preferences. This patient has experienced severe glycemic excursions, and severe hypoglycemic reactions with injectable prandial insulin via insulin pump, despite efforts and proper management directions. The patients HbA1c remained suboptimal, which indicates that she also had severe hyperglycemic fluctuations. The fluctuations were noted in the continuous glucose monitor (CGM) seven day test graph and report. There are hypoglycemic events under 70 and hyperglycemic events over 200 mg/dl. Afrezza is approved by the U.S. Food and Drug Adminitration. The provider prescribed inhaled insulin Afrezza for premeal administration. With Afrezza, the records indicate rare hypoglycemic reactions and less hyperglycemic events. The patient has been able to bring the diabetes under control and close to goal, staying longer within target range, as demonstrated by the CGM test graph. The patients hemoglobin HbA1c is now in target (6.9%). This is consistent with the American Diabetes Association guidelines. Afrezza is the only available inhaled insulin in the market. Studies that led to its approval showed that patients on this inhaled insulin had improved diabetes control that was not inferior to injectable prandial insulin, but had less hypoglycemia than injectable insulin, given its very rapid absorption through alveoli. The  providers letter delineates in detail the reasons why this patient needs to stay on Afrezza for her meal insulin treatment.  In this case, the patient benefits from taking Afrezza instead of injectable prandial insulin. The patients control is suboptimal on injectable insulin, with severe glycemic excursions and hyperglycemic and hypoglycemic events. Severe glycemic excursions and hyperglyemic and hypoglycemic events can have detrimental side effects, that has the probability to produce immediate and long term complications. The records show that this patient has an excellent response to inhaled insulin Afrezza. In sum, Afrezza is medically necessary for treatment of this patients type I diabetes. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism 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.