Afrezza denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the medication Afrezza for treatment of the enrollee’s 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 patient’s HbA1c remained suboptimal, which indicates that she also had severe hyperglycemic fluctuations.

Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for Afrezza. The medical guidelines indicates that inhaled insulin can be used as an alternative to the usual subcutaneous rapid acting insulin analogues (RAA). Studies comparing inhaled insulin with injectable insulin have demonstrated its faster onset and shorter duration compared with RAA insulin, as well as clinically meaningful HgA1c reductions and weight reductions compared with the RAA insulin aspart over 24 weeks. Further, the authors of another study indicated that patients treated with Afrezza significantly experienced fewer level 1 and 2 hypoglycemic event rates than participants treated with insulin aspart.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Afrezza. Type 1 diabetes is characterized by the destruction of the pancreatic beta cells, leading to insulin deficiency. Rapid-acting insulin analogs have a quicker onset and shorter duration than short-acting human insulin, resulting in reduced early postprandial hyperglycemia and fewer incidents of hypoglycemia several hours after the meal. Most patients with type 1 diabetes should use insulin regimens that mimic physiology as closely as possible.

Nature of Statutory Criteria/Case Summary: The patient is diagnosed with type 1 diabetes; he is being treated with insulin pump therapy. He states that the subcutaneous insulin, delivered via pump, is not fast acting enough to bolus for his meals. He has managed his insulin well in the past using both the insulin pump and Afrezza insulin. The Health Plan indicates that the requested medication is not medically necessary for the treatment of the patient’s medical condition. At issue in this case is whether Afrezza is medically necessary for the treatment of this patient. Afrezza is a recombinant human regular insulin adsorbed onto Technosphere microparticles delivered to the lungs using a breath-powered inhaler (Galderisi and colleagues).

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Afrezza, then check the rights and deadlines that apply to your plan.