Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 1 Diabetes.

Treatment: Formulary Exception for Apidra (insulin glulisine).

The insurer denied coverage for Formulary Exception for Apidra (insulin glulisine).

The denial is upheld.

According to the medical records, the patient is an adult with a history of Type 1 diabetes mellitus with hyperglycemia. A formulary exception for Apidra (insulin glulisine) is requested. There is no clinical information provided.

The formulary drugs have not been shown to be ineffective for the claimant. In this case there is no clinical information. There is no documentation of trial and failure of the available formulary alternatives. 

The requested drug would not be more effective than the formulary drug. Multiple head-to-head studies show similar efficacy between Glulisine, Aspart and Lispro which are the formulary alternatives. 

Overall, 42,736 patients of any age were eligible for analysis based on insulin pump usage with either glulisine (n (number) =707) or lispro/aspart (n=42,029) between 2004 and 2020. Patients receiving glulisine were older (median 20.0 vs.(versus) 16.2 years), equally often male (47.2% (percent) vs. 47.8%) and had a longer diabetes duration (median 9.4 vs. 7.4 years). After propensity score matching, 707 pairs remained (total n=1414). Patient characteristics between groups were similar. Achieved Hemoglobin A1c (glycated hemoglobin) values were also comparable: 8.04%, 64 versus 7.96%, 63 for glulisine and lispro/aspart. Fasting blood glucose (FBG) was 9.37 (168.9 milligrams per deciliter (mg/dL)) and 9.58 (172.6 mg/dL) in the glulisine and lispro/aspart groups. Total daily insulin doses and prandial to total insulin ratios were also similar. Glulisine group patients had higher rates of lipodystrophy (0.85% vs. 0.71%) and non-severe Diabetic ketoacidosis (DKA) (3.11% vs. 0.57%; p (probability) = 0.002). Fewer patients in the glulisine group had severe hypoglycemic events (7.66 vs. 9.09; p = 0.333) and severe ketoacidosis events (0.57% vs. 1.56%; p = 0.082) but more had hypoglycemic coma events (p = 0.773), although the differences were not statistically significant. Conclusions: Insulin glulisine had comparable glucose control to lispro/aspart (Bramlage, P. et al. 2022).

To control both fasting and prandial plasma glucose levels in people with diabetes, insulin therapy must mimic "normal" physiological insulin secretion as much as possible. This is achieved with a long-acting insulin injected once or twice daily and a bolus of insulin injected before every meal. Prandial (bolus) insulin can either be regular human insulin (RHI) or a rapid-acting insulin analogue (RAIA). Although the efficacy of RHI has been established over approximately 35 years of clinical use, RAIAs offer several clinical advantages over RHI, namely that they have been engineered with a reduced tendency to aggregate as hexamers, which allows for rapid dissociation and absorption after a subcutaneous injection. Conventional RAIAs include insulin lispro, insulin aspart, and insulin glulisine. The more recently developed fast-acting insulin aspart (faster aspart) is an ultrafast-acting mealtime insulin that contains the conventional insulin aspart in a new formulation with the excipients niacinamide and L-arginine to achieve faster insulin absorption than RHI and the conventional insulin aspart formulation. (Kruger, D. F. et al. 2019).                                                  

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication. No clinical records were provided.

The formulary drug is not expected to be ineffective.

The nonformulary drug is not expected to be more effective that the formulary alternatives.

The carrier's denial of Request for Formulary Exception for Apidra (insulin glulisine) to treat diabetes is upheld.