Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Type 1 Diabetes

Treatment: Formulary Exception for Humalog cartridge [insulin lispro (human)] to treat diabetes

The insurer denied coverage for formulary exception for Humalog cartridge [insulin lispro (human)] to treat diabetes.

The denial is overturned.

The patient is an adult male with a medical diagnosis of Type 1 Diabetes Mellitus (T1DM). Per the provider, the patient has tried and failed Novolog in the past. Per the denial letter of Humalog cartridge [insulin lispro (human)], it states the patient must also try Fiasp. Novolog and Fiasp are both insulin aspart so the outcome will be the same as Novolog.

The formulary drugs are likely to cause the patient an adverse reaction. 

The formulary drugs are likely to cause a reaction as Novolog and Fiasp are similar molecularly. The only difference is that Fiasp has excipients which facilitates the insulin's more rapid absorption as it has vasodilators.      

The requested drug Humalog would be more effective as the claimant has tried and failed Novolog due to reactions and will likely have the same reaction to Fiasp. Humalog is not inferior to Novolog for management of T1DM. Fiasp or Rapid Novolog is a newer type of rapid insulin analog; however, it is more expensive than Novolog and is basically a faster version of Novolog or Novolog plus excipients. Therefore, the request for Humalog cartridge [insulin lispro (human)] is medically necessary and should be approved.

Per Benoi, S. R, et al, "Diabetes is a common chronic condition and as of 2015, approximately 30 million people in the United States had diabetes (23 million with diagnosed and 7 million with undiagnosed. Diabetic ketoacidosis (DKA) is a life-threatening but preventable complication of diabetes characterized by uncontrolled hyperglycemia [&gt; (greater than) 250], metabolic acidosis, and increased ketone concentration that occurs most frequently in people with T1DM. The Centers for Disease Control and Prevention (CDC) United States Diabetes Surveillance System (USDSS) indicated an increase in hospitalization rates for DKA during 2009-2014, most notably in people aged &lt; (less than) 45 years."

Furthermore, Fullerton, B., et al states, "Our analysis found no clear benefits of short-acting insulin analogues over regular human insulin in people with type 2 diabetes. Overall, the certainty of the evidence was poor and results on patient-relevant outcomes, like all-cause mortality, microvascular or macrovascular complications and severe hypoglycemic episodes were sparse. Long-term efficacy and safety data are needed to draw conclusions about the effects of short-acting insulin analogues on patient-relevant outcomes."

Per Islam, et al, "Insulin lispro is an insulin analog that is Food and Drug Administration (FDA) approved for the treatment of patients with diabetes mellitus types 1 and 2 to control hyperglycemia. Its off-label uses include treating patients with mild-to-moderate diabetic ketoacidosis, gestational diabetes mellitus, and mild-to-moderate hyperosmolar hyperglycemic state."

The formulary drugs are expected to cause adverse effects.
 
The formulary drugs were tried, and the patient did have an adverse reaction or contraindication.

The formulary drug is expected to be ineffective.

The non-formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of request for formulary exception for Humalog cartridge [insulin lispro (human)] to treat diabetes is overturned.