Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Type 1 diabetes mellitus. 

Treatment: HumaLOG 100 UNIT/ML SC SOLN. 

The insurer denied coverage for HumaLOG 100 UNIT/ML SC SOLN. 

The denial is upheld. 

This is a male patient with a medical history of type 1 diabetes mellitus without complication. The patient switched to Tandem pump and uses Humalog U-100 insulin 100 units/milliliter (mL) injection via insulin pump. The patient uses the Tandem insulin pump with Humalog for management of his condition. Only Humalog brand insulin (or Novolog brand) are Food and Drug Administration (FDA) approved to be used with the Tandem pump system. Other types of insulins have not been tested for safety or efficacy. 

As per Lal et al. (2020), "Multiple breakthroughs in diabetes technology have advanced pump care. Klonoff et al. investigated the use of Fiasp in insulin pumps, which was found to be non-inferior to insulin Aspart with some improved measures of postprandial hyperglycemia. Another trial by Heise et al. evaluated BioChaperone insulin lispro in CSII [continuous subcutaneous insulin infusion] with euglycemic clamp and found earlier onset of action and faster offset than Aspart or Fiasp. At the release of this 2019 ATTD [Advanced Technologies and Treatments for Diabetes] Yearbook, commercial and do it yourself closed loop systems will be available for insulin pumps from all major manufacturers. These systems are critically dependent on the reliable and modifiable delivery of insulin from the pump. Understanding the crucial nature of interoperability, the United States Food and Drug Administration developed the new regulatory classification of alternate controller enabled insulin pumps. Future pumps meeting criteria specified in the special controls can go through the expedited 510(k) review process for regulatory approval. These special controls include certain assurances of secure device communications, safety, and accurate and reliable insulin delivery that must be included in device labeling. This year, there were two in vivo studies assessing the accuracy of bolus and basal delivery in several commercial pumps by Freckmann et al. and Laubner et al. Both groups had similar findings that highlight the reproducibility of the methodology. All pumps tested appeared to have reasonable performance. Whether the subtle differences in delivery have any clinical implication requires additional investigation." 

As per Thrasher et al. (2020), "[Insulin aspart (SAR-Asp)] and [NovoLog (NN-Asp)] were well tolerated and had similar infusion set occlusions over a 4-week period in insulin pump users with [type 1 diabetes (T1D)]." 

Based on the medical facts from the available records, claim documentation, and any additional information obtained from the patient's treating provider(s) from the perspective of Endocrinology, Diabetes, & Metabolism/Internal Medicine, HumaLOG was not medically necessary for this patient. Humalog and NovoLog have been tested by Tandem, and found to be compatible for use in the T:Slim Insulin Pump. It is not intended for use with any other delivery substance. The claim of the treating provider that only Humalog can work with the patient's pump is not true and is not supported by the safety trials and recommendations of the Tandem pump manufacturer. 

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient. 

The carrier's denial of coverage for HumaLOG 100 UNIT/ML SC SOLN should be upheld. The medical necessity is not substantiated.