Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Type 2 Diabetes 

Treatment: Toujeo SoloStar 300 units/milliliter SC SOPN

The insurer is denied coverage for Toujeo SoloStar 300 units/milliliter SC SOPN.

The denial is reversed. 

The patient is a male with Type 2 Diabetes, Hypertension (HTN), Hyperlipidemia, and history of Coronary artery disease (CAD) with a myocardial infarction (MI). For his diabetes management he takes Basaglar, Metformin and Trulicity. His most recent A1c was 6.1%. Appeal notes state that the has occasional low blood sugars on this regimen of 50-60s. When patient was on Toujeo in the past he did not have low blood sugars. The patient has tried and failed Farxiga, Glyxambi, Invokana, Januvia, Jardiance, Tradjenta, and Levemir in the past. Request is for Toujeo.

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The patient is having low blood sugars on his current regimen. He did not have low blood sugars while he was on Toujeo in the past. It would be reasonable to continue Toujeo in this case.      

Toujeo SoloStar 300 units/milliliter SC SOPN is considered medically necessary for this patient.  

Per White J. R., Jr (2016), "Gla-300 is a new formulation of insulin glargine that has a more constant and prolonged PK profile than Gla-100. The EDITION clinical trial program showed that the use of Gla-300 leads to noninferior glycemic control compared to Gla-100 in a range of populations of people with type 1 or type 2 diabetes. There was also evidence from individual trials for less nocturnal and anytime confirmed or severe hypoglycemia and less weight gain despite a slightly higher insulin requirement. A patient-level meta-analysis of the EDITION trials in people with type 2 diabetes suggests a reduction in confirmed or severe hypoglycemia both nocturnally and at any time of day in the population as a whole."

Lamos, et al. (2016) note, "The newest long-acting basal insulins (such as glargine, detemir, and degludec) were important advancements in basal coverage, with more prolonged and stable pharmacokinetic (PK) and pharmacodynamic (PD) characteristics than NPH insulin."Per Inzucchi, S. E. et al. (2015), "In any patient not achieving an agreed HbA1c target despite intensive therapy, basal insulin should be considered an essential component of the treatment strategy. After basal insulin (usually in combination with metformin and sometimes an additional agent), the 2012 position statement endorsed the addition of one to three injections of a rapid-acting insulin analog dosed before meals. As an alternative, the statement mentioned that, in selected patients, simpler (but somewhat less flexible) premixed formulations of intermediate- and short/rapid-acting insulins in fixed ratios could also be considered (44))..."                                                         

The patient has Type 2 Diabetes, Hypertension (HTN), Hyperlipidemia, and history of Coronary artery disease (CAD) with a myocardial infarction (MI). For his diabetes management he takes Basaglar, Metformin and Trulicity. His most recent A1c was 6.1%. Appeal notes stated that the patient has occasional low blood sugars on this regimen of 50-60s. When patient was on Toujeo in the past he did not have low blood sugars. The patient has tried and failed Farxiga, Glyxambi, Invokana, Januvia, Jardiance, Tradjenta, and Levemir in the past. The patient is having low blood sugars on his current regimen. He did not have low blood sugars previously while he was on Toujeo. It would be reasonable to continue Toujeo in this case.

The health plan did not act reasonably with sound medical judgment in the best interest of this patient.

Based on the above, the medical necessity for Toujeo SoloStar 300 units/milliliter SC SOPN is substantiated.  The insurer's denial is reversed.