Appeal type: Medical necessity
Decision: Overturned

Diagnosis: type 1 diabetes mellitus

Treatment: NovoLOG 100 unit/ml (millilitre)

The insurer is denied coverage for NovoLOG 100 unit/ml

The denial overturned. 

This female patient has a history of type 1 diabetes mellitus.

According to Fullerton, B. et al. (2018), "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 hypoglycaemic 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 Nicolucci, A. et al. (2020), "These results demonstrate that rapid-acting insulin analogs (RAIAs) are more effective at reducing postprandial plasma glucose (PPG) and improving HbA1c than regular human insulins (RHIs) in Type 1 Diabetes (T1D). More data are required to assess the effect of these agents on glucose control in Type 2 Diabetes (T2D). In patients with diabetes, the risk of complications is increased by poor control of blood glucose levels and high blood glucose variability. Complications may include cardiovascular disease, eye problems and amputation. Control and variability of blood glucose levels can be evaluated using a range of measures, including (i) glycated haemoglobin (HbA1c) level at the end of the treatment period; (ii) change in HbA1c level during the treatment period; (iii) fasting plasma glucose level; (iv) PPG level; (v) change in blood glucose level after a meal. PPG levels following a meal are an important measure of overall metabolic control in diabetes, and reduction of glycemic variability (GV) can be achieved via reductions in PPG. Both RAIAs; aspart, glulisine and lispro and RHI are widely used in the management of diabetes. Using data from 27 randomized controlled trials involving more than 7000 patients, we investigated the impact of RAIAs and RHI on measures of glycemic control and variability in patients with T1D or T2D. Our results show that, in patients with T1D, RAIAs are more effective than RHI at reducing PPG excursions and HbA1c. This indicates that glycemic control is better with RAIAs than with RHI. More data are required to assess the effects of RAIAs and RHI on glycemic control and variability in patients with T2D."

Lastly Melo, K. et al. (2019), "Short-acting insulin analogues are superior to regular human insulin in T1DM patients for the following outcomes: total hypoglycemic episodes, nocturnal hypoglycemia, severe hypoglycemia, postprandial glucose, and HbA1c."                                                         
    
The patient has been well controlled with an A1c of 6.0% and average blood glucose(BG) of 90 while utilizing branded Novolog for her insulin pump. She has tried and failed at least 3 formulary alternatives namely: Admelog, Humalog, and generic Aspart due to poor glucose control while on these types of rapid acting insulin and prefers Branded Novolog. Because this request is for continuity of care with a drug for a patient who has responded well, without adverse events and is successfully controlled, the requested medication is medically necessary.
The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for the NovoLOG 100 unit/ml is overturned.  The medical necessity is substantiated.