Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obesity, prediabetes

Treatment: Ozempic

The insurer denied coverage for Ozempic.

The denial is upheld.

 
The patient has a diagnosis of Obesity.  The patient was seen to discuss weight loss medication. The patient was previously treatment with Ozempic, for prediabetes. The patient was reported to have gained a significant amount of weight following the discontinuation of Ozempic. The patient's current body mass index (BMI) is 34. The provider requested approval for Ozempic and was denied.

According to a denial letter, "In accordance with Pharmacy Management Drug Policy-72, Ozempic is considered medically appropriate for treatment when all requisite criteria have been met, including but not limited to, you have had serious side effects or drug failure with generic metformin."

The appeal for denial of Ozempic is the topic of this review.  The patient has a history of prediabetes and obesity. At this time, the provider is requesting approval for Ozempic. However, the patient's plan requires a trial of generic Metformin prior to approval of Ozempic; which the patient has not completed.      

Based on the available records, claim documentation and any additional information obtained from the patient's treating provider, the use of Ozempic (Semaglutide) is not medically necessary for this patient. Ozempic is Food and Drug Administration (FDA) approved for use in those with type 2 diabetes; however, the provider prescribed the medication for an indication of prediabetes. As such, the request is not medically appropriate in this setting.

"Guidelines recommend treatment goals targeting hemoglobin A1c (HbA1c), body weight, blood pressure, and low-density lipoprotein cholesterol. Development of new treatments for type 2 diabetes requires an understanding of their mechanism and efficacy, as well as their relative effects compared to other treatment choices, plus demonstration of cardiovascular safety. Subcutaneous semaglutide is a glucagon-like peptide-1 receptor agonist currently approved in several countries for once-weekly treatment of type 2 diabetes" (1).

"These drugs vary in their efficacy and side-effect profiles, but all provide greater weight loss than do lifestyle changes alone. Even though obesity is widespread and associated with adverse health consequences, and anti-obesity drugs can help people to lose weight, very few patients use these drugs partly because of concerns about safety and efficacy, but also because of inadequate health insurance coverage. Despite great advances in our understanding of the biology of weight regulation, many clinicians still believe that patients with obesity should have the willpower to eat less. The tendency to hold the patient with obesity responsible for their condition can be a barrier to greater acceptance of anti-obesity drugs as appropriate options for treatment. Physicians should be comfortable discussing the risks and benefits of these drugs, and health insurance companies should provide reasonable coverage for their use in patients who are most likely to benefit. Although few promising anti-obesity medications are in the drug-development pipeline, the most promising drugs are novel molecules that are co-agonists for multiple gut hormones including glucagon-like peptide 1 (GLP-1), glucagon, and gastric inhibitory peptide" (2).

According to the FDA Prescribing Label For Ozempic, "OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus" (3).                                                         

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for the prescription drug, Ozempic, is not substantiated.