Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity

Treatment: Saxenda (liraglutide)

The insurer denied coverage for Saxenda (liraglutide)

The denial is overturned

 
This case involves a patient diagnosed with gastroesophageal reflux disease and peptic reflux disease who was seen for an office visit. At the time of the visit, the patient's weight was 213 pounds, down slightly from 218 pounds. Her body mass index was 39.6 with her vital signs otherwise stable. She felt generally well at the time of the visit aside from heartburn. She has struggled with her weight with reports that she had gone down with the Noom program and then regained. Laboratory testing showed low creatinine at 0.51, elevated cholesterol at 208, and elevated LDL (low-density lipoprotein) cholesterol of 135. The patient was advised to eat healthy, get routine exercise, and was being recommended for Saxenda 1.8 mg (milligrams) with plans to titrate daily up to 3.0 mg. The physician stated that Wegovy was out of stock, thus the change to Saxenda. The patient received a notice of adverse determination regarding Saxenda with claims that the criteria was not met as the patient had not taken or had a poor response to medications on the preferred drug list to include Trulicity, Ozempic, and Victoza. The physician stated that the medications on the preferred drug list are not Food and Drug Administration approved for weight loss. The patient noted that the patient had successful treatment with current weight loss totaling 21 pounds and she still had a diagnosis of morbid obesity. The letter stated that Saxenda was prescribed for weight loss to manage the patient's obesity. The physician stated that the denial for coverage of Saxenda was based on a lack of documentation showing the patient had not taken or had a poor response to Trulicity, Ozempic, or Victoza.  However, the physician noted that these drugs are prescribed for diabetic management of elevated glucose levels, which this patient does not have. The patient had a history of Roux-en-Y gastric bypass surgery and did well for several years, although her weight has gradually drifted back to where her body mass index was running between 35 and 40. The patient was suffering from gastroesophageal reflux disease and the extra weight was making this more difficult to control. She had tried several things to lose weight without success to include continued use of the Noom program. This review pertains to Saxenda.

Victoza-on formulary- and Saxenda are BOTH liraglutide marketed by Nova Nordisk. While technically Victoza is only for diabetes and would thus be off label, they are in fact the same drug by the same manufacturer. As per the Food and Drug Administration (FDA) package inserts: "Saxenda: Solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 milligrams (mg), 1.2 mg, 1.8 mg, 2.4 mg or 3 mg (6 mg/ milliliter (mL), 3 mL).  Victoza: Solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg (6 mg/mL, 3 mL). 

Thus, the only difference in these drugs is the multi-dose pen. The plan is to titrate the medication to 3.0 mg which is in fact the recommended starting dose as per Up to Date. As is evident Victoza's device does not accommodate 3.0 mg. A similar issue involves Ozempic- semaglutide- in which the available injector pen is for 0.25mg or 0.5 mg when the recommended dose as per Up to Date is 2.4 mg weekly. Finally, Up to Date does not note the use of Trulicity for obesity. 

Based on the above, the insurer's denial must be overturned. 

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Saxenda (liraglutide) is substantiated.