Drug - Victoza® (liraglutide [rDNA origin] injection), for subcutaneous use [Novo Nordisk Inc.]
Coverage is approved if the patient has
- a diagnosis of type 2 diabetes mellitus AND
- has not achieved adequate glycemic control on at least two of the following used separately or simultaneously:
- metformin (alone or in combination with a sulfonylurea or a thiazolidinedione)
- a sulfonylurea (alone or in combination with metformin)
- an oral DPP IV inhibitor (eg, Januvia, Onglyza) AND
- has been tried on Byetta (Exenatide) without successful therapeutic results or has a contraindication to Byetta or intolerance to Byetta
For all patients, Victoza should be initiated with a dose of 0.6 mg per day for one week. The 0.6 mg dose is a starting dose intended to reduce gastrointestinal symptoms during initial titration, and is not effective for glycemic control. After one week at 0.6 mg per day, the dose should be increased to 1.2 mg. If the 1.2 mg dose does not result in acceptable glycemic control, the dose can be increased to a maximum of 1.8 mg per day. For patients starting on 1.2 mg per day, the 2-pack provides a quantity sufficient for a one month supply. Therefore, approval of initial PA should be for NDC 00169406012.
Vicotoza FDA approved indication
Victoza 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.
Victoza contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist.
Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a glucose-dependent manner.
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