Subject: GLP-1 Agonist Victoza PA with Limit Policy 479-C UDR 05-2024

Drug

GLUCAGON-LIKE PEPTIDE 1 (GLP-1) RECEPTOR AGONIST

VICTOZA  (liraglutide)

Policy:

FDA-APPROVED INDICATIONS
Victoza is indicated:
  •  as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with
     type 2 diabetes mellitus.
  •  to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal
     myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established
     cardiovascular disease.

Limitations of Use:
  •  Victoza should not be used in patients with type 1 diabetes mellitus.
  •  Victoza contains liraglutide and should not be coadministered with other liraglutide-containing
     products.

Compendial Uses
Advanced chronic kidney disease (CKD) in adults with type 2 diabetes mellitus⁶


COVERAGE CRITERIA

Type 2 Diabetes Mellitus
Authorization may be granted for a diagnosis of type 2 diabetes mellitus when the following criteria is met:
  •  The patient has NOT been receiving a stable maintenance dose of a GLP-1 (glucagon-like
     peptide 1) Agonist for at least 3 months [Note: Examples of GLP-1 Agonists are Adlyxin,
     Bydureon, Byetta, Ozempic, Rybelsus, Trulicity, Victoza] and ONE of the following criteria are met:
          °  The patient has experienced an inadequate treatment response, intolerance, or has a
              contraindication to metformin
          °  The patient requires combination therapy AND has an A1C of 7.5 percent or greater
          °  The patient has a diagnosis of advanced chronic kidney disease (CKD) (estimated
              glomerular filtration rate [eGFR] less than 30 mL/min/1.73m²)
          °  The patient has established cardiovascular disease

CONTINUATION OF THERAPY

Type 2 Diabetes Mellitus
Authorization may be granted for a diagnosis of type 2 diabetes mellitus when the following criteria is met:
  •  The patient has been receiving a stable maintenance dose of a GLP-1 (glucagon-like peptide 1)
     Agonist for at least 3 months [Note: Examples of GLP-1 Agonists are Adlyxin, Bydureon, Byetta,
     Ozempic, Rybelsus, Trulicity, Victoza] and ONE of the following criteria are met:
               °  The patient has demonstrated a reduction in A1C since starting GLP-1 (glucagon-like
                   peptide 1) Agonist therapy
               °  The patient has a diagnosis of advanced chronic kidney disease (CKD) (estimated
                   glomerular filtration rate [eGFR] less than 30 mL/min/1.73m²)
               °  The patient has established cardiovascular disease

QUANTITY LIMITS APPLY
3 prefilled pens (9 mL) per 25 days* or 9 prefilled pens (27 mL) per 75 days*
*The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.

DURATION OF APPROVAL (DOA)
     •  479-C: DOA: 36 months

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Victoza [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; July 2023.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed March 11, 2024.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 03/11/2024).
4. Blonde L, Umpierrez GE, Reddy SS et. al. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan – 2022 Update. Endocr Pract. 2022;28(10):923-1049.
5. Davies MJ, Aroda VR, Collins BS, et. al. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753-2786.
6. American Diabetes Association Professional Practice Committee. American Diabetes Association, Standards of Care in Diabetes – Diabetes Care. 2024;47(Suppl. 1):S1-S322.
7. Samson SL, Vellank P, Blonde L, et. Al. American Association of Clinical Endocrinology Consensus Statement: Comprehensive Type 2 Diabetes Management Algorithm 2023 Update. Endocr Pract. 2023; 29: 305-340.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 27, 2024