Subject: GIP-GLP-1 Agonist Mounjaro PA with Limit Policy 5468-C UDR 05-2024

Drug

GLUCOSE-DEPENDENT INSULINOTROPIC POLYPEPTIDE (GIP)/GLUCAGON-LIKE PEPTIDE 1 (GLP-1) RECEPTOR AGONIST

MOUNJARO  (tirzepatide)

Policy:

FDA-APPROVED INDICATIONS
Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use
  •  Mounjaro has not been studied in patients with a history of pancreatitis.
  •  Mounjaro is not indicated for use in patients with type 1 diabetes mellitus.


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 the requested drug for at least
     3 months 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


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 the requested drug for at least 3
     months
  •  The patient has demonstrated a reduction in A1C since starting this therapy

QUANTITY LIMITS APPLY
4 single-dose pens or single-dose vials (2 mL) per 21 days* OR 12 single-dose pens or single-dose vials (6 mL) per 63 days*
*The duration of 21 days is used for a 28-day fill period and 63 days is used for an 84-day fill period to allow time for refill processing.

DURATION OF APPROVAL (DOA)
    •  5467-C: DOA: 12 months
    •  5468-C: DOA: 36 months

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Mounjaro [package insert]. Indianapolis, IN: Lilly USA, LLC; 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