CurrentHealth NetPolicy CP CPA.332

Liraglutide (Saxenda) for Weight Loss

Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, contraindications, and documentation requirements for coverage of Saxenda (liraglutide) for weight management for commercial lines of business.

Policy Summary

PayerHealth Net

PolicyLiraglutide (Saxenda) for Weight Loss

Policy CodePolicy CP CPA.332

Change TypeMultiple annual updates (pediatric indication, response criteria, documentation clarifications, label updates)

Effective DateJun 1, 2018

Next Review Date

Key ActionProvider must submit documentation supporting all approval criteria including BMI, weight, weight-loss program enrollment, prior GLP-1 therapy failure for T2DM members, and dosing; prior authorization may be required.

POLICY UPDATE CHANGES

Added pediatric indication for 12 years and older with body weight >60 kg and BMI criteria; references updated.

Clarified response criteria for pediatric members to use baseline BMI percentiles and revised continued therapy criteria.

For members with concurrent T2DM age ≥18, added requirement to document failure of ≥3 months of specific GLP-1 therapies (Ozempic, Rybelsus, Trulicity, Victoza) unless contraindicated.

Clarified weight loss program definition to be Health plan-approved or prescriber-recommended and requires enrollment for at least 6 months.

Updated FDA approved indication language and removed certain BMI thresholds per label changes.

3 mg/dayMaximum maintenance dose

Coverage Summary

Saxenda (liraglutide) for weight loss is covered with criteria under policy CP CPA.332. The policy aligns coverage with FDA labeling and defines medical necessity for adults and pediatric patients ≥12 years. Effective date: 2018-06-01; Last review date: 2025-05-25. Scope: coverage applies when documentation supports initiation criteria (including a minimum body weight of ≥ 60 kg, adult BMI thresholds, or pediatric BMI percentile criteria), required participation in a Health plan-approved or prescriber-recommended weight loss program, and response to therapy for continued coverage.

Initial Approval Criteria

Saxenda is medically necessary when ALL of the following are met:

ALL of the following

ONE of
- Adults
- Pediatric patients 12 to 17 years (see pediatric-specific criteria)
ALL of the following
- Body weight ≥ 60 kg≥ 60 kg
- ANY of the following
  - BMI ≥ 30 kg/m2 for adults≥ 30 kg/m2
  - OR BMI ≥ 27 kg/m2 with at least one weight-related comorbid condition (examples: coronary artery/heart disease, hypertension, dyslipidemia, diabetes, elevated waist circumference, obstructive sleep apnea)BMI ≥ 27 kg/m2 + ≥1 comorbidity
    Examples listed in policy
ALL of the following
- Age between 12 and 17 years
- BMI ≥ 95th percentile standardized for age and sex (see Appendix D)≥ 95th percentile
ALL of the following
- Failure of ≥ 3 consecutive months of Ozempic, Rybelsus, Trulicity and Victoza unless clinically significant adverse effects are experienced or all are contraindicated≥ 3 months failure
  Intolerance due to common class GI adverse effects is NOT acceptable justification
- Medical justification supports necessity for Saxenda (intolerance due to common class GI adverse effects is NOT acceptable justification)
ALL of the following
- Member has been actively enrolled in the program for at least 6 months≥ 6 months
- Member will continue to be actively enrolled while on Saxenda
Saxenda is NOT prescribed concurrently with other liraglutide-containing products or any other GLP-1 receptor agonist(s)
Requested dose does not exceed 3 mg per day (equates to 5 pens per month)≤ 3 mg/day
Maximum 5 pens per month
ANY of the following
- For age ≥ 18 years: maintenance dose is 3 mg per day3 mg/day
- For pediatric patients (< 18 years): maintenance dose is at least 2.4 mg per day≥ 2.4 mg/day

Continued Therapy Criteria

Continued coverage granted when ALL of the following apply:

ALL of the following

ANY of the following
- Currently receiving medication via Centene benefit
- Member has previously met initial approval criteria
ALL of the following
- First renewal - adults: For age ≥ 18 years: member has lost ≥ 4% of baseline body weight (first renewal case)≥ 4% baseline body weight
  Evaluate at 16 weeks per PI

Exclusions / Not Authorized

ALL of the following

Non-FDA approved indications are not covered unless supported by off-label use policy CP.CPA.09 or other evidence of coverage
Contraindications: personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2); hypersensitivity to liraglutide or excipients
Boxed warning: risk of thyroid C-cell tumors (use caution per prescribing information)
Safety and effectiveness not established in pediatric patients with type 2 diabetes

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization and documentation required

Provider must submit documentation (office notes, labs, or other clinical information) supporting that the member meets all approval criteria including BMI, weight, weight-loss program enrollment, prior GLP-1 therapy failure for T2DM members, and dosing. Prior authorization may be required.

Documentation Required

Weight loss program documentation

Provide evidence the member has been actively enrolled in a Health plan-approved or prescriber-recommended weight loss program involving reduced calorie diet, increased physical activity, and behavioral modification for at least 6 months, and that the member will continue to be actively enrolled while on Saxenda.

Applicable Codes

Product NDC / HCPCS (not explicitly listed in document)NDC|HCPCS

No codes listed

Clinical Evidence & Definitions

≥ 60 kgMinimum body weight for initiation

3 mg/dayMaximum allowed dose (equals 5 pens/month)

16 weeksAssessment time to evaluate response (discontinue if <4% weight loss)

Evidence includes the Saxenda Prescribing Information and clinical trials such as the NEJM randomized controlled trial of liraglutide in adolescents with obesity (NEJM, 2020). The prescribing information (PI) is referenced as the primary evidence source and provides dosing, safety, and response assessment guidance.

The policy notes contraindications and boxed warning from the PI: contraindication for personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), hypersensitivity to liraglutide or excipients, and a boxed warning regarding the risk of thyroid C‑cell tumors.

The PI recommends evaluation of weight change at 16 weeks and discontinuation if the patient has not lost at least 4% of baseline body weight (adults), which informs the policy's response assessment and continuation decisions.

GLP-1: glucagon-like peptide-1 receptor agonist.

T2DM: type 2 diabetes mellitus.

Background

Saxenda is FDA-approved for use in adults and pediatric patients ≥12 years with body weight >60 kg as an adjunct to a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction. The policy aligns coverage with FDA labeling and reflects RT4 label updates through 06.11.25.

The policy explicitly states contraindications: personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), and hypersensitivity to liraglutide or excipients. A boxed warning describes the risk of thyroid C‑cell tumors.

For continued coverage, the policy requires participation in a Health plan-approved or prescriber-recommended weight loss program (involving reduced calorie diet, increased physical activity, and behavioral modification) with documentation that the member has been actively enrolled for at least 6 months and will continue enrollment while on Saxenda.

Revision History

01.29.2021 / P&T 05.21.21added

Added pediatric indication for patients 12 years and older with body weight >60 kg and BMI criteria; references updated.

01.20.2022 / P&T 05.22.22revised

Updated pediatric response metric: for age <18 years added requirement of >1% baseline body weight loss (per PI); updated limitations of use and international pediatric BMI cut-offs.

01.11.2023 / P&T 05.23.23revised

Revised pediatric response metric to use baseline BMI percentiles per PI and removed the continued therapy criterion of BMIZ 25 kg/m2; references reviewed and updated.