ModifiedCentenePolicy CP PCH.12

Bupropion/naltrexone (Contrave) for weight management — coverage criteria

Covers medical necessity criteria, initial and continued therapy requirements, dosing limits, contraindications, and documentation expectations for Contrave (bupropion/naltrexone) as an adjunct to diet and exercise for adult weight management for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyBupropion/naltrexone (Contrave) for weight management — coverage criteria

Policy CodePolicy CP PCH.12

Change TypeClarifications and additions to initial authorization criteria

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of active enrollment in a behavioral-modification weight loss program for at least 6 months and evidence of meeting BMI and dosing criteria.

SourceLink

POLICY UPDATE CHANGES

Hypertension must be 'controlled' due to contraindication for uncontrolled hypertension.

Initial criteria require documentation that member has been actively enrolled in a structured weight loss program for at least 6 months including behavioral modification.

Hypertension contraindication language was clarified to indicate hypertension should be 'controlled' rather than simply referenced as a contraindication for uncontrolled hypertension.

Initial criteria for documentation of enrollment in a weight loss program now requires the member to have been actively enrolled for at least 6 months.

Weight loss program documentation must include a program that involves behavioral modification as supported by ACC/AHA guidelines.

References were reviewed and updated during the 2Q 2024 annual review and again in 2Q 2025.

32 mg/360 mgmax daily dose (naltrexone/bupropion)

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval: Member is an adult (age > 18 years).

Initial Approval: Member meets FDA-indicated BMI criteria: BMI >= 30 kg/m2, or BMI >= 27 kg/m2 with at least one weight-related comorbidity (e.g., coronary artery/heart disease, dyslipidemia, diabetes, elevated waist circumference, obstructive sleep apnea).

Initial Approval: Documentation supports the member has been actively enrolled in a structured weight loss program that involves a reduced-calorie diet, increased physical activity, and behavioral modification for at least 6 months (program content consistent with ACC/AHA guidance).

2Q 2024 clarification: specifies 6-month enrollment and behavioral modification requirement.

Initial Approval: Requested dose does not exceed 32 mg naltrexone / 360 mg bupropion per day (4 tablets per day).

Initial Approval: Contrave is not prescribed concurrently with other bupropion-containing products and there are no contraindications (e.g., uncontrolled hypertension, concomitant opioid use, seizure disorder, MAOI use, bulimia/anorexia nervosa, hypersensitivity).

Initial Authorization Criteria (clarified)

Covered when ALL of the following are met (as clarified in 2Q 2024 review):

Initial criteria (clarified): Member has been actively enrolled in a structured weight loss program for at least 6 months; the program involves behavioral modification consistent with ACC/AHA guidelines; cardiovascular risk indicators have been assessed and hypertension, if present, is controlled rather than uncontrolled; other standard prior authorization criteria are met.

Derived from 2Q 2024 clarifications.

Continuation/ Reauthorization

Covered when ALL of the following are met:

Continued Therapy: Member is currently receiving medication via the Centene benefit or previously met initial approval criteria (including meeting enrollment/documentation requirements).

Continued Therapy: Member remains actively enrolled in a weight loss program adjunct to pharmacotherapy that involves reduced-calorie diet, increased physical activity, and behavioral modification (documentation provided).

Continued Therapy: Member is responding positively to therapy: for the first renewal, member has lost >= 5% of baseline body weight after 12 weeks at maintenance dosage; for second or subsequent renewals, member has lost weight and/or maintained weight loss on therapy.

Continued Therapy: Contrave is not prescribed concurrently with other bupropion-containing products.

Non‑FDA approved indications are not covered under this policy. Requests for treatment of diagnoses or indications not addressed by the FDA label for Contrave must include sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (CP.CPA.09 for commercial lines and HIM.PA.154 for health insurance marketplace) or other evidence of coverage documents to be considered.

Uncontrolled hypertension is a contraindication to Contrave. The policy clarifies that hypertension must be controlled before initiating therapy and that cardiovascular risk indicators, including hypertension status, should be assessed as part of prior authorization.

Per the prescribing information and this policy, response should be assessed after 12 weeks at the maintenance dosage. If the member has not lost at least 5% of baseline body weight at that time, Contrave should be discontinued because continued treatment is unlikely to produce clinically meaningful and sustained weight loss.

Coding, Dosage & Key Metrics

Product strengthsmixed

naltrexone 8 mg / bupropion 90 mg

extended-release tablet strength listed in policy

inv-08: Maximum daily dose — 32 mg naltrexone / 360 mg bupropion per day

Maximum daily dose32 mg naltrexone / 360 mg bupropion per day (32/360 mg) — maximum of 4 tablets per day

Typical maintenance dosingFrom Week 4 onward: 2 tablets PO BID (per dosing schedule)

Approval duration tied to dosingApproval and reauthorization decisions reference the maintenance dosage phase (see 12-week assessment)

inv-09: FDA BMI thresholds — BMI >=30 or >=27 with comorbidity

Obesity threshold (FDA)BMI ≥ 30 kg/m2

Overweight with comorbidity threshold (FDA)BMI ≥ 27 kg/m2 with at least one weight‑related comorbidity (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia)

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of bupropion/naltrexone (Contrave). Providers must submit a prior authorization request and supporting clinical documentation demonstrating the member meets the policy's approval criteria (see Initial and Continued Therapy criteria). Approvals are time-limited per policy (initial approval and reauthorization durations apply).

Submit prior authorization request with clinical documentation
Approval durations: initial and reauthorization per policy (see criteria)

Documentation Required

Required Documentation

Providers must supply clinical documentation (office chart notes, lab results, weight measurements, enrollment verification) that supports meeting ALL applicable approval criteria. Documentation must include evidence of diagnosis/indication, baseline weight, percent weight change for renewals, and details of any comorbid conditions (e.g., controlled hypertension, dyslipidemia, diabetes, coronary artery disease, obstructive sleep apnea).

Background

Contrave is a fixed‑dose combination of bupropion and naltrexone indicated as an adjunct to a reduced‑calorie diet and increased physical activity for chronic weight management in adults meeting FDA BMI criteria. The policy's 2Q 2024 review clarified cardiovascular risk assessment requirements, specifying that hypertension must be controlled due to the contraindication for uncontrolled hypertension, and added documentation expectations that members be actively enrolled in a structured weight loss program for at least 6 months which includes behavioral modification consistent with ACC/AHA guidance. Contraindications listed in the policy include uncontrolled hypertension, seizure disorder, chronic opioid use, recent MAOI use, use of other bupropion‑containing products, eating disorders, and hypersensitivity; a boxed warning for increased risk of suicidal ideation in younger populations is also noted.

Definitions & Contraindications

inv-21: BMI calculation and definition

BMI definition and calculationBody Mass Index (BMI) = 703 × [weight (lbs) / (height (in))^2]

Purpose of BMI in policyUsed to determine eligibility per FDA‑indicated thresholds for Contrave treatment

Appendix referenceBMI abbreviation and calculation provided in Appendix A and C of the policy

inv-22: Contraindications / boxed warnings — list including uncontrolled hypertension, seizure disorder, chronic opioid use, MAOI interval, bulimia/anorexia nervosa

Uncontrolled hypertensionContraindication — uncontrolled hypertension is listed as a contraindication to Contrave

Seizure disorderContraindication — history of seizure disorder

Revision History & Policy Changes

2025-05-25annual_reviewLatest

2Q 2025 annual review: references reviewed and updated; no significant clinical changes to policy.

2024-05-24material_clarification

2Q 2024 annual review: clarified that hypertension must be 'controlled' (operationalizing uncontrolled hypertension as a contraindication), added requirement that members be actively enrolled in a weight loss program for at least 6 months, and specified the program must include behavioral modification per ACC/AHA guidance; references reviewed and updated.

Policy Summary

PayerCentene

PolicyBupropion/naltrexone (Contrave) for weight management — coverage criteria

Policy CodePolicy CP PCH.12

Change TypeClarifications and additions to initial authorization criteria

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of active enrollment in a behavioral-modification weight loss program for at least 6 months and evidence of meeting BMI and dosing criteria.

SourceLink

On This Page

Denial Risk

Documentation and Indication Risk — Denial Possible for Missing or Off‑Label Evidence

Lack of required clinical documentation or requests for non‑FDA indications without sufficient supporting evidence may result in denial. If the request does not include documentation that the member has met the stated criteria (including active enrollment in a weight loss program when required), the request may be denied.

Non‑FDA indications require off‑label policy review (CP.CPA.09 or HIM.PA.154) and sufficient evidence
Insufficient clinical documentation may result in denial

Documentation Required

Weight Loss Program Documentation Required

For initial approvals and some renewals, documentation must show the member has been actively enrolled in a structured weight loss program for at least 6 months. The program must include a reduced‑calorie diet, increased physical activity, and behavioral modification consistent with ACC/AHA guidance. Failure to document active enrollment >= 6 months or the program components may result in denial.

Evidence of enrollment duration (>= 6 months)
Description of program content: diet, physical activity, behavioral modification per ACC/AHA

Note

Formulary / Off‑Label Routing

Check formulary status and applicable routing prior to submission. If the drug is on formulary/PDL, follow the plan’s formulary criteria and non‑coverage rules (see CP.CPA.190 for commercial and HIM.PA.33 for marketplace where applicable). For non‑formulary requests or uses not listed in policy, follow the non‑formulary or off‑label policies (CP.CPA.190/HIM.PA.103 and CP.CPA.09/HIM.PA.154 respectively).

If on formulary: follow relevant formulary/PDL criteria (CP.CPA.190 or HIM.PA.33)
If not on formulary: follow non‑formulary policy (CP.CPA.190 or HIM.PA.103)
Off‑label uses: follow off‑label policies (CP.CPA.09 or HIM.PA.154)