ModifiedHealth NetPolicy CP.PCH.12

Bupropion/Naltrexone (Contrave) for chronic weight management

Medical necessity criteria and utilization management for Contrave (bupropion/naltrexone) as an adjunct to diet and exercise for adult weight management; applies to commercial and HIM lines of business.

Policy Summary

PayerHealth Net

PolicyBupropion/Naltrexone (Contrave) for chronic weight management

Policy CodePolicy CP.PCH.12

Change TypeMaterial clarifications to hypertension and weight loss program documentation

Effective DateMay 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age, BMI, and evidence of active enrollment in a behavioral weight loss program for at least 6 months and confirmation that hypertension is controlled.

SourceLink

POLICY UPDATE CHANGES

For indicators of increased cardiovascular risk, hypertension was clarified to require 'controlled' hypertension due to contraindication for uncontrolled hypertension.

Documentation of weight loss program requirement was expanded to specify active enrollment for at least 6 months and inclusion of behavioral modification.

Removed continued therapy criterion of BMI ≥ 25 kg/m2 in a prior update.

Hypertension is specified as needing to be 'controlled' because uncontrolled hypertension is a contraindication.

Documentation of weight loss program now requires that members have been actively enrolled for at least 6 months and that the program involves behavioral modification as supported by ACC/AHA guidelines.

Annual reviews in 2Q 2025 noted no significant changes; references reviewed and updated.

12 wksinitial approval duration

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Coverage Criteria for Contrave (bupropion/naltrexone)

inv-01: Initial Approval — Weight Management — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Approval Criteria: Member meets one of the following: (a) BMI ≥ 30 kg/m2 OR (b) BMI ≥ 27 kg/m2 with at least one indicator of increased cardiovascular risk (e.g., coronary artery/heart disease, controlled hypertension, dyslipidemia, diabetes, elevated waist circumference) or other obesity-related medical condition (e.g., sleep apnea); Age ≥ 18 years; Documentation supports participation in a weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification; Contrave is not prescribed concurrently with bupropion-containing products; Dose does not exceed 32 mg naltrexone/360 mg bupropion per day.see children nodes

Approval duration: 12 weeks

inv-02: Continued Therapy — Weight Management — Covered when ALL of the following are met

Covered when ALL of the following are met

Continued Therapy Criteria: Member currently receiving medication via benefit or has previously met initial approval criteria OR member is receiving medication under continuity of care provisions; Member is responding positively to therapy: (first renewal) ≥ 5% loss of baseline body weight OR (second or subsequent renewal) has lost weight and/or maintained weight loss on therapy; Documentation that member is actively enrolled in a weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification; Contrave is not prescribed concurrently with bupropion-containing products; If request is for a dose increase, new dose does not exceed 32 mg naltrexone/360 mg bupropion per day.≥5% weight loss at first renewal

First reauthorization 12 weeks; subsequent reauthorizations 6 months

inv-03: Other Diagnoses / Off-label Uses — If use is not specified in this policy or there has been a recent label change

If use is not specified in this policy or there has been a recent label change

Other/Off-label: If the drug has undergone a recent label change (within the last 6 months) not reflected in this policy, refer to the appropriate formulary/no-coverage or non-formulary policy for the line of business; if the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial; HIM.PA.154 for HIM/marketplace).N/A

See related policies: CP.CPA.190, HIM.PA.33, HIM.PA.103 for formulary/non-formulary guidance

inv-04: Initial therapy — Covered when ALL of the following are met (as clarified in 2Q 2024 review)

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

Cardiovascular risk and hypertension: For indicators of increased cardiovascular risk, hypertension must be controlled; uncontrolled hypertension is a contraindication to therapy.controlled vs uncontrolled

Clarified in 2Q 2024

Weight loss program documentation: Member has been actively enrolled in a weight loss program for at least 6 months and the program involves behavioral modification consistent with ACC/AHA guidelines.>= 6 months

Added enrollment duration and behavioral component in 2Q 2024

Non–FDA–approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial lines and HIM.PA.154 for HIM/marketplace).

Use of Contrave in members with uncontrolled hypertension is contraindicated. The policy clarifies that hypertension must be controlled for therapy initiation; requests for members with uncontrolled blood pressure may be denied.

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

Coding, Thresholds, and Key Values

Document identifiersmixed

No codes listed

inv-09: Weight loss response — ≥ 5% of baseline body weight at 12 weeks

Response required≥ 5% of baseline body weight at 12 weeks (evaluate after 12 weeks at maintenance dose; discontinue if not met)

Assessment timingEvaluate response at 12 weeks at the maintenance dosage per prescribing information

Effectiveness rationaleLack of ≥5% weight loss at 12 weeks indicates unlikely to achieve clinically meaningful sustained weight loss

inv-10: Maximum daily dose — 32 mg naltrexone / 360 mg bupropion per day

Maximum daily dose32 mg naltrexone / 360 mg bupropion per day (4 tablets per day)

Dose limitation on increaseIf request is for a dose increase, new dose must not exceed 32 mg/360 mg per day

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include evidence that the member meets all initial or continuation criteria (e.g., BMI threshold, age ≥18, enrollment in a weight loss program, absence of concurrent bupropion products, and dosing within limits). Approval duration for initial therapy is 12 weeks.

Affected policy: CP.PCH.12
Approval duration: 12 weeks
Dose limit: ≤ 32 mg naltrexone / 360 mg bupropion per day

Prior Authorization

Prior Authorization — Clinical Requirements

Prior authorization must document controlled hypertension when hypertension is listed as an indicator of increased cardiovascular risk; use in members with uncontrolled hypertension is contraindicated. Documentation must also show the member is actively enrolled in a weight loss program that includes reduced calorie diet, increased physical activity, and behavioral modification, and that enrollment has been ongoing for at least 6 months and will continue while on therapy.

Hypertension must be controlled — uncontrolled hypertension is a contraindication

Background and Rationale

Contrave is a fixed‑dose combination of naltrexone (an opioid antagonist) and bupropion (an aminoketone antidepressant) indicated as an adjunct to a reduced‑calorie diet and increased physical activity for chronic weight management in adults. Treatment response should be evaluated at 12 weeks at maintenance dose; absence of at least 5% weight loss at that time warrants discontinuation. The 2Q 2024 review clarified cardiovascular risk considerations by specifying that hypertension must be controlled (uncontrolled hypertension is a contraindication) and added a requirement that documentation demonstrate active enrollment in a behavioral weight loss program for at least 6 months.

Definitions and Calculations

inv-22: Contrave — Combination of naltrexone and bupropion indicated for chronic weight management as adjunct to diet and exercise.

DefinitionContrave is the combination of naltrexone and bupropion indicated for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity in adults

ComponentsContains naltrexone (opioid antagonist) and bupropion (aminoketone antidepressant)

Indication specificsIndicated for adults with BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with at least one weight-related comorbidity

inv-23: BMI calculation — BMI = 703 x [weight (lbs) / height (inches)^2].

Formula (US units)BMI = 703 x [weight (lbs) / height (inches)^2]

UseCalculate BMI using weight in pounds and height in inches as shown

Policy Summary

PayerHealth Net

PolicyBupropion/Naltrexone (Contrave) for chronic weight management

Policy CodePolicy CP.PCH.12

Change TypeMaterial clarifications to hypertension and weight loss program documentation

Effective DateMay 1, 2017

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Documentation Required / Denial Risk

Provider must submit supporting clinical documentation (e.g., office chart notes, laboratory results, program enrollment records) demonstrating that the member meets all approval criteria. Lack of adequate documentation to confirm BMI, age, controlled hypertension (when applicable), enrollment in a qualifying weight loss program, or absence of concurrent bupropion therapy may result in denial.

Acceptable documentation: office chart notes, lab results, weight loss program records
Insufficient documentation or non-covered indications will trigger denial or request for more information