CurrentmhnPolicy HNCA.CP.PCH.12

Bupropion/Naltrexone (Contrave) coverage

This policy governs medical necessity criteria and prior authorization requirements for Contrave (bupropion/naltrexone) for chronic weight management in adults for Health Net of California lines of business.

Policy Summary

Payermhn

PolicyBupropion/Naltrexone (Contrave) coverage

Policy CodePolicy HNCA.CP.PCH.12

Change TypeNo material change

Effective DateJan 17, 2024

Next Review Date

Key ActionSubmit documentation verifying BMI, baseline and current height/weight within 30 days and evidence of participation in and continued enrollment in an approved behavioral weight loss program.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥30 or ≥27+FDA BMI eligibility

12 wksInitial approval duration

≥5% lossFirst renewal response

32 mg /360 mgMax daily dose

8 mg/90 mgTablet strength

annual 2021-2025

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval for Weight Management

BMI criteria
- BMI ≥ 30 kg/m2
- 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
ALL of the following
- Active participation in a weight loss program for at least 6 months prior to use of Contrave
- Will continue to be actively enrolled in a weight loss program while prescribed Contrave
Documentation of member's baseline and current height and body weight within the last 30 days
Follow-up visits are planned to assess adherence and response to the treatment plan
Contrave is not prescribed concurrently with bupropion-containing products
Dose does not exceed 32 mg naltrexone/360 mg bupropion per day (4 tablets per day)

Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy for Weight Management

Membership/continuity
- Currently receiving medication via Centene benefit or previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state-specific addendums)
Evidence of response
- Response thresholds
  - If first renewal request: member has lost ≥ 5% of baseline body weight

Requests for uses that are not FDA‑approved and are not specifically addressed by this policy are excluded from coverage unless the provider submits sufficient documentation supporting the off‑label use per applicable off‑label policies (CP.CPA.09 for commercial and HIM.PA.154 for marketplace plans).

Contraindications to bupropion/naltrexone include: uncontrolled hypertension; seizure disorder; concurrent use of or use within 14 days of a monoamine oxidase inhibitor (MAOI); chronic opioid use; use of other bupropion‑containing products; bulimia or anorexia nervosa; abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs; and hypersensitivity to any ingredient in Contrave. The product also carries a boxed warning for increased risk of suicidal thinking and behavior in children, adolescents, and young adults.

The policy clarifies that hypertension must be controlled for patients to meet cardiovascular risk criteria; specifically, uncontrolled hypertension is a contraindication to therapy and lack of documentation of blood pressure control may lead to denial of coverage.

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

Clinical Thresholds & Dosing

inv-07: BMI — Initial eligibility thresholds (≥30 kg/m2 or ≥27 kg/m2 with comorbidity)

Initial BMI thresholdBMI ≥ 30 kg/m2

Alternate BMI threshold with comorbidityBMI ≥ 27 kg/m2 with at least one weight‑related comorbidity (e.g., coronary artery/heart disease, controlled hypertension, diabetes)

Age requirementMember must be ≥ 18 years old

inv-08: Response to therapy — First renewal threshold: ≥5% weight loss at 12 weeks

Response threshold (first renewal)Patient must have lost ≥5% of baseline body weight after 12 weeks at maintenance dose

Timing of assessmentEvaluate response after 12 weeks at maintenance dosage per prescribing information

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document that member meets BMI criteria (see Appendix B), is age ≥18, and meets other clinical criteria including participation in an approved weight loss program. Include documentation of planned follow-up visits to assess adherence and response. Note: dosing escalation must follow the documented regimen (see dosing callout).

PA required for initial and continued therapy
Member must not be taking excluded/contraindicated medications (e.g., concurrent bupropion products)

Documentation Required

PA Requirements and Dosing

Dosing for bupropion/naltrexone must follow the escalation: Week 3: two tablets PO QAM and one tablet PO QPM; Week 4 and onward: two tablets PO BID. Do not exceed 32 mg naltrexone/360 mg bupropion per day (4 tablets/day). Include dose and schedule on the PA request.

Document titration dates and current dose on PA request

Definitions

inv-18: Bupropion/naltrexone (Contrave) — definition of the combination drug components

Component 1Naltrexone — an opioid antagonist

Component 2Bupropion — an aminoketone antidepressant

Combination nameBupropion/naltrexone marketed as Contrave

inv-19: WHO BMI categories — BMI classification ranges

UnderweightBMI < 18.5 kg/m2

NormalBMI 18.5–24.9 kg/m2

OverweightBMI 25.0–29.9 kg/m2

Background

Contrave is a combination of naltrexone (an opioid antagonist) and bupropion (an aminoketone antidepressant). It is indicated as an adjunct to a reduced‑calorie diet and increased physical activity for chronic weight management in adults meeting BMI‑based eligibility criteria; its effect on cardiovascular morbidity and mortality and safety with other weight‑loss products has not been established.

Policy Summary

Payermhn

PolicyBupropion/Naltrexone (Contrave) coverage

Policy CodePolicy HNCA.CP.PCH.12

Change TypeNo material change

Effective DateJan 17, 2024

Next Review Date

SourceLink

On This Page

If second or subsequent renewal request: member has lost weight and/or maintained weight loss on therapy

Documentation of member's current weight within the last 30 days

Follow-up visits are planned to assess adherence and response to the treatment plan

Documentation that member is actively enrolled in a Health Net approved weight loss program or other prescriber-recommended program that includes 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 (4 tablets per day)

Approval duration: first reauthorization 12 weeks; subsequent reauthorizations 6 months

Action if not metIf <5% weight loss at 12 weeks, Contrave should be discontinued

inv-20: Extended-release tablet strength — tablet contains 8 mg naltrexone / 90 mg bupropion

Tablet composition per tabletEach extended‑release tablet contains 8 mg naltrexone and 90 mg bupropion

Dosage formExtended‑release tablet

Product availability noteStrength listed in product availability section

Maximum dose = 32 mg naltrexone / 360 mg bupropion per day

Denial Risk

Hypertension Control Requirement

Uncontrolled hypertension is a contraindication for use. Provider must document that hypertension is controlled if present (e.g., recent vitals, BP readings, plan for management). Requests lacking evidence of controlled blood pressure may be denied.

If member has hypertension, include recent blood pressure readings and documentation showing control

Documentation Required

Required Documentation

Required documentation to support approval: office chart notes, laboratory results or other clinical information showing BMI (see Appendix B), baseline and current height and weight within the last 30 days, and evidence of participation in and continued enrollment in an approved weight loss program. Also include planned follow-up visit schedule to assess adherence and response.

Baseline and current height and weight within 30 days for initial request; for reauthorization, current weight within 30 days
Proof of active participation in an approved weight loss program for ≥6 months prior to initiation
Provider office notes and labs as applicable

Prior Authorization

Behavioral Program Prerequisite

Member must have participated in an approved behavioral weight loss program for at least 6 months prior to initiation. The program must include a reduced calorie diet, increased physical activity, and a behavioral modification component. Provider must document active participation and intent to remain enrolled throughout therapy.

Examples of approved programs: Weight Watchers, Active&Fit, or other prescriber‑recommended programs that meet the three components
Active participation ≥6 months prior to use and continued enrollment while on therapy

Documentation Required

Behavioral Modification Program

Behavioral modification is required as part of the weight loss program per ACC/AHA guidelines. Members must agree to continue behavioral modification while on medication and this should be documented in the PA submission.

Behavioral modification must be one component of the documented program
Member agreement to continue behavioral modification during treatment must be included

Obese (general)BMI ≥ 30 kg/m2

Obesity classesClass I: 30.0–34.9; Class II: 35.0–39.9; Class III: ≥ 40 kg/m2