CurrentBlue Cross Blue Shield - MassachusettsPolicy 110

Pharmacy coverage for Contrave (naltrexone/bupropion) and Imcivree (setmelanotide)

Prior authorization and coverage criteria for Contrave and Imcivree for BCBSMA commercial members (pharmacy benefit), including initial and continuation requirements and documentation expectations.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyPharmacy coverage for Contrave (naltrexone/bupropion) and Imcivree (setmelanotide)

Policy CodePolicy 110

Change TypeAdministrative relocation of products

Effective Date

Next Review Date

Key ActionSubmit prior authorization with supporting documentation (chart notes, labs, medication names/strengths and dates of alternatives tried) to demonstrate member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Contrave and Imcivree were moved from Medical Policy 572 to their own Medical Policy.

2drugs covered

6 monthspre-init trial

12 moContrave approval

4 moImcivree initial

Coverage Criteria for Contrave and Imcivree

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Contrave (naltrexone/bupropion)

Covered when ALL of the following are met.

Contrave initial: Member is being treated for chronic weight management and meets ONE: (a) BMI ≥30 kg/m2 OR (b) BMI ≥27 kg/m2 with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes)see BMI

Physician attestation or documentation of ≥6-month trial of a comprehensive weight loss plan (reduced calorie diet, increased physical activity, behavioral modifications) prior to initiation

Contrave additional initial: Physician attestation or documentation that the member will use medication as an adjunct to a comprehensive weight management plan (reduced-calorie diet, increased physical activity, behavioral modifications)

Contrave continuation: Continued coverage when ALL of the following are met: (1) Member is ≥18 years of age; (2) Documentation of significant weight loss meeting ONE: (a) ≥5% of baseline body weight within first 12 weeks of treatment, (b) continued weight loss, OR (c) maintenance of at least 5% below baseline; (3) Documentation of adherence to therapy and tolerating recommended maintenance dose for ≥3 consecutive months; (4) Member continues with a comprehensive weight management plansee weight loss thresholds

Approval length for continuation: 12 months

Imcivree (setmelanotide)

Covered when ALL of the following are met.

Imcivree initial age/BMI: Diagnosis of obesity: (a) adults ≥18 years with BMI ≥30 kg/m2; (b) pediatric patients ≥2 years of ageBMI criteria

Approval length: 4 months

Imcivree genetic confirmation: Obesity due to a homozygous or presumed compound heterozygous variant in POMC, PCSK1, or LEPR confirmed by genetic testing with variants interpreted as pathogenic, likely pathogenic, or variant of uncertain significance (VUS)genetic test results

Imcivree adherence: Demonstration of treatment adherence

Imcivree renewal response:

Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review.

Definitions and BMI Thresholds

BMI thresholds — Contrave and Imcivree

Contrave (naltrexone/bupropion) BMI criteriaInitial BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 in presence of at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes); physician attestation of ≥6-month comprehensive weight loss program required prior to initiation.

Contrave continuation/response thresholdsDocumented significant weight loss: ≥5% weight loss in first 12 weeks OR continued weight loss OR maintained ≥5% below baseline; adherence and tolerating maintenance dose for ≥3 consecutive months (approval length for continuation: 12 months).

Imcivree (setmelanotide) adult BMI criteriaAdults (≥18 years): BMI ≥ 30 kg/m2 for initial approval (approval length: 4 months).

Imcivree pediatric criteriaPediatric patients: eligible starting at age ≥2 years (BMI criteria per age-specific guidance).

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for affected medications through BCBSMA Pharmacy Operations. Providers may call, fax, or submit the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) as instructed by BCBSMA (Tel: 1-800-366-7778; Fax: 1-800-583-6289). This requirement applies to Contrave (naltrexone/bupropion) and Imcivree (setmelanotide) under the BCBSMA commercial pharmacy benefit.

Affected drugs: Contrave (PA, QCD) and Imcivree (PA, QCD)
Prior authorization contact: Pharmacy Operations — Tel: 1-800-366-7778; Fax: 1-800-583-6289
Forms: Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or Form #434

Step Therapy

Step Therapy / Formulary Alternatives

When formulary alternatives exist, the provider must document trials of preferred formulary alternatives or provide a clear clinical justification for why such trials are not appropriate. Requests may be reviewed against prescription claims to confirm prior use of formulary agents or completion of step therapy.

Step therapy expectation: document trials of preferred formulary alternatives and dates when available
If two covered formulary alternatives exist for a non‑covered medication, prior failures or contraindications to both may be required (see Appendix)
If prescription claims do not establish prior use of preferred therapies, additional provider documentation will be requested

Documentation Required

Required Provider Documentation

Providers must submit supporting clinical documentation to demonstrate medical necessity and to justify any deviation from formulary or step therapy requirements. Acceptable documentation includes chart notes, lab results, and other clinical information that describe treatment response and reasons for failure or intolerance to alternatives.

Include medication names, strengths, dates of use, and specifics of treatment failure for each formulary alternative tried
Provide clinical rationale when a switch to a formulary alternative is medically contraindicated or otherwise not clinically appropriate
We may use prescription claims to corroborate prior use; if claims data are insufficient, providers will be required to supply additional records

Denial Risk

Documentation Insufficiency Triggers

Failure to provide adequate documentation of prior trials, dates, or clinical reasons preventing trials may result in denial of the prior authorization request. Requests based solely on samples will not meet coverage criteria. If documentation is incomplete, BCBSMA will request additional information and may deny coverage if the information is not supplied.

Insufficient documentation of prior trials or lack of clinical justification = denial risk
Requests based exclusively on samples are not sufficient for approval
Providers will be given an opportunity to submit additional information; absence of required documentation may lead to denial

Background

Obesity is managed with lifestyle modification and, when indicated, adjunctive pharmacotherapy. Contrave (naltrexone/bupropion) is indicated for chronic weight management in adults who meet BMI criteria and who have completed a prior comprehensive weight loss program; documentation from the prescriber is required to show the member meets the approval criteria. Imcivree (setmelanotide) is indicated for specific genetic forms of obesity due to variants in genes such as POMC, PCSK1, or LEPR and requires genetic confirmation and documentation of treatment response for renewal. For both products, prior authorization is required under the pharmacy benefit and the prescriber must submit supporting clinical documentation (e.g., chart notes, lab results) to demonstrate medical necessity.

Key Definitions

BMI definition for obesity — Contrave (adult criteria)

Definition of obesity for Contrave (adult)BMI ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes).

Required prior weight-loss programPhysician attestation that the member has engaged in at least a 6-month trial of a comprehensive weight loss plan (reduced calorie diet, increased physical activity, behavioral modifications) prior to initiation.

Age requirement (adults)Criteria shown apply to adult patients (age thresholds specified in drug-specific sections).

Genetic variant definitions relevant to Imcivree

Genetic variant types requiredHomozygous or presumed compound heterozygous variants in POMC, PCSK1, or LEPR confirmed by genetic testing.

Accepted variant interpretationsVariants must be interpreted as pathogenic, likely pathogenic, or Variants of Uncertain Significance (VUS) in the genetic report.

Relevant genesProopiomelanocortin (POMC); Proprotein convertase subtilisin/kexin type 1 (PCSK1); Leptin receptor (LEPR).