CurrentMass General Brigham Health PlanPolicy N/A

Imcivree (setmelanotide) — Coverage Criteria

Defines prior authorization, quantity limits, specialty pharmacy requirement, and medical necessity criteria for Imcivree (setmelanotide) for adults and pediatric patients (≥2 years) with specified genetic or syndromic obesity conditions under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyImcivree (setmelanotide) — Coverage Criteria

Policy CodePolicy N/A

Change TypeRevised — material clinical updates

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and specialty pharmacy fill with genetic test reports (if applicable) and baseline weight/BMI documentation.

SourceLink

POLICY UPDATE CHANGES

Updated language for members who are new to the Plan regarding authorization for those currently receiving the medication within the past 90 days.

Updated criteria to include Bardet-Biedl syndrome (BBS) supplemental indication and lowered approvable pediatric age to 2 years.

≥2 yrsminimum approved patient age

4 monthsinitial authorization

6 monthsreauthorization

3 mg/daydose limit

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Coverage and Medical Necessity Criteria

Initial Therapy

Authorization may be granted when ALL the following are met:

Initial approval criteria: Member is ≥2 years of age; for adult members meets documented BMI threshold; for pediatric members meets growth-chart thresholds (Bardet-Biedl syndrome: >97th percentile; POMC/PCSK1/LEPR deficiencies: ≥95th percentile); obesity is due to either (A) a homozygous or presumed homozygous variant in POMC, PCSK1, or LEPR with genetic test submitted and variants interpreted as pathogenic, likely pathogenic, or variant of uncertain significance (VUS) OR (B) Bardet-Biedl syndrome (BBS); prescriber is an endocrinologist or the prescriber is in consultation with an endocrinologist; documentation of baseline body weight (adults) or baseline BMI (pediatrics) and documentation of appropriate dosing not to exceed 3 mg per day.see text

Adult BMI value in source appears malformed and should be verified.

New-to-Plan Continuation

Authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication (excludes product obtained as samples or via manufacturer's patient assistance programs).

New-to-plan continuity: Member is new to the plan within the past 90 days and is currently receiving the requested medication (use obtained only through prescription fills; excludes samples or manufacturer's patient assistance programs); documentation consistent with ongoing therapy should be provided.90 days

Excludes sample or manufacturer assistance program recipients.

Continuation Therapy

Requests for reauthorization will be approved when ONE of the following is met:

Clinical benefit: Adults: at least a 5% reduction from baseline body weight or maintenance of at least a 5% reduction in baseline body weight; Pediatrics: at least a 5% reduction from baseline BMI or maintenance of at least a 5% reduction in baseline BMI in members with continued growth potential.>=5%

Member must also be adherent to medication.

Members with genetic variants in POMC, PCSK1, or LEPR that are interpreted as benign or likely benign are excluded from approval when authorization is sought on the basis of those variants. When requesting coverage on the basis of a POMC, PCSK1, or LEPR variant, submit the genetic test report showing the variant classification; requests relying on variants classified as benign or likely benign will not meet medical necessity under this policy.

Use of Imcivree (setmelanotide) is not supported for individuals who do not meet the policy’s genetic or syndromic criteria or who lack the required documented anthropometric thresholds. Specifically, approval requires either documented pathogenic/likely pathogenic/variant of uncertain significance (VUS) genetic test results for POMC, PCSK1, or LEPR when therapy is based on those genes, or a diagnosis of Bardet‑Biedl syndrome (BBS) with the growth-chart thresholds indicated. In addition, members must meet the policy’s age and BMI/growth-chart thresholds (member ≥ 2 years of age and the adult or pediatric BMI/growth percentiles described in the coverage criteria); absence of these documented measures means the request is not supported.

Pharmacy Product and Clinical Thresholds

Pharmacy / NDCNDC

Imcivree (setmelanotide) 10 mg/mL subcutaneous injection

Quantity limit: 1 = 10 mL per 30 days. NDC to be billed per product packaging (submit exact NDC on claim).

Clinical response thresholds and operational limits

Initial approval duration4 months

Reauthorization duration6 months

Quantity limitImcivree 10 mg/mL subcutaneous injection — 1 (10 mL) per 30 days

Maximum daily doseDo not exceed 3 mg per day

AgeMember must be 2 years of age or older

PrescriberPrescriber must be an endocrinologist or in consultation with an endocrinologist

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. This medication has been designated specialty and must be filled at a contracted specialty pharmacy.

Prior authorization required
Designated specialty medication — must be dispensed at contracted specialty pharmacy
Contact (All Plans) for Specialty/Medical and Specialty Medications: Phone 877-519-1908; Fax 855-540-3693
Non-Specialty Medications contact: Phone 800-711-4555; Fax 844-403-1029

Documentation Required

Genetic Evidence Required

Genetic test reports must be submitted when seeking approval for patients with suspected POMC, PCSK1, or LEPR-related obesity. The report must demonstrate variants interpreted as pathogenic, likely pathogenic, or variants of uncertain significance (VUS). Variants interpreted as benign or likely benign do not meet criteria for approval.

Drug Background and Indications

Setmelanotide (Imcivree) is a melanocortin‑4 receptor agonist indicated for treatment of certain monogenic and syndromic forms of obesity. Under this policy, therapy is considered for patients aged ≥2 years with obesity due to either homozygous or presumed homozygous variants in POMC, PCSK1, or LEPR (with genetic test report submitted showing variants classified as pathogenic, likely pathogenic, or VUS) or for patients with Bardet‑Biedl syndrome (BBS) meeting the specified growth‑chart thresholds. Prescriber specialty and documentation of baseline weight/BMI and dosing (not to exceed 3 mg/day) are required for authorization.

Definitions and Indication Details

Bardet-Biedl syndrome (BBS) — approved indication

Approved indication (syndromic)Bardet-Biedl syndrome (BBS) is listed as an approved indication for Imcivree (setmelanotide).

Age eligibilityIndicated for adults and pediatric patients 2 years of age and older for syndromic obesity including BBS.

DocumentationWhen approval is sought based on BBS, clinical documentation supporting the diagnosis should be provided as part of the request.

POMC / PCSK1 / LEPR deficiency — genetic evidence required

Genes specifiedPOMC, PCSK1, and LEPR deficiencies are recognized monogenic causes of obesity in the policy and can support coverage for Imcivree.

Required genetic result classificationsGenetic testing must demonstrate variants interpreted as pathogenic, likely pathogenic, or variants of uncertain significance (VUS) for approval when based on these genes.