110 Form

Pharmacy Medical Policy Non-GLP-1 Agonists for Anti-obesity Management Table of Contents
Authorization Information Clinical Criteria Appendix Policy History References

Policy Number: 110 BCBSA Reference Number: None Related Policies • Policy #621A Quality Care Dosing guidelines • GLP-1 Agonists for Anti-obesity Management and Other Non-Obesity Conditions #572

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 1/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.
See Appendix for additional information.

Please refer to the chart below for the formulary and step status of the medications affected by this policy.

Drug Formulary Status (BCBSMA Commercial Plan) Contrave (naltrexone / bupropion) PA, QCD Imcivree (setmelanotide) PA, QCD PA – Prior Authorization; QCD (Quality Care Dosing – refer to Policy 621b) Approval Length: See individual criteria

Clinical Guideline Coverage Criteria: Contrave (naloxone/bupropion)

INITIAL APPROVAL
Coverage may be considered MEDICALLY NECESSARY when ALL the following criteria are met. Diagnosis Obesity Applicable Medications Contrave
Approval Length 6 months

1. Member is being treated for chronic weight management that meets ONE of the following:
   a. An initial body mass index (BMI) of ≥ 30 kg/m2,
   b. ≥ 27 kg/m2 in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes)

   AND

2. Members 18 years of age or older AND

3. Physician attestation or documentation that the member has already engaged in at least 6-month trial of a comprehensive weight loss plan that includes a reduced calorie diet, increased physical activity, and behavioral modifications prior to initiation of therapy

   AND

4. Physician attestation or documentation that the member will be using medication as an adjunct to a comprehensive weight management plan including a reduced-calorie diet, increased physical activity and behavioral modifications

   CONTINUATION OF THERAPY
   Continued coverage may be considered MEDICALLY NECESSARY when all the following criteria are met Diagnosis Obesity Applicable Medications Contrave Approval Length 12 months

5. Documentation of significant weight loss by meeting ONE of the following conditions: a. Documented weight loss of at least 5% of baseline body weight after the initiation of treatment (first 12 weeks of treatment) b. Must demonstrate continued weight loss c. Maintain the plateau weight of at least 5% below baseline

   AND

2. Documentation that the patient is adherent to therapy and has been tolerating the recommended maintenance dose of medication for at least 3 consecutive months

   AND

3. Documentation that the patient continues with a comprehensive weight management plan including a reduced-calorie diet, increased physical activity and behavioral modifications

   Clinical Guideline Coverage Criteria: Imcivree (setmelanotide)

   INITIAL APPROVAL
   Coverage may be considered MEDICALLY NECESSARY when ALL the following criteria are met. Diagnosis Obesity Applicable Medications Imcivree
   Approval Length 4 months

4. Patient has a diagnosis of obesity, defined as: a. Adult patients (≥ 18 years old): BMI of ≥30 kg/m2, OR
   b. Pediatric patients 2 years of age or older

   AND

5. Obesity is due to a homozygous or presumed compound heterozygous variant in at least one of the following genes, confirmed by genetic testing including Documentation demonstrating that the variants in POMC, PCSK1, or LEPR genes are interpreted as pathogenic, likely pathogenic, or Variants of Uncertain Significant (VUS): • Proopiomelanocortin (POMC) • Proprotein convertase subtilisin/kexin type 1 (PCSK1) • Leptin receptor (LEPR) OR

6. Documentation of monogenic or syndromic obesity due to Bardet-Biedl Syndrome

   CONTINUATION OF THERAPY
   Continued coverage may be considered MEDICALLY NECESSARY when all the following criteria are met Diagnosis Obesity Applicable Medications Imcivree Approval
   Length • First Renewal: 4 Months • Subsequent Renewal: 12 months

   First Renewal:

7. Documentation of response to therapy, as evidenced by: a. At least a 5% reduction in baseline body weight, OR b. At least a 5% reduction in baseline BMI for patients with continued height growth potential AND

8. Demonstration of treatment adherence

   Subsequent Renewal:

9. Documentation of maintained response to therapy, as evidenced by: a. Maintenance of at least a 5% reduction in body weight relative to baseline OR b. Maintenance of at least a 5% reduction in baseline BMI for patients with continued height growth potential AND

2. Demonstration of treatment adherence

   Appendix Member cost share consideration For those drugs that may be covered under the pharmacy benefit, a higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non- covered drug. Samples 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. Criteria Documentation Provider must submit supporting documentation (e.g., chart notes, lab results or other clinical information) to show that member has met all approval criteria Formulary Status* All requests must meet the Prior Authorization requirement. For non-covered medications, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient.
   Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR
   Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434 Individual Consideration (for Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
   If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
   Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
   To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

   Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043 Phone: 1-800-366-7778 Fax: 1-800-583-6289

Policy History Date Action 1/2026 Moved Contrave and Imcivree from MP 572 to its own Medical Policy.

References

1. Contrave [package insert]. Takeda Pharmaceuticals America, Inc., La Jolla, CA -3/2021.
2. Imcivree [package insert]. Rhythm Pharmaceuticals, Inc., Boston, MA–12/2024.