Methylnaltrexone Bromide (Relistor) — Coverage Criteria
This policy defines medical necessity and authorization criteria for methylnaltrexone bromide (Relistor) for treatment of opioid-induced constipation (OIC) across Centene lines of business and specifies dosing, duration, and documentation requirements for providers.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial approval:
Provider must submit supporting documentation.
Continuation Therapy
Continuation Therapy — covered when ALL of the following are met:
Approval durations vary by line of business (Commercial tablets/injection 6 months; Medicaid/HIM 12 months for continuation).
Other Indications
Other diagnoses/indications
Requests for recently changed labeling (within 6 months) should be handled per referenced policies if not yet reflected in this policy.
Requests for non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety consistent with applicable off‑label use policies (see referenced off‑label policies for the member's line of business).
For Medicaid members, state Medicaid coverage provisions take precedence where they conflict with this clinical policy. Providers should consult the applicable state Medicaid manual for specific coverage requirements.
Use of methylnaltrexone (Relistor) in patients with known or suspected mechanical gastrointestinal obstruction (or those at increased risk of recurrent obstruction) is contraindicated/not medically necessary and requests for such patients will be denied.
Coding
| NDC/HCPCS not specified in this chunk | No explicit CPT/HCPCS/NDC codes listed in provided sections |
| J2212 | Injection, methylnaltrexone, 0.1 mg |
Provider Actions & Submission Requirements
Prior Authorization Required
Prior authorization is required for methylnaltrexone (Relistor) injections. Provider must submit documentation (e.g., office chart notes, lab results, medication history) supporting that the member meets the initial or continuation criteria and that all other policy requirements (including required prior laxative therapy and absence of contraindications) have been satisfied.
- Affected HCPCS: J2212 (injection, methylnaltrexone, 0.1 mg) — reference coding guidance when submitting claims.
- Prior authorization may be required for oral alternatives (e.g., Movantik) per plan rules.
Coding & Billing Guidance
Providers should reference the most up-to-date professional coding guidance when submitting claims. Codes listed in this policy (for example, HCPCS J2212) are for informational purposes only; inclusion or exclusion of any codes in this policy does not guarantee coverage or reimbursement.
- Verify current HCPCS/CPT/NDC codes and billing instructions prior to claim submission.
- Contact the plan or billing services for questions about claim coding.
Documentation Required
Provider must submit documentation that demonstrates the member has met the policy criteria. Acceptable documentation includes office chart notes, medication history showing trials of prior laxative classes, laboratory results when relevant, and notes addressing contraindications (e.g., known or suspected mechanical gastrointestinal obstruction). Requests lacking adequate documentation may be denied.
- Document trials and failures of one agent from each laxative class (stimulant, osmotic, stool softener) unless contraindicated.
- Document duration of opioid therapy (e.g., ≥4 weeks) and reason for continued opioid use (non‑cancer chronic pain if specified).
Step Therapy
No step therapy requirements are specified in this policy section for methylnaltrexone injections beyond the required prior laxative therapy and any plan-level prior authorization rules. Providers should follow the policy's initial and continuation criteria rather than a separate step-therapy pathway.
Non‑FDA Indications
Requests for non‑FDA approved (off‑label) indications that are not addressed in this policy may be denied unless sufficient supporting documentation of efficacy and safety is provided in accordance with the plan's off‑label use policies.
- See off‑label use policies: CP.CPA.09 (commercial) and HIM.PA.154 (health insurance marketplace).
Initial Therapy Criteria
Initial Therapy
Covered when ALL of the following are met for initial approval (grouped):
Provider must submit documentation supporting that member has met these criteria.
Continuation Therapy Criteria
Continuation Therapy
Covered when ALL of the following are met for continuation approval (grouped):
Approval durations vary by line of business (Commercial: 6 months; Medicaid/HIM: 12 months).
Step Therapy Requirements
| Required trials/failures or documented contraindication |
|---|
| Failure of at least one agent from each laxative class while on opioid therapy: stimulant laxative (e.g., bisacodyl, senna); osmotic laxative (e.g., lactulose, polyethylene glycol); and stool softener (e.g., docusate). |
| Failure of naloxegol (Movantik) unless contraindicated or clinically significant adverse effects were experienced (prior authorization for Movantik may be required). |
| Or documented contraindication/intolerance to the required laxative agents or to naloxegol (provide clinical rationale and supporting documentation). |
Quantity Limits & Dosing
Site of Care
Site of care and administration — SC injection per product labeling
Relistor injections are administered subcutaneously and may be given in office, infusion center, hospital outpatient, or home settings; follow product labeling for dosing and administration.
- Injection presentations include prefilled syringes and vials; follow weight‑based dosing per label (examples provided in dosing section).
Background
Opioid‑induced constipation (OIC) refers to constipation that develops during opioid therapy and is commonly defined in clinical trials as fewer than three bowel movements in the preceding week or no bowel movement for 2 days. Relistor (methylnaltrexone) is a peripherally acting mu‑opioid receptor antagonist indicated to treat OIC in adults with chronic non‑cancer pain and in adults with advanced illness or active cancer who require opioid dose escalation for palliative care. Management decisions should consider trial definitions, the clinical course, and product labeling for dosing and administration.
Definitions
Revision History & References
4Q 2024 annual review: references reviewed and updated.
4Q 2023 annual review: references reviewed and updated.
Consolidated commercial line of business, retired CP CPA.274, and added redirection to Movantik per February SDC and clinical guidance.
4Q 2022 annual review: general information (Appendix D) added; references reviewed and updated; template changes applied to other diagnoses/indications and continued therapy section.
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