CurrentCentenePolicy CP.PMN.169

Methylnaltrexone Bromide (Relistor) Coverage

Defines medical necessity criteria, dosing limits, and prior authorization requirements for Relistor (methylnaltrexone bromide) for treatment of opioid-induced constipation in adults across Centene lines of business.

Policy Summary

PayerCentene

PolicyMethylnaltrexone Bromide (Relistor) Coverage

Policy CodePolicy CP.PMN.169

Change TypeNo material changes

Effective DateDec 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age

4 weeksOpioid use prior

450 mg/dayOral max

12 mg/daySC max

J2212HCPCS

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met for Opioid Induced Constipation (initial approval):

OIC initial approval: 1) Diagnosis of opioid-induced constipation (OIC).

Age: 2) Patient is ≥ 18 years of age.

Opioid use duration: 3) Member has been taking opioid(s) for ≥ 4 weeks for chronic pain not caused by active cancer.

Step therapy failures: 4) Failure of one agent from each of the following classes while on opioid therapy, unless clinically significant adverse effects are experienced or all are contraindicated: a) stimulant laxative (e.g., bisacodyl, senna); b) osmotic laxative (e.g., lactulose, polyethylene glycol); c) stool softener (e.g., docusate).

Recent laxative use: 5) Member has used one of the aforementioned agents in the past 30 days, unless contraindicated.

Failure of naloxegol: 6) Failure of naloxegol (Movantik®), unless contraindicated or clinically significant adverse effects are experienced.

Dose limits: 7) Prescribed dose does not exceed one of the following: a) Tablets — both: i) ≤ 450 mg per day; ii) ≤ 3 tablets per day; OR b) Injection — FDA‑approved weight‑based dosing.Tablets: 450 mg/day and ≤3 tablets/day; Injection: FDA weight-based dosing

State-specific note: Note: For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Continuation Therapy

Continued therapy for OIC (must meet all):

Continuity of care or prior approval: 1) Member meets one of the following: a) currently receiving medication via the Centene benefit or previously met initial approval criteria; OR b) currently receiving medication and enrolled in a state/product with continuity of care regulations.

Ongoing opioid therapy: 2) Member continues to receive opioid therapy.

Clinical response: 3) Member is responding positively to therapy.

Dose change limits: 4) If request is for a dose increase, the new dose does not exceed: a) Tablets — both: i) ≤ 450 mg per day; ii) ≤ 3 tablets per day; OR b) Injection — FDA‑approved weight‑based dosing.Tablets: 450 mg/day and ≤3 tablets/day; Injection: FDA weight-based dosing

Initial Therapy / Indication and Dosing

Covered when ALL of the following are met for adults with OIC secondary to chronic non-cancer pain:

Indication: Patient is an adult with opioid‑induced constipation (OIC) associated with chronic non‑cancer pain.

Dosing: Use methylnaltrexone at either: 12 mg subcutaneously once daily OR 450 mg orally once daily; do not exceed 12 mg/day SC or 450 mg/day PO.Maximum: 12 mg/day SC; 450 mg/day PO

Product formulation: Prescribed formulation corresponds to available products (tablets: 150 mg; injections: 8 mg/0.4 mL or 12 mg/0.6 mL prefilled syringe or vial).

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage requirements.

Coding listed in this policy is provided for informational purposes only; inclusion or exclusion of any code does not guarantee coverage. Absence of a code or incorrect coding may result in claim denial — providers should reference current professional coding guidance before submitting claims.

Provider Actions & Requirements

Prior Authorization

Prior Authorization & Step-Therapy Requirements

Prior authorization is required for Relistor (methylnaltrexone). Requests must document that step-therapy requirements have been met prior to approval unless a medical exception is provided or state law (e.g., IL HB 5395 for Illinois HIM requests effective 1/1/2026) bypasses step therapy.

Prior authorization required
Step-therapy must be documented: failure of one agent from each class — stimulant laxative, osmotic laxative, and stool softener — while on opioid therapy, unless contraindicated or adverse effects.
Prior failure of Movantik (naloxegol) required unless contraindicated or adverse effects; Movantik may itself require prior authorization.

Documentation Required

Documentation Requirements

Providers must submit supporting clinical documentation with the authorization request. Acceptable documentation includes office chart notes, recent lab results, medication history showing opioid use ≥4 weeks, records of use/failure of required laxative agents and Movantik, and any documentation of contraindications or adverse events.

Include office notes and medication history confirming opioid use ≥4 weeks for chronic (non-cancer) pain.
Document trials and failures (or contraindications) of: stimulant laxative, osmotic laxative, stool softener, and naloxegol (Movantik).
Provide prescribing information or clinical literature if relying on clinical rationale for exception.

Billing Rule

Prior Authorization and Coding

Coding guidance included in this policy is informational only. Inclusion or exclusion of codes does not guarantee coverage; verify current professional coding guidance before billing.

HCPCS code: J2212 — Injection, methylnaltrexone, 0.1 mg (informational).
Providers should confirm applicable NDC, HCPCS, and CPT coding and any payer-specific billing rules prior to claim submission.

Denial Risk

Denial Risk — Documentation & Coding

Failure to provide required documentation or to follow step-therapy/coding guidance may result in denial of the authorization or claim. The presence or absence of codes in this policy does not ensure coverage; denials can occur if documentation is insufficient or coding is incorrect.

Lack of supporting clinical records (office notes, labs, medication trials) may cause denial.
Coding-based denial risk: verify up-to-date coding resources and payer-specific rules before submission.

Documentation Required

Supporting Documentation and References

Clinical references and the Relistor prescribing information can be provided to support medical necessity determinations on appeal or exception requests.

Relistor Prescribing Information (Salix) and cited clinical literature are acceptable supporting references.
Provide specific excerpts or clinical rationale when requesting an exception to step therapy.

Initial Therapy Criteria (Pharmacy)

Initial Therapy (Pharmacy)

Initial therapy criteria for OIC in chronic non-cancer pain

Initial therapy pharmacy nodes: 1) Diagnosis of opioid‑induced constipation; 2) Age ≥ 18 years; 3) Opioid use ≥ 4 weeks for chronic non‑cancer pain; 4) Failure of one agent from each class (stimulant laxative, osmotic laxative, stool softener) while on opioid therapy unless contraindicated; 5) Recent use of one of these agents within past 30 days unless contraindicated; 6) Failure of naloxegol (Movantik®) unless contraindicated; 7) Dosing limits: tablets ≤ 450 mg/day and ≤ 3 tablets/day OR injection per FDA weight‑based dosing.

Step therapy requirement: Providers must document failure of the step agents (stimulant, osmotic, stool softener) and failure of Movantik when required; prior authorization may be required for Movantik.

Initial therapy — dosing and product selection

Initial therapy — dosing and product selection per product availability and dosing regimen

Age and indication: Adult patients with opioid‑induced constipation associated with chronic non‑cancer pain.

Dosing options: 12 mg SC once daily OR 450 mg PO once daily; do not exceed the stated maximums (12 mg/day SC; 450 mg/day PO).

Available formulations: Tablets: 150 mg; Injections: 8 mg/0.4 mL or 12 mg/0.6 mL prefilled syringe or vial — select formulation consistent with prescribed dose.

Continuation Criteria

Continued Therapy

Continued therapy — continued therapy criteria

Continued therapy nodes: 1) Member is currently receiving the medication via the Centene benefit or previously met initial criteria (or has continuity of care); 2) Member continues opioid therapy; 3) Member is responding positively to therapy; 4) Dose limits maintained as per policy (tablets ≤ 450 mg/day and ≤ 3 tablets/day; injection per FDA weight‑based dosing).

Continuation therapy notes — policy maintenance and approval history; continuity rules

Policy history: Approval durations and administrative updates are recorded in policy history; the 4Q2025 annual review updated approval duration for initial and continued therapy for Medicaid/HIM and commercial tablets from 6 to 12 months and added a step therapy bypass for IL HIM per IL HB 5395.

Continuity rules: Continuity of care provisions apply where state regulations require; see state‑specific addendums for continuity rules.

Step Therapy

Requirement	Details
Step therapy requirement
For chronic non-cancer pain OIC: member must have failed one agent from each of the following classes while on opioid therapy unless contraindicated — stimulant laxative (e.g., bisacodyl, senna); osmotic laxative (e.g., lactulose, polyethylene glycol); and stool softener (e.g., docusate). Member must have used one of the aforementioned agents in the past 30 days unless contraindicated. Additionally, failure of naloxegol (Movantik) is required unless contraindicated or clinically significant adverse effects are experienced. Prior authorization may be required for Movantik.

Requirement

Details

Step therapy requirement

For chronic non-cancer pain OIC: member must have failed one agent from each of the following classes while on opioid therapy unless contraindicated — stimulant laxative (e.g., bisacodyl, senna); osmotic laxative (e.g., lactulose, polyethylene glycol); and stool softener (e.g., docusate). Member must have used one of the aforementioned agents in the past 30 days unless contraindicated. Additionally, failure of naloxegol (Movantik) is required unless contraindicated or clinically significant adverse effects are experienced. Prior authorization may be required for Movantik.

Policy history note	Implication
Consolidation and redirection to Movantik
Per policy maintenance notes, the commercial line was consolidated and CP.CPA.274 retired with redirection to Movantik (naloxegol) as an earlier step agent; prior authorization and coding implications were added during these updates.
Illinois HIM step therapy bypass (IL HB 5395)
Effective 1/1/2026, Illinois HIM requests are exempt from the step therapy requirements per IL HB 5395; 4Q2025 annual review added this step therapy bypass for IL HIM and updated approval durations.

Site of Care

Note

Injection is subcutaneous; site of care not restricted here

Relistor injection is administered subcutaneously; the policy does not limit administration to a specific site of care in this section.

Weight-based or fixed dosing regimens for injection are described elsewhere in the policy.

Note

Injectable forms (prefilled syringe or vial) for SC use; site‑specific coverage not specified

Injectable formulations are available as single‑dose prefilled syringes (8 mg or 12 mg) or single‑dose vial for subcutaneous administration; the policy does not specify site‑specific coverage limitations.

Product availability: 8 mg/0.4 mL and 12 mg/0.6 mL prefilled syringes or a single‑dose vial.
No site‑of‑care coverage restriction is specified in the provided policy fragment.

Background

Methylnaltrexone bromide (Relistor) is a peripherally acting μ‑opioid receptor antagonist used to treat opioid‑induced constipation (OIC) in adults. For chronic non‑cancer pain, the policy lists dosing of 12 mg subcutaneously once daily or 450 mg orally once daily, with available formulations including 150 mg tablets and injectable 8 mg/0.4 mL or 12 mg/0.6 mL prefilled syringes or vials. Relistor injection is also indicated for OIC in adults with advanced illness or active cancer who require opioid dose escalation for palliative care. Clinical trial definitions of OIC used in the prescribing information describe OIC as <3 bowel movements in the preceding week or no bowel movement for 2 days. Use beyond four months has not been well studied; providers should consult the prescribing information and referenced literature when assessing medical necessity.

Definitions

Opioid‑induced constipation (trial definition)

Trial definition of OICOpioid‑induced constipation was defined in Relistor trials as <3 bowel movements in the preceding week or no bowel movement for 2 days.

Clinical trial contextDefinition used for efficacy/safety assessments in Relistor studies

Applies toAdult patients with opioid‑induced constipation in clinical trials referenced by policy

Advanced illness — definition

DefinitionAdvanced illness: life‑ending or terminal disease.

Context in policyUsed to define population eligible for injection indication in Relistor labeling

SourceAppendix D: General Information (policy document)

Opioid‑induced constipation (OIC) — indication

Indication summaryOpioid‑induced constipation (OIC) in adult patients with chronic non‑cancer pain.

Populations includedAdults with OIC associated with chronic non‑cancer pain; includes chronic pain related to prior cancer or its treatment if no frequent opioid escalation needed.

Dosing referenced with indicationPolicy lists dosing for this population as 12 mg SC once daily or 450 mg PO once daily.

OpenPayer