CurrentBlue Cross Blue Shield - IowaPolicy 05.01.108

Methylnaltrexone (Relistor) for Opioid-Induced Constipation

This policy governs coverage and medical necessity criteria for Relistor (methylnrexone) tablets and injections for treatment of opioid-induced constipation in adult Blue Cross Blue Shield - Iowa members. It applies to benefit determinations where member contract allows coverage.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyMethylnaltrexone (Relistor) for Opioid-Induced Constipation

Policy CodePolicy 05.01.108

Change TypeMinor review — no material changes

Effective DateNov 5, 2022

Next Review DateOct 1, 2025

Key ActionObtain prior authorization documenting opioid‑induced constipation and trial/failure or intolerance to Movantik (or contraindication) before approving Relistor; approvals for injection are typically limited to 4 months and quantity limits may apply.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 monthsapproval duration (injection)

30/30dquantity limit (injection)

adultsindicated population

GI obstructionexplicit exclusion

Coverage and Medical Necessity Criteria

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Initial approval criteria — Relistor injection

Relistor injection is considered medically necessary when ALL of the following are met:

Injection indication: Relistor injection is prescribed for opioid-induced constipation in an adult patient with advanced illness or pain caused by active cancer who require opioid escalation for palliative care OR for an adult patient with chronic noncancer pain (including patients with chronic pain related to prior cancer or its treatment) who do not require frequent (e.g., weekly) opioid dosage escalation

FDA-approved indications reflected

Oral tolerability or prior therapy: Either: the patient is unable to tolerate oral medications; OR the patient experienced an inadequate treatment response or intolerance to Movantik (naloxegol) at optimal therapeutic dosages, or has a documented clinical reason (expected adverse reaction or contraindication) that prevents trialing Movantik

Step therapy requirement unless oral intolerance is present

Initial approval criteria — Relistor tablets

Relistor tablets are considered medically necessary when ALL of the following are met:

Tablet indication: Relistor tablets are prescribed for opioid-induced constipation in an adult patient with chronic noncancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation

FDA-approved indication reflected

Prior response to Movantik: The patient experienced an inadequate treatment response or intolerance to Movantik (naloxegol) at optimal therapeutic dosages OR has a documented clinical reason (expected adverse reaction or contraindication) that prevents them from trialing Movantik

Required before tablet approval

Coverage is not provided for patients with known or suspected mechanical gastrointestinal obstruction or for those who are at an increased risk of recurrent obstruction. This exclusion is based on the risk of gastrointestinal perforation associated with treatment in these situations and applies to all Relistor formulations.

Initial Therapy Rules

Initial therapy rules — criteria differ by formulation

Initial therapy rules differ by formulation.

Injection initial: Indication matches injection-approved populations AND either the patient is unable to tolerate oral medications OR there is inadequate response/intolerance/contraindication to Movantik

Approvals for injection may be limited to 4 months and subject to dosing/quantity limits

Tablet initial: Indication matches chronic noncancer pain population AND inadequate response/intolerance/contraindication to Movantik (naloxegol) at optimal dosages

Tablets require prior trial of Movantik unless contraindicated

Continuation and Renewal Criteria

Continuation therapy — approval duration and continuation considerations

Approval duration and continuation considerations

Approval duration: Approval for Relistor injection will be for 4 months

Continuation beyond the initial approval period should be supported by clinical documentation of continued benefit; approvals remain subject to dosing and quantity limits (e.g., 30 injections per 30 days)

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Approvals may be limited to FDA-based durations and dosing/quantity limits; requests should document the specific formulation and intended dosing.

Approval duration: Relistor injection — up to 4 months (per policy)
Quantity limits: Relistor 8mg/0.4mL & 12mg/0.6mL — 30 injections per 30 days

Denial Risk

Exclusion — Mechanical Gastrointestinal Obstruction

Coverage will not be provided for patients with known or suspected mechanical gastrointestinal obstruction or for patients at increased risk of recurrent obstruction due to the potential for gastrointestinal perforation.

Documentation Required

Required Clinical Documentation

Documentation must demonstrate a diagnosis of opioid‑induced constipation (OIC) and that formulation‑specific criteria are met (e.g., indication for injection formulation vs. oral tablets). Include prior treatment history, rationale for chosen formulation, and any contraindications to alternative therapies.

Document diagnosis of opioid‑induced constipation and whether patient has advanced illness/active cancer requiring opioid escalation (injection criteria) or chronic noncancer pain (tablet criteria)
Specify inability to tolerate oral medications when injection formulation is requested
If step therapy exemption is claimed, provide documentation of intolerance or inadequate response to Movantik at optimal dosage or a documented clinical reason (adverse reaction/contraindication) preventing trial of Movantik

Step Therapy

Step Therapy Requirement

Step therapy: prior trial and inadequate response or intolerance to Movantik is required for oral formulations unless there is a contraindication or the patient is unable to take oral medications. For injection requests, inability to tolerate oral meds is acceptable instead of prior oral trial.

Acceptable step therapy exception: documented adverse reaction or contraindication to Movantik, or documented inability to take oral medications (for injection)

Step Therapy Requirements

Step	Requirement	Notes
1	Trial and inadequate treatment response or intolerance to Movantik (naloxegol) at optimal therapeutic dosages is required prior to approval of Relistor (tablets or injection).	If the patient has a documented clinical reason (expected adverse reaction or contraindication) that prevents trialing Movantik, this requirement may be waived.
2	For Relistor injection only: prior trial of Movantik is not required when the patient is unable to tolerate or take oral medications (e.g., inability to swallow).	Injection may be considered without prior Movantik trial when oral administration is not possible; documentation of inability to take oral meds is required.
3	If Movantik trial is not possible due to contraindication or expected adverse reaction, provide documented clinical reason to support approval of Relistor without prior Movantik trial.	Documentation must be included with prior authorization request per policy requirements.

Site of Care and Setting Notes

Note

Site-of-care approvals subject to FDA/compendia dosing and quantity limits

Approvals may be subject to dosing and quantity limits in accordance with FDA labeling, accepted compendia, or evidence-based practice guidelines; site-specific setting considerations (e.g., infusion center) should follow those limits.

Approvals may follow FDA-approved dosing limits and compendia/guideline recommendations.
Quantity limits (injection) apply: 30 injections per 30 days.

Background

Opioid-induced constipation (OIC) is constipation that occurs as a result of opioid therapy in adult patients. Relistor (methylnaltrexone) is a peripherally acting mu-opioid receptor antagonist approved to treat OIC; it is available as subcutaneous injection and as oral tablets. The injection formulation includes a specific FDA indication for use in adults with advanced illness or active cancer who require opioid dose escalation, while the tablet formulation is indicated for adults with chronic noncancer pain (including chronic pain related to prior cancer).