CurrentUnitedHealthcarePolicy N/A

Prior Authorization and Medical Necessity Criteria for Relistor (methylnaltrexone) Injection

Defines prior authorization and medical necessity criteria for coverage of Relistor injection for opioid‑induced constipation in adult members, including initial and reauthorization rules and program intent to encourage lower‑cost alternatives.

Policy Summary

PayerUnitedHealthcare

PolicyRelistor (methylnaltrexone) injection prior authorization

Policy CodePolicy N/A

Change TypeRemoved tabletsupdated step therapy

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document failure or intolerance to lubiprostone (Amitiza) and Symproic or inability to swallow oral medications before requesting Relistor injection.

SourceLink

POLICY UPDATE CHANGES

Removed tablets from medical necessity criteria and updated references.

Removed OTC laxative and added generic Amitiza as step for Relistor.

Program requires trial of lower-cost options before coverage of Relistor injection.

Relistormedication covered

Prior Authorizationprogram type

12 monthsauthorization duration

Amitiza

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Coverage and Medical Necessity Criteria

Initial Authorization

Relistor injection is covered when ANY one of the following pathways is met:

Initial Authorization pathways

Pathway 1: Advanced illness/palliative care: Diagnosis of opioid‑induced constipation in patients with advanced illness receiving palliative care.
Pathway 2: Chronic non‑cancer or chronic cancer‑related pain: Both A and B must be met: A) Diagnosis of opioid‑induced constipation in patients with chronic, non‑cancer pain OR in patients with chronic pain related to prior cancer diagnosis or cancer treatment who do not require frequent (e.g., weekly) opioid dosage escalation; AND B) Either the patient is unable to swallow oral medications OR history of failure, contraindication, or intolerance to BOTH lubiprostone (generic Amitiza) AND Symproic.

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Reauthorization

Reauthorization is covered when the following is met:

Reauthorization: Documentation of positive clinical response to Relistor injection therapy.

Brand oral formulations referenced in prior versions of this policy are not routinely covered. Specifically, Amitiza (brand lubiprostone) and Relistor tablets are typically excluded from coverage, and Relistor tablets have been removed from the medical necessity criteria. Providers should request prior authorization only for the injectable formulation when the injection-specific criteria are met.

Use of Relistor (methylnaltrexone) injection without documentation of required prior trials or an inability to take oral therapy is not consistent with the policy criteria. For members in the chronic non‑cancer (or chronic pain related to prior cancer) pathway, the policy requires either that the patient is unable to swallow oral medications or has a documented history of failure, contraindication, or intolerance to BOTH lubiprostone (generic Amitiza) AND Symproic. Absent documentation of these conditions, approval for the injection would not meet the step‑therapy requirements.

Initial Therapy

Initial therapy coverage criteria

Initial approval pathways: See Initial Authorization criteria: approval for advanced illness/palliative pathway OR chronic pain pathway with inability to swallow oral meds OR documented failure/contraindication/intolerance to both lubiprostone (Amitiza) and Symproic.

Continuation and Reauthorization

Continuation Therapy

Reauthorization/continuation rules

Continuation: Positive clinical response documented to authorize continued Relistor injection; authorizations issued for 12 months.

Requirements and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for Relistor (methylnaltrexone bromide) injection. Approval is granted when documentation supports the applicable opioid‑induced constipation criteria (see clinical criteria).

Step Therapy

Step Therapy / Lower‑Cost Alternatives

Member must try lower‑cost alternatives before Relistor. Specifically, a trial (or documented contraindication/intolerance) of lubiprostone (Amitiza) and Symproic is required unless the patient is unable to take oral medications or has another contraindication.

Documentation Required

Documentation Requirements

Chart notes or other clinical documentation must demonstrate the applicable diagnosis of opioid‑induced constipation (advanced illness/palliative care OR chronic non‑cancer pain / chronic pain related to prior cancer or its treatment) and support initial authorization criteria. For reauthorization, documentation must show a positive clinical response and continued benefit from Relistor injection.

Step Therapy Requirements

Step	Requirement
1	Member must trial lower‑cost alternatives prior to approval of Relistor (methylnaltrexone) injection; specifically requires failure, contraindication, or intolerance to BOTH lubiprostone (generic Amitiza) AND Symproic unless the patient is unable to swallow oral medications.

Key Definitions

Opioid‑induced constipation (OIC) — definition

DefinitionOpioid‑induced constipation (OIC): constipation attributed to opioid therapy in patients receiving opioids for chronic non‑cancer pain (including chronic pain related to prior cancer) or in patients with advanced illness or active cancer receiving opioids for palliative care.

Clinical contextApplies to adult patients experiencing constipation that is attributable to opioid therapy and who are being considered for Relistor (methylnaltrexone) injection.

Relevant patient populationsAdults with chronic non‑cancer pain (including chronic pain related to prior cancer when opioid escalation is not required) and adults with advanced illness or active cancer receiving opioids for palliative care.

Implication for coverageOIC as defined above is the required diagnosis to meet the initial authorization pathways for Relistor injection per policy criteria.

Background and Clinical Context

Relistor (methylnaltrexone bromide) injection is indicated for the treatment of opioid‑induced constipation (OIC) in adults with chronic non‑cancer pain (including chronic pain related to prior cancer when opioid escalation is not required) and for OIC in patients with advanced illness or active cancer receiving palliative care. Physicians and patients should periodically reassess the need for ongoing Relistor therapy. Authorizations are issued for 12 months when criteria are met.

Policy Revision History

2025-10-01effective_dateLatest

Policy effective date set to 2025-10-01.

7/2025annual_review

Removed tablets from medical necessity criteria and updated references.

7/2023policy_change