CurrentCentenePolicy HIM.PA.167

Naloxegol (Movantik) (PDF)

Policy Summary

PayerCentene

PolicyNaloxegol (Movantik) (PDF)

Policy CodePolicy HIM.PA.167

Change TypeRevised initial approval duration (annual review)

Effective DateJun 1, 2023

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

Changed initial approval duration from 6 to 12 months (4Q 2025 annual review).

Policy created per February SDC with initial creation date 02.21.23 and initial P&T approval 05.23.23.

Multiple annual reviews noted with no significant changes except reference updates (2023 and 2024 reviews).

1Covered Indication (FDA-approved)

18+Minimum Age (years)

25 mgMaximum Daily Dose (mg)

12Approval Duration (months)

Clinical policy governing medical necessity criteria, dosing, contraindications, and authorization durations for naloxegol (Movantik) for treatment of opioid-induced constipation in adults within Centene-affiliated health plans (HIM line of business). This policy aligns coverage to the FDA-approved indication: treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Initial and continued authorization criteria require: diagnosis of OIC, age ≥ 18 years, and ongoing opioid use for ≥ 4 weeks for chronic non-cancer pain. Dosing is limited to a maximum of 25 mg per day and no more than 1 tablet per day; if 25 mg is not tolerated, reduction to 12.5 mg once daily is described. Approval duration is 12 months.

Contraindications per the policy include known or suspected gastrointestinal obstruction or increased risk of recurrent obstruction, concomitant use with strong CYP3A4 inhibitors, and known serious hypersensitivity to Movantik or its excipients.

Key thresholds and quick facts

Minimum age≥ 18 years

Required opioid use duration≥ 4 weeks

Maximum daily dose (mg)≤ 25 mg/day

Maximum tablets per day≤ 1 tablet/day

Approval duration12 months

Initial Therapy Criteria

I. Initial Approval Criteria - Opioid-Induced Constipation

Covered when ALL of the following are met:

ALL of the following

Diagnosis of opioid-induced constipation (OIC)
Age ≥ 18 years
Member has been taking opioid(s) for ≥ 4 weeks due to chronic pain not caused by active cancer
Dose limits (both must be met)
- Dose does not exceed 25 mg per day≤ 25 mg/day
- Dose does not exceed 1 tablet per day≤ 1 tablet/day

I. Initial Approval Criteria - Other diagnoses/indications

If initial criteria do not apply, must meet ONE of the following:

ANY of the following

If drug recently (within the last 6 months) underwent a label change not yet reflected in this policy and the drug is on the formulary, follow the no coverage criteria policy for the relevant line of business: HIM.PA.33 (health insurance marketplace)
If drug recently underwent a label change and is NOT on the formulary, refer to the non-formulary policy for the relevant line of business: HIM.PA.103 (health insurance marketplace)
If the requested use is NOT listed under section III AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 (health insurance marketplace)

Continuation Therapy Criteria

II. Continued Therapy - Opioid-Induced Constipation

Covered when ALL of the following are met:

ALL of the following

Member status
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member continues to receive opioid therapy
Member is responding positively to therapy
Dose increase limits (if request is for dose increase)
- New dose does not exceed 25 mg per day≤ 25 mg/day
- New dose does not exceed 1 tablet per day≤ 1 tablet/day

II. Continued Therapy - Other diagnoses/indications

If continued therapy criteria do not apply, must meet ONE of the following:

ANY of the following

If drug recently (within the last 6 months) underwent a label change not yet reflected in this policy and the drug is on the formulary, follow the no coverage criteria policy for the relevant line of business: HIM.PA.33 (health insurance marketplace)
If drug recently underwent a label change and is NOT on the formulary, refer to the non-formulary policy for the relevant line of business: HIM.PA.103 (health insurance marketplace)
If the requested use is NOT listed under section III AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 (health insurance marketplace)

Unapproved Indications / Exclusions

III. Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

ANY of the following

Non-FDA approved indications not addressed in this policy unless there is sufficient documentation of efficacy and safety per off-label use policies (HIM.PA.154) or evidence of coverage documents

Provider Actions & Authorization Rules

Prior Authorization

Documentation required for approval

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

Prior Authorization

Approval duration

Initial and continued approvals are authorized for 12 months.

Documentation Required

Continuity of care exceptions

If the member is enrolled in a state and product with continuity of care regulations, refer to the state-specific addendums CC.PHARM.03A and CC.PHARM.03B to support continued therapy authorization.

Denial Risk

Non-FDA use denial

Requests for non‑FDA approved indications not addressed by this policy may be denied unless sufficient documentation of efficacy and safety is provided per the off‑label use policy HIM.PA.154.

Documentation Required

Dose limit enforcement

Claims or requests exceeding 25 mg per day or more than 1 tablet per day do not meet the policy dosing criteria and may be denied.

Clinical Evidence & References

Reference - Prescribing Information: Movantik Prescribing Information, AstraZeneca, March 2023.

This policy aligns coverage to the FDA indication and specifies dosing limits and contraindications per the Movantik prescribing information: maximum 25 mg/day (reduce to 12.5 mg if not tolerated), tablet strengths 12.5 mg and 25 mg, and contraindications including gastrointestinal obstruction and strong CYP3A4 inhibitor coadministration.

Background

Naloxegol (Movantik) is a peripherally acting opioid antagonist approved for treatment of opioid-induced constipation in adults with chronic non-cancer pain. The FDA-approved indication specifies use in adult patients with chronic non-cancer pain, including pain related to prior cancer or its treatment when frequent opioid dose escalation is not required.

Policy aligns to the FDA indication and specifies dosing limits (maximum 25 mg per day; if not tolerated reduce to 12.5 mg once daily) and contraindications (e.g., known or suspected gastrointestinal obstruction, concomitant use with strong CYP3A4 inhibitors, and serious hypersensitivity). Tablet strengths available are 12.5 mg and 25 mg.

Definitions

OICOpioid-induced constipation

FDAFood and Drug Administration

Revision History

02.21.23created

Policy created per February SDC; initial creation date 02.21.23 with initial P&T approval 05.23.23.

05.23.23created

Initial P&T approval dated 05.23.23 following policy creation.

07.06.23administrative_update

4Q 2023 annual review: no significant changes; references reviewed and updated.

07.15.24administrative_update

4Q 2024 annual review: no significant changes; references reviewed and updated; P&T approval noted 11.24.

07.15.25revisedLatest

4Q 2025 annual review: References reviewed and updated; changed initial approval duration from 6 to 12 months. P&T approval dated 11.25 (11.2025).

Policy Summary

PayerCentene

PolicyNaloxegol (Movantik) (PDF)

Policy CodePolicy HIM.PA.167

Change TypeRevised initial approval duration (annual review)

Effective DateJun 1, 2023

Next Review Date

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

SourceLink

On This Page

OpenPayer

Naloxegol (Movantik) (PDF)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unapproved Indications / Exclusions

Provider Actions & Authorization Rules

Applicable Codes & Product Availability

Clinical Evidence & References

Background

Revision History

12.5 mg	Tablet strength available
25 mg	Tablet strength available