ModifiedCentenePolicy CP.PMN.112

Naldemedine (Symproic) for opioid‑induced constipation

Defines medical necessity and prior authorization criteria for naldemedine (Symproic) for treatment of opioid‑induced constipation in adults across Centene lines of business (Commercial, HIM, Medicaid). Affects prescribers and pharmacy authorization reviewers.

Policy Summary

PayerCentene

PolicyNaldemedine (Symproic) for opioid‑induced constipation

Policy CodePolicy CP.PMN.112

Change TypeMaterial: approval duration updatedstep therapy exception added

Effective DateMay 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing OIC diagnosis, age ≥18, ≥4 weeks opioid therapy, failure of one agent from each laxative class and naloxegol unless contraindicated, and dosing within 0.2 mg/day (1 tablet/day).

SourceLink

POLICY UPDATE CHANGES

Updated initial approval duration from 6 to 12 months.

Added step therapy bypass for Illinois HIM per IL HB 5395.

0.2 mgMaximum daily dose

1Maximum tablets per day

12 monthsApproval duration

≥18Minimum age

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Policy Header & Overview

Opioid‑Induced Constipation (OIC) is constipation that results from opioid therapy due to peripheral mu‑opioid receptor activation in the gastrointestinal tract. OIC is the target indication for naldemedine (Symproic), which is FDA‑approved for adults with chronic non‑cancer pain (including pain related to prior cancer or its treatment when frequent opioid dose escalation is not required).

Health Plan refers to a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC or one of its affiliates. Coverage decisions and the administration of benefits remain subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents and applicable Health Plan administrative policies and procedures.

Coverage Criteria

Prior Authorization

Prior Authorization and Provider Requirements

Prior authorization is required for coverage. Providers must obtain prior authorization and submit documentation supporting medical necessity, including prior therapy trials and relevant clinical information. Coverage decisions are subject to all plan terms, conditions, exclusions, and limitations found in the member’s evidence of coverage or contract. Providers must follow Health Plan-level administrative policies and procedures, including applicable prior authorization processes, billing and coding rules, and documentation requirements. Step therapy requirements apply as stated in the criteria; state-specific step therapy exceptions and continuity of care regulations (e.g., Illinois HB 5395 exception for certain requests effective 1/1/2026) must be honored. Failure to obtain required prior authorization or to provide requested documentation may result in denial of coverage.

Prior Authorization Required: obtain PA before dispensing.
Documentation: provide evidence of diagnosis, opioid use duration, prior laxative trials, and response to therapy.
Plan Terms: coverage subject to member’s contract, exclusions, and limitations.
Health Plan Policies: follow plan-level administrative policies and procedures for PA and billing.
Step Therapy & State Exceptions: follow step therapy; honor state-mandated exceptions (e.g., IL HB 5395).

Initial Therapy

Initial Therapy (Opioid‑Induced Constipation) — Initial approval requires meeting all criteria below:

ALL of the following

Diagnosis of opioid‑induced constipation (OIC).
Age ≥ 18 years.
Member has been taking opioid(s) for ≥ 4 weeks for chronic non‑cancer pain.
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). Note: For Illinois HIM requests the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.
Member has used one of the aforementioned agents in the past 30 days, unless contraindicated.

Continuation Therapy

Continuation Therapy (Opioid‑Induced Constipation) — Covered when all criteria below are met:

ALL of the following

Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) member is enrolled in a state/product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B).
Member continues to receive opioid therapy.
Member is responding positively to therapy.
If request is for a dose increase, new dose does not exceed both: (a) 0.2 mg per day; and (b) 1 tablet per day.
Approval duration: 12 months.

Continuation Criteria

inv cu-19 / inv cu-02: Continuation therapy

Continuation approval requires criteria below

Continuation: Member must be currently receiving medication via Centene benefit or have previously met initial criteria (or qualify under continuity of care), continue opioid therapy, be responding to therapy, and not exceed dosing limits

Approval duration: 12 months

Provider Actions & Requirements

Prior Authorization

Prior authorization — required documentation

Prior authorization requests must include evidence that the member meets all initial-therapy criteria: diagnosis of opioid‑induced constipation, age ≥18, and ≥4 weeks of opioid therapy for chronic non‑cancer pain, plus documentation of prior laxative and naloxegol trials and dosing within limits.

Diagnosis of OIC
Age ≥ 18 years
Opioid therapy ≥ 4 weeks for chronic non‑cancer pain
Failure of one agent from each laxative class while on opioid therapy (stimulant, osmotic, stool softener)
Recent use of one of the laxatives within 30 days unless contraindicated
Failure of Movantik (naloxegol) unless contraindicated
Requested dose does not exceed 0.2 mg/day and 1 tablet/day

Note

Prior authorization governed by plan terms

This clinical policy is guidance to assist coverage decisions; actual prior authorization requirements and benefit determinations are governed by the member's coverage documents and applicable Health Plan administrative policies and procedures.

Step Therapy Requirements

Step	Requirement	Exceptions / Notes
1	Failure of one agent from each laxative class (stimulant, osmotic, stool softener) while on opioid therapy and failure of Movantik (naloxegol) prior to approval of naldemedine	Member must have used one of the laxative agents in the past 30 days unless contraindicated; prior authorization may be required for Movantik
	Step therapy requirement does not apply for Illinois Health Insurance Marketplace (HIM) requests per Illinois HB 5395 effective 1/1/2026	Operational change added: step therapy bypass for IL HIM per IL HB 5395

Coding & Quantity Limits

Maximum daily dose

Maximum daily dose0.2 mg per day

Maximum tablets per day1 tablet per day

Approval duration associated with dose limits12 months

Quantity limit

Product and strengthnaldemedine (Symproic) tablet 0.2 mg

Quantity limit1 tablet per day

Dosing regimen0.2 mg PO QD with or without food

Background

Naldemedine is a peripherally acting mu‑opioid receptor antagonist that reduces opioid‑induced constipation by antagonizing opioid effects in the gastrointestinal tract. Symproic (naldemedine) is FDA‑approved for the treatment of OIC in adult patients with chronic non‑cancer pain, including select patients with chronic pain related to prior cancer or its treatment when frequent opioid dose escalation is not required.

Definitions

Opioid‑Induced Constipation (OIC)

DefinitionConstipation resulting from opioid therapy due to peripheral mu‑opioid receptor activation in the gastrointestinal tract; target indication for Symproic (naldemedine).

Typical patient populationAdult patients with chronic non‑cancer pain, including chronic pain related to prior cancer or its treatment when frequent opioid escalation is not required.

Mechanism related to definitionRelated to peripheral mu‑opioid receptor activation in the GI tract which decreases bowel motility and secretion when exposed to opioids.

Health Plan

Health Plan definitionHealth Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates.

Policy role

Revision History & Policy Changes

2025-07-14material updateLatest

Updated initial approval duration from 6 to 12 months and added a step therapy bypass for Illinois HIM requests per IL HB 5395.

2024-07-15annual review

4Q 2024 annual review: no significant clinical changes; references reviewed and updated.

2023-02-21policy modification

Policy Summary

PayerCentene

PolicyNaldemedine (Symproic) for opioid‑induced constipation

Policy CodePolicy CP.PMN.112

Change TypeMaterial: approval duration updatedstep therapy exception added

Effective DateMay 1, 2017

Next Review DateN/A

SourceLink

On This Page

Failure of Movantik (naloxegol), unless contraindicated or clinically significant adverse effects are experienced. (Prior authorization for Movantik may be required.)

Dose does not exceed both: (a) 0.2 mg per day; and (b) 1 tablet per day.

Approval duration: 12 months.

Step Therapy

Step therapy — requirements and IL HIM exception

Step therapy requires documented failure of one agent from each laxative class and failure of Movantik (naloxegol) prior to approval of naldemedine; however, the step therapy requirements do not apply for Illinois HIM requests per IL HB 5395 effective 1/1/2026.

Failure of a stimulant, an osmotic, and a stool softener while on opioid therapy is required
Failure of Movantik (naloxegol) is required unless contraindicated
Step therapy bypass for Illinois HIM per IL HB 5395 (effective 1/1/2026)

Note

General provider responsibilities

Providers should be aware of additional operational and administrative expectations when submitting requests, including adherence to Health Plan procedures and that this policy does not replace clinical judgment.

Documentation Required

Required documentation to support PA

Providers must submit clinical documentation supporting that the member meets all approval criteria, such as office chart notes, laboratory results, or other relevant clinical information.

Office chart notes documenting OIC diagnosis and opioid history
Evidence of prior laxative use and timing (one agent from each class)
Documentation of Movantik (naloxegol) trial and outcome or contraindication
Medication dosing information to confirm dose ≤ 0.2 mg/day and 1 tablet/day

Billing Rule

Adhere to Health Plan administrative policies

Providers must follow applicable Health Plan-level administrative policies and procedures when requesting coverage and are expected to exercise professional medical judgment in patient care.

Denial Risk

Insufficient documentation may lead to denial

Requests lacking required evidence that the member meets all approval criteria — for example, no documentation of OIC diagnosis, insufficient opioid exposure history (≥4 weeks), missing laxative or naloxegol trial documentation, or absent age information — may be denied or returned.

Missing documentation of diagnosis, opioid duration, or prior laxative/naloxegol trials risks denial
Failure to document dosing within 0.2 mg/day and 1 tablet/day may result in denial

Note

Coverage decisions subject to member coverage documents

Coverage and payment decisions remain subject to the terms, conditions, exclusions, and limitations in the member's coverage documents (e.g., evidence of coverage, certificate of coverage); meeting clinical criteria does not guarantee payment.

This clinical policy provides guidance to assist in making coverage decisions and administering benefits; it does not constitute a contract or guarantee regarding payment.

Provider expectationsProviders are expected to exercise professional medical judgment and are responsible for medical advice and treatment of members.

Added redirection to Movantik (naloxegol) and added the HIM line of business.

2022-07-26annual review

4Q 2022 annual review: no significant clinical changes; references reviewed and updated; template changes applied to other diagnoses/indications and continued therapy section.