CurrentCentenePolicy CP PMN.112

Clinical Policy: Naldemedine (Symproic)

Medical necessity criteria and coverage rules for naldemedine (Symproic) to treat opioid‑induced constipation (OIC) in adult patients across Centene lines of business (Commercial, HIM, Medicaid). Applies to providers requesting coverage under Centene plans.

Policy Summary

PayerCentene

PolicyClinical Policy: Naldemedine (Symproic)

Policy CodePolicy CP PMN.112

Change TypeNo material change

Effective DateMay 1, 2017

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis of OIC, that initial criteria are met, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0.2 mgrecommended daily dose

1maximum tablets per day

12 moapproval duration

Adultsage group

Commercial, HIM, Medicaidlines of business

Coverage Criteria for Naldemedine (Symproic)

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Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval Criteria: 1) Diagnosis of opioid-induced constipation (OIC). 2) Age >= 18 years. 3) Member has been on opioid therapy for at least 4 weeks for chronic non-cancer pain (or chronic pain related to prior cancer without frequent opioid dose escalation). 4) Failure of one agent from each of the following classes while on opioid therapy, unless contraindicated or clinically significant adverse effects: a) stimulant laxative (e.g., bisacodyl, senna); b) osmotic laxative (e.g., lactulose, polyethylene glycol); c) stool softener (e.g., docusate). 5) Member has used one of the aforementioned agents in the past 30 days unless contraindicated. 6) Failure of naloxegol (Movantik) unless contraindicated or clinically significant adverse effects are experienced. 7) Requested dose does not exceed both of the following: a) 0.2 mg per day; b) 1 tablet per day.dose <= 0.2 mg/day AND tablets <= 1/day

Provider must submit supporting documentation (office chart notes, lab results, or other clinical information).

Continued Therapy Criteria

Covered when ALL of the following are met:

Continuation: 1) Member meets one of the following: a) currently receiving naldemedine via the Centene benefit or previously met initial approval criteria; OR b) member is enrolled in continuity-of-care per state/product. 2) Member is responding positively to therapy. 3) If request is for dose increase or continuation, dose does not exceed both of the following: a) 0.2 mg per day; b) 1 tablet per day.dose <= 0.2 mg/day AND tablets <= 1/day

Approval duration: 12 months.

Naldemedine (Symproic) is contraindicated in patients with known or suspected gastrointestinal obstruction and in those at increased risk of recurrent obstruction. The policy also identifies hypersensitivity to naldemedine as a contraindication. These contraindications must be considered prior to authorizing therapy and documented in the patient record to support coverage decisions.

Requests for use of naldemedine for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid). Ensure off‑label rationale and supporting clinical evidence are included with the prior authorization submission.

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization and Approval Duration

Prior authorization is required for Symproic (naloxegol) when used for treatment of opioid‑induced constipation (OIC). Initial approvals are for 12 months. Continued therapy approvals are for 12 months when the member is responding to therapy or has previously met initial approval criteria; requests for dose increases must not exceed the maximum daily dose specified in the policy.

Prior authorization required for initial and continued therapy
Approval duration: 12 months for both initial and continued therapy

Documentation Required

Required Documentation

Provider must submit documentation supporting that the member meets all approval criteria. Acceptable documentation includes but is not limited to office chart notes, medication history, records showing opioid use (duration and indication), documentation of trials and failures of required laxative classes while on opioid therapy, laboratory results when relevant, and any rationale for contraindications or adverse effects to prior agents. For off‑label indications, include sufficient clinical evidence per applicable off‑label policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53).

Submit office chart notes, medication history, and opioid use documentation (e.g., duration ≥4 weeks)
Document trials/failures of one agent from each required class (stimulant laxative, osmotic laxative, stool softener) or reasons for contraindication/adverse effects
For off‑label requests, provide evidence per off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Step Therapy

Step‑Therapy and Documentation Risk

Failure of prior therapies is required per the policy: documentation must show trials and inadequate response to one stimulant laxative (e.g., bisacodyl, senna), one osmotic laxative (e.g., lactulose, polyethylene glycol), and one stool softener (e.g., docusate) while on opioid therapy, unless contraindicated or clinically significant adverse effects occurred. If documentation is incomplete or absent, the request may be denied.

Evidence of trial and failure of each laxative class while on opioids or documented contraindication
If trials are within the past 30 days where specified, provide dates and outcomes
Incomplete documentation may result in denial

Key Definitions

Opioid‑induced constipation (OIC) — definition and relation to therapy

DefinitionOpioid‑induced constipation (OIC): constipation attributed to opioid therapy impairing gastrointestinal motility and indicated for treatment with naldemedine in adults with chronic non‑cancer pain.

Relation to opioid therapyOccurs in patients receiving opioids for at least 4 weeks for chronic non‑cancer pain (or chronic pain related to prior cancer without frequent opioid dose escalation).

Treatment context in policyPolicy requires diagnosis of OIC and prior trials of laxative classes and naloxegol (Movantik) unless contraindicated before naldemedine is approved.

Background on Naldemedine (Symproic)

Naldemedine (Symproic) is a peripherally acting mu‑opioid receptor antagonist that reduces opioid‑induced constipation (OIC) by blocking opioid effects on gastrointestinal opioid receptors without significantly affecting central opioid analgesia. It is FDA‑approved for the treatment of OIC in adult patients with chronic non‑cancer pain, including pain related to prior cancer when opioid dose escalation is not frequently required. The recommended dosing is 0.2 mg once daily (one 0.2 mg tablet per day maximum).

OpenPayer

Clinical Policy: Naldemedine (Symproic)

Coverage Criteria for Naldemedine (Symproic)

Drug Dosing, Product Availability, and Dose Limits

Prior Authorization, Step Therapy, and Documentation Requirements

Key Definitions

Background on Naldemedine (Symproic)