CurrentBlue Cross Blue Shield - IowaPolicy 05.02.48

Symproic (naldemedine) coverage for opioid‑induced constipation

Policy governs coverage criteria for Symproic (naldemedine) for treatment of opioid‑induced constipation in adults with chronic non‑cancer pain, and describes formulary exception and dosing considerations. It applies to Wellmark members unless contract exclusions or FEP apply.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySymproic (naldemedine) coverage for opioid‑induced constipation

Policy CodePolicy 05.02.48

Change TypeNo material change

Effective DateAug 11, 2018

Next Review DateOct 1, 2025

Key ActionObtain prior authorization and document trial and failure, intolerance, or contraindication of all covered formulary alternatives when requesting non‑formulary approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1FDA‑approved indication captured

Initial ApprovalInitial approval present

Non‑FormularyNon‑formulary exception included

Dosing limitsDosing limits referenced

Coverage Criteria

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inv-01: Initial Approval

Covered when ALL of the following are met:

Initial Approval for Symproic: Patient is an adult with opioid-induced constipation (OIC) associated with chronic non-cancer pain, including chronic pain related to prior cancer or its treatment; AND patient does not require frequent (e.g., weekly) opioid dosage escalation; AND all applicable plan and contract conditions are met (no contract exclusions).

Aligns with FDA-approved indication and policy initial approval statement

inv-02: Non‑Formulary Exception

Non-formulary coverage granted when ALL of the following are met in addition to meeting approval criteria:

Non-Formulary Exception Requirements: 1) Requested drug is used for an FDA-approved indication or an indication supported by compendia/current accepted guidelines; AND 2) Prescribed dose and quantity fall within FDA-approved labeling or compendia dosing guidelines; AND 3) All covered formulary alternative drugs on any tier are ineffective, have been ineffective, would be less effective, or are contraindicated; documentation is required and must include chart note(s) or other documentation indicating prior treatment failure, severity of adverse event (if any), and dosage and duration of prior treatment, or contraindication to formulary alternatives.

Meets Non-Formulary Exception criteria as specified by policy

This policy applies to Wellmark members; however, it may not apply to Federal Employee Program (FEP) members. Benefit determinations for FEP members are made by the Federal Employee Program and not by Wellmark.

Wellmark will determine medical necessity only when the benefit exists and no contract exclusions apply. Benefit determinations are based on the contract language in effect when services were rendered, and exclusions, limitations, or exceptions in the member’s contract may preclude coverage.

Initial Therapy

inv-12: Initial Therapy

Initial approval conditions for Symproic:

Initial therapy eligibility: Adult patient with opioid-induced constipation (OIC) associated with chronic non-cancer pain, including chronic pain related to prior cancer or its treatment, who does not require frequent (e.g., weekly) opioid dosage escalation.

Matches FDA indication and Criteria for Initial Approval

Step Therapy Requirements

Requirement	Details
Trial and failure/intolerance/contraindication of formulary alternatives
All covered formulary alternative drugs on any tier must be ineffective, have been ineffective, would not be as effective, or would cause adverse effects; documentation required (chart notes or other documentation indicating prior treatment failure, severity of adverse event if any, and dosage and duration of prior treatment, or contraindication).
Non‑formulary request must be for an FDA‑approved indication or an indication supported by current compendia (e.g., AHFS, Micromedex, accepted guidelines).
Prescribed dose/quantity must fall within FDA‑approved labeling or compendia dosing guidelines.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization and Dosing Limits

Prior authorization is required for Symproic and approvals are subject to the policy's initial criteria and to dosing limits consistent with FDA labeling, compendia, and evidence‑based guidelines.

Prior authorization required
Approvals subject to initial criteria and dosing limits

Step Therapy

Formulary Alternatives Required Prior to Non‑Formulary Approval

The plan requires trial and documented failure, intolerance, or contraindication to all covered formulary alternatives before approving a non‑formulary request for Symproic. The prescriber must document why formulary options are not appropriate.

All covered formulary alternatives must be ineffective, not as effective, or not tolerated
Documentation of trial(s) required prior to non‑formulary approval

Documentation Required

Required Documentation for Non‑Formulary Exception

When requesting a non‑formulary exception, submit chart notes or other supporting documentation showing: the FDA‑approved or compendia‑supported indication; prescribed dose/quantity within labeled or compendia guidelines; prior treatment(s) tried (drug names and tiers), dose and duration of each trial; reason for discontinuation (lack of efficacy or specific adverse events with severity); or a documented contraindication to each formulary alternative. Requests may be denied if the prescriber does not document that all covered formulary alternatives were ineffective or not tolerated.

Indication must be FDA‑approved or supported in recognized compendia
Dose/quantity must be within FDA labeling or compendia guidance
Chart notes must document prior formulary trials, dose, duration, and reason for failure or intolerance
Documented contraindications to formulary alternatives acceptable

Definitions

Opioid‑induced constipation (OIC) — definition and clarifying points

DefinitionOpioid-induced constipation (OIC): constipation that develops in patients receiving opioid therapy and is addressed with peripherally acting mu-opioid receptor antagonists such as naldemedine.

Typical clinical contextOccurs in adult patients receiving chronic opioid therapy, including chronic non-cancer pain and pain related to prior cancer or its treatment.

Key eligibility noteSymproic (naldemedine) is indicated for OIC in adults with chronic non-cancer pain who do not require frequent (e.g., weekly) opioid dose escalation.

Coverage intentPolicy aligns coverage with FDA labeling, compendia, and evidence-based guidelines; covered when all approval criteria are met and no contract exclusions apply.

Treatment classManaged with peripherally acting mu-opioid receptor antagonists (PAMORAs), exemplified by naldemedine (Symproic).