CurrentBlue Cross Blue Shield - IowaPolicy 05.02.48

Wellmark Blue Cross and Blue Shield Symproic Policy

Defines coverage criteria for Symproic (naloxegol) for treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including formulary exception requirements, dosing limits per FDA labeling, and billing code guidance.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyWellmark Blue Cross and Blue Shield Symproic Policy

Policy CodePolicy 05.02.48

Change Typeclarified

Effective DateAug 11, 2018

Next Review Date

Key ActionWhen requesting a non-formulary exception, provide chart notes or other documentation indicating prior treatment failure, severity of adverse events, dosage and duration of prior treatments, or contraindication to formulary alternatives.

SourceLink

POLICY UPDATE CHANGES

Policy states that indications including FDA-approved indications and compendial uses are considered covered if approval criteria are met.

1Covered Indication (OIC in adults with chronic non-cancer pain)

05.02.48Policy Number

2018-08-11Effective Date

2025-10-01Last Review Date

Symproic (naloxegol) is indicated for treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, consistent with FDA labeling. Coverage is intended to align with product labeling, FDA guidance, standards of medical practice, and accepted compendia. The policy coverage stance is covered_with_criteria. Policy number 05.02.48; effective date 2018-08-11; last review 2025-10-01.

Policy identifiers

Policy Number05.02.48

Effective Date2018-08-11

Last Review Date2025-10-01

Coverage StanceCovered with criteria (coverage aligned with FDA labeling and compendia when approval criteria met)

Scope SummaryDefines coverage criteria for Symproic (naloxegol) for treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including formulary exception requirements and dosing limits per FDA labeling and accepted compendia.

Initial Therapy Criteria

Initial Approval

Symproic may be considered medically necessary when ALL of the following are met:

ALL of the following

Indication consistent with FDA labeling: treatment of opioid-induced constipation (OIC) in an adult patient with chronic non-cancer pain, including chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Age requirement: Member is an adult.
Use limitation: Use is for chronic non-cancer pain (including chronic pain related to prior cancer or its treatment) and not for patients requiring frequent opioid dosage escalation (e.g., weekly).
Dosing and quantity: Prescribed dose/quantity falls within FDA-approved labeling or dosing guidelines found in accepted compendia.
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.

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Non‑Formulary / Exception Criteria

Non-Formulary Exception Criteria

When Symproic is non-formulary, coverage may be granted if ALL of the following are met in addition to the Criteria for Initial Approval:

ALL of the following

Indication or compendia support: Requested drug is used for an FDA-approved indication or an indication supported in compendia of current literature (examples: AHFS, Micromedex, accepted guidelines).
Dosing and quantity: Prescribed dose/quantity is within FDA-approved labeling or compendia dosing guidelines.
Formulary alternatives requirement (ONE of)
- Alternative - ineffective: All covered formulary alternative drugs on any tier will be ineffective.
- Alternative - have been ineffective: All covered formulary alternative drugs on any tier have been ineffective.
- Alternative - not as effective: Formulary alternatives would not be as effective as the non-formulary drug.
- Alternative - adverse effects/contraindicated: Formulary alternatives would have adverse effects or are contraindicated.
Documentation requirement: Documentation must include chart notes or other documentation indicating prior treatment failure, severity of adverse event (if any), dosage and duration of prior treatment, or contraindication to formulary alternatives.

Documentation Required

Document prior therapy and rationale for non-formulary use

When requesting a non‑formulary exception, provide chart notes or other documentation indicating prior treatment failure, severity of adverse events (if any), dosage and duration of prior treatments, or contraindication to formulary alternatives.

Chart notes showing prior therapy and outcomes
Documentation of severity of adverse events
Dosage and duration of prior treatments
Evidence of contraindication to formulary alternatives

Prior Authorization

Prior authorization required for non-formulary requests (exception process)

Coverage determinations are based on applicable contract language and meeting medical necessity criteria; a non‑formulary exception/prior authorization review is required for products not on the formulary.

Continuation Therapy Criteria

Continuation/renewal approvals must continue to meet the initial approval criteria and dosing limits per FDA labeling and accepted compendia. Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and evidence-based practice guidelines.

Billing Rule

Adhere to FDA labeling and compendia dosing limits

Approvals may be subject to dosing limits consistent with FDA‑approved labeling and accepted compendia or evidence‑based practice guidelines.

Background & Definitions

Symproic (naloxegol) is indicated for treatment of opioid-induced constipation in adults with chronic non-cancer pain, and coverage is intended to align with FDA labeling, FDA guidance, standards of medical practice, and accepted compendia. This policy defines coverage criteria for Symproic for OIC in adults with chronic non-cancer pain, including formulary exception requirements and dosing limits per FDA labeling.

OIC - Opioid-induced constipation

Provider Actions & Administrative Notes

Note

Provider actions for non‑formulary requests and approvals

When requesting coverage or a non‑formulary exception: 1) Provide chart notes or other documentation indicating prior treatment failure, severity of adverse events (if any), dosage and duration of prior treatments, or contraindication to formulary alternatives. 2) Coverage determinations are based on applicable contract language and medical necessity criteria; a non‑formulary exception/prior authorization review applies for products not on the formulary. 3) Approvals may be subject to dosing limits consistent with FDA‑approved labeling, accepted compendia, and evidence‑based practice guidelines.

Documentation: chart notes, AE severity, dose/duration, contraindications
Prior authorization/exception review required per contract and medical necessity
Dosing limits per FDA labeling and accepted compendia/guidelines

Administrative metadata

PayerBlue Cross Blue Shield - Iowa / Wellmark

Policy TitleSymproic (naloxegol) for opioid-induced constipation