CurrentColorado Rocky Mountain Health PlansPolicy N/A

Prior Authorization and Coverage Criteria for Brand Suboxone (buprenorphine/naloxone)

This policy governs prior authorization and medical necessity criteria for coverage of brand Suboxone (buprenorphine/naloxone) for members, including required trials of preferred buprenorphine/naloxone products before brand Suboxone is approved.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior Authorization and Coverage Criteria for Brand Suboxone (buprenorphine/naloxone)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2025

Next Review DateApr 1, 2025

Key ActionObtain prior authorization and document a completed ≥30-day trial of preferred buprenorphine/naloxone (generic Suboxone or Zubsolv) or document contraindication/adverse effects with medical records.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

30 daysrequired trial length

brand onlycoverage applies to

7/1/2025effective date

Coverage Criteria for Brand Suboxone

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inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Authorization: Patient is being treated for opioid dependence

From policy: patient must be treated for opioid dependence

Preferred product trials or documented contraindications: Both of the following must be satisfied: 1) One of: medical records documenting an inadequate response to a minimum 30-day trial of Zubsolv (30-day trial must be completed prior to the prior authorization/medical necessity request) OR medical records documenting adverse effects or a contraindication to Zubsolv, including the manifestation of the adverse reaction or reason for contraindication. 2) One of: medical records documenting an inadequate response to a minimum 30-day trial of buprenorphine/naloxone (generic Suboxone) (30-day trial must be completed prior to the prior authorization/medical necessity request) OR medical records documenting adverse effects or a contraindication to generic buprenorphine/naloxone, including the manifestation of the adverse reaction or reason for contraindication.30-day trials must be completed prior to PA/medical necessity request

Medical records (e.g., chart notes) required to document inadequate response or adverse effects/contraindications

inv-02: Reauthorization

Covered when the following are met

Reauthorization: Documentation of positive clinical response

Authorization will be issued for 12 months when positive clinical response is documented; state mandates and member-specific benefit plans may affect coverage

Suboxone (brand) is typically excluded from coverage by this plan; however, plan-specific benefit documents may designate it as excluded or require specific tried/failed criteria before coverage is considered. Where exclusions or step-therapy rules apply, prior authorization may still be granted in accordance with the policy’s coverage criteria and documentation requirements, and automated approvals may occur based on prior claims/medication history or diagnosis coding per program rules.

Initial Authorization Criteria

inv-11: Initial Therapy

Initial authorization for brand Suboxone

Initial therapy: Patient is being treated for opioid dependence AND documentation of inadequate response to minimum 30-day trials of preferred products (Zubsolv and/or generic buprenorphine/naloxone) OR documentation of adverse effects or contraindications to those preferred products including manifestation/reason30-day trial completion prior to PA/medical necessity request

Submission of medical records (e.g., chart notes) required

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Brand Suboxone (buprenorphine/naloxone) requires prior authorization. Approval is for treatment of opioid dependence and is subject to the required trials and documentation described below.

Prior authorization required for brand Suboxone (buprenorphine/naloxone).
Approval limited to treatment of opioid dependence.

Step Therapy

Preferred Product Trial Required

Preferred product trial required — Member must complete and document a trial of preferred buprenorphine/naloxone combination (generic Suboxone) or Zubsolv prior to coverage of brand Suboxone, unless there is documented contraindication or adverse effect.

Member must complete a minimum 30-day trial of generic buprenorphine/naloxone (generic Suboxone) prior to prior authorization request, OR
Member must complete a minimum 30-day trial of Zubsolv prior to prior authorization request.
If member experienced adverse effects or has a contraindication to a preferred product, documentation of the adverse reaction or reason for contraindication is required.

Documentation Required

Medical Records and Clinical Response

Medical records and clinical response — Submission of medical records (e.g., chart notes) is required to document inadequate response to a minimum 30-day trial of preferred products or to document adverse effects/contraindication. For reauthorization, documentation of positive clinical response is required.

For initial approval: medical records documenting inadequate response to a minimum 30-day trial of Zubsolv and/or generic buprenorphine/naloxone (generic Suboxone) are required (30-day trial must be completed prior to the prior authorization/medical necessity request).
Alternatively, medical records documenting adverse effects or contraindication to the preferred product (including manifestation or reason) are acceptable.
For reauthorization: documentation of positive clinical response is required.

Denial Risk

Missing Trial or Documentation May Cause Denial

Missing trial or documentation — Failure to document a completed minimum 30-day trial of the preferred products or failure to submit required medical records may result in denial of the prior authorization request. Supply limits and plan-specific exclusion rules may apply; check the member's plan for coverage specifics.

Lack of documentation of the required 30-day trial or lack of medical records substantiating adverse effects/contraindication may lead to denial.
Supply limits may apply.
Brand Suboxone is typically excluded from coverage in some plans; refer to plan specifics to determine exclusion status.

Step Therapy Requirements

Step	Requirement	Documentation required	Coverage status
1	Member must try preferred buprenorphine/naloxone combination (generic Suboxone) and/or Zubsolv prior to coverage of brand Suboxone	Medical records documenting an inadequate response to a minimum 30-day trial of generic buprenorphine/naloxone OR documentation of adverse effects/contraindication to generic buprenorphine/naloxone including manifestation/reason	Try preferred products prior to brand Suboxone
2	If Zubsolv is used as the preferred trial, member must complete a minimum 30-day trial prior to prior authorization request	Medical records documenting an inadequate response to a minimum 30-day trial of Zubsolv OR documentation of adverse effects/contraindication to Zubsolv including manifestation/reason	Try preferred products prior to brand Suboxone
3	If trials are not possible, documentation of contraindication or adverse effect to the preferred product(s) must be provided	Medical records describing the adverse reaction or reason for contraindication to generic buprenorphine/naloxone and/or Zubsolv	May be considered with documentation

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior Authorization and Coverage Criteria for Brand Suboxone (buprenorphine/naloxone)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2025

Next Review DateApr 1, 2025

SourceLink

On This Page

OpenPayer

Prior Authorization and Coverage Criteria for Brand Suboxone (buprenorphine/naloxone)

Coverage Criteria for Brand Suboxone

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Provider Requirements and Documentation

Step Therapy Requirements

Key Coding and Durations

Quantity Limits

Site of Care and State-specific Rules

Background

Definitions