Buprenorphine

POLICY NUMBER

L.5.01.475

Sublocade (buprenorphine

extended-release

)

injection

Subutex (buprenorphine)

sublingual tablets

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Buprenorphine, a Schedule III narcotic, is most commonly administered in a combination preparation with naloxone to deter abuse by injection. Naloxone is an opioid antagonist and has no effect when used sublingually due to poor absorption. However, given intravenously, naloxone blocks opioid effect and precipitates immediate withdrawal. Maintenance therapy with buprenorphine should be limited to those patients who cannot tolerate naloxone or those who are pregnant or breastfeeding. Buprenorphine should be used as part of a complete treatment plan to include counseling and psychosocial support.

Subutex (buprenorphine) sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction.

Sublocade (buprenorphine extended-release) injection is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.  

Initial Criteria

Subutex (buprenorphine) may be considered medically necessary when ALL of the following criteria are met:

1. The individual is 16 years of age or older;

2. The individual is being treated for opioid dependence;

3. Treatment plan is provided to include counseling and/or psychosocial support;

4. ONE of the following:

   1. The individual is being treated for induction therapy;

   2. The individual is being treated for maintenance treatment due to naloxone intolerance; OR

   3. The individual is being treated for maintenance treatment because she is pregnant or breastfeeding;

5. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval:12 months

Renewal Criteria

Subutex (buprenorphine) may be approved for RENEWAL when ALLof the following criteria are met:

1. The individual has been previously approved for the requested agent through the BCBSMS PA process and continues to meet initial criteria;

2. The individual has been evaluated for any illicit drug use (including problematic alcohol use) within the initiation treatment period;

3. Treatment plan provided to include taper strategy, as appropriate;

4. The individual is compliant with all elements of the treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities); AND

5. The prescriber confirmed the individual has no concurrent opioid use or diversion of their medication (e.g., review of Prescription Drug Monitoring Program, urine drug screening).

Length of Approval:12 months

 Subutex (buprenorphine) tablet is considered investigational when used for all other conditions, including but not limited to:

• Treatment of pain

• Treatment of other substance dependence

• Concurrent treatment of pain and opioid dependence.

Sublocade (buprenorphine solution) is considered not medically necessary on all Blue Cross & Blue Shield of Mississippi formularies as there are other formulary alternatives covered by the Plan.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

Medication Intolerance

Medication intolerance is defined as the inability to digest, metabolize, or mitigate the expected adverse effects of a prerequisite medication as evidenced by documented attempted intervention(s) to minimize sensitivity where appropriate (i.e., dose titration, dose reduction, administered with food, administration at different times of day, use of alternative formulation(s) etc.) and claims history. Experience of common side effects of medication will not be considered medication intolerance for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If a member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

07/09/2012: New policy added. 

03/27/2014: Policy reviewed; no changes.

08/31/2015: Medical policy revised to add ICD-10 codes.

02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Policy guidelines updated to add medically necessary and investigative definitions.

05/31/2016: Policy number L.5.01.475 added.

11/14/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

05/31/2018: Updated links in Policy Guidelines and Sources section.

01/01/2019: Policy title updated to change "Suboxone / Subutex" to "Suboxone (buprenorphine/naloxone) / Subutex (buprenorphine)." Policy statement updated to state that a quantity limit of 2 (two) tablets/films per day will apply for all strengths except the 12mg which is 1 (one) tablet/film per day. It previously stated: A quantity limit of 2 (two) tablets a day will be approved for Suboxone/Subutex. Sources updated.

01/08/2020: Policy statement revised to state that a quantity limit of 2 (two) tablets/films per day will apply for all strengths of Suboxone (buprenorphine/naloxone) or Subutex (buprenorphine). It previously stated: A quantity limit of 2 (two) tablets/films per day will apply for all strengths except the 12mg which is 1 (one) tablet/film per day.

02/11/2022: Policy title changed from "Suboxone (buprenorphine/naloxone)/ Subutex (buprenorphine)" to "Buprenorphine." Added drug names to the top of the policy. Policy description updated regarding indications for Sublocade (buprenorphine solution) and Probuphine (buprenorphine implant). Policy section updated to add the following statements: 1) Effective 07/08/2021, buprenorphine/naloxone tablets do not require Prior Authorization. 2) Prior Authorization is required for Suboxone (buprenorphine/naloxone) films and Subutex (buprenorphine) tablets. Policy statements updated for clarification. Initial and renewal criteria revised. Policy Exceptions updated to state that prior authorization for Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine) is not required for Federal Employee Program (FEP) and State Health Plan members. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

06/27/2024: Policy updated to remove Suboxone (buprenorphine/naloxone) and Probuphine (buprenorphine implant) from the list of medications. Policy description revised. Policy statement revised to state the following: Prior Authorization is required for Subutex (buprenorphine) tablets. Revised initial and renewal criteria for Subutex (buprenorphine). Added statement that Sublocade (buprenorphine solution) is considered not medically necessary on all Blue Cross & Blue Shield of Mississippi formularies as there are other formulary alternatives covered by the Plan. Policy Guidelines updated. Sources updated.

06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to change "Sublocade (buprenorphine)" to "Sublocade (buprenorphine extended-release) injection" and "Subutex (buprenorphine)" to "Subutex (buprenorphine) sublingual tablets." Policy description updated regarding indications for buprenorphine, subutex (buprenorphine) sublingual tablets, and sublocade (buprenorphine extended-release) injection. Policy section updated to add that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary criteria updated regarding treatment plans, contraindications to therapy, dose requirements, and to replace "Suboxone" with "naloxone." Renewal criteria updated to add requirement that the individual has been previously approved for the requested agent through the BCBSMS PA process and continues to meet initial criteria. Revised statement regarding treatment plans. Length of approval for initial and renewal approval changed from "6 months" to "12 months." Policy Exceptions updated to remove statement that prior authorization for Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine) is not required for Federal Employee Program (FEP) members. Policy Guidelines updated to remove Appendix 1 information. Added information regarding medication intolerance. Sources updated.

SOURCE(S)

1. American Pain Society. National Clinical Guideline. Use of Chronic Opioid Therapy in Chronic Non-Cancer Pain: Evidence Review.

2. Brixadi prescribing information. Braeburn Inc. January 2025. Last accessed March 2025.

3. Buprenorphine tablet prescribing information. Sun Pharmaceutical Industries, Inc. November 2023. Last accessed March 2025.

4. Strain E. Opioid use disorder: Pharmacologic management. In: UpToDate, Connor RF (Ed), Wolters Kluwer. (Accessed on March 10, 2025) https://www.uptodate.com/contents/opioid-use-disorder-pharmacologic-management

5. Sublocade prescribing information. Indivior Inc. November 2024. Last accessed March 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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