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Date Printed: October 20, 2017: 02:06 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-68

Original Effective Date: 09/15/16

Reviewed: 09/13/17

Revised: 10/15/17

Subject: Buprenorphine HCl (Probuphine ®) Subdermal Implant

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates   Previous Version
           

DESCRIPTION:

Opioid dependence has reached a critical level in the United States, in part due to excessive and inappropriate use of opioid drug therapy in pain management and a growing heroin epidemic. Treatment of opioid dependence is complex and should include counseling and psychosocial support in addition to medication-assisted treatment (MAT) with opioid replacement therapy (e.g., methadone, buprenorphine (Subutex®), buprenorphine/naloxone (Bunavail®, Suboxone®, Zubsolv®), and naltrexone (Revia®, Vivitrol®)).

Office-based prescriptions of opioid replacement therapy with buprenorphine alone or Suboxone is restricted by federal and state regulations. Buprenorphine is a partial opioid agonist similar to methadone but with a “ceiling effect” that limits its efficacy at high doses but also is felt to limit its adverse effects. The passing of the federal Drug Addiction Treatment Act (DATA) of 2000 allows qualified physicians to obtain a waiver (also known as an “X” license) to prescribe and/or dispense opioid replacement therapy after receiving special training. Due to abuse and diversion concerns, physicians with a waiver may not treat more than 30 patients concurrently, but can apply for a second waiver after one year to treat up to 100 patients at one time.

In May 2016, the U.S. Food and Drug Administration (FDA) approved a new subdermal buprenorphine implant (Probuphine) for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet equivalent or generic equivalent).

In a randomized clinical trial (n=177) designed to evaluate the noninferiority of buprenorphine implant compared with oral transmucosal buprenorphine (the current standard of care), 90 patients received placebo oral transmucosal buprenorphine and active implants and 87 received placebo implants and active oral transmucosal buprenorphine. Counseling was uniformly provided and additional active oral transmucosal buprenorphine dosages were permitted based on identified signs of relapse.

For the primary outcome, buprenorphine implants were noninferior to oral transmucosal buprenorphine. A total of 81 of 84 patients (96.4%) receiving buprenorphine implants and 78 of 89 patients (87.6%) receiving sublingual buprenorphine were responders, a between-group 8.8% difference. Among the secondary outcomes, buprenorphine implants may have been more effective than sublingual buprenorphine in achieving long-term cumulative opioid abstinence, with response rates at 6 months of 85.7% (72/84 patients) in the implant group and 71.9% (64/89 patients) in the sublingual group (P = .03).

However, as the authors acknowledge, the generalizability of these results is limited, considering the demographic characteristics of the patient population (ie, the majority were white, employed, had at least a high school education, and were dependent on prescription opioids) and that enrollment was limited to stable patients who had maintained opioid abstinence for 90 days prior to randomization and were receiving buprenorphine treatment for several years.

POSITION STATEMENT:

Buprenorphine hydrochloride (Probuphine) subdermal implant is not considered a medical necessity for use beyond two lifetime treatments. A single lifetime treatment consists of four subdermal implants inserted into an arm for six months. Use of fewer than four implants during a treatment cycle (or if implants are removed prior to completion of a six month treatment cycle) is still considered a single lifetime treatment.

Initiation of buprenorphine hydrochloride (Probuphine) subdermal implant meets the definition of medical necessity when ALL of the following criteria are met:

1. Prescriber meets the qualification certification criteria in the Drug Addiction Treatment Act (DATA) of 2000 and has been issued a unique DEA identification number by the DEA, indicating that he or she is a qualified physician under the DATA to prescribe buprenorphine, Bunavail, Suboxone, buprenorphine/naloxone, or Zubsolv

2. Prescriber is certified by the PROBUPHINE REMS Program (www.PROBUPHINEREMS.com)

3. Member is diagnosed with opioid dependence – documentation (i.e., clinical notes) from medical record must be provided

4. Member is 16 years of age or older

5. Member is compliant with routine urine drug screening (minimum of every 60 days) – laboratory documentation must be provided

6. Member meets ONE of the following:

a. Compliant with substance abuse counseling – documentation (e.g., chart note, current treatment plan) must be provided

b. Treated with buprenorphine or buprenorphine/naloxone for at least two continuous years – documentation (e.g., chart note) must be provided

7. Member is currently treated with buprenorphine or buprenorphine/naloxone AND has achieved and sustained prolonged clinical stability with current treatment – documentation (i.e., clinical notes) from medical record must be provided

8. Member’s current buprenorphine or buprenorphine/naloxone dose does not exceed any of the following:

a. Subutex (buprenorphine) sublingual tablet (generic equivalent) 8 mg or less

b. Suboxone (buprenorphine and naloxone) sublingual tablet (generic equivalent) 8 mg/2 mg or less

c. Bunavail (buprenorphine and naloxone) buccal film 4.2 mg/0.7 mg or less

d. Zubsolv (buprenorphine and naloxone) sublingual tablets 5.7 mg/1.4 mg or less

9. Prescriber confirms that the patient is not diverting buprenorphine or buprenorphine/naloxone, according to the patient’s records in the state’s prescription drug monitoring program (PDMP), if applicable

10. Buprenorphine implant will not be used in combination with another buprenorphine or buprenorphine/naloxone product

11. Member has not previously been treated with buprenorphine hydrochloride implant OR has only received 1 lifetime treatment consisting of 4 or fewer buprenorphine hydrochloride implants

12. Dose does not exceed 4 implants per 6 month period

Approval duration: 6 months

Continuation of buprenorphine hydrochloride (Probuphine) subdermal implant meets the definition of medical necessity for members meeting the following criteria:

1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years for opioid dependence, OR the member has previously met all indication-specific initiation criteria

2. Prescriber meets the qualification certification criteria in the Drug Addiction Treatment Act (DATA) of 2000 and has been issued a unique DEA identification number by the DEA, indicating that he or she is a qualified physician under the DATA to prescribe buprenorphine, Bunavail, Suboxone, buprenorphine/naloxone, or Zubsolv

3. Prescriber is certified by the PROBUPHINE REMS Program (www.PROBUPHINEREMS.com)

4. Member is diagnosed with opioid dependence – documentation (i.e., clinical notes) from medical record must be provided

5. Member is 16 years of age or older

6. Member is compliant with routine urine drug screening (minimum of every 60 days) – laboratory documentation must be provided

7. Member meets ONE of the following:

a. Compliant with substance abuse counseling – documentation (e.g., chart note, current treatment plan) must be provided

b. Treated with buprenorphine or buprenorphine/naloxone for at least two continuous years – documentation (e.g., chart note) must be provided

8. Prescriber confirms that the patient is not diverting buprenorphine or buprenorphine/naloxone, according to the patient’s records in the state’s prescription drug monitoring program (PDMP), if applicable

9. Buprenorphine implant will not be used in combination with another buprenorphine or buprenorphine/naloxone product

10. Member has received 1 lifetime treatment consisting of 4 or fewer buprenorphine hydrochloride implants

11. Dose does not exceed 4 implants per 6 month period

Approval duration: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

• Prescription use of this product is limited under the Drug Addiction Treatment Act

• Four implants are inserted subdermally in the upper arm for 6 months of treatment and are removed by the end of the sixth month

• Implants should not be used for additional treatment cycles after one insertion in each upper arm

• Implants must be inserted and removed by trained Healthcare Providers only

• Implants should be administered in patients who have achieved and sustained prolonged clinical stability on transmucosal buprenorphine

• Examine the insertion site one week following insertion of PROBUPHINE implants for signs of infection or other problems

Dose Adjustments

None

Drug Availability

• Ethylene vinyl acetate (EVA) implant, 26 mm in length and 2.5 mm in diameter, containing 74.2 mg of buprenorphine (equivalent to 80 mg of buprenorphine hydrochloride)

PRECAUTIONS:

Boxed Warning

• Insertion and removal of implants are associated with the risk of implant migration, protrusion, expulsion, and nerve damage resulting from the procedure.

• Available only through a restricted program called the PROBUPHINE REMS Program

Contraindications

• Hypersensitivity to buprenorphine or any other ingredients

Precautions/Warnings

• Serious Complications from Insertion and Removal: Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion, and expulsion. Incomplete insertions or infections may lead to protrusion or expulsion. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified in the PROBUPHINE REMS program, prior to performing insertions or prescribing

• Addiction, Abuse, and Misuse: Buprenorphine can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors

• Respiratory Depression: Significant respiratory depression and death have occurred in association with buprenorphine particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol). Consider dose reduction of CNS depressants when used concomitantly

• Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy

• Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid

• Unintentional Pediatric Exposure: In the event an implant protrudes or comes out, keep the implant away from children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children

• Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately

• Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to initiation and during treatment

• Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine and not dependent on full agonists before inserting implant

• Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J0570

Buprenorphine implant, 74.2 mg

ICD-10 Diagnosis Codes That Support Medical Necessity

F11.10

Opioid abuse, uncomplicated

F11.20

Opioid dependence, uncomplicated

F11.21

Opioid dependence, in remission

F11.24

Opioid dependence with opioid-induced mood disorder

F11.250

Opioid dependence with opioid-induced psychotic disorder with delusions

F11.251

Opioid dependence with opioid-induced psychotic disorder with hallucinations

F11.252

Opioid dependence with opioid-induced psychotic disorder unspecified

F11.29

Opioid dependence with other opioid-induced disorder with unspecified opioid-induced disorder

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

Opioid Dependence: a medical diagnosis characterized by an individual's inability to stop using opioids (morphine, heroin, codeine, oxycodone, hydrocodone, etc.) even when objectively it is in his or her best interest to do so.

RELATED GUIDELINES:

None

OTHER:

None

REFERENCES:

  1. Braeburn Pharmaceuticals. PROBUPHINE (buprenorphine hydrochloride) implant. 2017 [cited 8/28/17]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10fd7088-cc4a-4bda-a5e3-a82563540a9a/.
  2. Center for Substance Abuse Treatment. Clinical Guidelines for the use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS publication no. (SMA) 04-3939. Rockville, MD: Substance Abuse and Mental Health Services Administration (SAMHSA); 2004.
  3. Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs. Treatment Improvement Protocol (TIP) Series 43. DHHS publication no. (SMA) 12-4214. Rockville, MD: Substance Abuse and Mental Health Services Administration (SAMHSA); 2005.
  4. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 8/28/17]. Available from: http://www.clinicalpharmacology.com/.
  5. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 8/28/17]. Available from: http://clinicaltrials.gov/.
  6. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 8/28/17]. Available from: http://www.thomsonhc.com/.
  7. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 8/28/17]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  8. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 8/28/17]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  9. Rosenthal RN, Lofwall MR, Kim S, et al. Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial. JAMA. 2016 Jul 19;316(3):282-90.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 09/13/17.

GUIDELINE UPDATE INFORMATION:

09/15/16

New Medical Coverage Guideline.

01/01/17

Revision: Added HCPCS code J0570.

10/15/17

Review and revision to guideline, consisting of updating position statement, coding, references.

Date Printed: October 20, 2017: 02:06 PM