Medical Policies - Prescription Drugs


Treatment of Opioid Dependence

Number:RX501.082

Effective Date:07-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Medical policies are a set of written guidelines that support current standards of practice. They are based on current peer-reviewed scientific literature. A requested therapy must be proven effective for the relevant diagnosis or procedure. For drug therapy, the proposed dose, frequency and duration of therapy must be consistent with recommendations in at least one authoritative source. This medical policy is supported by FDA-approved labeling and nationally recognized authoritative references. These references include, but are not limited to: MCG care guidelines, DrugDex (IIb level of evidence or higher), NCCN Guidelines (IIb level of evidence or higher), NCCN Compendia (IIb level of evidence or higher), professional society guidelines, and CMS coverage policy.

Probuphine® (buprenorphine) Implants

Probuphine® (buprenorphine) implants may be considered medically necessary for the maintenance treatment of diagnosed opioid dependent patients 16 years or older for a maximum of 12 months when ALL of the following criteria are met:

The patient has 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 or generic equivalent) for three months or longer without any need for supplemental dosing or adjustments (*Patients should not be tapered to a lower dose for the sole purpose of transitioning to Probuphine®); AND

The patient is compliant with all elements of a complete treatment program to include counseling and psychosocial support; AND

The patient is abstinent from illicit drug use (including problematic alcohol and/or benzodiazepine use); AND

If the patient is receiving any other opioid medication, the prescriber has submitted information supporting the medical necessity of the opioid, including the specific reason and the expected duration of the therapy with the opioid.

Probuphine® (buprenorphine) implants are considered experimental, investigational and/or unproven for all other indications.

Re-insertion into previously-used administration sites, insertions into sites other than upper arm, and treatment for longer than 12-months of Probuphine® (buprenorphine) implants are considered experimental, investigational and/or unproven.

NOTE 1: After one insertion of Probuphine® implants in each arm, most patients should be transitioned back to a transmucosal buprenorphine-containing product for continued treatment.

NOTE 2: Insertion and/or removal of Probuphine® implants must only be performed by healthcare providers who have successfully completed a live Risk Evaluation and Mitigation Strategies (REMS) training program.

SublocadeTM (buprenorphine extended-release) Injection

SublocadeTM (buprenorphine extended-release) injection for subcutaneous use may be considered medically necessary for adult patients (18 years of age or older) in the treatment of moderate to severe opioid use disorder when ALL of the following criteria are met:

The patient has initiated treatment on a transmucosal buprenorphine-containing product delivering the equivalent of 8 to 24 mg buprenorphine daily, followed by dose adjustment for a minimum of 7 days; AND

The patient is compliant with all elements of a complete treatment program to include counseling and psychosocial support; AND

The patient will receive monthly treatment with Sublocade with injections no less than

26 days apart; AND

The patient is abstinent from illicit drug use (including problematic alcohol and/or benzodiazepine use); AND

If the patient is receiving any other opioid medication, the prescriber has submitted information supporting the medical necessity of the opioid, including the specific reason and the expected duration of the therapy with the opioid.

SublocadeTM (buprenorphine extended-release) injection is considered experimental, investigational and/or unproven for all other indications.

NOTE 3: Sublocade is for abdominal subcutaneous injection only and each injection should only be administered using the syringe and safety needle included with the product.

NOTE 4: Sublocade must be dispensed in a healthcare settings or pharmacy that is certified in the Sublocade REMS program.

Description:

Probuphine® (buprenorphine) Implants

Probuphine® implant is a sterile, single, off-white, soft, flexible rod-shaped drug product. It is 26 mm in length and 2.5 mm in diameter. Each implant contains 74.2 mg buprenorphine (equivalent to 80 mg buprenorphine hydrochloride) and ethylene vinyl acetate (EVA). A single dose consists of four Probuphine® rods that are inserted subdermally in the inner side of the upper arm. The implants provide sustained delivery of buprenorphine for up to six months, at which time they are then removed. After one insertion of Probuphine® implants in each arm, most patients should be transitioned back to a transmucosal buprenorphine-containing product for continued treatment.

Buprenorphine is a schedule III narcotic under the Controlled Substances Act and a mixed agonist-antagonist agent that exerts analgesic effects by binding to central nervous system (CNS) opiate receptors. It produces partial agonistic effect at the mu-opioid receptors and an antagonistic effect at kappa-opioid receptors. (1)

The term opioid refers to natural and synthetic substances that act at one of the three main opioid receptor systems (mu, kappa, delta). Opioids, used medically for pain relief, have analgesic and CNS depressant effects as well as the potential to cause euphoria. Opioid use disorder (OUD) can involve misuse of prescribed opioid medications, use of diverted opioid medications, or use of illicitly obtained heroin. OUD is typically a chronic, relapsing illness, associated with significantly increased rates of morbidity and mortality. (2) Per the U.S. Food and Drug Administration (FDA) Summary Review, OUD, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), is a chronic, relapsing disease characterized by the repeated, compulsive seeking or use of an opioid despite adverse social, psychological, and physical consequences. Moderate to severe OUD corresponds, roughly, to the DSM-IV diagnosis “opioid dependence,” and to the widely-used term, “addiction.” Mild OUD corresponds to the DSM-IV diagnosis “opioid abuse.” (4)

Under the Drug Addiction Treatment Act (DATA) codified at 21 United States Code (U.S.C.) 823(g), use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe or dispense this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

Regulatory Status

In May 26, 2016 the Probuphine® implant (Braeburn Pharmaceuticals, Inc., Princeton, NJ, USA/Titan Pharmaceuticals, South San Francisco, CA, USA) received a New Drug Application (NDA) approval from the FDA. It is indicated 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 or generic equivalent). The safety and effectiveness of Probuphine® implants have not been established in children or adolescents < 16 years of age. There are no therapeutic equivalents. FDA NDA #204442.

The FDA approved package insert (PI) for Probuphine includes the following factors in determining clinical stability and suitability for Probuphine treatment:

Period free from illicit opioid drug use;

Stability of living environment;

Participation in a structured activity/job;

Consistency in participation in recommended behavioral therapy/peer support program;

Consistency in compliance with clinic visit requirements;

Minimal to no desire or need to use illicit opioids;

Period without episodes of hospitalizations (addiction or mental health issues), emergency room visits, or crisis interventions; and

Social support system.

The Probuphine® label includes a boxed warning that includes the risks associated with insertion and removal of the implant which states the following: “Insertion and removal of Probuphine® are associated with the risk of implant migration, protrusion, and expulsion resulting from the procedure. 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.”

Because of the risks associated with insertion and removal, Probuphine® is available only through a restricted program called the Probuphine® Risk Evaluation and Mitigation Strategies (REMS) Program. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing Probuphine® implants. Patients must be monitored to ensure that Probuphine® is removed by a healthcare provider certified to perform insertions. (3)

SublocadeTM (buprenorphine extended-release) Injection

SublocadeTM (buprenorphine extended-release) injection, also known as RBP-6000 is a clear, viscous, colorless to yellow to amber, sterile solution for subcutaneous only. (4) The active ingredient in SublocadeTM is buprenorphine free base, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist. It is designed to deliver buprenorphine at a controlled rate over a one-month period. Buprenorphine is dissolved in the Atrigel® delivery system. The Atrigel® delivery system is a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP).

Regulatory Status

November 30, 2017 SublocadeTM (Indivior Inc., Richmond, VA, USA) received an NDA approval from the FDA, the first once monthly injectable buprenorphine product for the treatment of moderate-to-severe OUD. (4) It should be used by patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustments for a minimum of 7 days and be part of a complete treatment program that includes counseling and psychosocial support. The safety and efficacy of SublocadeTM have not been established in children or adolescents less than 17 years of age. Clinical studies of SublocadeTM did not include participants over the age of 65. FDA NDA# 209819.

The FDA label includes a boxed warning, that states the following: “Serious harm or death could result if administered intravenously. Sublocade forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, Sublocade is only available through a restricted program called the Sublocade REMS Program. Healthcare settings and pharmacies that order and dispense Sublocade must be certified in this program and comply with the REMS requirements.” (4)

Rationale:

Probuphine® (buprenorphine) Implants

The efficacy of the Probuphine® implants was demonstrated in one randomized double-blind, double-dummy study in adults who met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition [Text Revision]) criteria for opioid dependence as their primary diagnosis, and were considered clinically stable, on a sublingual buprenorphine dose of no more than 8 mg per day, by their treating healthcare provider. (1)

In this study, clinically-stable subjects on maintenance treatment with no more than 8 mg per day sublingual buprenorphine were randomized 1:1 to either Probuphine® (4 implants) or treatment as usual with their pre-randomization dose of sublingual buprenorphine. A total of 87 were treated with Probuphine® and received placebo sublingual tablets; 89 were treated with sublingual buprenorphine/naloxone tablets and received placebo implants. Patients were seen monthly for six months and were also required to provide four randomly-scheduled urine samples for toxicology. Efficacy was evaluated through urine toxicology screening and patient self-report to detect opioid use, over the 6-month treatment period. Supplemental dosing with open-label sublingual buprenorphine/naloxone tablets was permitted as clinically indicated. The use of supplemental buprenorphine in patients on Probuphine®, which cannot be titrated, may be interpreted to indicate that the dose of buprenorphine provided by Probuphine® was inadequate for that patient (to maintain stability) and so patients who required supplemental dosing were not included in the table as successfully maintained, even if they did not have evidence of opioid use. Among adults with opioid dependence maintaining abstinence with a stable dose of sublingual buprenorphine, the use of buprenorphine implants compared with continued sublingual buprenorphine did not result in an inferior likelihood of remaining a responder. However, the study population had an exceptionally high response rate in the control group, and further studies are needed in broader populations to assess the efficacy in other settings. (1,4)

A search in ClinicalTrials.gov was completed and the following clinical trials were found in addition to two clinical trials that were terminated (NCT00768482, NCT00772785).

In 2010, Ling et al. published a randomized double-blind placebo-controlled 6-month trial. (5) The trial was conducted in 18 sites in the United States, with 163 adults, aged 18-65 years, diagnosed with opioid dependence. One hundred eight were randomized to receive buprenorphine implants and 55 to receive placebo implants. After induction with sublingual buprenorphine-naloxone tablets, patients received either 4 buprenorphine implants (80 mg per implant) or 4 placebo implants. A fifth implant was available if a threshold for rescue use of sublingual buprenorphine-naloxone treatment was exceeded. Standardized individual drug counseling was provided to all patients. Urine samples were collected 3 times a week for the full 6 months of the study for each subject. Implants were removed at a mean of 24 weeks for the Probuphine® group and 16.6 weeks in the control group. Additional implants were received in 20.3% of Probuphine® subjects and 58.2% of controls. During weeks 1-16, 59% of Probuphine® subjects and 91% of controls required supplemental medications. During weeks 17-24, these numbers changed to 12% and 20%, respectively. The primary outcome, percentage of negative urine samples out of the total collected between 1 and 16 weeks, was reported to be 40.4% in the Probuphine® group and 28.3% in the control group (p=0.04). For the secondary outcome, the same outcome for the period between 17 and 24 weeks, no specific data were provided other than that the difference remained significant (p<0.001). For the overall study period, the percentage of subjects with negative urine samples was 36.6% and 22.4%, respectively. The overall loss to follow-up was not provided, but for weeks 1-16, 18.5% of the Probuphine® subjects and 49.1% of the controls were lost. Significant differences were noted between groups with regard to results on the Clinical Opiate Withdrawal Scale (p<0.0001), Clinical Global Impressions (CGI) tool severity measure (p<0.001), and the CGI improvement scale (p<0.001). The authors concluded that among persons with opioid dependence, the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks as assessed by urine samples.

In 2013, Rosenthal et al. published another randomized, double-blind controlled trial. (6)

This randomized controlled trial (RCT) was aimed to evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence as well as comparing BI to open-label sublingual buprenorphine/naxolone tablets (BNX). Subjects received either 4 buprenorphine implants (80 mg implant) (n=114, four placebo implants (n=54) or open-label BNX (12-16 mg/day) (n=119). The 287 subjects consisted of adults ages 18-65 with DSM-IV-TR opioid dependence. The primary efficacy end-point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF). The authors reported that BI CDF was significantly different from placebo (P < 0.0001). Mean proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician-rated (P < 0.0001) and patient-rated (P < 0.0001) withdrawal, lower patient-ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). BI were non-inferior to BNX on percentage of urines negative for opioids [mean (95% confidence interval [CI]) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (-10.7, 6.2)]. It was concluded that compared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non-inferior to sublingual buprenorphine/naloxone tablets.

SublocadeTM (buprenorphine extended-release) Injection

The review of efficacy of SublocadeTM (RB-6000) for the use in moderate to severe Opioid use disorder (OUD) was focused on the findings from a randomized, double-blind, placebo-control efficacy study (RB-US-13-0001) and an opioid blockade study (RB-US-13-0002). (4)

The efficacy of SublocadeTM for the treatment of opioid use disorder was evaluated in a Phase 3, 24-week, randomized, double-blind, placebo-controlled, multicenter trial (RB-US-13-0001) in treatment-seeking patients who met the DSM-5 criteria for moderate or severe opioid use disorder. Subjects (n= 504) were randomized 4:4:1:1 (203 subjects in the 300 mg/100 mg group, 201 in the 300 mg/300 mg group and 100 in the placebo group [2 groups of volume-matched placebo]). The demographic and baseline characteristics were comparable across treatment groups. The primary efficacy endpoint was the cumulative distribution function (CDF) of the percentage of urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from Week 5 through Week 24. The purpose of analyzing efficacy starting from Week 5 instead of Week 1 was to allow subjects to stabilize in treatment. The percentage of negative drug use assessments was computed for each subject as the number of weeks of non-use divided by 20. The key secondary endpoint was treatment success, defined as any subject with at least 80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use from Week 5 through Week 24. The proportion of patients achieving treatment success was statistically significantly higher in both groups receiving SublocadeTM compared to the placebo group (28.4% [300 mg/100 mg], 29.1% [300 mg/300 mg], 2% [placebo]). (4)

RB-US-13-0002 is a double-blind, placebo-controlled, multiple-dose study in nontreatment seeking subjects (n=39) with moderate to severe OUD to evaluate blockade of the intramuscular (IM) hydromorphone (HM) subjective effects by subcutaneous (SC) depot injections SublocadeTM. Buprenorphine plasma levels and the safety of SC injections were also examined. Subjects were inpatient, started and stabilized on Suboxone sublingual film doses of 8-24 mg/day. The peak (Emax) effect of “Drug Liking” Visual Analog Scale (VAS) measurement after challenge with IM injections of 6 mg and 18 mg hydromorphone (HM) was not inferior (i.e., shown to be not substantially more likeable) compared to the Emax of “Drug Liking” VAS, measured after challenge with placebo (at weeks 1 through 4 following the first injection of 300 mg SublocadeTM). The noninferiority (NI) margin, the largest difference allowed for the 6 or 18 mg HM VAS to exceed the placebo VAS (the maximum VAS recorded following IM injection of 0 mg HM) before being considered significant, was set at 20. Based on comparison to the historical response to opioid agonists in unblocked subjects, a difference of less than 20 points (on a unipolar scale) between the mean maximum response to hydromorphone and the mean maximum placebo response for the same challenge was considered to indicate near-complete blockade. All 12 weeks of the treatment period demonstrated blockade for both 6 mg and 18 mg following SublocadeTM injections. Complete blockade continued throughout the 8 weeks of observation that followed the second SublocadeTM injection. (4)

Practice Guidelines and Position Statements

American College of Physicians

The American College of Physicians (ACP) published a position paper on health and public policy to facilitate effective prevention and treatment of substance use disorders involving illicit and prescription drugs. (8) ACP made recommendations specific to buprenorphine. As one of a number of strategies to address the epidemic of prescription drug misuse, ACP recommended “improved training in the treatment of substance use disorders, including buprenorphine-based treatment” as well as to “lift barriers that impede access to medication to treat opioid use disorder (methadone, buprenorphine, and naltrexone) and to medications for overdose prevention (naloxone)”.

Canadian Agency for Drugs and Technologies in Health

In 2016, the Canadian Agency for Drugs and Technologies in Health published a comparative effectiveness review and guideline on buprenorphine plus naloxone vs methadone for the treatment of opioid dependence. (9) The report evaluated the sublingual tablet containing buprenorphine and naloxone (Suboxone). Buprenorphine plus naloxone is available as a generic. Buprenorphine alone is not marketed for opioid use disorder in Canada.

American Society of Addiction Medicine

The American Society of Addiction Medicine’s 2015 national practice guidelines on the use of medications to treat addiction involving opioid use did not include buprenorphine implants. (10)

Summary of Evidence

For individuals who are addicted to opioids but stable on low-to-moderate doses of transmucosal buprenorphine who receive buprenorphine implants, the evidence includes a randomized controlled trial. Relevant outcomes are change in disease status, morbid events, health status measures, medication use, and treatment-related morbidity. In the pivotal trial, the proportion of patients who reported for no more than 2 out of 6 months any evidence of illicit opioid use was similar between the buprenorphine implant arm (63%) and the sublingual buprenorphine arm (64%). The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with moderate or severe opioid use disorder who have initiated treatment with a transmucosal buprenorphine-containing product who receive SublocadeTM, the evidence includes a phase 3, randomized controlled trial in which the proportion of patients achieving treatment success was statistically significantly higher in the groups receiving SublocadeTM compared to the placebo group. A double-blind, placebo-controlled, multiple-dose study in nontreatment seeking subjects demonstrated that SublocadeTM at a 300-mg dose provides durable and potent blockade of the subjective effects and reinforcing efficacy of hydromorphone in subjects with moderate or severe opioid use disorder. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

11981, 11982, 11983

HCPCS Codes

J0570, G0516, G0517, G0518, Q9991, Q9992

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Food and Drug Administration (FDA) - Probuphine – Product Label. Approval Letter (February 2018). Available at <http://www.accessdata.fda.gov> (accessed - 2018 April 18).

2. Strain, E. Opioid use disorder: Epidemiology, pharmacology, clinical manifestations, course, screening, assessment, and diagnosis. In: UpToDate, Post TW (Ed) UpToDate, Waltham, MA. Available at <http://uptodate.com> (accessed - 2016 August 19).

3. Buprenorphine. Micromedex Drug Summary Information. Truven Health Analytics Micromedex Solutions 2016. Available at <http://www.microdexsolutions.com> (accessed – 2016 August 17).

4. Food and Drug Administration (FDA) - Sublocade – Drugs@FDA: FDA Approved Drug Products. Product Label, Approval Letter, Summary Review (November 2017). Available at <http://www.accessdata.fda.gov> (accessed - 2018 April 18).

5. Rosenthal RN, Lofwall MR, Kim S, et al. PRO-814 Study Group. Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial. JAMA. Jul 2016; 316(3):282-290. PMID 2743441

6. Ling W, Casadonte P, Bigelow G, et al. Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial. JAMA. 2010; 304(14):1576-1583.PMID 20940383

7. Rosenthal RN, Ling W, Casadonte P, et al. Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone. Addiction. 2013; 108(12):2141-2149. PMID 23919595

8. Crowley R, Kirschner N, Dunn AS, et al. Health and Public Policy to Facilitate Effective Prevention and Treatment of Substance Use Disorders Involving Illicit and Prescription Drugs: An American College of Physicians Position Paper. Ann Intern Med. May 16 2017; 166(10):733-736. PMID 28346947

9. Canadian Agency for Drugs and Technologies in Health. Buprenorphine/Naloxone Versus Methadone for the Treatment of Opioid Dependence: A Review of Comparative Clinical Effectiveness, Cost-Effectiveness and Guidelines. Ottawa (ON)2016.

10. Kampman K, Jarvis M. American Society of Addiction Medicine (ASAM) national practice guideline for the use of medications in the treatment of addiction involving opioid use. J Addict Med. Sep-Oct 2015; 9(5):358-367. PMID 26406300

11. Buprenorphine Implant for Treatment of Opioid Dependence. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2017 August) Prescription Drugs 5.01.26.

Policy History:

Date Reason
7/1/2018 Document updated with literature review. The following change was made to Coverage: Added conditional coverage for Sublocade with associated NOTE 3 and 4. Document title changed from: Probuphine (buprenorphine) Implant for Treatment of Opioid Dependence. Referenced 4 and 8-11 added.
4/1/2017 Reviewed. No changes.
1/1/2017 New medical document. Probuphine® (buprenorphine) implants may be considered medically necessary for the maintenance treatment of diagnosed opioid dependent patients 16 years or older for a maximum of 12 months when ALL of the following criteria are met: 1) 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 or generic equivalent) for three months or longer without any need for supplemental dosing or adjustments (*Patients should not be tapered to a lower dose for the sole purpose of transitioning to Probuphine®); AND 2) It is used as part of a complete treatment program to include counseling and psychosocial support. Probuphine® (buprenorphine) implants are considered experimental, investigational and/or unproven for all other indications.

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