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Buprenorphine and Buprenorphine/Naloxone for Opioid Dependence Prior Authorization, Quantity Limit and Concomitant Use of Opioid Products Program Summary

Policy Number: PH-99999991003

This prior authorization program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies. 

Buprenorphine tablets are subject to prior authorization, quantity limits, and concomitant use of opioid products prior authorization restrictions.

All other products are only subject to quantity limits and concomitant use of opioid products prior authorization restrictions.

Buprenorphine for Opioid Dependence Prior Authorization with Quantity Limit

OBJECTIVE

The intent of the Buprenorphine for Opioid Dependence Prior Authorization (PA) with Quantity Limit (QL) program is to ensure appropriate selection of patients for treatment of opioid dependence in appropriate quantities according to product labeling and/or clinical guidelines and/or clinical studies. The product(s) will not be covered for the treatment of pain. Claims for opioids during buprenorphine therapy will only be covered with prior authorization and only in the event of acute pain/surgery not to exceed 5 day course of treatment (see separate criteria below “Concomitant Use of Opioid Products with Buprenorphine and Buprenorphine/Naloxone”).

TARGET AGENT(S)

buprenorphine

PROGRAM QUANTITY LIMIT

Brand (generic)

GPI

Multisource Code

Quantity Limit per 90 Days

buprenorphinea

2 mg sublingual tablet

65200010100760

M, N, O, or Y

5 tablets/90 days

8 mg sublingual tablet

65200010100780

M, N, O, or Y

5 tablets/90 days

a - generic available and included in the quantity limit program.

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Initial Evaluation for Induction and Stabilization

Please provide clinical notes to support information below.

Buprenorphine will be approved when ALL of the following are met and supported by the medical record (e.g., chart notes, physician letter of attestation):

  1. The patient has an active diagnosis of opioid dependence

AND

  1. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

    1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

  1. ONE of the following:
    1. The patient is currently enrolled in an ongoing outpatient drug addiction treatment program/counseling (appointment dates if available)

OR

    1. The patient has agreed to enroll in an ongoing outpatient drug addiction treatment program/counseling within the initial approval timeframe of 2 months

OR

    1. The patient has completed 6 months or more of outpatient drug addiction treatment/counseling and the prescriber provides rationale as to why the patient no longer needs to continue (to be reviewed and verified by a pharmacist or physician)

AND

  1. Evidence of an initial patient assessment and treatment plan which includes ALL of the following:
    1. Medication history review

AND

    1. Review of the patient’s records in the state’s prescription drug monitoring program (PDMP), if applicable

AND

    1. Performance of baseline urine drug screen (test results not required)

AND

    1. Current informed consent or written agreement for treatment of substance abuse signed by the prescriber and the patient

AND

  1. ONE of the following:
    1. The patient is not currently taking an opioid agent, including tramadol and tapentadol, to be verified by absence of claims in patient claims history upon request submission

OR

    1. Notation that the patient will discontinue use with the prescribed opioid agent(s) prior to/with the initiation of buprenorphine

AND

  1. BOTH of the following:
    1. The patient is either not currently taking other non-prescription drugs of abuse or alcohol or there is notation that the patient will discontinue use of non-prescription drugs and/or alcohol with the initiation of buprenorphine

AND

    1. ONE of the following:
      1. The patient is not currently taking other addictive prescription medications (e.g. muscle relaxants, benzodiazepines, sedative/hypnotics), to be verified by absence of claims in patient claims history upon request submission  

OR

      1. The prescriber has submitted documentation indicating benefits of treatment/use of the listed prescription agent(s) outweighs risk associated with concomitant buprenorphine product use (to be reviewed and verified by a pharmacist or physician)

AND

  1. The patient will NOT be using the requested agent in combination with another  buprenorphine or buprenorphine/naloxone agent (including implantable and injectable buprenorphine) for the requested indication

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The quantity (dose) requested is less than or equal to the program quantity limit

OR

    1. The quantity (dose) requested is within FDA-approved labeling and the prescriber has submitted documentation in support of therapy with a higher dose for the requested indication

OR

    1. The patient is pregnant

OR

    1. The patient has an intolerance or hypersensitivity to naloxone or naltrexone

OR

    1. The patient has an FDA labeled contraindication to naloxone or naltrexone

Length of Approval:  Allow for a single course of induction treatment within the quantity limit OR as requested and approved, based on submitted information up to 2 months OR duration of pregnancy if less than 2 months to term

Renewal Evaluation for Maintenance Therapy

Buprenorphine will be approved when ALL of the following are met and supported by the medical record (e.g., chart notes, physician letter of attestation):

  1. The prescriber has verified the patient has been through induction and stabilization therapy and is seeking approval for maintenance therapy

AND

  1. The patient has an active diagnosis of opioid dependence (may be subject to verification upon submission or during authorization timeframe)

AND

  1. ONE of the following:
    1. The patient is currently enrolled in an ongoing outpatient drug addiction treatment program/counseling (provider and appointment dates to be provided)

OR

    1. The patient has completed 6 months or more of outpatient drug addiction treatment/counseling and the prescriber provides rationale as to why the patient no longer needs to continue (to be reviewed and verified by a pharmacist or physician)

AND

  1. The prescriber has submitted a current (within 30 days) patient assessment and treatment plan which includes ALL of the following:
  1. Medication history review

AND

  1. Frequency of urine drug screening, including results of most recent drug screen indicating patient is free from illicit drug use or treatment plan has been adjusted based on the results of the drug screen

AND

  1. Informed consent or written agreement for treatment of substance abuse signed by the prescriber and the patient

AND

  1. Anticipated duration of therapy and plan for dose taper OR documentation of barriers to drug taper if patient is not a candidate for dose taper at this time

AND

  1. The patient is not currently taking an opioid agent, including tramadol and tapentadol, to be verified by absence of claims in patient claims history since last authorization (excluding short term use approved through the Concomitant Use of Opioid Products with Buprenorphine and Buprenorphine/Naloxone criteria below)

AND

  1. BOTH of the following:
    1. The patient is not currently taking other non-prescription drugs of abuse or alcohol

AND

    1. ONE of the following:
      1. The patient is not currently taking other addictive prescription medications (e.g. muscle relaxants, benzodiazepines, sedative/hypnotics, non-prescription drugs of abuse or alcohol) to be verified by absence of claims in patient claims history upon request submission

        OR

      1. The prescriber has submitted documentation indicating benefits of treatment/use of the listed prescription agent(s) outweighs risk associated with concomitant buprenorphine use (to be reviewed and verified by a pharmacist or physician)

AND

  1. The patient continues to be compliant with all elements of the treatment plan required at that time (including but not limited to recovery-oriented activities, psychotherapy, and/or other psychosocial modalities)

AND

  1. The prescriber has reviewed the patient’s records in the state’s prescription drug monitoring program (PDMP) as attestation that, to the best of the provider’s knowledge, the patient is not diverting the requested medication or other controlled substances

AND

  1. The patient will NOT be using the requested agent in combination with another  buprenorphine or buprenorphine/naloxone agent (including implantable and injectable buprenorphine) for the requested indication

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The quantity (dose) requested is less than or equal to the program quantity limit

OR

    1. The quantity (dose) requested is within FDA-approved labeling and the prescriber has submitted documentation in support of therapy with a higher dose for the requested indication

OR

    1. The patient is pregnant

OR

    1. The patient has an intolerance or hypersensitivity to naloxone or naltrexone

OR

    1. The patient has an FDA labeled contraindication to naloxone or naltrexone

Length of Approval: 6 months, or duration of pregnancy if less than 6 months to term

 

Buprenorphine/Naloxone for Opioid Dependence Quantity Limit

OBJECTIVE

The intent of the Buprenorphine/Naloxone for Opioid Dependence Quantity Limit (QL) program is to ensure appropriate selection of patients for treatment of opioid dependence in appropriate quantities according to product labeling and/or clinical guidelines and/or clinical studies.

These products will not be covered for the treatment of pain. Claims for opioids buprenorphine/naloxone therapy will only be covered with prior authorization and only in the event of acute pain/surgery not to exceed 5 day course of treatment (see separate criteria below “Concomitant Use of Opioid Products with Buprenorphine and Buprenorphine/Naloxone”).

TARGET AGENT(S)

buprenorphine/naloxone

Bunavail™ (buprenorphine/naloxone)

Suboxone® (buprenorphine/naloxone)

Zubsolv® (buprenorphine/naloxone)

PROGRAM QUANTITY LIMIT

Brand (generic)

GPI

Multisource Code

Quantity Limit per Day

Bunavail (buprenorphine/naloxone)

2.1 mg/0.3 mg buccal film

65200010208260

M, N, O, or Y

3 film/day

4.2 mg/0.7 mg buccal film

65200010208270

M, N, O, or Y

2 film/day

6.3 mg/1 mg buccal film

65200010208280

M, N, O, or Y

1 film/day

buprenorphine/naloxonea

2 mg/0.5 mg sublingual tablet

65200010200720

M, N, O, or Y

3 tablets/day

8 mg/2 mg sublingual tablet

65200010200740

M, N, O, or Y

2 tablets/day

Suboxone (buprenorphine/naloxone)a

2 mg/0.5 mg sublingual film

65200010208220

M, N, O, or Y

3 films/day

4 mg/1 mg sublingual film

65200010208230

M, N, O, or Y

2 films/day

8 mg/2 mg sublingual film

65200010208240

M, N, O, or Y

2 films/day

12 mg/3 mg sublingual film

65200010208250

M, N, O, or Y

1 film/day

Zubsolv (buprenorphine/naloxone)

0.7 mg/0.18 mg sublingual tablet

65200010200710

M, N, O, or Y

1 tablet/day

1.4 mg/0.36 mg sublingual tablet

65200010200715

M, N, O, or Y

3 tablets/day

2.9 mg/0.71 mg sublingual tablet

65200010200725

M, N, O, or Y

1 tablet/day

5.7 mg/1.4 mg sublingual tablet

65200010200732

M, N, O, or Y

1 tablets/day

8.6 mg/2.1 mg

sublingual tablet

65200010200745

M, N, O, or Y

1 tablets/day

11.4 mg/2.9 mg sublingual tablet

65200010200760

M, N, O, or Y

1 tablet/day

           

a - generic available and included in the quantity limit program.

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Evaluation

Please provide clinical notes to support information below.

Quantities above the program set limit for Bunavail/Suboxone/Zubsolv (buprenorphine/naloxone) will be approved when ALL of the following are met and supported by the medical record (e.g., chart notes, physician letter of attestation):

  1. The patient has an active diagnosis of opioid dependence

AND

  1. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

    1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

  1. The patient will NOT be using the requested agent in combination with another buprenorphine or buprenorphine/naloxone agent (including implantable and injectable buprenorphine) for the requested indication

AND

  1. ONE of the following:
    1. The quantity (dose) requested is less than or equal to the program quantity limit

OR

    1. The quantity (dose) requested is within FDA-approved labeling and the prescriber has submitted documentation in support of therapy with a higher dose for the requested indication  

Length of Approval:  6 months

 

Concomitant Use of Opioid Products with Buprenorphine and Buprenorphine/Naloxone

Prior Authorization for Opioid Use During buprenorphine or Bunavail/Suboxone/Zubsolv (buprenorphine/naloxone) therapy will be approved when the following is met:

  1. The prescriber has submitted documentation supporting concurrent use of an opioid and the requested buprenorphine product due to ONE of the following:
    1. Dental procedure with dates

OR

    1. Surgery with dates

OR

    1. Acute injury with dates

Length of Approval: 5 days

Acceptable rationale and supporting documentation for concurrent opioid and buprenorphine/buprenorphine-naloxone use include clinical notes indicating treatment of acute pain with surgery, acute injury or dental procedure with dates. The patient must remain enrolled in ongoing outpatient drug addiction treatment program/counseling if appropriate as established in original treatment plan. 

Prior Authorization for Opioid Use for Chronic Pain Management during authorization period for buprenorphine or Bunavail/Suboxone/Zubsolv (buprenorphine/naloxone) therapy will be approved when the following are met:

  1. The prescriber has submitted documentation supporting use of the opioid for chronic pain management

    AND

  1. The prescriber has indicated that the patient will no longer be using buprenorphine or Bunavail/Suboxone/Zubsolv

Buprenorphine or Bunavail/Suboxone/Zubsolv prior authorization will be terminated with an effective date of the request review. Prior authorization will no longer be required for the opioid once the buprenorphine or Bunavail/Suboxone/Zubsolv authorization will no longer be active in the claims system.

FDA APPROVED INDICATIONS AND DOSAGE1-5

Agent(s)

Indication(s)

Dosage

buprenorphine

sublingual tableta

Treatment of opioid dependence and is preferred for induction.

Should be used as part of a complete treatment plan to include counseling and psychosocial support.

Induction: 8 mg sublingually on day 1, 16 mg sublingually on day 2, and then the patient should begin maintenance treatment.

Following induction, buprenorphine/naloxone is preferred for maintenance and initiated after two days of buprenorphine sublingual tablets due to the presence of naloxone when clinical use includes unsupervised administration.

Bunavail®

(buprenorphine/

naloxone)

buccal film

Treatment of opioid dependence.

Should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Induction: Day 1, administer up to 4.2 mg/0.7 mg (in divided doses). On Day 2, administer up to 8.4 mg/1.4 mg of Bunavail as a single dose.

Maintenance: Recommended target dosage is 8.4 mg/1.4 mg as a single daily dose.

Dosage should be titrated in increments of 2.1 mg buprenorphine per day to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.

Dosages higher than 12.6 mg/2.1 mg have not been demonstrated to provide any clinical advantage.

buprenorphine/

naloxone

sublingual tableta

Maintenance treatment of opioid dependence.

Should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Should be used in patients who have been initially inducted using buprenorphine sublingual tablets.

Maintenance: Generally in the range of 4 mg/1 mg buprenorphine/naloxone to 24 mg/6 mg buprenorphine/naloxone per day depending on the individual patient. Titrated in increments/decrements of 2 mg/0.5 mg or 4 mg/1 mg.

The recommended target dose is 16 mg/4 mg per day as a single daily dose.

Doses higher than 24 mg/6 mg have not been demonstrated to provide any clinical advantage.

Suboxone®

(buprenorphine/

naloxone)

sublingual filma

Treatment of opioid dependence.

Should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Induction: Day 1 administer up to 8 mg/2 mg buprenorphine and naloxone sublingual film (in divided doses). On Day 2, administer up to 16 mg/4 mg as a single dose

Maintenance: The target dose is usually 16 mg/4 mg as a single daily dose.

Dosages higher than 24 mg/6 mg daily have not been demonstrated to provide a clinical advantage.

Zubsolv®

(buprenorphine/

naloxone)

sublingual tablet

Treatment of opioid dependence.

Should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Induction: Day 1 administer up to 5.7 mg/1.4 mg (in divided doses). On Day 2, administer up to a total dose of 11.4 mg/2.9 mg as a single dose.

Maintenance: The target dose  is 11.4 mg/2.9 mg as a single daily dose.

Dosages higher than 17.2 mg/4.2 mg have not been demonstrated to provide any clinical advantage.

a – generic available

CLINICAL RATIONALE

Opioid use disorder (OUD) is defined as a disorder characterized by loss of control of opioid use, risky opioid use, impaired social functioning, tolerance, and withdrawal. It is estimated that 1.8 million Americans have OUD related to opioid painkillers. Opioid addiction is considered a moderate to severe form of OUD. The Substance Abuse and Mental Health Services Administration (SAMHSA) and the National Institute on Drug Abuse indicate addiction is a lifelong, treatable illness and often requires continuing care for effective treatment. OUD treatment does not have a “one size fits all” approach and patients should receive information from their healthcare team regarding OUD and the options for treatment, including treatment with FDA approved medications. Patient’s receiving OUD treatment should have access to medical, mental health, addiction counseling, and recovery support services to supplement medication assisted treatment (MAT).8 Treatment of opioid dependence was transformed by Congressional approval of the Drug Addiction Treatment Act (DATA 2000). Under DATA 2000 and the Comprehensive Addiction Recovery Act of 2016, qualified physicians, nurse practitioners, and physicians assistants may obtain a waiver allowing them to prescribe and/or dispense approved Schedule III-V medications for the treatment of opioid dependence. The SUPPORT Act of 201 further amended the definition of qualifying other practitioners to include clinical nurse specialists, certified registered nurse anesthetist, and certified nurse midwives until October 2023.9 Previously, this type of treatment was available only in federally approved Opioid Treatment Programs (methadone clinics).8

To expand access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, exemptions to DATA 2000 were added in January 2021, including but not limited to:15

  • The exemption only applies to physicians who may only treat patients who are located in the states in which they are authorized to practice medicine.
  • Physicians utilizing this exemption will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time (note: the 30 patient cap does not apply to hospital-based physicians, such as Emergency Department physicians).
  • The exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the CSA, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD.
  • Physicians utilizing this exemption shall place an "X" on the prescription and clearly identify that the prescription is being written for opioid use disorders (along with the separate maintaining of charts for patients being treated for OUD).


For induction treatment, single-agent buprenorphine is preferred. For patients dependent on short-acting opioid products who are in opioid withdrawal, single agent buprenorphine or Suboxone (buprenorphine/naloxone) may be used for induction.  For patients dependent on methadone or long-acting opioid products, single-agent buprenorphine is recommended.  Single-agent buprenorphine should be limited to a maximum of 5 days, except in pregnant women and patients with a documented allergy to naloxone or naltrexone. These patients should be allowed treatment with single-agent buprenorphine beyond 5 days.6-8 When determining treatment initiation, consider the opioid's duration of action, time since last opioid use, and degree of opioid dependence. Administer first dose of buprenorphine at least 4 hours after the last used opioid or preferably when early signs of opioid withdrawal appear. Use of buprenorphine/naloxone during induction may result in more withdrawal symptoms than if single-agent buprenorphine is used.1-5

For maintenance treatment, patients should be transitioned from single-agent buprenorphine to buprenorphine/naloxone after 2 days of induction, except in pregnant women and patients with a documented allergy to naloxone or naltrexone.1-5 Buprenorphine/naloxone is preferred over single-agent buprenorphine for maintenance treatment, especially when drug administration will not be supervised. Buprenorphine is indicated for daily administration; however, administering the total weekly dose over three days (roughly every other day) may be effective in decreasing opioid dependence.1-5 Buprenorphine has a long elimination half-life, due to a slow dissociation rate from the mu opioid receptor, which gives rise to its prolonged suppression of opioid withdrawal and blockade of exogenous opioids. This enables buprenorphine dosing to occur on a less frequent basis than full opioid agonists.6  The half-life varies from 24 to 69 hours, with a mean of 24 to 42 hours. For example, a patient stabilized on 12 mg daily of buprenorphine/naloxone could be treated with 24 mg every other day or 24 mg on Mondays and Wednesdays and 36 mg on Fridays. These types of schedules allow for reduced travel burden for patients wanting supervised dosing at an OPT or may be useful for patients who must spend weekends in a jail that does not allow buprenorphine dosing.8 Doses up to 32 mg per day are needed by some patients, but this should be rare.14 

According to the Substance Abuse and Mental Health Services Administration (SAMHSA), dosing can vary between 2 mg/0.5 mg (buprenorphine/naloxone) to 8mg/2mg (Suboxone) on the first and second day of induction, with a recommended target dose of 16 mg/4 mg, and up to 32 mg/8 mg per day during maintenance therapy. Dosing depends on the stabilization of withdrawal symptoms.6 There is limited evidence regarding the relative efficacy of doses higher than 24 mg/6 mg per day and the use of higher doses may increase the risk of diversion.6-8 Dosages higher than 24mg/6mg have not been demonstrated to provide a clinical advantage.1-8 Evidence used to gain the FDA approval demonstrated efficacy in doses up to 16 mg/4 mg per day through clinical trial data with safety being supported in open label extensions in doses up to 24 mg/6 mg per day of the tablets. Justification for approval of the 24 mg/6 mg dose is based on data extrapolations comparing the pharmacokinetic profiles of the tablet and sublingual solutions.
 

Buprenorphine dosing for buprenorphine tablets and Suboxone is considered interchangeable.  Buprenorphine equivalency amongst available products is as follows: 8 mg buprenorphine is equivalent to 5.7 mg buprenorphine (1.4 mg naloxone) within Zubsolv and 4.2 mg buprenorphine (0.7 mg naloxone) within Bunavail. When switching between buprenorphine/naloxone sublingual tablets and buprenorphine/naloxone (Suboxone) sublingual film, start on the same dosage as the previously administered product. However, dosage adjustments may be necessary when switching between products because of the potentially greater relative bioavailability of sublingual film compared to sublingual tablet. Patients switching from sublingual film to sublingual tablet should be monitored for withdrawal or other indications of under-dosing.1-3 When switching between buprenorphine/naloxone sublingual tablet/film and Bunavail buccal film or Zubsolv sublingual tablets, the difference in bioavailability of Bunavail and Zubsolv compared to buprenorphine/naloxone sublingual tablet requires a different dosage strength to be administered to the patient.4,5

Efficacy

Buprenorphine is a partial opioid agonist and mixed opioid agonist-antagonist. As a partial mu-receptor agonist, buprenorphine exhibits a ceiling to its pharmacological effects; thus, the danger of overdose, abuse liability, and toxicity from buprenorphine may be less than with full opioid agonists. Naloxone is a full opiate antagonist. Since buprenorphine may be given outside of an opiate-treatment clinic, a formulation with naloxone (Suboxone, at a ratio of 4:1 buprenorphine: naloxone) was developed in an effort to decrease the potential for abuse of the combination product via the injection route. In this formulation, the naloxone component produces no clinical effect when administered sublingually; however, when dissolved in water and injected, the full opiate antagonist effect of naloxone occurs and will induce withdrawal symptoms. As a result, the buprenorphine with naloxone combination product is preferred for maintenance therapy in patients with unsupervised drug administration.6-8

Clinical practice guidelines indicate goals of the initial medical assessment of a patient who is addicted to opioids are to:6-8

  • Establish the diagnosis or diagnoses
  • Determine appropriateness for treatment
  • Make initial treatment recommendations
  • Formulate an initial treatment plan
  • Plan for engagement in psychosocial treatment
  • Ensure that there are no contraindications to the recommended treatments
  • Assess other medical problems or conditions that need to be addressed during early treatment
  • Assess other psychiatric or psychosocial problems that need to be addressed during early treatment

A careful evaluation of current and past use of alcohol and drugs, including nonmedical use of prescription medications, is required to diagnose opioid use disorder. Because opioid use disorder may co-occur with other use disorders, the evaluator should assess frequency and quantity of use. Prescription Drug Monitoring Programs (PDMPs) offer information about prescription opioid use. They can serve as important resources for clinicians’ use in completing full patient clinical assessments of opiate and other controlled substance use history, and it is recommended that they be utilized. Concurrent use of other drugs or active engagement in other addictive behaviors should lead to consideration of other treatment plan components for the patient. Psychosocial treatment should be implemented in conjunction with the use of buprenorphine in the treatment of opioid use disorder. Urine drug testing, or other reliable biological tests for the presence of drugs, during the initial evaluation and frequently throughout treatment, is highly recommended.6-8

Periodic assessment is necessary to determine compliance with the dosing regimen, effectiveness of the treatment plan, and overall patient progress. Once a stable dosage has been achieved and patient assessment (e.g., urine drug screening) does not indicate illicit drug use, less frequent followup visits may be appropriate. 1-5

There is no recommended time limit for treatment with buprenorphine. Providers and their patients should base decisions about discontinuing OUD medication on knowledge of the evidence base for the use of these medications, individualized assessments, and an individualized treatment plan they collaboratively develop and agree upon.8 Buprenorphine taper and discontinuation is a slow process and close monitoring is recommended. Buprenorphine tapering is generally accomplished over several months and patients should be encouraged to remain in treatment for ongoing monitoring past the point of discontinuation.7

The Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction issued by the US Dept of Health and Human Services recommends the following:

“The consensus panel recommends that the buprenorphine/naloxone combination be used for induction treatment (and for stabilization and maintenance) for most patients. However, pregnant women who are determined to be appropriate candidates for buprenorphine treatment should be inducted and maintained on buprenorphine monotherapy. In addition, patients who desire to change from long-acting opioids (e.g., methadone) to buprenorphine should be inducted using buprenorphine monotherapy. Patients and their physicians together need to reach agreement on the goals of treatment and develop a treatment plan based on the patient’s particular problems and needs. During the stabilization phase, patients receiving maintenance treatment should be seen on at least a weekly basis. Once a stable buprenorphine dose is reached and toxicologic samples are free of illicit opioids, the physician may determine that less frequent visits (biweekly or longer, up to 30 days) are acceptable. During opioid addiction treatment with buprenorphine, toxicology tests for relevant illicit drugs should be administered at least monthly."6

The American Society of Addiction Medicine National Practice Guideline For the Use of Medications in the Treatment of Addiction Involving Opioid Use recommends the following:7

  • Buprenorphine mono-product is a reasonable and recommended alternative to methadone for pregnant women.
  • Methadone is recommended for patients who may benefit from daily dosing and supervision in an opioid treatment program (OTP), or for patients for whom buprenorphine for the treatment of opioid use disorder has been used unsuccessfully in an OTP or office based opioid treatment (OBOT) setting.

The occurrence of acute and chronic pain among patients with an opioid use disorder is not uncommon. Temporarily increasing buprenorphine dosing or dividing the dose may be effective for acute pain management. Patients’ pain may not be adequately addressed with buprenorphine and may require a full opioid agonist. In situations when a full opioid agonist is needed for pain control, patients may be taken off buprenorphine and switched to a full opioid agonist until analgesia is no longer necessary, such as elective surgery. However, there are data to suggest that the discontinuation of buprenorphine is unnecessary and that adequate analgesia may be possible by simply adding non-narcotic and narcotic analgesics to the patient’s baseline buprenorphine dose.6-7

Continuation or modification of pharmacotherapy should be based on the physician’s evaluation of treatment outcomes and objectives such as:1-5

  1. Absence of medication toxicity
  2. Absence of medical or behavioral adverse effects
  3. Responsible handling of medications by the patient
  4. Patient’s compliance with all elements of the treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities)
  5. Abstinence from illicit drug use (including problematic alcohol and/or benzodiazepine use)

If treatment goals are not being achieved, the physician should re-evaluate the appropriateness of continuing the current treatment.1-5

Safety1-5

Buprenorphine-containing products are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported.

REFERENCES

  1. Buprenorphine prescribing information. Hikma Pharmaceuticals USA Inc. July 2020.
  2. Buprenorphine/naloxone tablet prescribing information. Amneal Pharmaceuticals LLC. December 2019.
  3. Suboxone sublingual film prescribing information. Indivor Inc. October 2019.
  4. Zubsolv prescribing information. Orexo US, Inc. October 2019.
  5. Bunavail buccal film prescribing information. BioDelivery Sciences International. June 2020.
  6. 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, 2004. Available at: http://www.naabt.org/documents/TIP40.pdf. Accessed January 2021.
  7. National Practice Guideline For the Use of Medications in the Treatment of Addiction Involving Opioid Use. The American Society of Addiction Medicine. Available at: http://www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-national-practice-guideline-supplement.pdf?sfvrsn=24. Accessed January 2021.
  8. Substance Abuse and Mental Health Services Administration. Medications for Opioid Use Disorder. Treatment Improvement Protocol (TIP) Series 63, Full Document. HHS Publication No. (SMA) 19-5063FULLDOC. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2018.
  9. Statutes, Regulations, and Guidelines. U.S. Department of Health & Human Services. Substance Abuse and Mental Health Services Administration. Available at: https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines. Accessed January 2021.
  10. Johnson RE, Chutuape MA, Strain EC, et al. A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000;343:1290-1297.
  11. Fudala PJ, Bridge T, Herbert S, et al. Office-Based Treatment of Opiate Addiction with a Sublingual-Tablet Formulation of Buprenorphine and Naloxone. N Engl J Med. 2003;349(10):949-958.
  12. Gowing L, Ali R, White J. Buprenorphine for the management of opioid withdrawal. Cochrane Database of Syst Rev 2009;July 8;(3)CD002025.
  13. Fareed et al. Treatment Outcome for Flexible Dosing Buprenorphine during Maintenance Treatment. Am. J. Drug Alcohol Abuse. 2012 Mar;38(2):155-160.
  14. Strain, E, MD. Pharmacotherapy for Opioid Use Disorder. UpToDate, Post, TW (Ed), UpToDate, Waltham. Last updated August 2020. Literature review current through December 2020. Accessed January 2021.
  15. HHS Releases New Buprenorphine Practice Guidelines, Expanding Access to Treatment for Opioid Use Disorder. U.S. Department of Health & Human Services. Available at: https://www.hhs.gov/about/news/2021/04/27/hhs-releases-new-buprenorphine-practice-guidelines-expanding-access-to-treatment-for-opioid-use-disorder.html Accessed May 2021.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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