SUBUTEX, Buprenorphine HCl Form

Buprenorphine (Subutex®) is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. FDA Approved Indication(s) Subutex is indicated for the treatment of opioid dependence and is preferred for induction. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that buprenorphine is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Opioid Dependence (must meet all):

1. Diagnosis of opioid dependence;

2. Member meets one of the following conditions (a, b, or c): a. Member is pregnant; b. Member has experienced clinically significant adverse effects or contraindication(s) to buprenorphine/naloxone (e.g., Suboxone®); c. Request is for induction therapy (treatment duration of ≤ 5 days);

   3. Dose does not exceed both of the following (a and b):
      a. 24 mg per day;
      b. 3 tablets per day. Approval duration:
      Induction therapy: 5 days
      Maintenance therapy: Duration of request or 12 months, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
   4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 7

   CLINICAL POLICY Buprenorphine b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Opioid Dependence Induction Therapy
   3. Re-authorization for continuation of treatment beyond initial induction therapy is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable B. Opioid Dependence Maintenance Therapy (must meet all):
   4. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B;Note: Subutex will not be renewed for pregnancy unless there is documentation supporting that member is pregnant again.
   5. Member is responding positively to therapy;

3. One of the following conditions is met (a or b):
   a. Member has NOT received an opioid analgesic since last approval; b. Prescriber submits documentation acknowledging that the use of opioid during the last approval period was due to a diagnosis of acute pain;

   4. If request is for a dose increase, new dose does not exceed both of the following (a and b):
      a. 24 mg per day;
      b. 3 tablets per day. Approval duration: Duration of request or 12 months, whichever is less C. Other diagnoses/indications (must meet 1 or 2):
   5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 2 of 7

   CLINICAL POLICY Buprenorphine CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents; B. Pain management.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
      This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
      Dosing Regimen Drug Name Dose Limit/ Maximum Dose 24 mg/6 mg per day buprenorphine/ naloxone (Suboxone®) Opiate agonist dependence • DAY 1 DOSING: First induction dose buprenorphine; naloxone 2 mg/0.5 mg or 4 mg/1 mg SL film; may titrate in 2 or 4 mg increments of buprenorphine, at approximately 2-hour increments, under supervision, up to a total dose of buprenorphine/naloxone 8 mg/2 mg SL film.
      • DAY 2 DOSING: A single daily dose of buprenorphine; naloxone up to 16 mg/4 mg SL film is recommended.
      • DAY 3 DOSING AND BEYOND: Progressively adjust dose in increments or decrements of 2 mg/0.5 mg or 4 mg/1 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Page 3 of 7

   CLINICAL POLICY Buprenorphine Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of hypersensitivity to buprenorphine • Boxed warning(s): none reported V. Dosage and Administration
   Indication Opioid dependence Maximum Dose 24 mg per day Dosing Regimen Induction Adults: 8 mg sublingually (SL) on Day 1 and 16 mg SL on Day 2; then the patient should start maintenance treatment. Maintenance The maintenance dose is generally in the range of 4 mg to 24 mg buprenorphine per day depending on the individual patient. The recommended target dose is 16 mg. Doses higher than 24 mg have not been demonstrated to provide any clinical advantage. The dosage of buprenorphine should be progressively adjusted in increments/decrements of 2 mg or 4 mg buprenorphine to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. VI. Product Availability
   Sublingual tablets: 2 mg, 8 mg
   VII.