Opioid Analgesics, Form

Opioid analgesics exert their analgesic effect through opiate receptors distributed in tissues throughout the body.
This policy applies to all formulary long and short acting opioids requiring prior authorization (PA) or any non-formulary opioid request. FDA Approved Indication(s) Opioid analgesics are indicated for the management and treatment of moderate to severe pain. Policy/Criteria Provider must submit documentation (including such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
I. Initial Approval Criteria
Please note: For HIM-Arkansas – if a member's covered prescription pain medication requires a prior authorization, then the prior authorization shall not be denied if the member has a terminal illness. A. Cancer, Sickle Cell Disease, or Palliative Care (must meet all): *Requests for transmucosal immediate-release fentanyl products (TIRFs) should be evaluated using the Fentanyl IR (Abstral, Actiq, Fentora, Lazanda, Subsys) policy – CP.PMN.127.

1. Prescribed for pain associated with one of the following (a, b, or c):
   a. Cancer;
   b. Sickle cell disease;
   c. Palliative care (hospice or any terminal condition);

   2. Member has failed an adequate trial of two formulary short-acting opioid analgesics that does not require PA, dosed around the clock, unless clinically significant adverse effects are experienced, or all are contraindicated; Approval duration: 12 months B. Short-Acting Agents – Requests for ≤ a 14-day Supply (must meet all):
   3. Prescribed for the treatment of pain unrelated to cancer, palliative care, or sickle cell disease; Page 1 of 9

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   Opioids Analgesics

   2. Member has failed an adequate trial of two formulary short-acting opioids analgesics that does not require PA, dosed around the clock, unless clinically significant adverse effects are experienced, or all are contraindicated;
   3. For OHIO requests ONLY: Total opioid dose does not exceed 80 MME per day or for members who are stable (history of > 7 days of therapy) on doses higher than 80 MME per day, one of the following is met (a or b): a. Provider will initiate a dose taper; *Future approval will require decrease from current dose. b. Documentation that a dose taper has been attempted within the past 6 months, with the reasons for taper failure;
   4. For OHIO requests ONLY: If opioid is being prescribed concomitantly with a benzodiazepine, member meets both of the following (a and b): a. Documentation that the provider has acknowledged combined use of opioid medication and benzodiazepine; b. Prescribed for short term (< 3 months) use or provider will discontinue concurrent use of benzodiazepine and opioid therapy within a 3-month period. *Re-authorization request for concurrent use of opioid and benzodiazepine will not be approved. Approval duration: 14 days
      C. Long-Acting Agents OR Requests Exceeding a 14-day Supply Within 28 Days OR Requests Exceeding a 28-day Supply Within 90 Days (must meet all):

2. Prescribed for the treatment of pain unrelated to cancer, palliative care or sickle cell disease;

   2. Member meets ALL of the following (a, b, and c), unless clinically significant adverse effects are experienced, or all are contraindicated:
      a. Failure ≥ 2 non-opioid ancillary treatments (e.g., non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen, anticonvulsants, antidepressants); b. For short-acting agent requests, one of the following (i or ii):
      i. Prescribed agent is a formulary short-acting agent that does not require PA; ii. Failure of an adequate trial of two formulary short-acting opioids analgesics, dosed around the clock; c. For long-acting agent requests, both of the following (i and ii):
      i. Except Louisiana ONLY, failure of an adequate trial of two short-acting opioids analgesics, dosed around the clock;
      ii. Failure of an adequate trial of two formulary long-acting agents;
      For Louisiana, if request is for an abuse deterrent formulation, substitution shall not be made to an extended-release medication that does not have defined abuse deterrent properties.
   3. For OHIO requests ONLY: Total opioid dose does not exceed 80 MME per day or for members who are stable (history of > 7 days of therapy) on doses higher than 80 MME per day, one of the following is met (a or b): a. Provider will initiate a dose taper; *Future approval will require decrease from current dose. b. Documentation that a dose taper has been attempted within the past 6 months, with the reasons for taper failure; Page 2 of 9

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   4. For OHIO requests ONLY: If opioid is being prescribed concomitantly with a benzodiazepine, member meets both of the following (a and b): a. Documentation that the provider has acknowledged combined use of opioid medication and benzodiazepine; b. Prescribed for short term (< 3 months) use or provider will discontinue concurrent use of benzodiazepine and opioid therapy within a 3-month period. Approval duration:
      Short-acting agents – 3 months or duration of request (whichever is less) Long-acting agents – 12 months D. Diabetic Peripheral Neuropathy (must meet all):
   5. Request is for Nucynta ER;
3. Diagnosis of diabetic peripheral neuropathy;
4. Age ≥ 18 years;
5. Failure of gabapentin at ≥ 1,800 mg/day, unless contraindicated or clinically significant adverse effects are experienced;
   5. Failure of a formulary tricyclic antidepressant (TCA) (e.g., amitriptyline, nortriptyline, imipramine) at up to maximally indicated doses, unless clinically significant adverse effects are experienced, or all are contraindicated;
   6. Failure of a formulary serotonin-norepinephrine reuptake inhibitor (SNRI) (e.g., duloxetine, venlafaxine) at up to maximally indicated doses, unless clinically significant adverse effects are experienced, or all are contraindicated;
   7. Dose does not exceed 500 mg per day. Approval duration: 6 months or duration of request (whichever is less) E. Other diagnoses/indications – Not applicable
      II. Continued Therapy Please note: For HIM-Arkansas – if a member's covered prescription pain medication requires a prior authorization, then the prior authorization shall not be denied if the member has a terminal illness. A. Cancer, Sickle Cell Disease, Palliative Care (must meet all):
      *Requests for transmucosal immediate-release fentanyl products (TIRFs) should be evaluated using the Fentanyl IR (Abstral, Actiq, Fentora, Lazanda, Subsys) policy – CP.PMN.127.

6. Currently receiving prescribed agent via Centene benefit for cancer, sickle cell disease, and palliative care or have previously met initial approval criteria; Approval duration: 12 months Page 3 of 9

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   Opioids Analgesics B. Short-Acting Agents – Requests for ≤ a 14-day Supply (must meet all):

   1. 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);
   2. For OHIO requests ONLY: Total opioid dose does NOT exceed 80 MME/day or if the current dose is higher than 80 MME/day, one of the following is met (a, b or c): a. Dose reduction has occurred since previous approval; b. A dose taper has been attempted within the past 6 months and was not successful;
      *Reason(s) for taper failure must be provided c. Prescribed by or in consultation with a pain management specialist;
   3. For OHIO requests ONLY: If the requested dose is for > 80 MME/day, an increase in dose has not occurred since previous approval;
   4. For OHIO requests ONLY: If opioid is being prescribed concomitantly with a benzodiazepine, member meets all of the following (a, b, and c): a. Currently receiving concurrent opioid and benzodiazepine therapy via Centene benefit or member has previously met the initial approval criteria;
      b. Documentation supports that discontinuation of combination opioid and benzodiazepine therapy has been attempted in the last 3 months without success;
      c. Prescribed by or in consultation with a pain management specialist. Approval Duration: 14 days C. Long-Acting Agents OR Requests Exceeding a 14-day Supply Within 28 Days OR
      28-day Supply Within 90 Days (must meet all):

7. 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);

   2. Has received more than a 14-day supply of opioid within 28 days or a 28-day supply within 90 days; *If member does not meet this requirement, please use the initial approval criteria to review this request
   3. Member continues to need opioid analgesics as evidenced by, including but not limited to any of the following:
      a. Provider submits medical justification;
      b. Documentation of recent (within the last 6 months) office visit or office chart notes demonstrating follow-up with the member;
      c. Attestation that provider has reviewed the treatment plan with the member and assessed the risks and benefits of opioid dose and duration;
   4. For OHIO requests ONLY: Total opioid dose does NOT exceed 80 MME/day or if the current dose is higher than 80 MME/day, one of the following is met (a, b, or c): a. Dose reduction has occurred since previous approval; Page 4 of 9

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   Opioids Analgesics b. A dose taper has been attempted within the past 6 months and was not successful;
   *Reason(s) for taper failure must be provided c. Prescribed by or in consultation with a pain management specialist;

   5. For OHIO requests ONLY: If the requested dose is for > 80 MME/day, an increase in dose has not occurred since previous approval;
   6. For OHIO requests ONLY: If opioid is being prescribed concomitantly with a benzodiazepine, member meets all of the following (a, b, and c): a. Currently receiving concurrent opioid and benzodiazepine therapy via Centene benefit or member has previously met the initial approval criteria;
      b. Documentation supports that discontinuation of combination opioid and benzodiazepine therapy has been attempted in the last 3 months without success;
      c. Prescribed by or in consultation with a pain management specialist. Approval duration:
      Short-acting agents – 3 months or duration of request (whichever is less) Long-acting agents – 12 months D. Diabetic Peripheral Neuropathy (must meet all):
   7. Request is for Nucynta ER;

8. Currently receiving Nucynta ER for the diagnosis of diabetic peripheral neuropathy or member has met initial approval criteria;

   3. Member continues to need Nucynta ER as evidenced by, including but not limited to any of the following:
      a. Provider submits medical justification;
      b. Documentation of recent (within the last 6 months) office visit or office chart notes demonstrating follow-up with the member;
      c. Attestation that provider has reviewed the treatment plan with the member and assessed the risks and benefits of Nucynta ER;
   4. If request is for a dose increase, new dose does not exceed 500 mg per day. Approval duration: 6 months or duration of request (whichever is less) E. Other diagnoses/indications – Not applicable III. Diagnoses/Indications for which coverage is NOT authorized – Not applicable IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration MME: morphine milligram equivalents NSAID: non-steroidal anti-inflammatory drug PA: prior authorization Appendix B: Therapeutic Alternatives Not applicable REMS: Risk Evaluation and Mitigation Strategy SNRI: serotonin-norepinephrine reuptake inhibitor TIRF: transmucosal immediate-release fentanyl TCA: tricyclic antidepressant Page 5 of 9

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   Opioids Analgesics Appendix C: Contraindications/Boxed Warnings • Contraindication(s): significant respiratory depression; acute or severe bronchial asthma; gastrointestinal obstruction, including paralytic ileus; hypersensitivity to the opioid active ingredient, salts, or any component of the product; concurrent use of monoamine oxidase inhibitors or use of these within the last 14 days (Nucynta ER only). • Boxed warning(s): potential for addiction, abuse, and misuse; Risk Evaluation and Mitigation Strategy (REMS); life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; cytochrome P450 3A4 interactions; risks from concomitant use with benzodiazepines or other CNS depressants. Appendix D: General Information Opioid Oral MME Conversion Factors Type of Opioid (strength units) Codeine (mg) Dihydrocodeine (mg) Fentanyl buccal or SL tablets, or lozenge/troche (mcg) Fentanyl film or oral spray (mcg) Fentanyl nasal spray (mcg) Fentanyl patch (mcg) Hydrocodone (mg) Hydromorphone (mg) Levorphanol tartrate (mg) Meperidine hydrochloride (mg) Methadone (mg)

   0, ≤ 20 20, ≤ 40 40, ≤ 60 60 Morphine (mg) Opium (mg) Oxycodone (mg) Oxymorphone (mg) Pentazocine (mg) Tapentadol (mg) Tramadol (mg) MME Conversion Factor 0.15 0.25 0.13 0.18 0.16 7.2 1 4 11 0.1 4 8 10 12 1 1 1.5 3 0.37 0.4 0.1 V. Dosage and Administration There are numerous opioid analgesics, please refer to the package insert of your drug of interest for information on appropriate dosage and administration. Page 6 of 9

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   Opioids Analgesics VI. Product Availability There are numerous opioid analgesics, please refer to the package insert of your drug of interest for product availability information. VII.