Clinical Policy: Opioid Analgesics Form

Page 1 of 9 Clinical Policy: Opioid Analgesics* Reference Number: CP.PMN.97 Effective Date: 02.01.11

Last Review Date: 05.26 Line of Business: Medicaid Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description
Opioid analgesics exert their analgesic effect through opiate receptors distributed in tissues throughout the body.

All opioid analgesic therapies (both preferred and non-preferred agents) that do not abide with the short term therapy criteria (I.A) will require prior authorization.

FDA Approved Indication(s) Opioid analgesics are indicated for the management and treatment of moderate to severe pain.

6. Total opioid dose does NOT exceed 90 morphine milligram equivalents (MME) per day.

   B. Cancer, Sickle Cell Disease, or Palliative Care (must meet all):

7. 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);

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2. Member meets one of the following (a, b, or c):
   a. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); b. Request is for a preferred drug; c. Member has failed two or more preferred drugs, unless clinically significant adverse effects are experienced or all are contraindicated;
3. Member meets one of the following (a or b):
   a. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); b. If request is for an ADF, member must use a generic non-ADF of the same active ingredient as the requested opioid;

4. If request is for Oxycontin®, age ≥ 11 years AND one of the following (a or b):
   a. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); b. Member has failed two other preferred long acting opioids, unless clinically significant adverse effects are experienced or all are contraindicated; Long acting opioid therapy may require prior authorization.

   a. One or more prescriptions totaling 90 MME or more per day; b. Is concurrently obtaining an opioid and a benzodiazepine, and document within the patient record the action taken. Approval duration: 12 months

   C. Members Transitioning from Short Term Therapy to Long Term Therapy (defined as a claims history of > 28-day supply of opioid within a 90 day period or request for an extended release opioid) (must meet all):

5. Previously received short term opioid therapy via Centene benefit;
6. Prescribed for the treatment of pain unrelated to active cancer, sickle cell disease or palliative care;
7. Member meets one of the following (a or b):
   a. Failure of at least 2 non-opioid ancillary treatments (e.g., non-steroidal anti- inflammatory drugs [NSAIDs], acetaminophen, anticonvulsants, antidepressants), unless clinically significant adverse effect are experienced or all are contraindicated; b. Member has received a total of 90 cumulative days of opioid therapy in the last 120 days;
8. One of the following (a or b):
   a. Request is for a preferred drug;

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Opioid Analgesics Page 3 of 9 b. Member has failed two or more preferred drugs, unless clinically significant adverse effects are experienced or all are contraindicated;

5. If request is for an extended release agent, documented failure of an immediate release opioid;
6. If request is for an ADF, member must use a generic non-ADF of the same active ingredient as the requested opioid;
7. If request is for Oxycontin, both of the following (a and b):
   a. Age ≥ 11 year; b. Member has failed two other preferred long acting opioids, unless clinically significant adverse effects are experienced or all are contraindicated; Long acting opioid therapy may require prior authorization.

8. Member will be maintained on no more than 2 opioid analgesics concurrently;
   *If member requires therapy with two opioid analgesics, regimen must consist of one immediate- release and one extended-release analgesic.

   Approval duration: 3 months

   D. Other diagnoses/indications – Not applicable

   II. Continued Therapy A. Cancer, Sickle Cell Disease, or Palliative Care (must meet all):

9. Currently receiving therapy for pain associated with cancer, sickle cell disease, or palliative care;
10. If request is for an ADF, member must use a generic non-ADF of the same active ingredient as the requested opioid;
11. If request is for Oxycontin, both of the following (a and b):

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Opioid Analgesics Page 4 of 9 a. Age ≥ 11 year; b. Member has failed two other preferred long acting opioids, unless clinically significant adverse effects are experienced or all are contraindicated; Long acting opioid therapy may require prior authorization

Approval duration: 3 months

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C. Other diagnoses/indications – Not applicable

III. Diagnoses/Indications for which coverage is NOT authorized: Not applicable

IV. Appendices/General Information Appendix A: Abbreviation Key ADF: abuse-deterrent formulation FDA: Food and Drug Administration MME: morphine milligram equivalents NSAID: non-steroidal anti-inflammatory drug PDL: preferred drug list
PDMP: prescription drug monitoring program

Appendix B: Therapeutic Alternatives Not applicable

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. • Boxed warning(s): potential for addiction, abuse, and misuse; 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) MME Conversion Factor Codeine (mg) 0.15 Dihydrocodeine (mg) 0.25 Fentanyl buccal or SL tablets, or lozenge/troche (mcg) 0.13 Fentanyl film or oral spray (mcg) 0.18 Fentanyl nasal spray (mcg) 0.16 Fentanyl patch (mcg) 7.2 Hydrocodone (mg) 1 Hydromorphone (mg) 4 Levorphanol tartrate (mg) 11 Meperidine hydrochloride (mg) 0.1 Methadone (mg)

0, ≤ 20 4 20, ≤ 40 8 40, ≤ 60 10 60 12 Morphine (mg) 1 Opium (mg) 1

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Opioid Analgesics Page 6 of 9 Opioid Oral MME Conversion Factors Oxycodone (mg) 1.5 Oxymorphone (mg) 3 Pentazocine (mg) 0.37 Tapentadol (mg) 0.4 Tramadol (mg) 0.1

Appendix E: States with Regulations against Redirections in Cancer State Step Therapy Prohibited? Notes

FL Yes For stage 4 metastatic cancer and associated conditions GA Yes For stage 4 metastatic cancer. Redirection does not refer to review of medical necessity or clinical appropriateness IA Yes For standard of care stage 4 cancer drug use, supported by peer- reviewed, evidence-based literature, and approved by FDA IN Yes For advanced, metastatic cancer and associated conditions LA Yes≠ For stage 4 advanced, metastatic cancer or associated conditions. ≠Exception if clinically equivalent therapy, contains identical active ingredient(s), and proven to have same efficacy MS Yes For advanced metastatic cancer and associated conditions NV Yes Stage 3 and stage 4 cancer patients for a prescription drug to treat the cancer or any symptom thereof of the covered person OH Yes For stage 4 metastatic cancer and associated conditions OK Yes For advanced metastatic cancer and associated conditions PA Yes For stage 4 advanced, metastatic cancer TN Yes^ For advanced metastatic cancer, metastatic blood cancer, and associated conditions ^ Exception if step therapy is for AB-rated generic equivalent, interchangeable biologic product, or biosimilar product to the equivalent brand drug TX Yes For stage 4 advanced, metastatic cancer and associated conditions

V. Dosage and Administration Please refer to the package insert of the requested drug for information on appropriate dosage and administration.

VI. Product Availability Please refer to the package insert of the requested drug for product availability information.

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2. 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 2015 Sep-Oct; 9(5):358-67.
3. State of Hawaii Dept of Human Services. QI-1926 Support Act Med-QUEST Division Minimum Standards Effective October 1, 2019. Available at: https://medquest.hawaii.gov/en/plans-providers/provider-memo.html. Accessed January 30,
5. State of Hawaii Dept of Human Services. QI-2148 Support Act Med-QUEST Division Minimum Standards Effective October 1, 2019 (Replaces QI-1926). State https://medquest.hawaii.gov/content/dam/formsanddocuments/provider-memos/qi-memos/qi- memos-2021/QI-2148%20Replaces%20QI- 1926%20Support%20ACT%20MQD%20Minimum%20Standards%20Eff%2010.1.2019%20- %20signed.pdf. Accessed January 30, 2025.
6. State of New Jersey Dept of Law and Public Safety Division of Consumer Affairs. Naloxone prescribing by health care practitioners – DCA Administrative Order No. 2020-08. Available at: https://www.njconsumeraffairs.gov/Documen6s/Naloxone%20rule%20adoption.pdf. Accessed January 30, 2026.

7. Dowell D, Ragan KR, Jones CM, Baldwin GT, and Chou R. CDC clinical practice guideline for prescribing opioids for pain – United States, 2022. MMWR Recomm Rep 2022;71(No. RR-3):1-95.

   Reviews, Revisions, and Approvals Date P&T Approval Date 1Q 2022 annual review: no significant changes; changed “Medical justification” language to “Member must use”; references reviewed and updated. 11.23.21 02.22 1Q 2023 annual review: no significant changes; references reviewed and updated.
   11.08.22 02.23 Wellcare New Jersey and Hawaii Medicaid policy (WCG.CP.PMN.97) retired and combined by adding the following:
   NJ specific naloxone requirement for the duration of the COVID-19 State of Emergency or the Public Health Emergency, added NJ specific request must be for ≤ 5 day supply to short term therapy criteria and for HI requests only total daily opioid dose is not more than 120 MME for members transition from short term therapy to long term therapy.
   02.15.23 05.23 2Q 2024 annual review: for NJ, removed the statement “for the duration of the COVID-19 State of Emergency or the Public Health Emergency” as the requirement to provide a prescription for an opioid antidote is independent of the PHE and an ongoing regulation in the state; references reviewed and updated.
   01.19.24 05.24 Added by-passing of redirection if state regulations do not allow step therapy in certain oncology settings along with Appendix E.
   06.05.24

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Opioid Analgesics Page 8 of 9 Reviews, Revisions, and Approvals Date P&T Approval Date 2Q 2025 annual review: no significant changes; references reviewed and updated.
01.09.25 05.25 2Q 2026 annual review: removed disclaimers directing to CP.PMN.127 for fentanyl IR products due to policy retirement; updated Appendix D with revised language and exception for Tennessee; references reviewed and updated. Updated Appendix D to include Indiana. 03.26.26 05.26