BUTORPHANOL TARTRATE, Butorphanol Tartrate Form

Butorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series.
FDA Approved Indication(s) Butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitation(s) of use: Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve butorphanol tartrate nasal spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics)
• Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia. 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 butorphanol nasal spray is medically necessary when the following criteria are met:
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. Pain Management (must meet all):

1. Prescribed for the management of pain;
   
   2. Age ≥ 18 years;
   3. Failure of at least 2 non-opioid ancillary treatments (such as non-steroidal anti- inflammatory drugs (NSAIDs) or acetaminophen-containing products (see Appendix B for examples), unless contraindicated or clinically significant adverse effect are experienced;

2. For pain related to migraine headache: failure of at least 2 anti-migraine agents (see Appendix B for examples), unless contraindicated or clinically significant adverse effect are experienced;
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   Butorphanol Nasal Spray

3. For chronic pain: failure of an antidepressant or anticonvulsant agent (see Appendix B for examples), unless contraindicated or clinically significant adverse effect are experienced;
4. Member is unable to use oral medications for pain relief. Approval duration: 12 months
   B. 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: HIM.PA.33 for health insurance marketplace; 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: HIM.PA.103 for health insurance marketplace; or
6. 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: HIM.PA.154 for health insurance marketplace. 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. Pain Management (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. Member is responding positively to therapy. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

8. 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: HIM.PA.33 for health insurance marketplace; 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: HIM.PA.103 for health insurance marketplace; or Page 2 of 6

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   Butorphanol Nasal Spray

9. 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: HIM.PA.154 for health insurance marketplace. 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 policy – HIM.PA.154 or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation Key FDA: Food and Drug Administration NSAID: non-steroidal anti-inflammatory disease REMS: Risk Evaluation and Mitigation Strategy 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 formulary agents and may require prior authorization.
   Drug Class Commonly Used Examples Dose Limit/ Maximum Dose Varies according to the agent used Varies according to the agent used Varies according to the agent used Varies according to the agent used Varies according to the agent used Varies according to the agent used NSAIDs Non-opioid analgesics Anti-migraine agents (non- triptans) Anti-migraine agents (triptans) Anticonvulsants Antidepressants/ tricyclic antidepressants ibuprofen (Motrin®), naproxen (Naprosyn®), Relafen® (nabumetone), Voltaren® (diclofenac), Orudis® (ketoprofen), Clinoril® (sulindac), Toradol® (ketorolac) aspirin, acetaminophen opioid combinations (APAP/codeine, APAP hydrocodone) Cafergot® (ergotamine/caffeine), D.H.E.- 45® (dihydroergotamine), Midrin® (isometheptene/APAP), Fiorinal® (butalbital/aspirin), Fioricet® (butalbital/APAP) almotriptan (Axert®), eletriptan (Relpax®), frovatriptan (Frova®), naratriptan (Amerge®), rizatriptan (Maxalt®), sumatriptan (Imitrex®), zolmitriptan (Zomig®)
   Carbamazepine (Tegretol®), gabapentin (Neurontin®), divalproex (Depakote®), topiramate (Topamax®) amitriptyline (Elavil®), desipramine (Norpramin®), imipramine (Tofranil®), Page 3 of 6

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   Butorphanol Nasal Spray Drug Class Commonly Used Examples Dose Limit/ Maximum Dose nortriptyline (Pamelor®), duloxetine (Cymbalta®), venlafaxine (Effexor®) 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. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; hypersensitivity to butorphanol tartrate, the preservative benzethonium chloride, or any of the formulation excipients (e.g., anaphylaxis). • Boxed warning(s): risks of addiction, abuse, and misuse; opioid analgesic Risk Evaluation and Mitigation Strategy (REMS); life-threatening respiratory depression; accidental exposure; neonatal opioid withdrawal syndrome; cytochrome P450 3A4 interactions; concomitant use with benzodiazepines or other central nervous system depressants. V. Dosage and Administration
   Indication Dosing Regimen Pain 1 mg (1 spray in one nostril) Maximum Dose Not applicable If adequate pain relief is not achieved within 60 to 90 minutes, an additional 1 mg dose may be given. This initial dose sequence may be repeated in 3 to 4 hours as required after the second dose of the sequence. Depending on the severity of the pain, an initial dose of 2 mg (1 spray in each nostril) may be used in patients who will be able to remain recumbent in the event drowsiness or dizziness occurs. In such patients single additional 2 mg doses should not be given for 3 to 4 hours. VI. Product Availability
   Nasal spray solution bottle: 2.5 mL (10 mg/mL)
   VII.