ModifiedCentenePolicy HIM.PA.46

Butorphanol Nasal Spray

Covers medical necessity and prior authorization criteria for butorphanol tartrate nasal spray for management of severe pain when alternatives are inadequate; applies to members under Centene-affiliated health plans (HIM line of business).

Policy Summary

PayerCentene

PolicyButorphanol Nasal Spray

Policy CodePolicy HIM.PA.46

Change TypeStep therapy bypass addedHCPCS code added

Effective Date12.01.14

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation to demonstrate the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added option to bypass redirection if prescribed by or in consultation with a pain management specialist or an oncologist; added bypass for use in palliative care or hospice care.

12 monthsapproval duration

2.5 mLproduct availability

S0012HCPCS added

HIM.PA.33, HIM.PA.103, HIM.PA.154related policies

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met:

Initial Pain Management Criteria: 1) Patient is ≥18 years of age; 2) Prescribed for management of pain requiring an opioid analgesic when alternatives are inadequate; 3) One of the following: (a) treatment associated with cancer or use in palliative/hospice care OR (b) prescribed by or in consultation with a pain management specialist or an oncologist OR (c) failure of at least 2 non-opioid/ancillary treatments (e.g., NSAIDs, acetaminophen) unless contraindicated; 4) For migraine-related pain: failure of at least 2 anti-migraine agents unless contraindicated; 5) For chronic pain: failure of an antidepressant or anticonvulsant agent unless contraindicated; 6) Patient is unable to use oral medications for relief.

Approval duration: 12 months

Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy Criteria: 1) Member is currently receiving medication via a Centene benefit or has previously met the initial approval criteria or is enrolled in continuity-of-care per applicable state/product regulations; 2) Member is responding positively to therapy.

Approval duration: 12 months

Non‑FDA approved indications that are not specifically addressed in this clinical policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the off‑label use policy HIM.PA.154 or the member's evidence of coverage documents. Documentation should support clinical rationale for use in the off‑label indication.

Coverage determinations and benefit administration are governed by the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance) and by applicable state and federal laws and Health Plan administrative policies and procedures. This clinical policy is guidance and does not guarantee payment, alter coverage terms, or substitute for provider clinical judgment; providers remain responsible for diagnosis and treatment decisions.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Butorphanol nasal spray is medically necessary only when all approval criteria are met. Providers must obtain prior authorization before dispensing.

Policy: HIM.PA.46
Approval duration: 12 months

Documentation Required

Documentation Requirement

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Failure to provide requested documentation may result in denial or delay of the request.

Examples of acceptable documentation: progress notes, medication trial history, specialist consultation notes, diagnostic test results

Step Therapy

Step Therapy Requirements and State Exceptions

Step therapy is required: members must have failed specified prior therapies before butorphanol nasal spray will be authorized unless contraindicated or clinically significant adverse effects are documented. State-specific exceptions to step therapy apply.

General step requirements: failure of ≥2 non-opioid ancillary treatments (e.g., NSAIDs, acetaminophen) unless contraindicated; for migraine-related use, failure of ≥2 anti-migraine agents; for chronic pain, failure of an antidepressant or anticonvulsant agent when applicable; member unable to use oral medications.
State exceptions: Several states prohibit step therapy in certain oncology or advanced metastatic cancer settings (see notes and Appendix D).

Step Therapy

Step Therapy Bypass Options

Step therapy redirection/bypass options have been added. Redirection/step therapy may be bypassed when the prescription is made by or in consultation with a pain management specialist or an oncologist, or when intended for palliative or hospice care. Additional bypasses apply where state law prohibits step therapy in specified oncology settings.

Added bypass for Illinois HIM per IL HB 5395 (effective 1/1/2026) — step therapy requirements do not apply for IL HIM requests.
Other state-specific bypass notes: MS, NV, OH, OK, PA, TN, TX — step therapy prohibited for advanced/metastatic cancer or specified stages per state guidance.

Denial Risk

Coding and Denial Risk

Coding and coverage determinations are subject to change. Inclusion or exclusion of codes in this policy does not guarantee coverage; providers should reference current professional coding resources when submitting claims.

HCPCS code S0012 (Butorphanol tartrate, nasal spray 25 mg) has been added to the coding list.
Claims should reference most up-to-date coding guidance.

Initial Therapy

Initial Therapy — Initial authorization requirements

Initial authorization requirements:

Initial: See Initial Therapy criteria: patient ≥18 years, prescribed for pain, meets cancer/palliative or specialist involvement OR has failed specified alternative therapies as outlined (failure of ≥2 non-opioid/ancillary treatments; migraine: failure of ≥2 anti-migraine agents; chronic pain: failure of an antidepressant or anticonvulsant), and patient unable to use oral medications for relief.

Approval duration: 12 months

Step Therapy

Step	Requirement / Notes
1
Step therapy is required: member must have failure of at least 2 non‑opioid/ancillary treatments (e.g., NSAIDs, acetaminophen combinations) unless contraindicated; for migraine-related pain, failure of ≥2 anti‑migraine agents; for chronic pain, failure of an antidepressant or anticonvulsant unless contraindicated. Step therapy does not apply where state law prohibits step therapy for specified oncology or palliative situations (see state-specific notes). Approval duration: 12 months.

Step

Requirement / Notes

Step therapy is required: member must have failure of at least 2 non‑opioid/ancillary treatments (e.g., NSAIDs, acetaminophen combinations) unless contraindicated; for migraine-related pain, failure of ≥2 anti‑migraine agents; for chronic pain, failure of an antidepressant or anticonvulsant unless contraindicated. Step therapy does not apply where state law prohibits step therapy for specified oncology or palliative situations (see state-specific notes). Approval duration: 12 months.

Bypass Option	When Bypass Applies
Prescriber specialty / consultation
Step therapy/redirection may be bypassed when the medication is prescribed by or in consultation with a pain management specialist or an oncologist; bypass also allowed for use in palliative care or hospice care. Additionally, state‑specific regulations (e.g., IL HB 5395 for Illinois HIM requests) require bypass where applicable.

Background

Butorphanol tartrate is a synthetic opioid agonist‑antagonist analgesic indicated for management of severe pain when alternative treatments are inadequate. Use is reserved for patients with inadequate response or intolerance to non‑opioid and other specified alternatives, and for settings where oral administration is not feasible. The formulation available as a nasal spray is supplied in a 2.5 mL (10 mg/mL) bottle, with a standard delivered dose of 1 mg per spray.

Because butorphanol is an opioid with known risks including respiratory depression, addiction, and neonatal opioid withdrawal, therapy is limited to patients meeting the policy's initial or continuation criteria and requires prior authorization. Initial and continued approvals are issued for 12 months when criteria are met.

Definitions & Product

Butorphanol tartrate (nasal spray)

Drug name (term)Butorphanol tartrate (nasal spray)

Drug classSynthetic opioid agonist–antagonist analgesic (phenanthrene series)

FDA‑approved indicationManagement of severe pain requiring an opioid analgesic when alternative treatments are inadequate.

Limitations of useReserve for patients who have not achieved adequate analgesia or cannot tolerate alternative treatments; avoid extended use unless pain remains severe and alternatives remain inadequate.

Product formulation

FormulationNasal spray solution bottle: 2.5 mL (10 mg/mL).

Per‑spray dose (standard)1 mg per spray (standard dosing noted in policy stats).

ReferencesSee prescribing information and product monographs for full formulation and handling details.