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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsWashington HCA Fentanyl Prior Auth | OpenPayer
    Ask Trek AI about this page
    CurrentWashington State Health Care AuthorityPolicy 65.10.00.25-3

    Transmucosal Fentanyl Products

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    Prior authorization and medical necessity criteria for transmucosal fentanyl products used to treat breakthrough cancer pain in patients receiving around-the-clock opioid therapy for persistent cancer pain through Washington State Health Care Authority Apple Health fee-for-service.

    Policy Summary
    PayerWashington State Health Care Authority
    PolicyTransmucosal Fentanyl Products
    Policy CodePolicy 65.10.00.25-3
    Change TypeClinical criteria revision
    Effective DateAugust 1, 2026
    Next Review DateN/A
    Key ActionDocument failure of two oral immediate-release opioid products before requesting transmucosal fentanyl authorization.
    SourceLink
    POLICY UPDATE CHANGES

    The policy removed the attestation requirement for doses between 120 and 200 MME daily.

    The policy was reformatted throughout for clarity and consistency.

    The policy note and Apple Health Preferred Drug List link were updated to reflect current language and formatting.

    6 monthsInitial authorization duration
    6 monthsReauthorization duration
    60 MME/dayOpioid tolerance threshold
    2 productsRequired opioid failures
    16 yearsMinimum patient age
    6Products listed

    Coverage Criteria

    Initial Therapy

    Transmucosal fentanyl products may be considered medically necessary when approved under prior authorization for breakthrough cancer pain in patients receiving around-the-clock opioid therapy for persistent cancer pain. If all criteria are met, authorization may be approved for 6 months.

    ALL of the following

    • The requested product is one of the following transmucosal fentanyl products: fentanyl sublingual tablet (Abstral), fentanyl lozenge/troche (Actiq), fentanyl buccal tablet (Fentora), fentanyl nasal spray (Lazanda), fentanyl buccal soluble film (Onsolis), or fentanyl sublingual spray (Subsys).
    • Prior authorization is approved.

    • Chronic, long-acting opioid criteria under Policy 65.10.00

      • The patient is currently receiving around-the-clock long-acting opioids for persistent cancer pain.
      • The patient is tolerant to at least 60 MME per day of chronic, long-acting opioids.>= 60 MME/day

    • Criteria for appropriate use

      • The patient has a confirmed diagnosis of cancer.
      • The patient is using transmucosal fentanyl for the treatment of breakthrough cancer pain.
      • The patient has a history of failure to two oral immediate-release opioid products, such as morphine, hydromorphone, or oxycodone.>= 2 failed oral immediate-release opioid products
      • The patient is 16 years of age or older.>= 16 years
      • The patient is tolerant to opioids.
      • The patient is taking a long-acting opioid for the treatment of cancer pain.
      • The product is prescribed by, or prescribed in consultation with, a specialist in oncology or pain management related to oncology, unless the patient is enrolled in or eligible for hospice care.
      • The prescribed dose does not exceed the applicable limits in the Dosage and Quantity Limits table.

    Continuation Therapy

    If all continuation criteria are met, authorization may be approved for 6 months.

    ALL of the following

    • The patient continues to meet the initial authorization criteria for transmucosal fentanyl products.
    • The patient's cancer-related pain is controlled and the therapy is titrated appropriately to minimize use of transmucosal fentanyl products.

    Transmucosal fentanyl products are not covered for non-cancer-related pain, including acute or postoperative pain not related to cancer treatment, headache or migraine, dental pain, or other non-cancer pain indications. These products must not be used to manage such pain.

    Clinical Thresholds and Coding Rules

    Chronic Long-Acting Opioid Tolerance
    Minimum opioid tolerance60 MME per day
    Required baseline therapyAround-the-clock long-acting opioids for persistent cancer pain
    Patient statusOpioid tolerant

    Prior Authorization and Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for transmucosal fentanyl products used to treat breakthrough cancer pain in patients receiving around-the-clock opioid therapy for persistent cancer pain. Submit documentation showing that all initial authorization criteria are met.

    • Initial authorization may be approved for 6 months when all required criteria are satisfied.
    Documentation Required

    Non-Preferred Opioid Agents

    New-to-market drugs included in this class based on the Apple Health Preferred Drug List are non-preferred and subject to these prior authorization criteria. Non-preferred agents require documentation of the applicable preferred-agent step therapy.

    • Consult the current Apple Health Preferred Drug List (AHPDL): https://www.hca.wa.gov/assets/billers-and-providers/applehealth-preferred-drug-list.xlsx
    Prior Authorization

    Authorization Duration

    When initial criteria are met, authorization for transmucosal fentanyl products may be approved for 6 months. Reauthorization may also be approved for 6 months when continued criteria are satisfied.

    • Initial authorization period: 6 months.
    • Reauthorization period: 6 months.
    Documentation Required

    Failure of Oral Immediate-Release Opioids

    Document a history of failure with two oral immediate-release opioid products before requesting transmucosal fentanyl.

    • Examples include morphine, hydromorphone, and oxycodone.
    Step Therapy

    Preferred Drug List Step Therapy

    For a non-preferred agent, document an inadequate response or documented intolerance to at least two preferred agents. Intolerance must be due to a severe adverse reaction or contraindication.

    • If only one preferred agent is available in the class, document inadequate response to that one preferred agent.
    • Use the current Apple Health Preferred Drug List to identify preferred agents.
    Documentation Required

    Cancer Diagnosis and Indication

    Submit documentation of a confirmed cancer diagnosis and use of the requested transmucosal fentanyl product for breakthrough cancer pain.

    • The covered indication is breakthrough cancer pain in a patient with persistent cancer pain receiving around-the-clock opioid therapy.
    Documentation Required

    Baseline Opioid Therapy

    Document that the patient is currently receiving around-the-clock long-acting opioids for persistent cancer pain and is tolerant to at least 60 MME per day of chronic, long-acting opioids.

    • Minimum opioid tolerance: 60 MME per day.
    • The long-acting opioid therapy must be for persistent cancer pain.
    Documentation Required

    Prior Opioid Treatment History

    Document failure of two oral immediate-release opioid products as part of the patient's prior treatment history.

    • Examples include morphine, hydromorphone, and oxycodone.
    Documentation Required

    Patient and Prescriber Requirements

    The patient must be at least 16 years of age, and the product must be prescribed by or used in consultation with a specialist in oncology or pain management related to oncology, unless the patient is enrolled in or eligible for hospice care.

    • Transmucosal fentanyl must be limited to cancer-related pain.
    • The patient must be opioid tolerant and taking a long-acting opioid for cancer pain.
    Billing Rule

    Dose and Quantity Limits

    Ensure that the requested dose and quantity do not exceed the applicable product-specific limits in the dosage and quantity limits table.

    • Abstral: 120 sublingual tablets per 30 days.
    • Actiq: 120 lozenges per 30 days.
    • Fentora: 120 buccal tablets per 30 days.
    • Lazanda: 30 bottles per 30 days.
    • Onsolis: 120 unit-dose systems per 30 days.
    • Subsys: 120 unit-dose systems per 30 days.
    Documentation Required

    Reauthorization Documentation

    For reauthorization, document that the patient continues to meet all initial authorization criteria and that cancer-related pain is controlled and appropriately titrated to minimize use of transmucosal fentanyl products.

    • Reauthorization may be approved for 6 months when both requirements are met.
    Denial Risk

    Non-Cancer or Non-Indicated Pain

    Requests for non-cancer pain or indications outside breakthrough cancer pain do not meet the policy criteria. Transmucosal fentanyl must not be used to manage non-cancer-related pain.

    • Examples include acute or postoperative pain unrelated to cancer treatment, headache or migraine, and dental pain.
    Denial Risk

    Insufficient Baseline Opioid Therapy

    Authorization may be denied when the patient is not receiving around-the-clock long-acting opioid therapy for persistent cancer pain or is not tolerant to at least 60 MME per day of chronic, long-acting opioids.

    • Document both the baseline long-acting opioid regimen and opioid tolerance.
    Denial Risk

    Clinical Eligibility Not Met

    Authorization may be denied when required clinical eligibility criteria are absent, including a confirmed cancer diagnosis, age of at least 16 years, or opioid tolerance.

    • The patient must also be taking a long-acting opioid for cancer pain.
    Denial Risk

    Required Criteria or Limits Not Met

    Authorization may be denied when required step therapy, documentation, dosage, quantity, indication, or other policy criteria are not satisfied.

    • Document failure or intolerance to the required preferred agents for non-preferred products.
    • Document failure of two oral immediate-release opioid products.
    • Keep the requested dose and quantity within the applicable product-specific limits.
    • Document specialist prescribing or consultation unless the patient is enrolled in or eligible for hospice care.

    Policy Background

    Opioid agonists are reserved for severe pain that cannot be managed with non-pharmacologic or other pharmacologic treatments. Transmucosal fentanyl is a potent opioid agonist used for breakthrough cancer pain in patients receiving around-the-clock opioid therapy for persistent cancer pain. Products should be used in accordance with the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program.

    Initial Authorization Criteria

    Initial Authorization

    Patients who meet all of the following criteria may be considered for initial authorization.

    Initial authorization

    • Chronic long-acting opioid criteria: Patient is currently receiving around-the-clock long-acting opioids for persistent cancer pain and is tolerant on at least 60 MME per day of chronic long-acting opioids.60 MME/day

      See Policy 65.10.00 for additional chronic long-acting opioid criteria.

    • Appropriate use criteria

      • Cancer indication: Patient has a confirmed diagnosis of cancer and uses transmucosal fentanyl for breakthrough cancer pain.
      • Prior opioid failure: Patient has a history of failure of two oral immediate-release opioid products, such as morphine, hydromorphone, or oxycodone.2 products
      • Age: Patient is at least 16 years of age.>= 16 years
      • Opioid status: Patient is opioid tolerant and is taking a long-acting opioid for cancer pain.
      • Excluded pain uses: Non-cancer-related pain, including acute or postoperative pain unrelated to cancer treatment, headache or migraine, dental pain, or other non-cancer pain, will not be managed with transmucosal fentanyl.
      • Prescriber or hospice pathway: The product is prescribed by or in consultation with a specialist in oncology or pain management related to oncology, or the patient is enrolled in or eligible for hospice care.
      • Dose limit: The requested dose does not exceed the applicable dosage and quantity limits.Product-specific limits

        See dosage and quantity limits table.

    Reauthorization Criteria

    Reauthorization

    Reauthorization may be approved for 6 months when all criteria are met.

    Continuation therapy

    • Continued initial criteria: All initial authorization criteria remain satisfied.
    • Pain control and titration: Cancer-related pain is controlled and therapy is appropriately titrated to minimize use of transmucosal fentanyl products.

    Step Therapy Requirements

    StepRequired prior treatmentRequirement
    1Oral immediate-release opioidsHistory of failure of two products, such as morphine, hydromorphone, or oxycodone
    StepApplies toRequirement
    2Non-preferred agentsDocument inadequate response or intolerance due to a severe adverse reaction or contraindication to at least two preferred agents; if only one preferred agent is available, document failure of that one agent

    Product-Specific Quantity Limits

    Quantity Limit
    Maximum quantity120 sublingual tablets
    Dispensing periodPer 30 days
    Dosage formFentanyl sublingual tablet (Abstral)
    Quantity Limit
    Maximum quantity120 lozenges
    Dispensing periodPer 30 days
    Dosage formFentanyl lozenge/troche (Actiq)
    Quantity Limit
    Maximum quantity120 buccal tablets
    Dispensing periodPer 30 days
    Dosage formFentanyl buccal tablet (Fentora)
    Quantity Limit
    Maximum quantity30 bottles
    Dispensing periodPer 30 days
    Dosage formFentanyl nasal spray (Lazanda)
    Quantity Limit
    Maximum quantity120 unit-dose systems
    Dispensing periodPer 30 days
    Dosage formFentanyl buccal soluble film (Onsolis)
    Quantity Limit
    Maximum quantity120 unit-dose systems
    Dispensing periodPer 30 days
    Dosage formFentanyl sublingual spray (Subsys)
    Policy Summary
    PayerWashington State Health Care Authority
    PolicyTransmucosal Fentanyl Products
    Policy CodePolicy 65.10.00.25-3
    Change TypeClinical criteria revision
    Effective DateAugust 1, 2026
    Next Review DateN/A
    Key ActionDocument failure of two oral immediate-release opioid products before requesting transmucosal fentanyl authorization.
    SourceLink
    On This Page
    Coverage CriteriaClinical Thresholds and Coding RulesPrior Authorization and DocumentationPolicy BackgroundInitial Authorization CriteriaReauthorization CriteriaStep Therapy RequirementsProduct-Specific Quantity Limits

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