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Clinical Policy: Fentanyl IR (Actiq, Fentora, Lazanda, Subsys)
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Defines medical necessity and prior authorization requirements for immediate-release transmucosal fentanyl products (Actiq, Fentora, Lazanda, Subsys) for members under Centene-affiliated health plans (Commercial, HIM, Medicaid).
Initial approval criteria for cancer pain were removed due to discontinuation of all TIRF products by manufacturers.
Appendix E added describing manufacturer discontinuation of all TIRF products effective September 30, 2024, and impact on REMS enrollments.
Coverage Criteria
II.A Continued Therapy - Cancer Pain
Covered when ALL of the following are met for cancer pain continued therapy (initial initiation not permitted):
Initiation of TIRF products is not permitted due to manufacturer discontinuation; continuation criteria apply only to existing users or continuity of care situations.
I.A Initial Therapy - Cancer Pain
Initial approval for cancer pain:
See continued therapy section for existing users (Appendix E).
I.B / II.B Other Diagnoses
Other diagnoses/indications:
Cross-reference applicable policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as appropriate.
inv-04: Appropriate use and dosing constraints
Covered when ALL of the following dosing and use conditions are met
Opioid tolerance is required to avoid life‑threatening hypoventilation.
Initial approval criteria were removed due to product discontinuation; dosing constraints still apply for existing users.
Conversion guidance provided for Actiq switchers to Fentora/Subsys.
If >4 breakthrough episodes/day, re-evaluate baseline long-acting opioid regimen.
These transmucosal immediate‑release fentanyl (TIRF) products are not for use in opioid non‑tolerant patients and are not for the management of acute or postoperative pain (examples include headache/migraine, dental pain, or use in the emergency department). Outpatient dispensing is restricted under the TIRF REMS Access program and requires enrollment of prescriber, pharmacy, and patient; inpatient administration does not require REMS enrollment.
Use in patients who are not opioid tolerant is a listed contraindication because of the risk of life‑threatening respiratory depression (hypoventilation). Only patients meeting the policy definition of opioid tolerant (see definitions) should be considered for TIRF therapy; do not initiate in non‑tolerant individuals.
Outpatient prescribing and dispensing of TIRF products requires enrollment in the TIRF REMS Access program. Note the REMS program is no longer accepting enrollments for new patients, prescribers, or pharmacies following manufacturer discontinuation of all TIRF products; prescriptions may be denied if REMS enrollment is not documented for applicable dispenses.
Authorization for initiation of TIRF products is not permitted because manufacturers announced discontinuation of all TIRF products effective September 30, 2024. Existing patients may be considered under continuation criteria where applicable, but new starts are not authorized.
Different transmucosal fentanyl formulations have important pharmacokinetic differences and are not interchangeable. Substituting one TIRF product for another on a microgram‑per‑microgram basis is not medically appropriate and may lead to fatal overdose; exercise caution and do not perform mcg‑for‑mcg substitutions.
Coding / Definitions
Provider Actions & Prior Authorization
Prior Authorization Required
Prior authorization is required for transmucosal immediate‑release fentanyl (TIRF) products (Actiq, Fentora, Lazanda, Subsys) when approval criteria are met. Note: For Health Insurance Marketplace (HIM) pharmacy benefit requests, Fentora and Lazanda are non‑formulary and should not be approved under these criteria; refer to HIM.PA.103 for formulary exception process.
- Affected products: Actiq, Fentora, Lazanda, Subsys
- HIM pharmacy benefit: Fentora and Lazanda are non‑formulary — follow HIM.PA.103
Initiation Prohibited — TIRF Discontinuation
Initial authorization for initiating TIRF therapy is not permitted due to manufacturer discontinuation of all TIRF products. Members may not start a TIRF product; requests for new starts should be denied. If a member is currently using a TIRF product, review continuation criteria in the policy and Appendix E (TIRF Product Discontinuation).
- Manufacturers discontinued production of all TIRF products effective September 30, 2024
- Authorization for initiation: Not permitted
- Continuation: Only consider for current users per continuation criteria and Appendix E
Supportive Documentation Required
Providers must submit supportive clinical documentation to substantiate that the member meets all approval criteria. Incomplete documentation may result in denial of the request.
- Acceptable documentation: office chart notes, medication administration records, lab results, prior therapy documentation, and relevant consult notes
- Include documentation of opioid tolerance and rationale for continued TIRF use if member is an existing TIRF user
REMS Documentation and Enrollment
Document Risk Evaluation and Mitigation Strategy (REMS) enrollment status when applicable. The TIRF REMS requires prescriber, pharmacy, and patient registration to prescribe, dispense, and receive TIRF products; include REMS enrollment details in the submission.
- Provide prescriber, pharmacy, and patient REMS enrollment confirmation when available
- Note: TIRF REMS is no longer accepting new enrollments for patients, prescribers, or pharmacies due to product discontinuation; lack of REMS enrollment may affect dispensing for current patients
- Reference: https://www.tirfremsaccess.com and TIRF REMS contact 1‑866‑822‑1483
Background
Transmucosal immediate‑release fentanyl (TIRF) products are potent opioid agonists indicated for the management of breakthrough cancer pain in opioid‑tolerant patients. These agents require enrollment in the TIRF REMS Access program for outpatient dispensing and are intended only for patients who meet established opioid tolerance thresholds to reduce the risk of life‑threatening respiratory depression.
Definitions
Initial Therapy Criteria
inv-24: Initial therapy
Initial therapy:
Appendix E describes discontinuation effective September 30, 2024; prescribers should transition patients to non‑TIRF treatments when supply diminishes.
inv-25: Initial therapy dosing
Initial dosing and titration recommendations by product:
Conversion table in policy provides mapped starting doses for switchers from Actiq.
Individually titrate to adequate analgesia while minimizing side effects.
Individually titrate; follow product-specific spray-count rules.
Continuation Criteria
inv-26: Continuation criteria
Continued therapy for cancer pain (existing users):
Refer to continuity of care addendums where applicable.
inv-27: Continuation during discontinuation
Continuation limited by product availability and REMS status:
Manufacturers announced discontinuation effective September 30, 2024; fewer than 150 patients remained at announcement; the TIRF REMS is not accepting new enrollments for patients/prescribers/pharmacies.
Step Therapy / Therapeutic Alternatives
| Preferred alternative | Typical immediate‑release dosing / notes |
|---|---|
| Morphine sulfate (immediate‑release) | |
| 10–30 mg PO every 4 hours PRN; individualize based on pre‑existing opioid tolerance | |
| Oxycodone (immediate‑release, Roxicodone) | |
| 5–15 mg PO every 4–6 hours PRN; individualize based on pre‑existing opioid tolerance | |
| Hydromorphone (immediate‑release, Dilaudid) | |
| 2–4 mg PO every 3–4 hours PRN; individualize based on pre‑existing opioid tolerance | |
| Oxymorphone (immediate‑release, Opana) | |
| 5–20 mg PO every 4–6 hours PRN; individualize based on pre‑existing opioid tolerance | |
| Fentanyl transdermal (Duragesic patch) | |
| Apply one patch topically every 72 hours (transdermal formulation as an alternative for baseline opioid therapy) |
| Exception | Applicability / note |
|---|---|
| Step therapy redirection exception for oncology settings | |
| Policy added by‑passing of redirection (step therapy) when state regulations prohibit step therapy in certain oncology settings; see policy history and Appendix E for details and subsequent removal/updates following TIRF product discontinuation. |
Quantity Limits
Site of Care
REMS enrollment required for outpatient dispensing; not required for inpatient use
Outpatient dispensing of TIRF products requires enrollment in the TIRF REMS Access program for the prescriber, pharmacy, and patient; inpatient administration (e.g., hospitals, hospices, long‑term care inpatient use) does not require REMS enrollment.
- Outpatient prescribing/dispensing: REMS enrollment required
- Inpatient administration: REMS enrollment not required
No other site‑of‑care restrictions documented; REMS still required
No additional site‑of‑care restrictions beyond REMS requirements are documented in the policy chunks provided; while REMS is active, prescribing and dispensing require enrollment.
- Policy contains no other site‑of‑care limitations in provided sections
- REMS enrollment is the operative requirement for outpatient prescribing/dispensing while REMS remains in effect
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