Health Net Transmucosal Fentanyl Prior Auth

Coverage Criteria

Continuation Therapy

Covered when ALL of the following are met:

Cancer Pain continuation: 1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; 2. Member is responding positively to therapy as evidenced by reduction in breakthrough pain and no significant toxicity.

Approval duration: 12 months

Other diagnoses/indications - Continued Therapy

Covered when ONE of the following is met:

Other indications continuation: 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy (approval duration: duration of request or 12 months, whichever is less); OR 2. Refer to the off-label use policy for the relevant line of business if diagnosis is not specifically listed under exclusions (see CP.CPA.09, HIM.PHAR.21, CP.PMN.53).

Medical necessity criteria

Covered when ALL of the following are met

Core coverage requirements: Member is currently receiving an extended-release opioid analgesic (or concurrent fentanyl transdermal patches as specified for some lines of business); clinician documents a treatment plan; trial and failure of 2 formulary short-acting narcotic analgesics unless contraindicated or clinically significant adverse effects are experienced; titration and dosing limits are followed per product prescribing information (initiate at recommended initial dose, limit doses per episode and no more than 4 doses per day for many products).

Derived from revision history and product dosing guidance; all items must be met

Non‑FDA approved indications that are not addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies (see CP.CPA.09, HIM.PHAR.21, CP.PMN.53).

These transmucosal immediate‑release fentanyl products are not to be used in opioid non‑tolerant patients and are not indicated for acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency department. Requests for these indications are outside the scope of coverage per the policy limitations and contraindications.

No additional exclusions are explicitly listed in the provided document excerpt.

Use of transmucosal immediate‑release fentanyl in opioid non‑tolerant patients or for acute/postoperative pain (including headache/migraine, dental pain, or emergency department use) is a contraindication and therefore considered not medically necessary under this policy.

Coverage requires documentation that the member meets core medical necessity elements: the patient is currently receiving an extended‑release opioid analgesic (or concurrent fentanyl transdermal patches where specified), the clinician has documented a treatment plan (including pain intensity, functional status, current analgesic regimen, and plan for misuse or treatment failure), and there is documented trial and failure of two formulary short‑acting narcotic analgesics unless contraindicated. Failure to provide required trial/failure documentation, evidence of concurrent long‑acting opioid therapy, or an adequate treatment plan may render the request not medically necessary and subject to denial.

Initial Therapy Criteria

Initial Therapy — Initial dosing and trial requirements

Initial dosing and trial requirements

Initial dosing and requirements: Age criteria (Actiq ≥16; others ≥18); member on fentanyl transdermal patches (per line of business requirements); failure of trial of two formulary short-acting opioid analgesics unless contraindicated; failure of generic Actiq required before certain brand products when specified; treatment plan required; follow product-specific titration and dosing limits (see product dosing guidance).Maximum 4 doses/day for many products; product-specific limits apply

Prescribers must follow REMS enrollment and product-specific titration

Initial therapy dosing — Product-specific initial dosing guidance

Product-specific initial dosing guidance

Product initial dosing examples: Actiq: individually titrate; patients may take only 1 additional dose of same strength and must wait at least 4 hours before another episode; initial prescription recommendation for maximum of 6 units; no more than 4 doses per day. Fentora: initiate dosing with 100 mcg PO; if not relieved in 30 minutes may take one additional dose (wait at least 4 hours); maximum varies. Abstral: begin titration at 100 mcg SL for all patients; do not convert mcg-per-mcg from other fentanyl products; safety/efficacy not evaluated >800 mcg; maximum two doses per episode; wait at least 2 hours before treating another episode. Lazanda: initial dose 100 mcg, titrate up to 200/400/800 mcg as needed; single spray per nostril per episode; no more than four doses per day. Subsys: initial 100 mcg SL, individually titrate; no more than two doses per episode; wait at least 4 hours before another episode; limit to four or fewer doses per day once effective dose found.

Continuation Criteria

Continuation Therapy — Continuation criteria for cancer pain

Continuation criteria for cancer pain

Cancer pain continuation: Member currently receiving via benefit or previously met initial criteria; documentation of positive response with reduction in breakthrough pain and no significant toxicity; continued coverage requires ongoing adherence to treatment plan and concurrent long-acting opioid therapy as applicable.

Approval duration: 12 months

Continuation therapy — Continuation/renewal considerations described in revision history

Continuation/renewal considerations described in revision history

Continuation requirements: Approval durations and renewal expectations were modified in revision history (e.g., initial approval duration changed to 6 months for HIM and to 12 months for commercial continuation); continued coverage typically requires demonstration of ongoing benefit, adherence to treatment plan, and concurrent use of a long-acting opioid or fentanyl transdermal patches where specified.

See policy revision history for specific duration changes and line-of-business differences

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Abstral, Actiq, Fentora, Lazanda, and Subsys. Providers must obtain approval before dispensing these transmucosal immediate‑release fentanyl products.

Affected products: Abstral, Actiq, Fentora, Lazanda, Subsys
Prior authorization required for outpatient dispensing to members (TIRF REMS applies)

Denial Risk

Use Limitations / REMS Enrollment Warning

Requests may be denied if the patient is opioid non‑tolerant, the request is for acute or postoperative pain (including headache/migraine, dental pain, or emergency use), or if outpatient dispensing is requested without enrollment in the TIRF REMS Access program. Inpatient administration in hospitals, hospices, and long‑term care does not require REMS enrollment.

Do not use in opioid non‑tolerant patients

Step Therapy Requirements

Requirement	Details
Documented failure of two formulary short-acting opioid analgesics
Therapeutic alternatives listed in Appendix B (examples: immediate‑release morphine, oxycodone, hydromorphone, oxymorphone) — trials of two such formulary short‑acting agents must be documented unless contraindicated or intolerant
Member is currently receiving an extended‑release opioid regimen (fentanyl transdermal patches specified for some lines of business) as part of eligibility for transmucosal fentanyl therapy
Diagnosis of cancer pain and prescribed for management of breakthrough pain
Treatment plan documentation required (pain intensity, functional status, patient goals, current analgesic regimen, non‑pharmacologic treatments, opioid‑related side effects, indications of misuse, action plan if failure occurs)
Age criteria: ≥16 years for Actiq requests OR ≥18 years for Abstral, Fentora, Lazanda, or Subsys requests

Step requirement	Policy detail
Trial of generic fentanyl citrate oral transmucosal lozenge (generic Actiq) required before brand Actiq
For brand Actiq requests, failure of a trial of the generic lozenge (Actiq) must be documented unless contraindicated or clinically significant adverse effects are experienced; this formulary step was added in 2Q 2020

Quantity Limits

Actiq (on HIM plan) — dosing limits

LimitActiq on HIM plan: no more than 4 lozenges per day

Per-episode guidanceIndividually titrate to one dosage unit per breakthrough pain episode; patients may take only 1 additional dose of same strength and must wait at least 4 hours before another dose

If >4 episodes/dayRe-evaluate dose of the long-acting opioid used for persistent underlying cancer pain

Transmucosal products (general) — dosing limits

Daily maximumTransmucosal products (general): no more than 4 doses per day

Inter-episode intervalWait at least 2–4 hours before treating another episode (product-dependent: Abstral/Lazanda minimum 2 hours; Actiq/Fentora/Subsys typically 4 hours)

Coding and Thresholds

Opioid tolerance thresholds (examples)

Oral morphine≥ 60 mg oral morphine per day

Transdermal fentanyl≥ 25 mcg transdermal fentanyl per hour

Oxycodone≥ 30 mg oral oxycodone per day

Hydromorphone≥ 8 mg oral hydromorphone per day

Hydrocodone≥ 60 mg oral hydrocodone per day

Oxymorphone≥ 25 mg oral oxymorphone per day

Definitions

Opioid tolerant — definition and examples

DefinitionOpioid tolerant: taking around-the-clock opioid therapy for one week or longer at doses equivalent to specified daily opioid thresholds (e.g., ≥60 mg oral morphine/day or ≥25 mcg/hr transdermal fentanyl)

Minimum durationOne week or longer of continuous, around-the-clock opioid therapy

Clinical implicationPatients must remain on around-the-clock opioids while taking transmucosal fentanyl products

TIRF REMS — restricted distribution requirements

REMS programTransmucosal Immediate-Release Fentanyl (TIRF) REMS: restricted distribution program requiring prescriber, pharmacy, and patient enrollment for outpatient dispensing

Enrollment requirementOnly prescribers, pharmacies, and patients registered with TIRF REMS can prescribe, dispense, and receive these products for outpatient use

Background

Transmucosal immediate‑release fentanyl products are potent opioid agonists indicated for the management of breakthrough cancer pain in opioid‑tolerant patients. These agents are subject to the TIRF REMS restricted distribution program and are not interchangeable on a microgram‑for‑microgram basis; prescribers, pharmacies, and patients must follow REMS requirements for outpatient dispensing.

Site of Care

Note

Outpatient dispensing requires TIRF REMS enrollment

Outpatient dispensing of transmucosal immediate‑release fentanyl products is permitted only for patients and prescribers enrolled in the TIRF REMS access program; inpatient administration (e.g., hospitals, hospices, long‑term care inpatient use) does not require REMS enrollment.

Revision History

2016-05-01clinical_revision

HIM criteria wording changed: 'Documented severe chronic pain requiring around-the-clock analgesia' updated to 'Currently receiving an extended-release opioid analgesic'; requirement added for trial and failure of 2 formulary short-acting narcotic analgesics unless contraindicated or intolerant.

2017-06-13administrative_update

Commercial policy converted to new template with minor wording and grammar edits; Lazanda 300 mcg strength added.

2018-02-21approval_duration_change

OpenPayer

Transmucosal Immediate-Release Fentanyl (Abstral, Actiq, Fentora, Lazanda, Subsys) - Prior Authorization