CurrentCignaPolicy N/A

Opioids - Fentanyl Transmucosal Drugs Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for transmucosal fentanyl products (Actiq, Fentora, Lazanda, Subsys) for prescription benefit coverage, primarily for cancer breakthrough pain in opioid-tolerant patients.

Policy Summary

PayerCigna

PolicyOpioids - Fentanyl Transmucosal Drugs Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document opioid tolerance, cancer breakthrough pain diagnosis, and REMS enrollment status as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4listed TIRF products (Actiq, Fentora, Lazanda, Subsys)

1 yrapproval duration for FDA-approved indication

<150patients receiving TIRF medicines as of Sep 16, 2024

REMSTIRF REMS program required enrollment

Coverage Criteria

Initial Therapy (FDA-Approved Breakthrough Pain)

Covered when ALL of the following are met

FDA-Approved Indication for Breakthrough Cancer Pain

Criterion A: Patient meets ONE of the following: (i) patient is unable to swallow, has dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting; OR (ii) patient is unable to take two other short-acting narcotics secondary to allergy or severe adverse events
Examples of short-acting narcotics include immediate-release formulations of oxycodone, morphine sulfate, hydromorphone.
Criterion B: Patient is on or will be on an oral or transdermal long-acting narcotic, or is on an intravenous, subcutaneous, or spinal (intrathecal, epidural) narcotic
Examples include transdermal fentanyl, extended-release oxycodone, morphine extended-release, or parenteral morphine/hydromorphone/fentanyl.

Policy Summary

PayerCigna

PolicyOpioids - Fentanyl Transmucosal Drugs Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document opioid tolerance, cancer breakthrough pain diagnosis, and REMS enrollment status as applicable.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Covered Products and Coding

Covered drugs (by product name)mixedCovered

Actiq	oral transmucosal fentanyl citrate - Teva, generic (brand obsolete as of 07/12/2023)
Fentora	fentanyl buccal tablet - Teva, authorized generic (obsolete as of 11/30/2024)
Lazanda	fentanyl nasal spray - West Therapeutic Development (obsolete as of 12/30/2022)
Subsys	fentanyl sublingual spray - West Therapeutic Development (obsolete as of 6/1/2024)

Covered drugs (by product name) — neutral notemixed

No codes listed

Opioid tolerance thresholds — examples of daily opioid dose equivalents

Oral morphine equivalent>= 60 mg oral morphine per day

Transdermal fentanyl>= 25 mcg transdermal fentanyl per hour

Oral oxycodone>= 30 mg oral oxycodone per day

Oral hydromorphone>= 8 mg oral hydromorphone per day

Oral oxymorphone>= 25 mg oral oxymorphone per day

Equianalgesic dosingAn equianalgesic dose of another opioid for one week or longer

Provider Actions and Requirements

Prior Authorization

Prior authorization required; approvals for 1 year when criteria met

Prior authorization is required for prescription benefit coverage of transmucosal fentanyl (TIRF) products. When the FDA‑approved breakthrough cancer pain criteria are met, approve for 1 year.

Step Therapy

Required prior trials / concurrent opioid therapy

For the FDA‑approved breakthrough cancer pain indication, the patient must meet ONE of Criterion A(i–ii) and Criterion B: either be unable to swallow (or have dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting) OR be unable to take two other short‑acting narcotics due to allergy or severe adverse events; AND the patient must be on or will be on a long‑acting oral/transdermal narcotic or an IV/subcutaneous/spinal narcotic.

Examples of short‑acting narcotics: immediate‑release oxycodone, morphine sulfate, hydromorphone.
Examples of long‑acting/parenteral narcotics: transdermal fentanyl (Duragesic), extended‑release oxycodone (OxyContin), morphine extended‑release, or parenteral morphine/hydromorphone/fentanyl.

Documentation Required

Required clinical documentation to demonstrate cancer breakthrough pain and opioid tolerance

Prescribers must document that the request is for cancer breakthrough pain and that the patient is opioid tolerant (documentation of opioid tolerance thresholds and that the patient meets the FDA‑approved indication criteria).

Document presence of breakthrough pain in the setting of cancer and which A and B criteria are met.
Document opioid tolerance per thresholds (e.g., ≥60 mg oral morphine/day or ≥25 mcg transdermal fentanyl/hr, or equivalent for ≥1 week).

Documentation Required

REMS enrollment documentation required for outpatient prescribing

For outpatient prescribing, documentation must reflect enrollment status in the TIRF REMS ACCESS program for patient, prescriber, and pharmacy as applicable.

Denial Risk

Excluded indications — acute/postoperative and similar uses are not covered

Use of transmucosal fentanyl products for acute or postoperative pain (including surgery, trauma, acute medical illnesses, and migraine) is considered not medically necessary and will be denied.

TIRF products are contraindicated in the management of acute or postoperative pain and in patients who are not opioid tolerant.

Denial Risk

Coding/documentation denial risk — missing covered diagnosis/procedure codes

Claims submitted without a covered diagnosis or procedure that supports the policy criteria (e.g., cancer breakthrough pain and opioid tolerance) will be denied as not covered.

Conservative Treatment Requirements

Either intolerance/allergy to two short-acting narcotics OR inability to swallow due to GI conditions

Conservative treatment requirement — patient must meet ONE of the following

Either/Or: Either intolerance/allergy to two short-acting narcotics OR inability to swallow due to GI conditions

If invoking intolerance/allergy, document inability to take two different short-acting narcotics due to allergy or severe adverse events. If invoking inability to swallow, document dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting.

Definitions

Definition of opioid tolerant — specific daily dose examples and equianalgesic guidance

Definition (opioid tolerant)Patient taking at least 60 mg oral morphine daily, or at least 25 mcg transdermal fentanyl/hour, or at least 30 mg oral oxycodone daily, or at least 8 mg oral hydromorphone daily, or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid for one week or longer.

Duration requirementOpioid doses must be maintained for one week or longer to meet tolerance definition

Relevance to TIRF useTIRF medications indicated only for management of breakthrough pain in patients with cancer who are already receiving and tolerant to opioid therapy

Products referencedActiq (generic), Fentora, Subsys (oral transmucosal) and Lazanda (intranasal)

OpenPayer