Cigna transmucosal fentanyl Coverage Update

Coverage Criteria

inv-01: Actiq (oral transmucosal lozenge) — Initial therapy

Actiq is considered medically necessary when ALL of the following are met:

ALL of the following

Age 16 years or older
B: One of: continuation of fentanyl transmucosal therapy; inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; unable to take two other short-acting narcotics due to allergy or severe adverse events
C: On oral or transdermal long-acting narcotic or on an intravenous, subcutaneous, or spinal narcotic
Documented trial of fentanyl citrate oral transmucosal lozenge (the bioequivalent [Actiq] generic product) AND cannot take it due to a formulation difference in the inactive ingredient(s) causing a significant allergy or serious adverse reaction

Indication: Treatment of breakthrough pain in an individual with cancer

inv-02: Fentanyl citrate oral transmucosal lozenge (generic) — Initial therapy

Fentanyl citrate oral transmucosal lozenge is considered medically necessary when ALL of the following are met:

ALL of the following

Age 16 years or older
B: One of: continuation of fentanyl transmucosal therapy; inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; unable to take two other short-acting narcotics due to allergy or severe adverse events
C: On oral or transdermal long-acting narcotic or on an intravenous, subcutaneous, or spinal narcotic

Indication: Treatment of breakthrough pain in an individual with cancer

inv-03: Fentanyl buccal tablet (generic) — Initial therapy

Fentanyl citrate buccal tablet is considered medically necessary when ALL of the following are met:

ALL of the following

Age 18 years or older
B: One of: continuation of fentanyl transmucosal therapy; inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; unable to take two other short-acting narcotics due to allergy or severe adverse events
C: On oral or transdermal long-acting narcotic or on an intravenous, subcutaneous, or spinal narcotic
Documentation of one of the following (product-specific per policy)

inv-04: Fentora (buccal tablet) — Initial therapy

Fentora is considered medically necessary when ALL of the following are met:

ALL of the following

Age 18 years or older
B: One of: continuation of fentanyl transmucosal therapy; inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; unable to take two other short-acting narcotics due to allergy or severe adverse events
C: On oral or transdermal long-acting narcotic or on an intravenous, subcutaneous, or spinal narcotic
Documentation of one of the following including continuation of Fentora

inv-05: Lazanda (nasal spray) — Initial therapy

Lazanda is considered medically necessary when ALL of the following are met:

ALL of the following

Age 18 years or older
B: One of: continuation of fentanyl transmucosal therapy; inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; unable to take two other short-acting narcotics due to allergy or severe adverse events
C: On oral or transdermal long-acting narcotic or on an intravenous, subcutaneous, or spinal narcotic
Documentation of one of: continuation of Lazanda; has cancer with mucositis; failure/contraindication/intolerance to fentanyl citrate oral transmucosal lozenge (Actiq generic)

inv-06: Subsys (sublingual spray) — Initial therapy

Subsys is considered medically necessary when ALL of the following are met:

ALL of the following

Age 18 years or older
B: One of: continuation of fentanyl transmucosal therapy; inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; unable to take two other short-acting narcotics due to allergy or severe adverse events
C: On oral or transdermal long-acting narcotic or on an intravenous, subcutaneous, or spinal narcotic
Documentation of one of: continuation of Subsys; failure/contraindication/intolerance to fentanyl citrate oral transmucosal lozenge (Actiq generic)

These transmucosal fentanyl products are contraindicated for treatment of acute or postoperative pain, including pain related to surgery, trauma, or acute medical illness. The policy explicitly excludes use for acute/postoperative indications such as surgical recovery, post‑trauma pain, acute abdominal or pelvic pain, muscle spasm, and migraine headache. Coverage will be denied when these agents are prescribed for acute or postoperative pain.

Any use of transmucosal fentanyl products other than for the management of breakthrough cancer pain in opioid‑tolerant patients is considered experimental, investigational, or unproven and is not covered. The policy lists non‑covered uses explicitly and states that indications outside breakthrough cancer pain will be denied.

Initial Therapy

inv-16: Initial therapy — product-specific medical necessity criteria (age, opioid tolerance, breakthrough cancer pain) grouped for initial authorization

Initial authorization requires meeting product-specific medical necessity criteria including age, opioid tolerance, and indication for breakthrough cancer pain; product-specific trial/continuation or contraindication conditions also apply.

ALL of the following

Age requirement per product: Actiq and Actiq generic age ≥16; Fentora, buccal products, Lazanda, and Subsys age ≥18
See product-specific criteria
B: Patient is opioid tolerant (e.g., receiving at least 60 mg oral morphine/day or equivalent) as defined in policy
C: Indication: Treatment of breakthrough pain in an individual with cancer

Reauthorization / Continuation

inv-17: Reauthorization / Continuation — criteria for continuation or reauthorization of transmucosal fentanyl therapy

Continuation/reauthorization is considered medically necessary when ALL of the following are met:

ALL of the following

1: Medical necessity criteria continue to be met (age, opioid tolerance, indication of breakthrough cancer pain)
2: Documentation of beneficial response is provided for reauthorization

Product-specific continuation: Continuation of the same transmucosal fentanyl product is an acceptable reason for coverage per product criteria

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Transmucosal fentanyl products (Actiq, fentanyl citrate oral transmucosal lozenge, Fentora, Lazanda, Subsys) are covered only when product‑specific medical necessity criteria are met for treatment of breakthrough cancer pain.

Affected products: Actiq, fentanyl citrate oral transmucosal lozenge (generic Actiq), Fentora, fentanyl citrate buccal tablet (Fentora generic), Lazanda, Subsys
Coverage limited to breakthrough pain in individuals with cancer and requires documentation per medical necessity criteria
REMS/TIRF REMS ACCESS program enrollment requirements apply for prescribers, pharmacies, and outpatients

Step Therapy

Step / Sequence Requirements

Documentation must show prior therapy continuation or failure/intolerance/contraindication as applicable. For initial requests, indicate why the member cannot use other short‑acting opioids or why continuation of a transmucosal fentanyl product is clinically necessary. For reauthorization, provide documentation of beneficial response to therapy.

Coding and Definitions

Opioid tolerance thresholds — examples

Oral morphine>= 60 mg per day (oral morphine)

Transdermal fentanyl>= 25 mcg per hour (transdermal fentanyl)

Oxycodone>= 30 mg per day (oxycodone)

Oral hydromorphone>= 8 mg per day (oral hydromorphone)

Oral oxymorphone>= 25 mg per day (oral oxymorphone)

Other opioidsAn equianalgesic dose of another opioid for one week or longer

Opioid tolerant — definition

Step Therapy / Sequencing

Product / Situation	Required documentation (failure, contraindication, intolerance, or continuation)
Actiq (oral transmucosal lozenge)	Documentation of one of the following: continuation of fentanyl transmucosal therapy; inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; unable to take two other short-acting narcotics due to allergy or severe adverse events; or documented trial of fentanyl citrate oral transmucosal lozenge (generic) and inability to take it due to formulation difference in inactive ingredient(s) causing significant allergy or serious adverse reaction.
Fentanyl citrate oral transmucosal lozenge (generic)	Documentation of one of the following: continuation of fentanyl transmucosal therapy; inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; or unable to take two other short-acting narcotics due to allergy or severe adverse events.
Fentanyl buccal tablet (Fentora generic)	Documentation of one of the following: continuation of fentanyl transmucosal therapy; inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; or unable to take two other short-acting narcotics due to allergy or severe adverse events. Product-specific documentation may include evidence of continuation of Fentora.
Fentora (brand buccal tablet)	Documentation of one of the following: continuation of fentanyl transmucosal therapy (including continuation of Fentora); inability to swallow (dysphagia, esophagitis, mucositis) or uncontrollable nausea/vomiting; or unable to take two other short-acting narcotics due to allergy or severe adverse events.
Lazanda (nasal spray)	Documentation of one of the following: continuation of fentanyl transmucosal therapy (including continuation of Lazanda); has cancer with mucositis; or failure, contraindication, or intolerance to fentanyl citrate oral transmucosal lozenge (Actiq generic).
Subsys (sublingual spray)	Documentation of one of the following: continuation of fentanyl transmucosal therapy (including continuation of Subsys); or failure, contraindication, or intolerance to fentanyl citrate oral transmucosal lozenge (Actiq generic).

Site of Care Considerations

Billing Rule

Site-of-care and dosing must be reasonable and supported by evidence

When coverage is available, the dosage, frequency, duration, and site of care must be reasonable, clinically appropriate, and supported by evidence-based literature; these parameters should be adjusted based on severity, alternative treatments, and prior response.

Ensure dosing, frequency, and duration are consistent with the documented severity and prior therapeutic response.
Specify the intended site of care (e.g., home) and justify with clinical rationale and evidence when applicable.

Background

Transmucosal fentanyl products are immediate‑release formulations intended solely for management of breakthrough pain in patients with cancer who are already receiving and tolerant to opioid therapy. They are not appropriate for patients who are not opioid tolerant and are contraindicated for acute or postoperative pain (including migraine). Specific formulations named in the policy (for example, Actiq, Fentora, Lazanda, and Subsys) are governed by product‑specific criteria and restrictions reflecting these indication limitations.

OpenPayer

Transmucosal Fentanyl Products (Actiq, Fentora, Lazanda, Subsys and generics)

Coverage Criteria

Initial Therapy

Reauthorization / Continuation

Provider Actions and Requirements

Coding and Definitions

Step Therapy / Sequencing

Site of Care Considerations

Background