CurrentCignaPolicy N/A

Formulary exception for Subsys (fentanyl sublingual spray)

Defines Cigna's coverage criteria and prior authorization requirements for Subsys (fentanyl sublingual spray) as a formulary exception for breakthrough cancer pain; applies to Cigna-administered health benefit plans. Affects prescribers and reviewers making coverage determinations.

Policy Summary

PayerCigna

PolicyFormulary exception for Subsys (fentanyl sublingual spray)

Policy CodePolicy N/A

Change TypeRevision with material changes

Effective DateN/A

Next Review DateDec 29, 2023

Key ActionSubmit prior authorization with clinician verification of prior transmucosal fentanyl trials and documentation that criteria A, B, and C are met.

SourceLink

POLICY UPDATE CHANGES

Approval duration changed from 1 year to 6 months.

Removal of Abstral as an option in the formulary criteria for breakthrough cancer pain.

Changed examples of intolerance to the sugar content of fentanyl citrate lozenge to a note specifying glucose intolerance, diabetes, or high risk of dental caries.

6 monthsApproval duration

2Required transmucosal trials

1Required long-acting opioid

Coverage Criteria for Subsys (fentanyl sublingual spray)

Breakthrough Pain in Patients with Cancer (Initial)

Covered when ALL of the following are met:

Main criteria: Approval for 6 months if ALL of A, B, and C are met6 months

A) Conditions allowing use: 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

From criteria A (i or ii).

B) Background opioid therapy: Patient is on or will be on an oral or transdermal long-acting narcotic, OR is on intravenous, subcutaneous, or spinal (intrathecal, epidural) narcotics

From criteria B.

Policy Summary

PayerCigna

PolicyFormulary exception for Subsys (fentanyl sublingual spray)

Policy CodePolicy N/A

Change TypeRevision with material changes

Effective DateN/A

Next Review DateDec 29, 2023

Key ActionSubmit prior authorization with clinician verification of prior transmucosal fentanyl trials and documentation that criteria A, B, and C are met.

SourceLink

On This Page

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C) Prior transmucosal fentanyl trials or intolerance: Patient meets ONE of: i) has tried two of the following if two are formulary (or one if only one is formulary or none if none are formulary): fentanyl citrate oral transmucosal lozenge (Actiq, generic) or Fentora (verification of therapies required); OR ii) in patients who cannot tolerate the sugar content of fentanyl citrate oral transmucosal lozenge (Actiq, generic), the patient has tried Fentora if Fentora is formulary (verification of therapies required)

Examples of intolerance to the lozenge sugar content include glucose intolerance, diabetes, or high risk of dental caries.

Coverage for Subsys (fentanyl sublingual spray) is limited to the situations described in the criteria. Any use of Subsys that does not meet the specified coverage criteria is considered not medically necessary.

Requests for Subsys that fall outside the listed criteria and exceptions in this policy are considered not medically necessary. No other exceptions beyond the stated criteria will be covered.

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization required — Subsys is covered as medically necessary only when specified breakthrough cancer pain criteria are met.

Approval duration: 6 months when criteria are met

Step Therapy

Transmucosal Fentanyl Step Requirement

Transmucosal fentanyl step requirement — patient must have tried two formulary short-acting transmucosal fentanyl products (or adjusted per formulary availability). Examples include fentanyl citrate oral transmucosal lozenge (Actiq, generic) and Fentora; if only one is formulary then one trial is required, and if none are formulary this step may be waived.

If only one transmucosal fentanyl product is on formulary, one trial required
If none are formulary, the transmucosal trial requirement may be adjusted

Documentation Required

Required Documentation

Required documentation — clinician verification of prior trials when referenced as verification of therapies. The Coverage Review Department must have clinician-documented evidence of prior trials or reasons why trials could not be completed (e.g., allergy, severe adverse event, intolerance to sugar content).

Document trials of two short-acting transmucosal fentanyl products when indicated
Document intolerance or contraindication (e.g., allergy, severe adverse event, inability to swallow, dysphagia, mucositis, uncontrollable nausea/vomiting, sugar intolerance)

Denial Risk

Denial for Failure to Meet Criteria

Denial for failure to meet criteria — requests that do not meet the specified criteria (including lack of required prior trials, absence of documentation, or not meeting breakthrough cancer pain and concomitant long-acting narcotic requirements) are not medically necessary and may be denied.

Denial risk if criteria A, B, and C for breakthrough cancer pain are not met
Denial risk if clinician verification of prior trials is not provided

Background

This policy addresses use of transmucosal fentanyl (Subsys) for short-term management of breakthrough pain in patients with cancer who are already receiving around-the-clock opioid therapy. Subsys is intended for opioid-tolerant patients with severe breakthrough pain episodes and is covered only when the documented clinical criteria are met, including demonstrated need due to inability to use or adverse reactions to other options, appropriate background long-acting or parenteral/spinal opioid therapy, and verification of prior transmucosal fentanyl trials or documented intolerance where applicable.

Key Definitions

inv-09: Breakthrough pain in patients with cancer — definition entry

DefinitionBreakthrough pain in patients with cancer (policy context): transient, severe episodes of pain occurring despite around‑the‑clock opioid therapy in patients with cancer; Subsys covered when criteria A, B, and C are met and approved for 6 months.

ContextPolicy applies to use of Subsys (fentanyl sublingual spray) as a formulary exception for breakthrough cancer pain in opioid‑tolerant patients.

Approval durationApproval provided for 6 months when criteria are met (changed from 1 year).

inv-10: Short-acting narcotics — examples (immediate-release oxycodone, morphine sulfate, hydromorphone)

ExamplesImmediate‑release oxycodone

ExamplesMorphine sulfate (immediate‑release)

ExamplesHydromorphone (immediate‑release)

NoteThese are listed as examples of short‑acting narcotics referenced in criteria A (ii).

inv-11: Long-acting or parenteral/spinal narcotics — examples (transdermal fentanyl, OxyContin, morphine ER, parenteral/spinal examples)

Examples — long‑actingTransdermal fentanyl (Duragesic)

Examples — long‑actingOxyContin (oxycodone extended‑release)

Examples — long‑actingMorphine extended‑release

Examples — parenteral/spinalIntravenous/subcutaneous/spinal opioids such as morphine sulfate, hydromorphone, and fentanyl citrate

Initial Therapy Criteria

Initial Therapy

Initial coverage criteria for Subsys:

Initial criteria summary: Patient with cancer experiencing breakthrough pain who meets criteria A, B, and C as specified6 months

Approve for 6 months when all criteria are met.

Step Therapy and Prior Therapy Verification

Step	Requirement	Verification
1
Patient must have tried two formulary short-acting transmucosal fentanyl products (or one if only one is formulary, or none if none are formulary); alternatively, if the patient cannot tolerate the sugar content of the fentanyl citrate lozenge (e.g., glucose intolerance, diabetes, or high risk of dental caries), the patient must have tried Fentora if Fentora is formulary.
Clinician verification of prior trials of other fentanyl transmucosal therapies is required when referenced; documentation must support the trial(s) or intolerance as specified.

Continuation and Approval Duration

Continuation/Approval Duration

Approval duration and continuation:

Approval duration: Approvals are provided for 6 months when criteria are met6 months

Changed from 1 year to 6 months per history.