CurrentCignaPolicy N/A

Opioids Transmucosal - Subsys Formulary Exception Policy

Defines medical necessity criteria and authorization rules for coverage of Subsys (fentanyl sublingual spray) as a formulary exception for breakthrough cancer pain for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyOpioids Transmucosal - Subsys Formulary Exception Policy

Policy CodePolicy N/A

Change TypeApproval duration reducedformulary options updated

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and verify trials of other transmucosal fentanyl therapies; approvals granted for 6 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Approval duration changed from 1 year to 6 months.

Removed Abstral and Lazanda as formulary options in the breakthrough pain criteria.

Changed examples of patients who cannot tolerate the sugar content of fentanyl lozenge to a note (e.g., glucose intolerant, diabetic, high risk of dental caries).

6 monthsstandard approval duration for Subsys when criteria met

2prior short-acting fentanyl options generally required

1long-acting opioid requirement

Coverage Criteria

Breakthrough Pain in Patients with Cancer

Subsys is covered as medically necessary for breakthrough cancer pain when ALL of the following are met:

Overall requirement

A) Unable to use oral route or intolerant to other short-acting narcotics: Patient meets ONE of: (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: immediate-release formulations of oxycodone, morphine sulfate, and hydromorphone.
B) Background opioid requirement: Patient is on or will be on an oral or transdermal long-acting narcotic, or the patient is on intravenous, subcutaneous, or spinal (intrathecal, epidural) narcotics
Examples of long-acting narcotics include Duragesic, OxyContin, and morphine extended-release; parenteral examples include morphine sulfate, hydromorphone, and fentanyl citrate.

Policy Summary

PayerCigna

PolicyOpioids Transmucosal - Subsys Formulary Exception Policy

Policy CodePolicy N/A

Change TypeApproval duration reducedformulary options updated

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and verify trials of other transmucosal fentanyl therapies; approvals granted for 6 months when criteria 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) for 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 sugar content of Actiq: glucose intolerant, diabetic, or at high risk of dental caries.

Any use of Subsys (fentanyl sublingual spray) for indications other than breakthrough pain in patients with cancer, or any use that does not meet ALL of the required criteria (A, B, and C), is considered not medically necessary.

Any exception requests that do not satisfy the specified coverage criteria for breakthrough cancer pain (the required elements A, B, and C) will be considered not medically necessary and are subject to denial.

Initial Therapy

Initial therapy

Initial coverage criteria for Subsys

Initial criteria: See Breakthrough Pain in Patients with Cancer criteria (A, B, C).

Approval for 6 months if met.

Continuation / Approval Duration

Continuation/Approval Duration

Approval duration for continued therapy when criteria met

Approval duration: Approvals provided for 6 months when criteria met

Renewal would require documentation meeting the same clinical criteria.

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are provided for 6 months when all criteria for breakthrough cancer pain are met. Clinician documentation must support the criteria listed in the policy.

Approval duration: 6 months
Criteria: A, B, and C must be met

Denial Risk

Denial Risk for Unmet Criteria

Requests that do not meet all listed criteria for breakthrough cancer pain (A, B, and C) will be considered not medically necessary and may be denied.

Documentation Required

Transmucosal Fentanyl Trial Verification

When the criteria indicate "[verification of therapies required]," the clinician must verify prior trials of other fentanyl transmucosal therapies. Verification will be reviewed by the Coverage Review Department.

Clinician verification required for prior trials of other fentanyl transmucosal therapies
Verification reviewed by Coverage Review Department

Documentation Required

Verification of Prior Therapies and Clinical Documentation

Clinician must document trials (or documented intolerance/allergy) of other short-acting narcotics and the use of long-acting or parenteral narcotics as specified in criteria A and B when applicable.

Document trials or intolerance/allergy to two short-acting narcotics when required
Document current or planned use of long-acting oral/transdermal or IV/subcutaneous/spinal narcotics

Drug Coding

Drug referencedNDC | mixed

Subsys

fentanyl sublingual spray - West Therapeutic Development (brand name referenced)

Step Therapy / Prior Trials

Requirement	Details
Verification of prior transmucosal fentanyl trials
Clinician must verify previous trials of other fentanyl transmucosal therapies when the criteria specify [verification of therapies required]; verification is completed by the clinician in the Coverage Review Department.
When required in criterion C(i)
Patient 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 required.
When required in criterion C(ii)
For patients who cannot tolerate the sugar content of Actiq (e.g., glucose intolerant, diabetic, or high risk of dental caries), the patient must have tried Fentora if Fentora is formulary — verification required.

Definitions

inv-10: Breakthrough pain (cancer) — definition and criteria

DefinitionBreakthrough pain in patients with cancer: episodic exacerbations of pain occurring despite baseline long-acting opioid therapy; eligibility for Subsys requires meeting all criteria A, B, and C.

A) Unable to use oral route or intolerant to other short-acting narcoticsPatient meets ONE: (i) unable to swallow, has dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting; OR (ii) unable to take two other short-acting narcotics due to allergy or severe adverse events.

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

C) Prior transmucosal fentanyl trials or intolerancePatient meets ONE: (i) has tried two of the following (if two are formulary): fentanyl citrate oral transmucosal lozenge (Actiq, generic) or Fentora [verification of therapies required]; OR (ii) if cannot tolerate the sugar content of the lozenge, has tried Fentora if formulary [verification required].

Approval durationIf A, B, and C are met, approve Subsys for 6 months.

inv-11: Short-acting and long-acting narcotics (examples) — examples of agents

Short-acting narcotics (examples)Immediate-release oxycodone; morphine sulfate (immediate-release); hydromorphone (immediate-release).

Long-acting narcotics (examples)Transdermal fentanyl (Duragesic); OxyContin (oxycodone ER); morphine extended-release (morphine ER).

Parenteral/spinal narcotics (examples)Morphine sulfate (IV/SC), hydromorphone (IV/SC), fentanyl citrate (IV/SC or spinal).

Background

Transmucosal fentanyl products, including Subsys, are intended for management of breakthrough pain in patients with cancer who are already opioid‑tolerant on around‑the‑clock opioid therapy. Sublingual spray is an option when patients cannot use or have failed other short‑acting transmucosal fentanyl formulations; coverage requires documentation that the patient meets the policy criteria, including inability to use the oral route or intolerance to other short‑acting narcotics (A), concurrent use of a long‑acting or parenteral/spinal opioid (B), and prior trials of or intolerance to other transmucosal fentanyl products as specified (C).

Site of Care

Note

Home site-of-care — subject to benefit plan terms

Coverage determinations for home administration are subject to the terms of the applicable benefit plan and any applicable laws/regulations; site-of-care rules are governed by the benefit plan.

Review the member's specific benefit plan document for site-of-care coverage rules and any plan-specific exclusions or requirements.