CurrentNeighborhood Health Plan of Rhode IslandPolicy 288-C

Oral Transmucosal Fentanyl Products (Actiq, Fentora) — Coverage Criteria

Coverage rules for oral fentanyl products (Actiq and Fentora) for management of breakthrough cancer-related pain in opioid-tolerant patients; applies to prescribers and pharmacists reviewing prior authorization for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOral Transmucosal Fentanyl Products (Actiq, Fentora) — Coverage Criteria

Policy CodePolicy 288-C

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart notes confirming cancer-related pain, opioid tolerance per equianalgesic thresholds, and plan to remain on around-the-clock opioids.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

120standard quantity limit (30-day fill)

360standard quantity limit (90-day fill)

180titration limit (30-day)

540titration limit (90-day)

12duration of approval (months)

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Coverage Criteria for Oral Transmucosal Fentanyl

Initial Therapy

Covered when ALL of the following are met:

Initial authorization criteria: 1) Drug is prescribed for management of breakthrough pain in a patient with underlying cancer-related pain; documentation (chart notes and cancer type) must be provided and the ICD diagnosis code must support the cancer-related diagnosis.

[ACTION REQUIRED: Documentation required]

Opioid tolerance: 2) Patient is opioid tolerant: has been taking for ≥ 1 week around-the-clock opioids at or above the specified equianalgesic doses; patient will remain on around-the-clock opioids when taking the requested oral fentanyl product.see opioid tolerance thresholds

Indication restriction: 3) Indication is breakthrough cancer-related pain only; not for acute/postoperative pain, headache/migraine, dental pain, or emergency department use.

TIRF REMS outpatient dispensing requirements also apply.

Additional quantities: If additional quantities are requested, patient must meet ONE of: a) the dose of a concomitant long-acting analgesic is being increased; OR b) additional quantities are needed because the long-acting analgesic dose cannot be increased.

These oral transmucosal fentanyl products are not indicated for opioid non‑tolerant patients. Requests for use in opioid non‑tolerant individuals will be denied. In addition, these products are not for management of acute or postoperative pain and must not be used for headache/migraine, dental pain, or for treatment in the emergency department.

Outpatient dispensing is restricted under the TIRF REMS program: outpatient pharmacies may only dispense these oral fentanyl products to outpatients who are enrolled in the REMS. Inpatient administration is exempt from patient and prescriber enrollment requirements.

Initial Therapy Requirements

Initial Therapy — documentation and opioid tolerance

Initial approval requires documentation and opioid tolerance per thresholds.

Documentation requirement: Prescriber must submit chart notes or other documentation supporting a diagnosis of cancer-related pain and list the type of cancer; the ICD diagnosis code provided must support the cancer-related diagnosis.

[ACTION REQUIRED: Documentation required]

Opioid tolerance documentation: Documentation that the patient has been taking, for ≥ 1 week, around-the-clock opioids at or above the specified equianalgesic doses is required; the patient must be expected to remain on around-the-clock opioid therapy while using the oral fentanyl product.see opioid tolerance thresholds

Prescribing and safety note: The requested oral fentanyl product must be intended for breakthrough cancer-related pain and prescribed only by clinicians knowledgeable about opioid use and risk mitigation.

Continuation and Additional Quantity Criteria

Continuation/Additional Quantities

Criteria for additional quantities or continuation when dosing changes occur

Continuation/additional quantity conditions: Patient's dose of a concomitant long-acting analgesic is being increased OR additional quantities are needed because the long-acting analgesic dose cannot be increased; quantity limits and higher limits for titration may apply.See quantity limits: standard 120 units/25 days (360/75 days) or titration 180 units/25 days (540/75 days)

See quantity limits for specific allowed quantities during titration or when long-acting analgesic cannot be increased.

Quantity Limits for Oral Fentanyl Products

Quantity limits — oral fentanyl products (all forms/strengths)

Standard quantity limit (30-day fill)120 units per 25 days (used for a 30-day fill)

Standard quantity limit (90-day fill)360 units per 75 days (used for a 90-day fill)

Dose-titration / additional quantity (30-day fill)180 units per 25 days (used for a 30-day fill when titrating or unable to increase long-acting analgesic)

Dose-titration / additional quantity (90-day fill)540 units per 75 days (used for a 90-day fill when titrating or unable to increase long-acting analgesic)

Rationale for day-periods25 days corresponds to a 30-day fill and 75 days corresponds to a 90-day fill to allow time for refill processing.

Opioid Tolerance Equianalgesic Thresholds

Opioid tolerance equianalgesic thresholds

Oral morphine equivalent threshold>= 60 mg oral morphine per day

Transdermal fentanyl threshold>= 25 mcg transdermal fentanyl per hour

Oral oxycodone threshold>= 30 mg oral oxycodone per day

Oral hydromorphone threshold>= 8 mg oral hydromorphone per day

Oral oxymorphone threshold>= 25 mg oral oxymorphone per day

Oral hydrocodone threshold>= 60 mg oral hydrocodone per day

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for oral fentanyl products prescribed for breakthrough cancer-related pain. Approval requires documentation supporting a cancer diagnosis and that the request meets the policy's clinical criteria.

Prior authorization required for breakthrough cancer pain
Prescriber must submit chart notes or other documentation supporting a diagnosis of cancer-related pain and list the type of cancer
ICD diagnosis code provided MUST support the cancer-related diagnosis

Documentation Required

Cancer diagnosis and chart documentation

The prescriber must submit chart notes or other documentation supporting a diagnosis of cancer-related pain and list the type of cancer. Documentation must demonstrate that the requested drug is being prescribed for management of breakthrough pain in a patient with underlying cancer-related pain.

Site-of-Care Restrictions

Billing Rule

TIRF REMS enrollment required for outpatient dispensing

Outpatient pharmacies may dispense oral fentanyl products only to outpatients enrolled in the TIRF REMS program; inpatient administration does not require patient and prescriber enrollment.

Definitions

Opioid tolerant — examples of equivalent dosing (≥1 week)

Definition — opioid tolerantTaking, for one week or longer, around-the-clock opioids at or above specified equianalgesic doses (examples below); patient must remain on around-the-clock opioids when using oral fentanyl.

Example 1>= 60 mg oral morphine per day

Example 2>= 25 mcg transdermal fentanyl per hour

Example 3>= 30 mg oral oxycodone per day

Example 4>= 8 mg oral hydromorphone per day

Background

Actiq and Fentora are oral transmucosal fentanyl products intended for management of breakthrough cancer pain in opioid‑tolerant patients who are already receiving around‑the‑clock opioid therapy. Use is limited to cancer‑related breakthrough pain and is not appropriate for opioid non‑tolerant patients or for acute/postoperative pain scenarios.

Because these agents are part of the Transmucosal Immediate‑Release Fentanyl (TIRF) REMS, outpatient dispensing requires that the outpatient patient be enrolled in the REMS program; inpatient use does not require patient or prescriber enrollment.