CurrentNeighborhood Health Plan of Rhode IslandPolicy 288-C 02-2023

Oral fentanyl products prior authorization and quantity limits (Actiq, Fentora, Subsys)

Defines prior authorization, clinical documentation, opioid-tolerance requirements, and quantity limits for oral fentanyl products (Actiq, Fentora, Subsys) for treatment of breakthrough cancer-related pain for members of Neighborhood Health Plan of Rhode Island (CVS Caremark criteria).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOral fentanyl products prior authorization and quantity limits (Actiq, Fentora, Subsys)

Policy CodePolicy 288-C 02-2023

Change TypeNo material change

Effective DateFeb 2, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes and an ICD code supporting a cancer-related diagnosis and documentation that the patient is opioid tolerant and maintained on around-the-clock opioids.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3brand products listed (Actiq, Fentora, Subsys)

25 / 75 daysquantity-limit windows

definedopioid-tolerance threshold

cancer-onlyindication restriction

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inv-01: Initial prior authorization criteria

Covered when ALL of the following are met:

Covered criteria: 1) The requested drug is prescribed for management of breakthrough CANCER-related pain; 2) The prescriber submits chart notes or other documentation supporting a cancer-related diagnosis and lists the type of cancer; 3) The patient is currently receiving, and will continue to receive, around-the-clock opioid therapy for underlying cancer pain; 4) The patient is opioid tolerant as defined by the policy (see opioid tolerance thresholds); 5) The requested drug is intended only for use in opioid-tolerant patients and the patient can safely take the requested dose based on their opioid history; 6) Quantity limits are respected or justification provided for additional quantity.

ICD diagnosis code provided MUST support the cancer-related diagnosis.

inv-02: Additional quantity approval conditions

Additional quantities may be approved when ONE of the following applies:

Additional quantity conditions: - The patient's dose of a concomitant long-acting analgesic is being increased; - Additional quantities of the requested drug are needed for breakthrough pain because the dose of the patient's long-acting analgesic is unable to be increased.

Ensure the patient can safely take the requested dose based on opioid history; Quantity limits apply.

This class of oral transmucosal fentanyl products is not for use in opioid non‑tolerant patients. These agents are not indicated for management of acute or postoperative pain, including headache/migraine, dental pain, or emergency department use. Outpatient dispensing is subject to the TIRF REMS Access program requirements (inpatient administration in hospitals, hospices, and long‑term care facilities is handled per institutional policies).

Coverage is restricted to treatment of breakthrough cancer‑related pain in patients with underlying cancer pain. Use for non‑cancer pain or use in patients who are not opioid tolerant is not covered. Prior authorization requires documentation that the prescription is for cancer‑related breakthrough pain and that the patient meets opioid‑tolerance and around‑the‑clock opioid therapy requirements.

Initial Therapy

inv-15: Initial therapy

Initial approval limited to opioid-tolerant patients with documented cancer-related breakthrough pain and continued around-the-clock opioid therapy.

Initial approval nodes: - Medication is for management of breakthrough cancer-related pain only (FDA-approved indications for Actiq, Fentora, Subsys); - Prescriber must provide chart notes and an ICD diagnosis code that supports a cancer-related diagnosis and list the type of cancer; - Patient must be currently receiving and will continue to receive around-the-clock opioid therapy for underlying cancer pain; - Patient must meet the policy definition of opioid tolerant (e.g., at least 60 mg oral morphine per day or equivalent); - The requested drug is intended only for use in opioid-tolerant patients and the patient can safely take the requested dose based on their opioid history; - Quantity limits must be respected unless justification for additional quantity is provided per policy.

Refer to opioid tolerance thresholds and quantity limits in policy.

Continuation Therapy

inv-16: Continuation therapy

Continuation requires documented ongoing around-the-clock opioid therapy and continued cancer-related pain.

Continuation: Patient must remain on around-the-clock opioids when taking the requested oral fentanyl product and continue to have cancer-related pain requiring breakthrough therapy.

Documentation of ongoing around-the-clock opioid therapy must be provided.

Coding & Diagnostic Requirements

Diagnosis requirementICD-10

No codes listed

Quantity specification (units/sprays/blisters)NDC | mixed

No codes listed

Opioid tolerance thresholds

Minimum daily opioid-equivalentAt least 60 mg oral morphine per day (or an equianalgesic dose of another opioid) for one week or longer

Transdermal fentanyl equivalentAt least 25 mcg/hour transdermal fentanyl

Other oral opioid equivalentsAt least 30 mg oral oxycodone/day; at least 60 mg oral hydrocodone/day; at least 8 mg oral hydromorphone/day; at least 25 mg oral oxymorphone/day

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be approved only when documentation shows the drug is prescribed for breakthrough cancer-related pain.

Note

Concomitant Long-Acting Analgesic Considerations

Additional quantities may be approved when a concomitant long-acting analgesic dose is being increased or cannot be increased.

Documentation Required

Chart Notes and ICD Diagnosis

Prescriber must submit chart notes or documentation confirming a cancer-related diagnosis and type of cancer; ICD diagnosis code preferred.

Denial Risk

Documentation Supports Cancer Diagnosis Required

Requests lacking supporting ICD diagnosis or chart notes will be at risk for denial. Ensure chart notes or other documentation supporting a diagnosis of cancer-related pain are submitted; the ICD diagnosis code provided must support the cancer-related diagnosis.

Quantity Limits

Subsys (1200 mcg; 1600 mcg) quantity limits

Standard quantity (25 days)240 sprays (120 blisters) per 25 days

Standard quantity (75 days)720 sprays (360 blisters) per 75 days

Product strengthsApplies to Subsys 1200 mcg and 1600 mcg strengths

Actiq, Fentora, Subsys (100–800 mcg) quantity limits

Standard quantity (25 days)120 units per 25 days

Standard quantity (75 days)360 units per 75 days

Expanded quantity (titration or when long-acting analgesic cannot be increased)Up to 180 units per 25 days OR 540 units per 75 days

Applicable productsActiq (all strengths), Fentora (all strengths), Subsys (100, 200, 400, 600, 800 mcg)

Step Therapy / Additional Documentation

Documentation requirement	When applicable
Chart notes or other clinical documentation confirming that the patient's dose of a concomitant long-acting (around-the-clock) analgesic is being increased	When the additional quantity request is to support an increase in the long-acting analgesic dose
Documentation that the long-acting analgesic dose cannot be increased and additional short-acting oral fentanyl is needed for breakthrough pain	When the requested additional quantity is for situations where the long-acting analgesic dose cannot be increased
Evidence the patient is opioid tolerant and maintained on around-the-clock opioids (per policy opioid-tolerant definition)	Required for all requests that seek quantities beyond standard limits
Statement or notes ensuring the patient can safely take the requested dose based on opioid use history	Required whenever additional quantity is requested; reviewer must confirm safety given opioid history
Quantity limits calculation (note: quantity limits still apply)	Applies to all additional quantity requests — specify units (sprays, blisters, or units) and per-day window as appropriate

Definitions

Opioid tolerant — definition and examples

Primary definitionOpioid tolerant: taking around-the-clock opioid therapy equivalent to at least 60 mg oral morphine per day (for one week or longer)

Examples of equivalent regimensAt least 25 mcg/hour transdermal fentanyl; at least 30 mg oral oxycodone/day; at least 60 mg oral hydrocodone/day

Additional examplesAt least 8 mg oral hydromorphone/day; at least 25 mg oral oxymorphone/day; or an equianalgesic dose of another opioid daily for one week or longer

TIRF REMS access

Outpatient dispensing requirementOral fentanyl products may be dispensed only to outpatients enrolled in the TIRF REMS Access program

Inpatient administrationInpatient use in hospitals, hospices, and long-term care facilities does not require patient or prescriber enrollment for inpatient administration

Program purposeTIRF REMS Access program enforces safe distribution of transmucosal immediate-release fentanyl products to outpatients