CurrentNeighborhood Health Plan of Rhode IslandPolicy 288-C 02-2022

Oral and Intranasal Fentanyl Prior Authorization

Defines prior authorization, quantity limits, and coverage criteria for oral and intranasal fentanyl products for breakthrough cancer pain in opioid-tolerant patients; applies to pharmacy benefit adjudication for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOral and Intranasal Fentanyl Prior Authorization

Policy CodePolicy 288-C 02-2022

Change TypeNo material changes

Effective DateFeb 1, 2022

Next Review Date

Key ActionPrescriber must submit chart notes or other documentation showing cancer-related breakthrough pain and that the patient is opioid tolerant and receiving around-the-clock opioid therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

120/25dTypical quantity limit for most products

30/25dTypical quantity limit for Lazanda

≥60 mg MED/dayOpioid-tolerant threshold

Cancer onlyIndication restriction

Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

inv-01: Initial Therapy

Covered when ALL of the following are met:

Primary coverage requirements: 1) The requested drug is prescribed for breakthrough CANCER-related pain in a patient with underlying cancer pain (ICD diagnosis code provided must support the cancer-related diagnosis).; 2) Chart notes or other documentation supporting a diagnosis of cancer-related pain and the type of cancer have been submitted.; 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 dose equivalents).; 5) For outpatient dispensing, patient and prescriber enrollment in the TIRF REMS Access program is required when applicable.

See policy for full opioid-tolerance dose equivalents and REMS requirements.

inv-02: Exceptions for additional quantities

Additional quantities may be approved when EITHER:

Additional quantity conditions: A) The patient’s dose of a concomitant long-acting analgesic is being increased.; OR B) Additional quantities of the requested drug are needed because the dose of the patient’s long-acting analgesic cannot be increased.

Ensure the patient can safely take the requested dose based on their opioid history; quantity limits apply (see quantity limits and titration allowances).

Not for use in opioid non-tolerant patients. These products are not indicated for acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency department. (See policy Limitations of Use for full details.)

Use of oral or intranasal fentanyl products for non-cancer–related pain or in patients who are opioid non‑tolerant is not covered/not approved under this policy. Prior authorization approval is limited to management of breakthrough cancer‑related pain with documentation supporting the cancer diagnosis and opioid tolerance.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Abstral, Actiq, Fentora, Lazanda, and Subsys. Approval is limited to treatment of breakthrough cancer-related pain in patients enrolled in the TIRF REMS Access program (outpatients) and requires submission of supporting documentation including chart notes that list the type of cancer. The ICD diagnosis code submitted must support a cancer-related diagnosis.

Affected products: Abstral, Actiq, Fentora, Lazanda, Subsys
Requirement: Documentation of cancer-related breakthrough pain and type of cancer; ICD diagnosis code MUST support cancer-related diagnosis
TIRF REMS: Outpatient dispensing requires patient and prescriber enrollment in TIRF REMS; inpatient administration does not require enrollment

Step Therapy

Quantity / Step Limits

Quantity limits apply to all oral/intranasal fentanyl products. Standard and temporary (titration/inability to increase long-acting analgesic) limits are defined; additional quantities may be authorized when the patient is undergoing dose titration of the concomitant long-acting analgesic or when the long-acting analgesic cannot be increased.

Standard quantity limits: Abstral/Actiq/Fentora/Subsys (200–800 mcg): 120 units per 25 days or 360 units per 75 days; Lazanda: 30 bottles per 25 days or 90 per 75 days; Higher-strength Subsys (1200/1600 mcg): 240 sprays per 25 days or 720 per 75 days
Titration/additional allowance: e.g., Abstral (100–400 mcg)/Actiq/Fentora/Subsys (200–800 mcg): 180 units per 25 days or 540 per 75 days; Lazanda 100 mcg: 45 bottles per 25 days or 135 per 75 days; Subsys (1200/1600 mcg): 360 sprays per 25 days or 1080 per 75 days
Note: 25 days corresponds to a 30-day fill period and 75 days corresponds to a 90-day fill period

Documentation Required

Required Documentation

The prescriber must submit chart notes or other documentation supporting a diagnosis of cancer-related pain and list the type of cancer. For approval, documentation must demonstrate the patient is receiving around-the-clock opioid therapy for underlying cancer pain and is opioid-tolerant per defined thresholds.

Required documentation: chart notes or equivalent confirming cancer-related breakthrough pain and type of cancer
Must show patient is on around-the-clock opioid therapy for underlying cancer pain and will continue to receive it
Opioid tolerance definition: e.g., ≥60 mg oral morphine/day, ≥25 mcg/hr transdermal fentanyl, ≥30 mg oral oxycodone/day, ≥60 mg oral hydrocodone/day, ≥8 mg oral hydromorphone/day, ≥25 mg oral oxymorphone/day, or equianalgesic dose of another opioid daily for ≥1 week

Denial Risk

Denial Risk: Missing / Non‑indicated Documentation or Non‑tolerant Patient

Requests will be denied if the ICD diagnosis code does not support a cancer-related diagnosis or if chart notes do not document cancer-related pain. Requests will also be denied for non-indicated uses (non-cancer pain, acute or postoperative pain, headache/migraine, dental pain, emergency department use) or if the patient is not opioid-tolerant.

Denial triggers: ICD code not supporting cancer-related diagnosis or absence of documentation of cancer-related pain
Not indicated: non-cancer pain, acute/postoperative pain (including headache/migraine, dental pain), or emergency department use
Opioid non-tolerant patients: not eligible for coverage

Initial Authorization Criteria

inv-15: Initial authorization

Initial authorization requires documentation of cancer-related breakthrough pain and opioid tolerance; Actiq has age ≥16 indication noted.

Initial authorization nodes: Prescriber submits documentation (chart notes or equivalent) supporting a diagnosis of cancer-related breakthrough pain and lists the type of cancer (ICD code must support cancer-related diagnosis).; The patient is currently receiving, and will continue to receive, around-the-clock opioid therapy for underlying cancer pain.; The patient meets the policy definition of opioid tolerant (see opioid-tolerance dose equivalents).; For outpatients, dispensing is subject to TIRF REMS enrollment when applicable.; Note: Actiq labeling indicates use in patients 16 years of age and older; other listed products are indicated for 18+ per labeling.

Documentation must support opioid tolerance and safe use of the requested dose.

Step Therapy and Titration Rules

Condition	Policy rule / quantity limits
Additional quantities during dose titration
For patients undergoing dose titration (increase) of their concomitant long-acting analgesic: Abstral (100, 200, 300, 400 mcg), Actiq (all strengths), Fentora (all strengths), Subsys (200, 400, 600, 800 mcg): 180 units per 25 days OR 540 units per 75 days; Lazanda 100 mcg: 45 bottles per 25 days OR 135 bottles per 75 days; Subsys (1200 mcg, 1600 mcg): 360 sprays (180 blisters) per 25 days OR 1080 sprays (540 blisters) per 75 days.
Additional quantities when long-acting analgesic cannot be increased
{"text":"If additional quantities are needed because the dose of the patient\'s long-acting analgesic cannot be increased: follow the same increased limits as for titration (see above). Ensure patient can safely take the requested dose based on opioid history.","status":""}

Quantity Limits by Product

Abstral, Actiq, Fentora, Subsys (200–800 mcg) quantity limits

Standard limit (25-day)120 units per 25 days for Abstral, Actiq, Fentora, and Subsys (200-800 mcg)

Standard limit (75-day)360 units per 75 days for Abstral, Actiq, Fentora, and Subsys (200-800 mcg)

Titration limit (25-day)180 units per 25 days during dose titration

Titration limit (75-day)540 units per 75 days during dose titration

Lazanda quantity limits

Standard limit (25-day)30 bottles per 25 days for Lazanda (all strengths)

Standard limit (75-day)90 bottles per 75 days for Lazanda (all strengths)

Titration limit for 100 mcg (25-day)45 bottles per 25 days during titration for Lazanda 100 mcg

Titration limit for 100 mcg (75-day)135 bottles per 75 days during titration for Lazanda 100 mcg

Subsys (1200 mcg, 1600 mcg) quantity limits

Standard limit (25-day)240 sprays (120 blisters) per 25 days for Subsys 1200 mcg and 1600 mcg

Standard limit (75-day)720 sprays (360 blisters) per 75 days for Subsys 1200 mcg and 1600 mcg

Titration limit (25-day)360 sprays (180 blisters) per 25 days during titration

Titration limit (75-day)1080 sprays (540 blisters) per 75 days during titration

Background

Oral and intranasal fentanyl products are rapid‑acting transmucosal opioids indicated for management of breakthrough pain in patients with underlying cancer pain. These agents must be used only in patients who are already receiving and will continue to receive around‑the‑clock opioid therapy and who meet the policy definition of opioid tolerant (minimum equianalgesic dose of at least 60 mg oral morphine per day or an equivalent; see policy for full list of equivalents). Outpatient dispensing of transmucosal immediate‑release fentanyl (TIRF) products requires patient and prescriber enrollment in the TIRF REMS Access program when applicable; inpatient administration in hospitals, hospices, or long‑term care settings does not require REMS enrollment.

Definitions

Opioid tolerant (definition)

Definition (summary)Opioid tolerant: taking around-the-clock opioid therapy equivalent to at least 60 mg oral morphine/day for one week or longer

Transdermal fentanyl equivalentAt least 25 mcg/hr transdermal fentanyl

Oral oxycodone equivalentAt least 30 mg oral oxycodone/day

Oral hydrocodone equivalentAt least 60 mg oral hydrocodone/day

Other equianalgesic dosesAt least 8 mg oral hydromorphone/day or 25 mg oral oxymorphone/day or equianalgesic dose of another opioid

TIRF REMS enrollment

TIRF REMS Access program requirementOutpatient dispensing of transmucosal immediate‑release fentanyl (TIRF) products requires patient and prescriber enrollment in the TIRF REMS Access program

Inpatient exceptionInpatient administration in hospitals, hospices, and long‑term care does not require patient or prescriber REMS enrollment

ScopeREMS requirement applies specifically to outpatient dispensing of oral/intranasal fentanyl products

OpenPayer