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ph-1076

Transmucosal Immediate Release Fentanyl (TIRF) Prior Authorization (Through Generic) and Quantity Limit Program Summary

Policy Number: PH-1076

This program applies to Commercial, Blue Partner, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
4/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Actiq® (fentanyl)* Transmucosal lozenge	Management of breakthrough pain in cancer patients 16 years of age and older who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain	*- Generic equivalent available	2
Fentora®, Fentanyl Buccal tablet	Management of breakthrough pain in cancer patients 18 years of age and older who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain		3
Lazanda® (fentanyl) Nasal spray	Management of breakthrough pain in cancer patients 18 years of age and older who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain		4
Subsys® (fentanyl) Sublingual spray	Management of breakthrough pain in cancer patients 18 years of age and older who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain		5

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Transmucosal immediate release fentanyl (TIRF) products are indicated only in patients who are already receiving opioid therapy and who are tolerant to opioid therapy. Life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily. Patients must remain on around-the-clock opioids while taking TIRF products. TIRF products are not bioequivalent with other TIRF products. Patients should not be converted on a mcg per mcg basis from one TIRF product to another.(2-5)

Safety

TIRF products carry a boxed warning for the following:(2-5)

Life-threatening respiratory depression
Accidental ingestion, especially by children
Concomitant use with CYP3A4 inhibitors
Concomitant use with benzodiazepines and/or other CNS depressants
Risk of medication errors (e.g. conversion or substitution with other fentanyl products)
Addiction, abuse, and misuse
Risk Evaluation and Mitigation Strategy
Neonatal opioid withdrawal syndrome (i.e., prolonged use during pregnancy)

TIRF products have the following contraindications:(2-5)

Opioid non-tolerant patients
Significant respiratory depression
Management of acute or postoperative pain including headache, migraines, dental pain, or use in the emergency department
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment
Known or suspected gastrointestinal obstruction
Known hypersensitivity to fentanyl or any other components of the agent

Actiq, Fentora, Lazanda, and Subsys are available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.(2-5)

For additional clinical information see Prime Therapeutics Formulary Chapter 10.2A: Opioid Analgesics.

REFERENCES

Number	Reference
1	~~Abstral prescribing information. Sentynl Therapeutics, Inc. October 2019.~~ Reference no longer used.
2	Actiq prescribing information. Cephalon, Inc. March 2021.
3	Fentora prescribing information. Cephalon, Inc. March 2021.
4	Lazanda prescribing information. West Therapeutic Development, LLC. March 2021.
5	Subsys prescribing information. Insys Therapeutics, Inc. April 2021.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Preferred Status	Effective Date

Actiq	fentanyl citrate lozenge on a handle	1200 MCG ; 1600 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	M ; N ; O ; Y	O ; Y
Fentora	fentanyl citrate buccal tab	100 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	M ; N ; O ; Y	M
Lazanda	Fentanyl Citrate Nasal Spray 100 MCG/ACT (Base Equiv)	100 MCG/ACT	M ; N ; O ; Y	N
Lazanda	Fentanyl Citrate Nasal Spray 400 MCG/ACT (Base Equiv)	400 MCG/ACT	M ; N ; O ; Y	N
Subsys	fentanyl sublingual spray	100 MCG ; 1200 MCG ; 1600 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	M ; N ; O ; Y	N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Days Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist	Effective Date

Actiq	fentanyl citrate lozenge on a handle	1200 MCG ; 1600 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	120.0	LOZNGS	30	Days
Fentora	fentanyl citrate buccal tab	100 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	120.0	TABS	30	Days
Lazanda	Fentanyl Citrate Nasal Spray 100 MCG/ACT (Base Equiv)	100 MCG/ACT	30.0	BOTTS	30	Days
Lazanda	Fentanyl Citrate Nasal Spray 400 MCG/ACT (Base Equiv)	400 MCG/ACT	30.0	BOTTS	30	Days
Subsys	Fentanyl Sublingual Spray 100 MCG	100 MCG	120.0	SPRAYS	30	Days
Subsys	Fentanyl Sublingual Spray 1200 MCG (600 MCG X 2)	1200 MCG	240.0	SPRAYS	30	Days
Subsys	Fentanyl Sublingual Spray 1600 MCG (800 MCG X 2)	1600 MCG	240.0	SPRAYS	30	Days
Subsys	Fentanyl Sublingual Spray 200 MCG	200 MCG	120.0	SPRAYS	30	Days
Subsys	Fentanyl Sublingual Spray 400 MCG	400 MCG	120.0	SPRAYS	30	Days
Subsys	Fentanyl Sublingual Spray 600 MCG	600 MCG	120.0	SPRAYS	30	Days
Subsys	Fentanyl Sublingual Spray 800 MCG	800 MCG	120.0	SPRAYS	30	Days

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Actiq	fentanyl citrate lozenge on a handle	1200 MCG ; 1600 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Fentora	fentanyl citrate buccal tab	100 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Lazanda	Fentanyl Citrate Nasal Spray 100 MCG/ACT (Base Equiv)	100 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Lazanda	Fentanyl Citrate Nasal Spray 400 MCG/ACT (Base Equiv)	400 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Subsys	fentanyl sublingual spray	100 MCG ; 1200 MCG ; 1600 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Actiq	fentanyl citrate lozenge on a handle	1200 MCG ; 1600 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Fentora	fentanyl citrate buccal tab	100 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Lazanda	Fentanyl Citrate Nasal Spray 100 MCG/ACT (Base Equiv)	100 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Lazanda	Fentanyl Citrate Nasal Spray 400 MCG/ACT (Base Equiv)	400 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Subsys	Fentanyl Sublingual Spray 100 MCG	100 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Subsys	Fentanyl Sublingual Spray 1200 MCG (600 MCG X 2)	1200 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Subsys	Fentanyl Sublingual Spray 1600 MCG (800 MCG X 2)	1600 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Subsys	Fentanyl Sublingual Spray 200 MCG	200 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Subsys	Fentanyl Sublingual Spray 400 MCG	400 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Subsys	Fentanyl Sublingual Spray 600 MCG	600 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Subsys	Fentanyl Sublingual Spray 800 MCG	800 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Evaluation Target Agent(s) will be approved when ALL of the following are met: The patient has a diagnosis of chronic cancer pain due to active malignancy AND ONE of the following: The patient’s age is within FDA labeling for the requested agent OR The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND The patient is currently opioid tolerant (taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily) AND The patient is taking a long-acting opioid concurrently with the requested TIRF agent AND The patient will NOT be using the requested agent with any other TIRF agent in any other strength AND ONE of the following: The request is for a generic TIRF agent OR The request is for a brand TIRF agent AND ONE of the following: The patient’s medication history includes use of at least ONE generic TIRF agent within the past 90 days OR Information has been provided that indicates the patient is currently being treated with the requested agent within the past 90 days OR The prescriber states the patient is currently being treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR The patient has an intolerance or hypersensitivity to at least ONE generic TIRF agent that is not expected to occur with the requested agent OR The patient has an FDA labeled contraindication to ALL generic TIRF agents that is not expected to occur with the requested agent AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 1 month for increased dose requests during a dose titration period Up to 6 months for all other requests NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Evaluation

Target Agent(s) will be approved when ALL of the following are met:

The patient has a diagnosis of chronic cancer pain due to active malignancy AND
ONE of the following:
1. The patient’s age is within FDA labeling for the requested agent OR
2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
The patient is currently opioid tolerant (taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily) AND
The patient is taking a long-acting opioid concurrently with the requested TIRF agent AND
The patient will NOT be using the requested agent with any other TIRF agent in any other strength AND
ONE of the following:
1. The request is for a generic TIRF agent OR
2. The request is for a brand TIRF agent AND ONE of the following:
  1. The patient’s medication history includes use of at least ONE generic TIRF agent within the past 90 days OR
  2. Information has been provided that indicates the patient is currently being treated with the requested agent within the past 90 days OR
  3. The prescriber states the patient is currently being treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR
  4. The patient has an intolerance or hypersensitivity to at least ONE generic TIRF agent that is not expected to occur with the requested agent OR
  5. The patient has an FDA labeled contraindication to ALL generic TIRF agents that is not expected to occur with the requested agent AND
The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:

1 month for increased dose requests during a dose titration period
Up to 6 months for all other requests

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
QL with PA	Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) is greater than the program quantity limit AND ONE of the following: ALL of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose AND The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit AND Episodes of breakthrough pain cannot be controlled by modifying the dose of the maintenance long-acting opioid used for underlying persistent pain AND The prescriber has provided information in support of therapy with a higher quantity (dose) for the requested indication OR ALL of the following: The requested quantity (dose) is greater than the maximum FDA labeled dose AND Episodes of breakthrough pain cannot be controlled by modifying the dose of the maintenance long-acting opioid used for underlying persistent pain AND The prescriber has provided information in support of therapy with a higher quantity (dose) for the requested indication Length of Approval: 1 month for increased dose requests during a dose titration period Up to 6 months for all other requests

Module

Clinical Criteria for Approval

QL with PA

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
The requested quantity (dose) is greater than the program quantity limit AND ONE of the following:
1. ALL of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose AND
  2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit AND
  3. Episodes of breakthrough pain cannot be controlled by modifying the dose of the maintenance long-acting opioid used for underlying persistent pain AND
  4. The prescriber has provided information in support of therapy with a higher quantity (dose) for the requested indication OR
2. ALL of the following:
  1. The requested quantity (dose) is greater than the maximum FDA labeled dose AND
  2. Episodes of breakthrough pain cannot be controlled by modifying the dose of the maintenance long-acting opioid used for underlying persistent pain AND
  3. The prescriber has provided information in support of therapy with a higher quantity (dose) for the requested indication

Length of Approval:

1 month for increased dose requests during a dose titration period
Up to 6 months for all other requests

CONTRAINDICATION AGENTS

Contraindicated as Concomitant Therapy
Lazanda (fentanyl nasal spray) Opioid non-tolerant patients Management of acute or postoperative pain including headache, migraines, dental pain, or use in the emergency department Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment Known or suspected gastrointestinal obstruction, including paralytic ileus Known hypersensitivity to fentanyl or any other component of the requested agent
Fentora (fentanyl buccal tablet) Opioid non-tolerant patients Significant respiratory depression Management of acute or postoperative pain including headache, migraines, dental pain, or use in the emergency department Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment Known or suspected gastrointestinal obstruction, including paralytic ileus Known hypersensitivity to fentanyl or any other component of the requested agent
Actiq (fentanyl transmucosal lozenge) Opioid non-tolerant patients Significant respiratory depression Management of acute or postoperative pain including headache, migraines, dental pain, or use in the emergency department Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment Known or suspected gastrointestinal obstruction, including paralytic ileus Known hypersensitivity to fentanyl or any other component of the requested agent
Abstral (fentanyl sublingual tablet) Opioid non-tolerant patients Management of acute or postoperative pain including headache, migraines, dental pain, or use in the emergency department Known hypersensitivity to fentanyl or any other component of the requested agent

Contraindicated as Concomitant Therapy

Lazanda
(fentanyl nasal spray)

Opioid non-tolerant patients
Management of acute or postoperative pain including headache, migraines, dental pain, or use in the emergency department
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to fentanyl or any other component of the requested agent

Fentora
(fentanyl buccal tablet)

Opioid non-tolerant patients
Significant respiratory depression
Management of acute or postoperative pain including headache, migraines, dental pain, or use in the emergency department
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to fentanyl or any other component of the requested agent

Actiq
(fentanyl transmucosal lozenge)

Opioid non-tolerant patients
Significant respiratory depression
Management of acute or postoperative pain including headache, migraines, dental pain, or use in the emergency department
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to fentanyl or any other component of the requested agent

Abstral
(fentanyl sublingual tablet)

Opioid non-tolerant patients
Management of acute or postoperative pain including headache, migraines, dental pain, or use in the emergency department
Known hypersensitivity to fentanyl or any other component of the requested agent

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

Commercial _ PS _ Transmucosal Immediate Release Fentanyl Prior Authorization with Quantity Limit _ProgSum_ 4/1/2023

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