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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

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: 

  1. The patient has a diagnosis of chronic cancer pain due to active malignancy AND
  2. 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
  3. 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
  4. The patient is taking a long-acting opioid concurrently with the requested TIRF agent AND
  5. The patient will NOT be using the requested agent with any other TIRF agent in any other strength AND
  6. 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
  7. 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:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. 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

 

 

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