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Transmucosal Immediate Release Fentanyl (TIRF) Prior Authorization with 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 |
04-01-2024 |
|
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 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)
TIRF products have the following contraindications:(2-5)
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) |
REFERENCES
Number |
Reference |
1 |
Reference no longer used. |
2 |
Actiq prescribing information. Cephalon, Inc. November 2022. |
3 |
Fentora prescribing information. Cephalon, Inc. November 2022. |
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 |
Final Age Limit |
Preferred Status |
|
||||||
Fentora |
fentanyl citrate buccal tab |
100 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG |
M ; N ; O ; Y |
M |
|
|
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 |
|
|
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 |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
|
|
|
120 |
Tablets |
30 |
DAYS |
Approval duration is 1 month for dose titration requests and up to 6 months for all other requests |
|
|
Actiq |
fentanyl citrate lozenge on a handle |
1200 MCG ; 1600 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG |
120 |
Lozenges |
30 |
DAYS |
|
|
|
Fentora |
fentanyl citrate buccal tab |
100 MCG ; 200 MCG ; 400 MCG ; 600 MCG ; 800 MCG |
120 |
Tablets |
30 |
DAYS |
|
|
|
Lazanda |
Fentanyl Citrate Nasal Spray 100 MCG/ACT (Base Equiv) |
100 MCG/ACT |
30 |
Bottles |
30 |
DAYS |
|
|
|
Lazanda |
Fentanyl Citrate Nasal Spray 400 MCG/ACT (Base Equiv) |
400 MCG/ACT |
30 |
Bottles |
30 |
DAYS |
|
|
|
Subsys |
Fentanyl Sublingual Spray 100 MCG |
100 MCG |
120 |
Sprays |
30 |
DAYS |
|
|
|
Subsys |
Fentanyl Sublingual Spray 1200 MCG (600 MCG X 2) |
1200 MCG |
240 |
Sprays |
30 |
DAYS |
|
|
|
Subsys |
Fentanyl Sublingual Spray 1600 MCG (800 MCG X 2) |
1600 MCG |
240 |
Sprays |
30 |
DAYS |
|
|
|
Subsys |
Fentanyl Sublingual Spray 200 MCG |
200 MCG |
120 |
Sprays |
30 |
DAYS |
|
|
|
Subsys |
Fentanyl Sublingual Spray 400 MCG |
400 MCG |
120 |
Sprays |
30 |
DAYS |
|
|
|
Subsys |
Fentanyl Sublingual Spray 600 MCG |
600 MCG |
120 |
Sprays |
30 |
DAYS |
|
|
|
Subsys |
Fentanyl Sublingual Spray 800 MCG |
800 MCG |
120 |
Sprays |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
|
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
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 |
|
|
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
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 |
|
Target Agent(s) will be approved when ALL of the following are met:
Length of Approval:
NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. |
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:
Length of Approval:
|
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.
ALBP _ Commercial _ CSReg _ TIRF_PAQL _ProgSum_ 04-01-2024 _© Copyright Prime Therapeutics LLC. January 2024 All Rights Reserved