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ph-91149

Topical NSAID (Non-Steroidal Anti-Inflammatory Drug) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91149

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

POLICY REVIEW CYCLE

Effective Date	Date of Origin
01-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Flector®, Diclofenac epolamine Topical patch	Topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.		1
Licart® (diclofenac epolamine) Topical system	Topical treatment of acute pain due to minor strains, sprains, and contusions		10

Agent(s)

FDA Indication(s)

Notes

Ref#

Flector®, Diclofenac epolamine

Topical patch

Topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.

Licart®

(diclofenac epolamine)

Topical system

Topical treatment of acute pain due to minor strains, sprains, and contusions

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

CLINICAL RATIONALE

Acute Pain

The American College of Physicians (ACP) and American Academy of Family Physicians (AAFP) recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical nonsteroidal anti-inflammatory drugs (NSAIDs) with or without menthol gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient's treatment satisfaction. ACP and AAFP suggest that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with oral NSAIDs to reduce or relieve symptoms, including pain, and to improve physical function, or with oral acetaminophen to reduce pain.(3)

Osteoarthritis (OA)

The American Academy of Orthopedic Surgeons recommended the following:

For the management of knee OA:(8)
- NSAIDs (oral or topical) or tramadol are recommended for patients with symptomatic OA of the knee. (Strong recommendation; high level evidence)
- The panel was unable to recommend for or against the use of acetaminophen, opioids, or pain patches for patients with symptomatic OA of the knee. (Inconclusive recommendation)
For the management of hip OA:(9)
- NSAIDs improve short-term pain, function, or both

The American College of Rheumatology and the Arthritis Foundation states the following for the management of OA in the hand, hip, or knee:(4)

Usual care includes the use of oral NSAIDs and/or acetaminophen
Oral NSAIDs are strongly recommended for knee, hip, and/or hand OA
Topical NSAIDs are strongly recommended for knee OA and conditionally recommended for hand OA
Topical NSAIDs should be considered prior to use of oral NSAIDs to limit systemic exposure

A current review suggests topical NSAIDs are as effective as oral NSAIDs and generally safer, but only effective for OA of more superficial joints such as hands and knees.(5) For multiple or deep arthritic joints, oral NSAIDs are easier to use and more efficacious. The American Geriatric Society recommendeds that the chronic use of all NSAIDs, including high dose aspirin, should be avoided because of the risk of gastrointestinal bleeding. High-risk groups include: age above 75 years, corticosteroid use, current use of anticoagulants or antiplatelet agents.(6)

Safety

Flector and Licartcontain the following box warnings:(1,3,10)

Cardiovascular risk
- Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
- NSAIDs are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

Flector and Licart carry the following contraindications:

Known hypersensitivity to diclofenac or any components of the product
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
In the setting of CABG surgery
For use on non-intact or damaged skin

REFERENCES

Number	Reference
1	Flector prescribing information. Pfizer, Inc. April 2021.
2	Reference no longer used.
3	Qaseem A, McLean RM, O’Gurek D, Batur P, Lin K, Kansagara DL. Nonpharmacologic and pharmacologic management of Acute Pain from Non–Low Back, Musculoskeletal Injuries in Adults: a clinical guideline from the American College of Physicians and American Academy of Family Physicians. Annals of Internal Medicine. 2020;173(9):739-748. doi:10.7326/m19-3602.
4	Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis & Rheumatology. 2020; 72(2):220-233.
5	Reference no longer used.
6	Wongrakpanich S, Wongrakpanich A, Melhado K, Rangaswami J. A Comprehensive Review of Non-Steroidal Anti-Inflammatory Drug Use in The Elderly. Aging Dis. 2018 Feb 1;9(1):143-150. doi: 10.14336/AD.2017.0306.
7	Reference no longer used.
8	American Academy of Orthopedic Surgeons. Management of Osteoarthritis of the Knee (Non-Arthroplasty). August 2021. https://www.aaos.org/globalassets/quality-and-practice-resources/osteoarthritis-of-the-knee/oak3cpg.pdf
9	American Academy of Orthopedic Surgeons. Management of Osteoarthritis of the Hip Evidence-based Clinical Practice Guideline. March, 2023. Available at: https://www.aaos.org/globalassets/quality-and-practice-resources/osteoarthritis-of-the-hip/oah-cpg.pdf.
10	Licart prescribing information. IBSA INST BIO. 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

Flector	diclofenac epolamine patch	1.3 %	M ; N ; O ; Y	M
Licart	diclofenac epolamine patch	1.3 %	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

Flector	Diclofenac Epolamine Patch 1.3%	1.3 %	60	Patches	30	DAYS
Flector	Diclofenac Epolamine Patch 1.3%	1.3 %	60	Patches	30	DAYS
Licart	diclofenac epolamine patch	1.3 %	30	Systems	30	DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Flector	diclofenac epolamine patch	1.3 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Licart	diclofenac epolamine patch	1.3 %	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
Flector	Diclofenac Epolamine Patch 1.3%	1.3 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Flector	Diclofenac Epolamine Patch 1.3%	1.3 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Licart	diclofenac epolamine patch	1.3 %	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: The patient has a diagnosis of acute pain due to minor strains, sprains, and/or contusions AND ONE of the following: The patient has tried and had an inadequate response to a generic topical NSAID (non-steroidal anti-inflammatory drug) agent within the past 90 days OR The patient has an intolerance or hypersensitivity to a generic topical NSAID agent OR The patient has an FDA labeled contraindication to ALL generic topical NSAID 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: 3 months 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.

Module

Clinical Criteria for Approval

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

The patient has a diagnosis of acute pain due to minor strains, sprains, and/or contusions AND
ONE of the following:
1. The patient has tried and had an inadequate response to a generic topical NSAID (non-steroidal anti-inflammatory drug) agent within the past 90 days OR
2. The patient has an intolerance or hypersensitivity to a generic topical NSAID agent OR
3. The patient has an FDA labeled contraindication to ALL generic topical NSAID 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: 3 months

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
	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) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication Length of Approval: up to 3 months

Module

Clinical Criteria for Approval

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) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR
3. BOTH of the following:
  1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 3 months

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.