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

Policy Number: PH-1149

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

POLICY REVIEW CYCLE

Effective Date

Date of Origin 

1/1/2024

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Flector®

(diclofenac epolamine)

180 mg Topical patch (1.3% in aqueous base)

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

6

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

CLINICAL RATIONALE

Acute Pain

The American Family Physician review suggests that data was insufficient to make conclusions regarding comparisons of topical vs. oral NSAIDs, a specific topical NSAID vs. another, or different formulations of the same topical NSAID.(11) A 2016 review suggests topical NSAIDs are good options for acute musculoskeletal pain in patients at risk of adverse effects from oral NSAIDs who present with a focal area pain. Topical agents are only effective for treating more superficial structures.(6)

A Cochrane Review (2015) evaluating topical NSAIDs for acute pain due to strains, sprains, or sports/overuse type injuries found there was insufficient data to reliably compare individual topical NSAIDs with each other or to the same oral NSAID.(5)

Efficacy

Efficacy of Flector was demonstrated in two of four studies of patients with minor sprains, strains, and contusions. Patients were randomly assigned to treatment with Flector or a placebo patch. In the first of the two studies, patients with ankle sprains were treated once daily for a week. In the second study, patients with sprains, strains, and contusions were treated twice daily for up to two weeks. Pain was assessed over the period of treatment. Patients treated with Flector experienced a greater reduction in pain compared to patients randomized to the placebo patch. The safety and effectiveness of Flector patch in pediatric patients have not been established.(1)

Efficacy of Licart was demonstrated in two randomized, double-blind, parallel-arm, placebo- and active-controlled studies in patients with minor sprains, strains, and/or contusions. Patients were randomized equally to receive Licart, placebo, or Flector and treatment was applied as a 24-hour, once daily application for 7 or 14 days. Flector was not administered according to its approved twice daily (BID) dosing regimen; therefore, conclusions regarding comparative efficacy between Licart and Flector cannot be made based on these studies. In both studies, Licart demonstrated a statistically significant difference versus placebo on the primary efficacy endpoint, reduction in pain on movement at Day 3.(6)

Safety

Flector and Licart contain the following black box warnings:(1-6)

  • 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

Adili A, Bhandari M. Cochrane in CORR®: Topical NSAIDs for Chronic Musculoskeletal Pain in Adults. Clin Orthop Relat Res. 2018 Nov;476(11):2128-2134. doi: 10.1097/CORR.0000000000000486. 

3

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.

4

Rogers N, Rowland K, Hickner J. An alternative to oral NSAIDs for acute musculoskeletal injuries. J Fam Practice. March 2011;60(3):147-148.

5

Topical NSAID for acute musculoskeletal pain in adults. American Family Physician. 2016 Jul 1; 94(1): Available at: https://www.aafp.org/pubs/afp/issues/2016/0701/od1.html

6

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

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

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

  1. The patient has a diagnosis of acute pain due to minor strains, sprains, and/or contusions AND
  2. 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
  3. 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:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
    1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose for the requested indication

Length of Approval: 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.

BCBSAL _  Commercial _ CS _ Topical NSAID (Non-Steroidal Anti-Inflammatory Drug) _PAQL _ProgSum_ 1/1/2024