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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)
Flector and Licart carry the following contraindications:
|
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:
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:
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