ph-91006
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Flector® Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91006

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

Flector Prior Authorization with Quantity Limit

TARGET AGENT(S)

   Flector®, Diclofenac Epolamine Patch

  

Brand (generic)   

GPI

Multisource Code

Quantity Limit (per day or as listed)

Flector, Diclofenac Epolamine Patch

 180 gram topical patch

 (1.3% in aqueous base)

90210030205920

M, N, O, or Y

60 patches/30 days

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Flector will be approved when ALL of the following are met:

  1. Patient must have diagnosis of ACUTE pain due to minor strains, sprains, and/or contusions

AND

  1. ONE of the following:

A.  The patient has tried and had an inadequate response to at least TWO oral prescription NSAIDs, one within the past 6 months

            OR

    1. The patient has an intolerance or hypersensitivity to oral NSAIDs (i.e., renal failure, history of gastrointestinal bleed, etc.)

OR

    1. The patient has an FDA labeled contraindication to ALL oral NSAIDs that is not expected to occur with the requested agent

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

  AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

  AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

      1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of approval: 3 months

FDA APPROVED INDICATIONS AND DOSAGE1

Agent(s)

Indication(s)

Dosage

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.

One patch to the most painful area

twice a daya

  1. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

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.5

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.3

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.2

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

Safety

Flector has the following boxed warnings:1-3

  • 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 is contraindicated in:

  • Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product.
  • Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
  • The setting of coronary artery bypass graft (CABG) surgery.
  • For use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds.

REFERENCES

  1. Flector prescribing information. Pfizer, Inc. December 2020.
  2. Cochrane Data System Review 2015;6: CD007402.
  3. Medical Clinics of North America 2016;100:869-890.
  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/afp/2016/0701/od1.pdf.

 

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 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.

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