Generic Flector Approved!
Tuesday, April 23, 2019
Flector® (diclofenac epolamine) 1.3% topical patch is a nonsteroidal anti-inflammatory drug (NSAID) which is FDA indicated for acute pain due to minor strains, sprains and contusions. As with all NSAIDs, it is recommended to be used for the lowest effective dose for shortest duration possible. The Official Disability Guidelines do not recommend Flector patch as a first-line treatment. They further state there is no data to substantiate efficacy beyond two weeks.
Based on the official FDA approved label, maintenance use of Flector® would be excluded by Center for Medicare and Medicaid Services (CMS) on the grounds that it is only for acute pain, not chronic. Such changes can significantly reduce the Workers Compensation Medicare Set-Aside Arrangement (WCMSA) and facilitate settlement.
As part of best practices, we continually monitor CMS’ recognized proprietary source, Red Book, for real-time changes for newly generic agents and for average wholesale price (AWP) for medications used to treat the injured worker. Red Book lists two generic manufacturers of Flector® (manufactured by Pfizer), Teva and Greenstone, with the latter being a Pfizer company. As depicted in the table below, a significant difference in price between the brand and generic agent may take approximately six months to be realized, as more companies enter the market.
Diclofenac epolamine (manufacturer)
AWP per patch
Diclofenac is available in oral form and is the only FDA approved NSAID for topical application. It is available as diclofenac sodium topical formulations including gel, solution and cream. While topical medications are clinically appropriate in certain cases, numerous first-line alternative therapeutic and cost-effective alternative NSAIDs can be offered.
Considerations for topical therapy:
- Is the pain in a localized area requiring administration directly at the site of pain?
- Is there a need to avoid first-pass metabolism?
- Has the claimant failed first-line oral agents?
- Is the claimant unable to tolerate oral NSAIDs?
- Does systemic exposure need to be avoided?
- Are drug-drug interactions a concern?
ExamWorks Clinical Solutions strives to provide the most accurate and defensible MSA by utilizing technology and compendia databases which are recognized and supported by the CMS to support inclusion or exclusion of a drug under the Part D benefit. We will continue to monitor changes in medication pricing as well as availability of generic equivalents within the marketplace.
For questions about medications, please contact Nahla D. Rizkallah, PharmD at 678.256.5086 or firstname.lastname@example.org