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FDA approves first alternative medications to Lyrica (pregabalin)

by User Not Found | Jul 22, 2019

Much anticipated alternative medications for Lyrica® (pregabalin) were approved by the U.S. Food and Drug Administration (FDA) on July 19, 2019. This approval follows a six-month delay announced last year.

Pregabalin is an anticonvulsant with FDA approval to treat neuropathic (nerve) pain associated with diabetes, postherpetic neuralgia (shingles), fibromyalgia and neuropathic pain associated with spinal cord injury. In addition, it is approved as adjunct therapy for the treatment of partial onset seizures.

Impact on workers’ compensation
Lyrica, pregabalin, is commonly used in workers’ compensation for the treatment of neuropathic pain conditions. In fact, Lyrica is currently allowed on our global workers’ comp and standard chronic musculoskeletal formularies. Also, it has been ranked #1 ― by spend ― on our drug trends report for the past year. With the availability of a non-brand medication, we expect a decrease in spend for our book of business in the coming months.

Additionally, because Lyrica is commonly found in workers’ compensation Medicare Set-Asides (MSA), we anticipate the availability of pregabalin alternatives to have a positive impact on MSA allocations.

Availability and pricing
According to the FDA, the following companies have been granted approval to launch the alternative version: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals. Amneal and Rising have already announced the launch to the U.S. market.

Lyrica capsules are available in eight strengths: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg. It is uncertain if each alternative manufacturer will market all strengths. The current average wholesale price (AWP) for brand-name Lyrica is approximately $9.83 per capsule. Although the cost from other manufacturers’ versions will vary, at this time, the AWP for pregabalin capsules is expected to cost approximately 15 – 20 percent less.

For more information on the FDA announcement, please click here. You can find our November 2018 blog announcing the delay, here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

Sources:

  1. U.S. Food and Drug Administration. News & Events. Newsroom. Press Announcements. FDA News Release. July 22, 2019. FDA approves first generics of Lyrica. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-lyrica .
  2. Business Wire. Press Release. July 19, 2019. Rising Pharmaceuticals Announces the U.S. Launch of a Generic Version of Pregabalin Capsules. Available at: https://www.businesswire.com/news/home/20190719005382/en/.
  3. Business Wire. Press Release. July 22, 2019. Amneal Announces Launch of Generic Lyrica®. Available at: https://www.businesswire.com/news/home/20190722005225/en/Amneal-Announces-Launch-Generic-Lyrica%C2%AE
  4. RED BOOK™ [database online]. Truven Health Analytics, an IBM Company. July 2019.

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