|This is a cross-post from our Optum Insights blog.
The U.S. Food and Drug Administration’s (FDA) recent decision to grant pediatric exclusivity for Lyrica® ― as it may be used as an adjunctive therapy for partial onset seizures in pediatric epilepsy patients ― extends the period of market exclusivity in the U.S. by an additional six months. As a result, generic pregabalin will not be available until sometime after June 30, 2019.
We informed you in an August 2018 blog that the generic for Lyrica (pregabalin) may be delayed until summer 2019. And we notified you in another August blog post that Pfizer had announced that its July 2018 medication price increases were rolled back due to market pressures. These intended price increases were not permanently suspended and Pfizer stated that the increases had been deferred until the end of the year. This included Lyrica, a medication which historically had an average wholesale price increase of over nine percent every six to 12 months.
Pfizer price increases coming
On November 16, 2018, Pfizer announced that in January 2019, it is raising the list price of its entire medication portfolio by 10 percent. According to this report, three medications will increase by three percent and one medication will increase by nine percent “due to the completion of two extensive development programs that have led to recent FDA approvals of two new medical uses that meet unmet patient needs.” The remaining 37 medications will increase by five percent. The pharmaceutical company did not disclose which medications will be impacted.
Based on historical trends and the recent pediatric exclusivity extension, we will be monitoring the situation to see if the price of Lyrica will increase again by nine percent in 2019.
For more information about the exclusivity approval for Lyrica, click 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.
1. Business Wire News. Pfizer Receives Six Months Pediatric Exclusivity for LYRICA® (pregabalin). November 27, 2018. Available at: https://www.businesswire.com/news/home/20181127005811/en/Pfizer-Receives-Months-Pediatric-Exclusivity-LYRICA%C2%AE-pregabalin.
2. Fierce Pharma. Pfizer, plotting 41 price hikes for January, returns to ‘business as normal’ after price-raising pause. November 19, 2018. Available at: https://www.fiercepharma.com/pharma/after-deferring-price-hikes-summer-pfizer-plans-41-increases-january .