FDA Approves Generic Versions of Lyrica
On Monday, the FDA issued a press release announcing the approval of generic versions of the drug Lyrica (pregabalin). Those of us operating in the workers compensation industry are all too familiar with Lyrica. It’s a high-priced medication utilized for the treatment of pain related to nerve damage, and its inclusion within Workers’ Compensation Medicare Set-Asides (WCMSAs) has become more common and problematic in recent years. You may recall that last October, we published a detailed blog article on the inclusion of Lyrica within WCMSAs submitted to CMS for approval. However, our concerns mounted when CMS’ published its most recent WCMSA reference guide in January, 2019, which specifically noted Lyrica as an example in the WCMSA Reference guide for off-label medication inclusion, as
Example 1: Lyrica (Pregabalin) is cited in MicroMedEx for an off-label medication use related to neuropathic pain from spinal cord injury, and a number of scientific studies indicate that Pregabalin shows statistically significant positive results for the treatment of radicular pain (a type of neuropathic pain). Spinal cord neuropathy includes injuries directly to the spinal cord or its supporting structures causing nerve impingement that results in neuropathic pain. Lyrica is considered acceptable for pricing as a treatment for WCMSAs that include diagnoses related to radiculopathy because radiculopathy is a type of neuropathy related to peripheral nerve impingement caused by injury to the supporting structures of the spinal cord.
Lyrica was initially approved by the FDA in December of 2004 for a single indication of neuropathic pain associated with diabetic peripheral neuropathy. Lyrica was developed by Pfizer, a large pharmaceutical manufacturing company. Over the course of the next fourteen years, Pfizer was successful in securing FDA approval for additional indications including fibromyalgia, neuropathic pain associated with spinal cord injury, post-herpetic neuralgia and adjunctive therapy for adult patients with partial onset seizures. In addition, Lyrica has seemed to gain medical acceptance for the treatment of low back pain and radiculopathy in an off-label capacity, hence the inclusion of this medication in many CMS approved WCMSAs, as we mentioned in our earlier blogs. Pfizer’s patent protection for Lyrica was scheduled to expire in December of 2018. However, in November of 2018, Pfizer secured a six-month patent extension for a new pediatric indication of Lyrica. At that time, there was a collective sigh of disappointment, because news of the patent extension meant that a generic version of Lyrica would be delayed.
In Monday’s press release, the FDA announced that it had approved generic drug applications for pregabalin submitted by nine manufacturers: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals and Teva Pharmaceuticals. The multitude of manufacturers who are entering the market at this early stage could have significant implications for the price of pregabalin in the coming months. A common regulatory scenario for generic drugs is that the first generic manufacturer to secure FDA approval of a generic drug application will receive a 180-day period of marketing exclusivity. During this 180-day period of exclusivity, other generic manufacturers are precluded from entering the market. The potential for six months of exclusive generic drug marketing was incorporated into the Hatch-Waxman Amendments in 1984 with the best of intentions. The exclusivity period was established to stimulate the development of generic medications in an effort to lower drug costs. In more recent years, however, the award of exclusivity to a generic manufacturer has come under fire because exclusivity can have the unintended result of delaying the entrance of the generic product into the market. Generic manufacturers sometimes enter into reverse payment arrangements with the brand name manufacturer, whereby the generic manufacturer accepts payment from the brand name manufacturer in exchange for an agreement to delay the production of the generic product for a certain length of time. In the pharmaceutical industry, these agreements are known as “pay-to-delay” or “pay-for-delay” arrangements.
In the case of pregabalin, the FDA did not grant a period of generic exclusivity to a single manufacturer. This will likely produce favorable market conditions over the next few months, as these eight manufacturers will begin to distribute the generic pregabalin products. With several manufacturers entering the market sooner rather than later, the increased competition for market share will likely result in price decreases over the course of the next several months. Of course, we’ll continue to monitor the average wholesale price (AWP) of pregabalin products and post noteworthy developments here on our blog. Pregabalin will be available in generic formulations of all commercially available formulations of Lyrica: 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg capsules. It will also be available as a 20mg per ml oral solution.