On Thursday, July 19, 2012, Pfizer Pharmaceuticals along with Northwestern University won the first legal battle over the release of pregabalin, the generic formulation of Lyrica. Lyrica is an anticonvulsant which is approved to treat diabetic neuropathy, post herpetic neuralgia, partial onset seizures in adults and fibromyalgia. Recently, the FDAU.S. Food and Drug Administration also approved its use for the treatment of neuropathic pain associated with spinal cord injuries.
Pfizer Pharmaceuticals and Northwestern University own the patents for the active ingredient pregabalin and its indications. Collectively, they filed patent infringement lawsuits in 2009 against several companies which applied to the FDAU.S. Food and Drug Administration for approval to market a generic version of Lyrica before expiration of the patents. These defendant companies included TEVA of Israel, Lupin LTD and Sun Pharmaceuticals of India as well as Mylan and Watson from the United States. A trial was held in October of 2011 before Judge Sleet of the U.S. District Court of Delaware, but no decision was rendered at that time. The pharmaceutical companies involved reached an agreement not to put generic products on the market before July 20, 2012 or until Judge Sleet had rendered a decision, whichever came first.
Continue reading 'The Battle over Generic Lyrica'»
Lyrica is currently a commonly prescribed medication approved for the treatment of diabetic nerve pain, post herpetic neuralgia (pain after shingles), fibromyalgia, and partial onset seizures. On June 21, 2012, the FDAU.S. Food and Drug Administration announced that Lyrica (capsules CV) would additionally be approved for the treatment of neuropathic pain associated with a spinal cord injury. The drug company who produces Lyrica, Pfizer, issued a press release which confirms this.
As we know, WCMSAs are to only include drugs which are FDAU.S. Food and Drug Administration approved to treat the particular diagnosed condition. In other words, if a drug is being used for an “off-label” indication it should not be included in the WCMSAWorkers' Compensation Medicare Set-Aside (for more information, please see CMSCenters for Medicare and Medicaid Services memorandum dated May 14, 2010).
Due to Lyrica now being approved for the treatment of neuropathic pain associated with a spinal cord injury, we can expect to see it included in more WCMSAs going forward. It will no longer be considered an “off-label” usage of this drug when there is neuropathic pain related to a spinal cord injury, which is a frequent occurrence in workers’ compensation claims. Additionally, it is anticipated that CMSCenters for Medicare and Medicaid Services will also be taking this new FDAU.S. Food and Drug Administration determination for Lyrica into account when reviewing MSAMedicare Set-Aside proposals previously submitted and still pending approval as well as those being submitted presently. This may result in an increase of counter-high approvals from CMSCenters for Medicare and Medicaid Services on spinal cord injury cases where Lyrica was not included due to off-label usage but would now be considered appropriate.
PMSI will monitor the effect of this new approved usage for Lyrica as it relates to WCMSAs as well as future prescription drug updates and changes which may impact claims and WCMSAWorkers' Compensation Medicare Set-Aside allocations.