FDA Approves Lyrica for Treatment of Neuropathic Pain Associated with Spinal Cord Injury

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 FDA 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 FDA 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 WCMSA (for more information, please see CMS 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 CMS will also be taking this new FDA determination for Lyrica into account when reviewing MSA 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 CMS 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 WCMSA allocations.

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