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At Last, High Ticket Item, Lyrica, Has Finally Gone Generic!

Tuesday, July 16, 2019

Lyrica® (pregabalin) is at last available generically through manufacturer/distributor, Rising Pharmaceuticals! The exclusive patent was extended for six months when Lyrica® was approved for pediatric epilepsy, and has now expired as of 6.30.2019. This high ticket item has become prevalent in Workers Compensation Medicare Set-Aside Arrangements (WCMSA) as an on-label indication for the management of radicular pain. The current Center for Medicare and Medicaid Services (CMS) WCMSA Reference Guide, section 9.4.6.2, notes “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.” Such a statement could be considered broad and overarching to include neuropathic-related conditions. Moreover, it is medically accepted practice that gabapentinoids, such as pregabalin and gabapentin, provide opioid-sparing effects, and play an important role in reducing opioid utilization. Lyrica® (pregabalin) is an anticonvulsant or anti-epilepsy drug which is recommended by the Official Disability Guidelines as first-line therapy for the treatment of neuropathic pain conditions and as an adjunct to opioid medications to provide opioid-sparing effects.

Lyrica® is FDA approved for the following indications:  pain related to diabetic peripheral neuropathy, fibromyalgia, neuropathic pain related to spinal cord injury, adjunct to treatment of partial seizures and postherpetic neuralgia. The Centers for Medicare and Medicaid Services has been accepting of the inclusion of Lyrica® in Workers Compensation Medicare Set-Aside for some neuropathic-related conditions.

The table below outlines the previous lowest average wholesale price (AWP) and the current AWP.

Lyrica strength

Previous AWP of Lyrica

Current AWP of pregabalin

25mg

$9.36

$8.42

50mg

$9.36

$7.58

75mg

$9.36

$7.58

100mg

$9.36

$7.58

150mg

$9.36

$7.58

200mg

$9.36

$8.42

225mg

$9.36

$8.42

300mg

$9.36

$8.42

It is anticipated that the AWP of pregabalin will drop further in price in approximately six months as more approved generic manufacturers for Lyrica enter the market.

ExamWorks Clinical Solutions strives to provide the most accurate and defensible MSA by utilizing technology and compendia databases which are recognized and supported by the CMS to support inclusion or exclusion of a drug under the Part D benefit. We will continue to monitor changes in medication pricing as well as availability of generic equivalents within the marketplace. 

For questions about medications, please contact Nahla D. Rizkallah, PharmD at 678.256.5086 or nahla.rizkallah@examworks-cs.com