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New generic for Lyrica® CR – pregabalin extended-release tablet – now on the market
Pregabalin extended-release (ER) tablets, the generic formulation of Lyrica® CR, was released on April 13, 2021, according to the U.S. Food and Drug Administration (FDA). Pregabalin ER is only FDA-approved to manage pain caused from damaged nerves (neuropathic pain) related to diabetes (diabetic peripheral neuropathy) and shingles (postherpetic neuralgia). Unlike the immediate-release formulation of pregabalin (Lyrica®), pregabalin ER is not FDA-approved for the treatment of fibromyalgia, seizures, or nerve pain associated with spinal cord injury.
Impact on workers’ compensation and auto no-fault industry
Treatment guidelines indicate, Lyrica CR and its generic pregabalin ER are not recommended as a first-line treatment for pain. In addition, although it has been prescribed off-label to treat nerve pain, it is not recommended unless there is a compelling reason for once-daily dosing over the standard twice-daily dosing with pregabalin immediate-release capsules (Lyrica).
Prior to authorizing pregabalin ER tablets, claims professionals should review the claimant’s complete medical and medication history and determine if other first-line anticonvulsants, such as pregabalin immediate-release or gabapentin immediate-release (Neurontin®), have been tried for the treatment of nerve pain related to an injury.
As determined by our Pharmacy and Therapeutics (P&T) Committee, since this medication is classified as a miscellaneous psychotherapeutic and neurological agent and not first-line therapy, pregabalin ER formulations require prior authorization on our global workers’ compensation, auto and standard injury-based formularies.
Impact on Optum Settlement Solutions
Lyrica CR is not commonly seen in Workers’ Compensation Medicare Set-Asides (WCMSAs). However, any claim including Lyrica CR in the medication regimen will see a cost decrease as claimants switch to the generic formulation. Based on current RED BOOK® average wholesale price (AWP) data, we expect to see a 40% cost decrease by utilizing the generic formulation compared to brand Lyrica CR when the generic formulation information becomes available in the WCMSA portal.
Please note, when claimants have a history of brand-name medication use, the Centers for Medicare and Medicaid Services (CMS) generally require generic medication fills reflected on pharmacy invoices to allow allocation for the lower cost generic product in a WCMSA.
It is our recommendation that carriers, TPAs and claim handlers flag cases where brand-name Lyrica CR has been prescribed to determine if generic pregabalin ER is prescribed in the near future. It is expected that over the next several months, we will see prescriptions for brand-name Lyrica CR transitioned to the generic formulation. If not, it is recommended that a request be made to the treating physician to initiate a trial of the generic medication.
For more information on Lyrica and Lyrica CR, please click here.
- U.S. Food and Drug Administration (FDA). Drugs@FDA: FDA-Approved Drugs. April 13, 2021. Available at: https://www.accessdata.fda.gov/.
- ODG by MCG Treatment Guidelines [database online]. An MCG Health Company. Accessed on April 19, 2021.
- Lyrica CR (pregabalin extended-release tablets) [package insert]. New York, NY: Pfizer; April 2020. Accessed on April 20, 2021.
- Lyrica (pregabalin capsules) [package insert]. New York, NY: Pfizer; June 2020. Accessed on April 20, 2021.
- RED BOOK - https://www.ibm.com/products/micromedex-red-book (Subscription required)
- WCMSA Portal - https://www.cob.cms.hhs.gov/WCMSA/login