On July 19, 2019 the Food and Drug Administration (FDA) approved multiple applications for the first generics of Lyrica (pregabalin). This follows the expiration of Pfizer's patent on Lyrica at the end of June. The generic is expected to be available at pharmacies in the coming weeks.
Lyrica remains FDA approved for the following indications:
Diabetic peripheral neuropathy
Neuropathic pain associated with spinal cord injury
Adjunct therapy for the treatment of partial onset seizures
If an injured worker is being prescribed Lyrica for any of the above indications and such Medicare Set-aside. In workers' compensation injuries, Lyrica is most frequently prescribed for neck or back pain. For years, CMS considered Lyrica non-Medicare-covered for neck or back pain unless such treatment stemmed from a traumatic spinal cord injury. However, CMS recently expanded its interpretation of what is considered a spinal cord injury, explaining in the updated WCMSA Reference Guide released this past January:
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.
As a result, MSAs have included Lyrica more frequently.
Red Book currently prices brand-name Lyrica in the range of at $9.36 to $10.30 per pill depending upon the dosage.The MSA for a person taking Lyrica 50mg three times a day over a 20-year life expectancy would allocate $222,580 for the medication. Red Book shows a generic price range of $7.58 to $8.43 per pill depending on the dosage. While not a significant per-pill decrease, the generic switch over the 20-year life expectancy produces an allocation of $163,728 – a $58,752 reduction. The good news is with multiple manufacturers approved to sell the generic, we expect the per-pill price to drop even further.
Will CMS automatically allocate the Lyrica in the MSA at the generic price?
As with any medication, including Lyrica, it is important to keep in mind that CMS will not automatically use the generic price when the treatment records and/or prescription history document brand name use. Instead, it must be proven to CMS typically, through prescription payment history, that the claimant has been switched to the generic. One fill documenting the switch to generic should be sufficient.
If the MSA was previously approved by CMS with brand-name Lyrica can it be re-priced to generic?
CMS will not consider an MSA Re-Review or Amended Review based solely upon a prescription medication pricing change. An Amended Review MSA would need to document not only the switch to generic Lyrica, but other changes as well, such as a previously allocated medication having been discontinued.
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