On July 19, the Food and Drug Administration 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.

Dan Anders

Lyrica remains FDA approved for the following indications:

• Diabetic peripheral neuropathy.
• Fibromyalgia.
• Neuropathic pain associated with spinal cord injury.
• Adjunct therapy for the treatment of partial-onset seizures.
• Postherpetic neuralgia.

If a claimant is being prescribed Lyrica for any of the above indications, and such indication is related to the workers’ compensation injury, then it will be included in the MSA.

In workers’ compensation injuries, Lyrica is most frequently prescribed for neck or back pain. For years, the Centers for Medicare and Medicaid Services considered Lyrica non-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 Workers' Compensation Medicare Set-Aside 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, Medicare set-asides 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 50 milligrams of Lyrica 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 $58,852 reduction.

The good news is with multiple manufacturers approved to sell the generic. We expect the per-pill price to drop even further.

Practical questions

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.

What is Tower doing for MSA referrals that include brand-name Lyrica?

If the claim prescription history documents brand Lyrica, we will advise you that a generic version of Lyrica has been approved and is or will soon be available. Tower will show you the price difference between brand and generic, and recommend working with the treating physician and your pharmacy benefit manager to make the switch. 

If a statement from the treating physician is required to authorize the switch, Tower can obtain it from the physician (although we will still need prescription history documenting at least one fill of the generic).

If the MSA was previously approved by CMS with brand-name Lyrica, can it be repriced 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.

Dan Anders is chief compliance officer at Tower MSA Partners LLC. This entry is republished with permission from the Tower MSP Compliance Blog.