Lyrica: No Brand-Name Swansong
Roy Franco
July 27, 2012

Lyrica is one of the most expensive chronically prescribed drugs used in workers compensation spine/back cases. Lyrica is a anticonvulsant drug used to treat chronic neuropathic back or spine pain, such as pain in a leg that persists after a lumbar spine injury.

Prior to Lyrica, Gabapentin had been the primary anticonvulsant drug used for neuropathic pain, and its cost was mitigated by generic availability; however, Lyrica is now being used more frequently and currently is prescribed for about half of all anticonvulsant spinal nerve drug therapy.

While Lyrica has been used off-label for regular neuropathic pain, particularly for neuropathic spine-related pain, but it was not FDA approved for spinal neuropathic painonly for treatment of diabetic neuropathy pain, fibromyalgia, post-herpetic pain, and seizures.

As a result, CMS initially did not include Lyrica in the future Part D WCMSA costs for neuropathic spine pain, due to a lack of documentation of its efficacy. However, more recently, CMS has started including Lyrica as a part of the future Part D WCMSA costs even though there was no FDA approval for spine pain. This can partly be explained by the fact that CMS also includes “common” off-label uses as documented in the peer review literature and in the compendiums, wherein common off-label uses are listed.

In 2012, the FDA officially granted Lyrica specific FDA approval for spinal cord related neuropathic pain. Therefore, from this point forward Lyrica will definitely have to be included in the Part D allocation for medications if the claimant has spine-related neuropathic pain.

Therapy with Lyrica at 400 mg/day costs about $2680/year (AWP). This cost could be the crushing blow that breaks the back of back/spine injury settlements, due to elevated WCMSA costs. (And usually people on Lyrica are also on other pricey medications, such as Cymbalta.)

Momentary hopefulness arose when generic makers challenged Pfizer’s Lyrica exclusivity rights, which currently run until 2018. But this was quashed with the recent Delaware District Court decision wherein Pfizer’s exclusivity was upheld. While generic makers’ appeals to this decision are reportedly in the works, it’s questionable whether they will prevail and litigation will undoubtedly be time-consuming.

On a happier note, the Third Circuit Court of Appeals just issued a decision that Big Pharma’s “pay for delay” schemes were illegal, which may ultimately catapult the pay for delay issue to the Supreme Court.

Brand-name drug makers have frequently used pay for delay, literally paying generic makers huge amounts of money to not produce their generic brands. The effect is that while the generic medication had FDA approval and could have been produced legally, it was not on the market because the brand-name maker was paying them what amounted to generous amounts of “hush money”. (The fact that this was ever legal in the first place is rather incredulous).

However, with “pay for delay” now deemed illegal, the unfortunate result may be that drug companies will fight even more viciously for their exclusivity rights, with the Delaware District Court decision giving them some “precedent ammunition” to mount a substantive case.

In summary, the pharmaceutical issues in WCMSA’s are often where the bulk of the settlement costs reside, and accurately estimating those costs can be vital to successful claim settlement. Awareness of specific drug issues is necessary in order to accurately allocate future medication costs and Franco Signor is ready to provide that insight to assist in claim settlement.