Lyrica In the News

CMS, MSP News, Rx/Pharmacy on November 26, 2018
Posted by Complex Claims Division

Lyrica and its manufacturer Pfizer have been in the news quite frequently this month, and the publicity has not been positive.  Most recently, on November 14th, the Supreme Court of the United Kingdom (U.K.) ruled against Pfizer in a patent infringement lawsuit that has spanned the past several years.

It’s no secret that pharmaceutical manufacturers employ several strategies to extend patent protection and market exclusivity for their products. One of those strategies is to file for, and receive approval for, new indications for existing drugs. In the case of Lyrica, the original patent based on two indications – epilepsy and generalized anxiety[1] – expired in 2014. However, patent protection for the expanded indication of neuropathic pain had not yet expired and Pfizer fiercely defended it. Pfizer sent letters to physicians warning them not to prescribe generic versions of Lyrica for the treatment of neuropathic pain. Pfizer’s letters reportedly threatened legal action against physicians who failed to heed the warning. The National Health Service (NHS), which is the agency that administers the national health care system in the U.K., issued guidance for prescribers regarding Lyrica. The message from NHS reinforced Pfizer’s message that generic versions of Lyrica should not be utilized for the treatment of pain. Pfizer’s market exclusivity for the neuropathic pain indication was scheduled to expire in 2017.

In September of 2015, a court in the U.K. ruled that Lyrica’s neuropathic pain patent was invalid. Pfizer appealed the ruling, and the case has been bogged down in the U.K.’s court system for more than three years. The Supreme Court’s ruling bought an official end to the battle, but it was certainly not the outcome Pfizer wanted. As a result of the ruling, Pfizer may be subject to recoupment actions by the NHS as a result of payments for brand name Lyrica, which were made a result of Pfizer’s appeals.

What has happened in the U.K. may be a preview of what’s to come in the United States, since Lyrica’s patent protection is scheduled to expire next month. With this in mind, it should be noted that Pfizer is attempting to secure a six-month patent extension based on new pediatric use(s) for Lyrica.

Even more recently in the news, Pfizer announced a nine percent price increase for Lyrica which will take effect January 15th of 2019. The price increase was initially communicated in July, but was postponed after Pfizer was admonished on Twitter in July 2018.

As you may recall, we discussed CMS’ recent decision to start including Lyrica in WCMSAs in our October 11, 2018 blog post.

It remains to be seen if these developments will change CMS’ opinion regarding inclusion of Lyrica but due to the impact that Lyrica has on Medicare set-asides, we’ll continue to post updates here.

[1] Please note that the approved indications for Lyrica in the U.K. differ from those in the United States.