July 3, 2012
On June 21, 2012, the Food and Drug Administration announced its approval of Lyrica for use in the management of neuropathic pain associated with chronic, debilitating spinal cord injuries. Lyrica, the brand name for pregabalin, is manufactured by Pfizer (NYSE: PFE) and is already widely used to treat fibromyalgia pain.
Prevalence of SCI Associated Neuropathic Pain
According to Pfizer, about 40 percent of the 270,000 Americans with spinal cord injuries suffer from chronic neuropathic pain that they describe as severe or excruciating. An estimated 12,000 new spinal cord injury patients are diagnosed in the U.S.each year.
Patients may experience neuropathic pain above, at or below the level of the spinal cord injury, and it may persist for up to 25 years. The pain stems from traumatic causes, such as motor vehicle accidents, violence, falls and sports injuries; where displaced bone fragments, disc material, or ligaments bruise or tear into spinal cord tissue.
Spinal neuropathic pain can also stem from non-traumatic causes, such as congenital and developmental abnormalities, genetics, infections and inflammation, removal of a benign spinal tumor and spinal cord ischemic stroke.
Treatment Options Previously Available
“Until now, no FDA approved treatment options were available in the U.S.for people with neuropathic pain associated with spinal cord injury, a condition which can be extremely disabling,” said Steven J. Romano, MD, senior vice president of Pfizer’s global primary care unit.
The FDA’s approval was based on studies of 357 patients – some with traumatic spinal cord injuries, and some with both traumatic and non-traumatic injuries. In addition to Lyrica, patients in the randomized, double-blind, placebo controlled Phase III trials were allowed to continue taking other pain medications, including NSAIDS, opioids and non-opioids.
Pain Reduction & Side Effects
According to Pfizer, patients taking Lyrica received up to a 50% reduction in pain than did patients receiving a placebo. Some experienced relief as early as week one and continuing through the duration of the 12 and 16 week trials.
Side effects experienced by patients included somnolence, dizziness, dry mouth, fatigue and peripheral edema.
Pfizer recently halted studies testing Lyrica’s effectiveness in treating neuropathic pain caused by HIV infection or diabetes after preliminary results showed that it was no more effective than a placebo.
Potential Impact on WCMSA and Settlement Cost
Though FDA approved only for neuropathic pain associated with fibromyaligia, Lyrica has consistently been listed in the Top 5 drugs used ‘off label’ in workers’ compensation (NCCI Research Brief, Workers’ Compensation Prescription Drug
Study: 2011 Update). And, while CMS, in its May 2010 Memo, noted that off label drugs would be approved for inclusion in a WCMSA only as follows: “For a Part D drug to be covered by Medicare, and thus included properly in a WCMSA, the drug should be prescribed for an outpatient use that is approved under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. § 301 et seq.], or supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(I) of 42 U.S.C. Section 1396r-8. “, in practice, CMS has included Lyrica as an approved drug more frequently than its has accepted its exclusion from the WCMSA based on the cited compendia.
As an added cost to those who prepare WCMSA’s, the recent FDA approval of Lyrica for spinal cord injuries allowed Pfizer to apply for an extension to its patent, and on July 19, 2012, patent rights preventing any generic substitutions of Lyrica® were extended by a district court until at least 2018.
A generic version of Lyrica called ‘Lupin’ was approved on July 5th, 2012, which would have make it available for use in the WCMSA next summer. Unfortunately, the district court’s decision to extend the patent rights will prevent the sale of this generic until December 2018. As a result, MSA providers will be forced to price for the ‘branded’ single source version of Lyrica for an extended period of time, thus making the MSA cost projection for life expectancy much higher.
At Tower MSA Partners, our methdology, as it relates to Lyrica will continue to be as follows:
- Review the appropriateness of the medical and drug treatment for the specific injury with our panel of physicians.
- Identify triggers that warrant intervention and stop the WCMSA process.
- Work with the adjuster to establish an action plan to change treatment.
- Involve our team of physicians to review and contact the treating physician.
Combining evidentiary based medical guidelines with peer-to-peer contact, many treating physicians have been open to dialogue and willing to make changes.
As one of the most expensive drugs prescribed in workers’ compensation, we see the FDA approval of Lyricanal for spinal cord injuries to be of concern to those who seek to settle claims involving future medical for Medicare beneficiaries. Lyrica is, and will continue to be, a significant cost driver for the MSA. We do not, however, anticipate a change in our course of action when reviewing medical and pharmacy records prior to completing the MSA. We will include Lyrica among our list of pre-MSA triggers, and will work proactively with our clients to get it removed by the treating physician prior to submission of the MSA for CMS approval.
Going forward, we will continue to monitor Lyrica and the prescribing patterns followed in workers’ compensation. We will also monitor CMS’s inclusion of Lyrica as an approved drug for spinal cord injuries when reviewing a WCMSA. For more information about Lyrica, or any aspect of our pre-MSA review process, please contact us directly.