The Lyrica Saga Continues

1/17/2019

By Lori Dickson, MSN, RN, MSCC, CLCP, CNLCP, Director of Clinical Operations

Lyrica is an expensive medication and the price just got higher. Parke-Davis, a division of Pfizer, Inc. issued a price increase of 5% for all formulations effective 1/15/2019. Pricing per dose is $9.36. The FDA indications for the use of Lyrica include such conditions as:

  • Diabetic peripheral neuropathy 
  • Fibromyalgia
  • Partial seizure
  • Postherpetic neuralgia

Neuropathic pain related to spinal cord injury was approved in 2012. The new indication made pregabalin the first FDA-approved treatment for neuropathic pain from spinal cord injury 

However, the medical community has expanded the use of Lyrica further to treat most types of central or peripheral type nerve pain and as such has become a widely accepted practice. This is possibly due to several factors including search for non-opioid pain management options, it is a well-tolerated medication with few drug interactions, and benefit can be seen faster and at lower doses. 

Then there is gabapentin. While a much less expensive alternative, it tends to require higher doses to achieve benefit and has a slower onset of action. Additionally gabapentin has experienced an increase with respect to abuse. Gabapentin can produce euphoric effects at high doses when taken with alcohol; it acts as an opioid potentiator; and has been reportedly used in conjunction with illicit drugs such as heroin or cocaine to enhance their effects as well. Since August of 2016, 14 of 51 states have issue mandates requiring heightened pharmacovigilance, attempting to place controls in the use of gabapentin. In October 2018, the DEA issued a statement regarding the illicit uses of gabapentin. To date, gabapentin is not listed as a controlled substance within the U.S. 

With the inclusion of Lyrica in pain management scenarios on the rise, CMS’ contractor has been including Lyrica where attempts have been made to identify ‘off-label’ uses and exclude it from Workers’ Compensation Medicare Set-Aside Allocations (WCMSA).

ExamWorks Clinical Solutions Compliance experts had the opportunity to sit down with CMS to discuss the matter. The bottom line is that CMS explained that it has been pushing Medicare’s Workers’ Compensation Review Contractor (WCRC) to move beyond the strict FDA view of Lyrica since October 2016. Based on their review of medical literature, CMS has instructed the WCRC to include Lyrica on cases where it appears to be related to the claimant’s workers’ compensation claim, and the drug is being used to treat neuropathic pain (spinal cord pain).

Not long after this discussion, we saw the release of an updated WCMSA Reference Guide on 1/4/2019 that further addresses the inclusion of Lyrica within the MSA. Section 9.4.6.2 Medically Accepted Indications and Off-Label Use, notes that use of Lyrica shows significant positive outcomes for the treatment of radicular pain. The guide further notes that spinal cord neuropathy includes injuries directly to the spinal cords or its supporting structure causing nerve impingement that result on neuropathic pain. In such conditions, Lyrica is considered acceptable treatment, and should be included within a WCMSA. 

While we now have clear guidance regarding central type nerve pain, what about peripheral nerve pain such as is seen in Complex Regional Pain Syndrome (CRPS)? Official Disability Guidelines (ODG) recommends Lyrica for use in neuropathic pain conditions. We also know the FDA has approved the use of Lyrica for peripheral nerve pain associated with Diabetic Peripheral Neuropathy and Fibromyalgia, and we know the medical community is widely accepting the use of Lyrica for these other peripheral nerve conditions, such as CRPS. So, how should these be addressed with in a WCMSA? Such claims should be addressed on a case-by-case basis looking closely at the medical details to determine if an off-label argument can be supported. 

There are positive points to keep in mind with regard to the allocation of Lyrica:

  • All dosage forms of Lyrica are priced the same, yielding potential for reduction in the cost of therapy, such as use of twice daily over three times daily. There are several cost effective first line alternatives:
    • Tricyclic Antidepressant medications (TCA), though these can have more side effects to address
    • Serotonin and Norepinephrine Reuptake Inhibitors (SNRI) which can be especially beneficial for those claimants with a pain-related type depression
    • For those claimants who have not been tried on gabapentin, there is opportunity to mitigate the claim with step therapy and trial of first-line agent gabapentin as a cost-effective alternative
    • A generic equivalent for Lyrica is anticipated to be released in July of 2019, which will help to curtail the ongoing cost.

ExamWorks Clinical Solutions best practices is to continually monitor for the launch of therapeutically equivalent generic agents onto the market and in utilizing evidence based guidelines to ensure first-line cost-effective agents are utilized for inclusion or exclusion of a drug under the Part D benefit. For questions about medications, please contact Nahla D. Rizkallah, PharmD, MSCC at 678.256.5086 or nahla.rizkallah@examworks-cs.com

About Lori Dickson 

Lori Dickson is the Director of Clinical Operations, a Masters-prepared Registered Nurse, a Certified Life Care Planner, and MSCC certified. She has worked within the MSP Compliance industry since 2004 and has provided oversight in a variety of areas including Life Care Planning, Medical Cost Projections, and MSA development. She is a contributing author to the Scope and Standards of Practice for Nurse Life Care Planning. Lori is based in the Lawrenceville, Georgia area and can be reached at 678-256-5008 or via email at lori.dickson@examworks-cs.com