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Wake up, modafinil's price dropped!

Monday, July 15, 2019

Provigil® (modafinil) is a wakefulness-promoting agent, which is FDA approved for excessive somnolence associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder. It also has a multitude of non-FDA medically accepted uses including: attention deficit hyperactivity disorder, cancer-related fatigue, adjunct treatment of unipolar or bipolar depression, adjunctive treatment of fatigue related to depression, fatigue related to multiple sclerosis; adjunct to schizophrenia, sleep deprivation, spastic cerebral palsy, and Steinert myotonic dystrophy syndrome. While modafinil has been commercially available as a generic agent since 2012, the cost has still been high. Please refer to the table below outlining a significant difference in the lowest average wholesale price (AWP) between the previous and current AWP.

Modafinil Strength

Previous AWP

New AWP

% Change

100mg tablet

$21.99

$1.52

93.1%

200mg tablet

$33.31

$1.56

95.3%

If utilized for the aforementioned indications listed above, maintenance use of modafinil would be included by Center for Medicare and Medicaid Services (CMS) in a Workers Compensation Medicare Set-Aside Arrangement (WCMSA). The dramatic reduction in cost would markedly reduce the Part D allocation of the WCMSA and potentially facilitate settlement.

The Official Disability Guidelines (ODG) on modafinil

  • In the pain chapter, the ODG does not recommend modafinil solely to counteract sedation effects of narcotics until after first considering reducing excessive narcotic prescribing. If modafinil is being utilized for management of opioid-related sedation, this would be considered an off-label indication and could be excluded from the WCMSA.
  • In the Head chapter, the ODG recommends to use with caution to help decrease daytime sleepiness caused by sleep apnea in brain injury.

The FDA required a boxed warning on the modafinil product label, signifying the drug carries a significant risk of serious or even life-threatening adverse effects. Modafinil is a federally controlled substance (C-IV) because it can be abused or lead to dependence. As such, compliance monitoring is recommended particularly for claimants that have a history of drug or stimulant abuse.

As part of best practices, ExamWorks Clinical Solutions continually monitor CMS’ recognized proprietary source, Red Book, for real-time changes for newly generic agents and for average wholesale price (AWP) for medications used to treat the injured worker.

ExamWorks Clinical Solutions strives to provide the most accurate and defensible MSA by utilizing technology and compendia databases which are recognized and supported by the CMS to support inclusion or exclusion of a drug under the Part D benefit. We will continue to monitor changes in medication pricing as well as availability of generic equivalents within the marketplace. 

For questions about medications, please contact Nahla D. Rizkallah, PharmD at 678.256.5086 or nahla.rizkallah@examworks-cs.com