Celecoxib (Celebrex®), the only available cyclooxygenase-2a (COX-2) in the United States, has had a price drop this month in the 200mg capsule formulation. Celecoxib is FDA indicated to treat signs and symptoms of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis. It is also indicated to manage acute pain and to treat primary dysmenorrhea. The cost of celecoxib 200mg capsule has seen some fluctuations in price over the years and the current cost is outlined in the table below.
Lowest Average Wholesale Price (AWP) of Celecoxib 200mg Capsule
The considerable reduction in cost would markedly reduce the Part D allocation of the updated Workers Compensation Medicare Set-Aside Arrangement (WCMSA) and potentially facilitate settlement.
The FDA required a boxed warning on the celecoxib product label, as well as for all NSAIDs, signifying the drug carries a significant risk of serious or even life-threatening adverse effects. NSAIDs cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. There is also a contraindication for use in patients who have recently undergone Coronary Artery Bypass Grafting (CABG). The risks may occur early in treatment and may increase with duration of use. Furthermore, NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, perforation of the stomach or intestines, which can be fatal. As with the CV warnings, these events can occur at any time during use and without warning symptoms. Elderly patients and patients with prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. Based on currently available data, the FDA concluded that short-term use of low doses of currently available over-the-counter (OTC) NSAIDs is not associated with increased CV risk.
As part of best practices, ExamWorks Compliance 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, as well as PharmD review of all Part D medications for the indication for use for potential exclusion from the WCMSA.
ExamWorks Compliance 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.