Drug Review: Volume 21, Issue 9 - Download PDF
Behçet’s disease (BD) is a rare but chronic disorder that results in inflammation of the blood vessels. It is associated with a wide array of symptoms, the most prominent of which includes oral ulcers. Oral ulcers affect nearly all patients suffering from BD and can lead to severe physical impairment including difficulties eating and speaking. BD can result in significant disability and productivity loss, which profoundly impacts an individual’s quality of life. The prevalence of BD in Canada is approximately 1 to 50 per 100,000 individuals.
Prior to the approval of Otezla®, there were no approved drugs indicated for the treatment of BD in Canada. The treatment options involved the use of off-label medications for the management of BD-associated symptoms such as oral ulcers. Topical corticosteroids are typically used for mild cases; however, they only provide short-term relief. Colchicine could also be used off-label for prevention of recurrent ulcers. If the symptoms remain persistent despite these measures, immunosuppressants such as azathioprine or biologics such as etanercept could be used off-label. However, these options are associated with significant safety issues such as an increased risk of infection. This highlights a need for a safe and effective medication for the treatment of BD-associated ulcers.
Otezla® is Health Canada approved for the treatment of plaque psoriasis and psoriatic arthritis. Otezla® is the first agent approved for the treatment of oral ulcers associated with BD. Otezla® works by limiting the inflammatory process involved in forming ulcers. During clinical trials, Otezla® reduced oral ulcers and pain scores and improved quality of life. The common side effects of Otezla® include diarrhea, headache, and nausea, all of which were mild in severity. Otezla® presents a new treatment option for oral ulcers associated with BD that is both safe and effective.
The annual cost of $13,800 makes Otezla® significantly more costly than standard therapy. For this reason, Otezla® will be placed under Special Authorization for ClaimSecure groups subscribing to managed formularies to ensure that Otezla® is reserved for patients that have tried or are intolerant to more cost-effective options. Otezla will be fully covered for groups subscribing to open formularies.
ClaimSecure Inc. reserves the right to amend in part, or in its entirety, its Special Authorization guidelines.
- Otezla Product Monograph. Amgen Canada Inc. August 2020
- Hatemi G, Mahr A, Ishigatsubo Y, et al. Trial of Apremilast for Oral Ulcers in Behçet’s Syndrome. N Engl J Med. 2019;381(20):1918-1928. doi:10.1056/NEJMoa1816594
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