MedicalResearch.com Interview with:
Thomas S. G. Sehested MD
Department of Cardiology
Copenhagen University Hospital Gentofte
Jenny Bjerre, MD
Department of Cardiology
Department of Health Research and Policy
Stanford University School of Medicine
MedicalResearch.com: What is the background for this study?
Response: n 2017, the results from the much-awaited Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) trial were published, confirming the inflammatory hypothesis, i.e. that targeting inflammation can reduce cardiovascular disease. The trial tested the monoclonal antibody canakinumab in a population of post-myocardial infarction patients with elevated inflammation markers (hs-CRP). Canakinumab is currently used for rare diseases and carries an orphan drug price: the 150mg dose used in CANTOS costs approximately $73,000 per year.
Due to the high prevalence of cardiovascular disease, millions of patients could potentially be eligible for treatment with this high-priced anti-inflammatory drug. Therefore, we wanted to investigate the cost-effectiveness for canakinumab for secondary prevention of cardiovascular disease, using the reported results from CANTOS.
MedicalResearch.com: What are the main findings?
Response: Our main finding is that the price of canakinumab needs to be reduced by more than 98% to reach any commonly accepted cost-effectiveness threshold. At the current drug price, one quality-adjusted life-year added would cost $6.4 million.
The methodology used in this study also allowed us to simulate different scenarios to explore what factors were driving the result. A post hoc analysis of CANTOS data including only drug responders (those with a decrease in inflammatory markers after the first dose) reported a mortality reduction of 31% in this “responders” group. However, when we simulated this scenario, canakinumab was still not cost-effective at more than $800,000 per quality-adjusted life-year added.
MedicalResearch.com: What should readers take away from your report?
Response: The combination of small benefits and a high price makes canakinumab far from cost-effective for secondary prevention of cardiovascular disease. To reach commonly accepted cost-effectiveness thresholds, future studies should either show a substantial mortality benefit or the company could make a very substantial price-cut.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The idea of only treating drug responders is intriguing and would also increase canakinumab’s cost-effectiveness. However, these results are based on post-randomization data so it would be appropriate to investigate this approach in a proper randomized manner.
Treating inflammation to prevent cardiovascular disease is an interesting and new area in cardiovascular medicine. We hope to see more trials in the future with other drugs that decrease inflammation and hopefully improve cardiovascular outcomes.
MedicalResearch.com: Is there anything else you would like to add?
Response: It is important to note that canakinumab has not been approved by the FDA for this indication. After receiving a rejection from the FDA on their application based on the “responders only” scenario, it is unknown whether the manufacturer (Novartis) will continue to apply for their approval.
Disclosures: Dr Sehested has received grants unrestricted from the Lundbeck Foundation. Dr Bjerre has received grants from the Danish Society of Cardiology and the Danish Heart Foundation.
Sehested TSG, Bjerre J, Ku S, et al. Cost-effectiveness of Canakinumab for Prevention of Recurrent Cardiovascular Events. JAMA Cardiol. Published online January 16, 2019. doi:10.1001/jamacardio.2018.4566
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