Re: Cytisine, the world’s oldest smoking cessation aid
Prochaska, Das and Benowitz(1) give and excellent overview of the history and current position of cytisine. However, they fail to highlight the compelling cost/benefit evidence why this effective, safe and extremely inexpensive drug should be licensed immediately throughout the world. Fortunately, this case has been made by Aveyard and West(2) and readers interested in this drug and a classic case of the inflexibility of western regulatory systems are directed to their article. Prochaska and colleagues are right to call for further research, but this should not delay making the existing proven cytisine treatment regimen available now. This historical 25-day treatment course is unlikely to be optimal in either dosing or duration and future trials should be directed to improving this and moving forward, rather than re-testing what is clear. Clinical experience, were cytisine to be made available to clinicians, is also likely to be beneficial to this end. Further basic Phase III efficacy/safety trials for licensing would take years – years of additional world-wide smoking-related deaths and money spent on more expensive drugs in the west.
Prochaska and colleagues mention the low cost of cytisine but do not translate this into cost per life years saved or QALYs. This has been estimated to be as low as $162 (95% CI = $106 to $363) for smokers treated at age 35–54 years(3). The equivalent figure for similar efficacy with the nicotine patch, the currently most popular licensed treatment in the west, is around $2,000 - $3,000(3). In the UK, where the nicotine patch is NHS funded, the potential for health service (tax payer) savings from the introduction of cytisine are obvious, and it is extraordinary that government ministers and their civil servants have not realised the prize of a more flexible regulatory approach in the particular case of cytisine.
John Stapleton
Reader in Addictions Statistical Analyses, Kings College London, Institute of Psychiatry, Addictions Department
References
1 Prochaska JJ, Das S, Benowitz NL. Cytisine, the world's oldest smoking cessation aid. BMJ. 2013 Aug 23;347:f5198. doi: 10.1136/bmj.f5198.
2 Aveyard P, West R. Cytisine and the failure to market and regulate for human health. Thorax 2013; 0:1. doi:10.1136/thoraxjnl-2013-203246
3 Stapleton JA, West R. A direct method and ICER tables for the estimation of the cost-effectiveness of smoking cessation interventions in general populations: application to a new cytisine trial and other examples. Nicotine Tob Res. 2012 Apr;14(4):463-71. doi: 10.1093/ntr/ntr236. Epub 2012 Jan 9.
Rapid Response:
Re: Cytisine, the world’s oldest smoking cessation aid
Prochaska, Das and Benowitz(1) give and excellent overview of the history and current position of cytisine. However, they fail to highlight the compelling cost/benefit evidence why this effective, safe and extremely inexpensive drug should be licensed immediately throughout the world. Fortunately, this case has been made by Aveyard and West(2) and readers interested in this drug and a classic case of the inflexibility of western regulatory systems are directed to their article. Prochaska and colleagues are right to call for further research, but this should not delay making the existing proven cytisine treatment regimen available now. This historical 25-day treatment course is unlikely to be optimal in either dosing or duration and future trials should be directed to improving this and moving forward, rather than re-testing what is clear. Clinical experience, were cytisine to be made available to clinicians, is also likely to be beneficial to this end. Further basic Phase III efficacy/safety trials for licensing would take years – years of additional world-wide smoking-related deaths and money spent on more expensive drugs in the west.
Prochaska and colleagues mention the low cost of cytisine but do not translate this into cost per life years saved or QALYs. This has been estimated to be as low as $162 (95% CI = $106 to $363) for smokers treated at age 35–54 years(3). The equivalent figure for similar efficacy with the nicotine patch, the currently most popular licensed treatment in the west, is around $2,000 - $3,000(3). In the UK, where the nicotine patch is NHS funded, the potential for health service (tax payer) savings from the introduction of cytisine are obvious, and it is extraordinary that government ministers and their civil servants have not realised the prize of a more flexible regulatory approach in the particular case of cytisine.
John Stapleton
Reader in Addictions Statistical Analyses, Kings College London, Institute of Psychiatry, Addictions Department
References
1 Prochaska JJ, Das S, Benowitz NL. Cytisine, the world's oldest smoking cessation aid. BMJ. 2013 Aug 23;347:f5198. doi: 10.1136/bmj.f5198.
2 Aveyard P, West R. Cytisine and the failure to market and regulate for human health. Thorax 2013; 0:1. doi:10.1136/thoraxjnl-2013-203246
3 Stapleton JA, West R. A direct method and ICER tables for the estimation of the cost-effectiveness of smoking cessation interventions in general populations: application to a new cytisine trial and other examples. Nicotine Tob Res. 2012 Apr;14(4):463-71. doi: 10.1093/ntr/ntr236. Epub 2012 Jan 9.
Competing interests: No competing interests