6.17: Tobacco Use Cessation
Priority Medicines for Europe and the World
"A Public Health Approach to Innovation"
Background Paper
Tobacco Use Cessation:
Importance and Implications
By Warren Kaplan
With materials provided by
Dr. Samira Asma
Centers for Disease Control
USA
Coordinated by Derek Yach
YaleUniversity
12 October 2004
Table of ContentsIntroduction
What is the Size and Nature of the Disease Burden?
Health Consequences of Smoking
What is the Control Strategy?
Importance of smoking cessation in reducing disease burden
Why Does the Disease Burden Persist?
Need for Intervention to Increase Cessation
Evidence Base for Effective Intervention
What Can Be Learned from Past/Current Research into Pharmaceutical Interventions?
Nicotine replacement Therapy-Available Technologies
Nicotine Replacement Products and Government Policies
Policies and Problems for the Availability of NRTs
Accessibility of NRT Products
a.Geographical Accessibility
b.Financial Accessibility
What Are the Opportunities for Research Into New Pharmaceutical Interventions?
Discussion/Summary
References
Appendix
Introduction
Cigarette smoking and other tobacco use imposes a huge and growing global public health burden. Every year, tobacco use is currently estimated to kill nearly five million people worldwide, accounting for one of every five deaths among males over age 30 and one in twenty deaths among females over age 30. Based on current smoking patterns, annual tobacco deaths will rise to ten million by 2030. During the 21st century as a whole, we are likely to see 1 billion tobacco deaths, most of them in developing countries. In contrast the 20th century saw 100 million tobacco deaths and most of them were in developed countries.
Much of tobacco’s substantial death toll is avoidable. Numerous studies from high-income countries, and a growing number from low and middle-income countries, provide strong evidence that tobacco tax increases, dissemination of information about health risks from smoking, restrictions on smoking in public places and in workplaces, comprehensive bans on advertising and promotion, and increased access to cessation therapies are all effective in reducing tobacco use and its consequences. Cessation by the 900 million current smokers in developing countries is central to meaningful reductions in tobacco deaths over the next five decades. Price and non-price interventions are, for the most part, highly cost-effective. Potentially, tens or hundreds of millions of premature deaths would be avoided if these interventions could be widely applied.
There is overwhelming evidence for the health benefits, effectiveness and cost-effectiveness of quitting smoking and of treatment for tobacco dependence, a disorder recognized by the tenth version of WHO’s International Classification of Diseases.[1] Treatment for tobacco dependence is safe and efficacious. However, despite availability of cost-effective treatment for tobacco dependence, the public health sector in many countries, is not investing in smoking cessation services, nor in the development of an infrastructure that will motivate smokers to quit and support them on doing so. Furthermore, in most countries, provisions for treatment, training of health care providers, education and information on wide use of cessation therapies, as well as financial resources are limited and rarely incorporated into standard health care. Also, smoking cessation is not seen as a public health priority and is not necessarily approached as a key tobacco control strategy in governmental and institutional workplans. Beside specific interventions for smoking cessation, a general supportive environment that will stimulate smokers to quit is not usually considered a component of smoking cessation policies.
This paper examines the relevant set of policies on information, availability, accessibility and affordability of Nicotine Replacement therapy (NRT) products from the pharmaceutical policy perspective for developed and developing countries.
What is the Size and Nature of the Disease Burden?
Tobacco use is the single largest preventable cause of death worldwide. Every year, nearly 5 million people die from tobacco-related illnesses.[2] The prevalence of tobacco use worldwide is estimated at 29%, and it is rising.[3] The global rate of tobacco use is significantly higher for men (47%) than women (12%),3 but the tobacco industry has targeted women in their promotional strategies. In many regions of the world this targeting has proved effective, resulting in alarming rates of increase in tobacco use among women in both developed and developing countries.3,[4] In Denmark, Germany, and Sweden, more women aged 14 to 19 years than ever now smoke, even in the midst of national declining rates. Similarly, in some countries in Asia, smoking among women aged 18 to 24 years has increased. The number of women smokers will likely triple over the next generation.4 The prevalence of smoking among youth is also increasing. Data from the Global Youth Tobacco Survey show that one out of five children in the world smokes his or her first cigarette by age 10 years. The prevalence of tobacco use among schoolchildren aged 13 to 15 years ranges greatly throughout the world, from 10% to as high as 60%.[5]
Health Consequences of Smoking
Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general. Forty years after the first Surgeon general’s report in 1964, the list of diseases and other adverse effects caused by smoking continues to expand. Epidemiologic studies are providing a comprehensive assessment of risks faced by smokers who continue to smoke across their lifespan. Laboratory research now reveals how smoking causes disease at the molecular and cellular levels. Fortunately for former smokers, studies show that the substantial risks of smoking can be reduced by successfully quitting at any age.6
Tobacco use was a known or probable cause of more than twenty-five specific diseases and is an important cause of, and risk factor for, chronic disease.[6] Independently and often in combination, these risk factors are the major causes of cancer, cardiovascular disease, diabetes, respiratory disease, and other chronic diseases.[7] The list of disease caused by smoking has been expanded to include abdominal aortic aneurysm, acute myeloid leukemia cataract, cervical cancer, kidney cancer, pancreatic cancer, pneumonia, periodontitis, and stomach cancer.6 Prolonged smoking causes lung cancer, other cancers (i.e., cancer of kidneys, cervix and bone marrow), chronic respiratory and cardiovascular diseases (in particular ischemic heart disease), and many other diseases. Smoking diminishes health generally. Adverse health effects begin before birth and continue across the life span. Smoking also causes cataracts and contributes to the development of osteoporosis, thus increasing the risk for fracture in the elderly.7 In populations in which cigarette smoking has been common for several decades, about 90% of lung cancer, 15% to 20% of other cancers, 75% of chronic bronchitis and emphysema, and 25% of deaths from cardiovascular disease at ages 35 to 69 years are attributable to tobacco use.8 Tobacco-related cancer constitutes 16% of the total annual incidence of cancer cases – and 30% of cancer deaths – in developed countries, and 10% of deaths in developing countries.7
Chronic diseases are expected to account for an increasing share of the disease burden, rising from 43% in 1998 to 73% by 2020.8 The expected increase is likely to be most rapid in developing countries. For example, in India, the number of deaths from chronic causes each year is projected to almost double, from 4.5 million in 1998 to about 8 million in 2020.2 The steep projected increase in chronic diseases worldwide is largely driven by the rapidly increasing numbers of people presently exposed to tobacco via smoking or secondhand smoke (SHS) as well as to other risk factors.
What is the Control Strategy?
Importance of smoking cessation in reducing disease burden
Quitting smoking has immediate as well as long terms benefits, reducing risks for disease caused by smoking and improving health in general.6 Smoking cessation is a priority for preventing disease and reducing its burden.[8] At any age, quitting confers substantial and immediate health benefits including reduced cardiovascular disease risks,7 improved lipid profiles and platelet reactivity[9] and reduced risk of stroke7 and smoking-attributable cancers.10 The World Bank suggests that, if adult consumption were to decrease by 50% by the year 2020, approximately 180 million tobacco related deaths could be avoided.[10] Thus promotion of smoking cessation and treatment of tobacco dependence can have great impact in reducing the burden of disease and improving population health. (See Appendix 6.17.1)
According to the Commission on Macroeconomics and Health, smoking is on a short list of specific conditions-including HIV/AIDS, malaria, tuberculosis, childhood infectious disease, maternal and perinatal conditions, and micronutrient deficiencies-that needs to be a priority in low income countries to save million of lives, reduce poverty, spur economic development, and promote global security.[11] In addition, cessation interventions are described specifically in the WHO Framework Convention on Tobacco Control (FCTC). Signing the FCTC and its ratification will obligate countries to work on cessation as part of a comprehensive effort in tobacco prevention and control.[12]
In recent years governments at all levels have adopted a variety of macro-level interventions. These include tobacco tax increases, restrictions on smoking in public places, limits on youth access to tobacco products, bans on advertising and other promotions, counter advertising, efforts to increase information about the harmful consequences of tobacco use. Most of these interventions aimed at reducing the demand (consumption) for tobacco products and are considered preventive policies.
Demand for smoking cessation interventions is increased in an environment that discourages and denormalizes tobacco use. Smoke-free indoor air policies, tobacco taxation to increase price, and public information campaigns increase interest in stopping smoking. Banning the use of misleading labeling on tobacco products, for example, ‘light’ and ‘mild’, can also help prevent smokers from relapsing and increase quitting.[13] The impact of a smoking cessation program is the product of its effectiveness and population reach (e.g., the proportion of smokers in the population who use it). Brief low-intensity interventions that focus on education and increasing motivation to quit and produce a low but measurable success rate, and have a higher potential for population impact. Most smokers that have quit in Western countries have done so without any therapies or even doctor’s advice.7 In contrast, multi-session, high-intensity treatments targeting nicotine-dependent smokers requiring individual treatment are characterized by a higher success rate, but reach only a small fraction of the population. This balance of the two approaches may differ across time, between countries and within countries. As prevalence falls, dependence in remaining smokers is likely to be high. In countries with a high smoking rate and low population awareness of the risks of tobacco use, awareness of the hazards of smoking and the benefits of cessation, plus focused efforts that reach large numbers (e.g., quit phone lines) are the priority. In countries or populations where smoking prevalence has started to fall and awareness of the health risks of tobacco is higher, higher intensity clinical interventions may be needed.
Near term reductions in smoking-related mortality depend heavily on smoking cessation. There are numerous behavioral smoking cessation treatments available, including self-help manuals, community-based programs, and minimal and intensive clinical interventions.[14] In clinical settings, pharmacological treatments, including nicotine replacement therapies (NRT) and bupropion, have become much more widely available in recent years in high-income countries.14, 15
Why Does the Disease Burden Persist?
Need for Intervention to Increase Cessation
Tobacco dependence is recognized as a disease in the WHO’s International Classification of Diseases (ICD-10) and the American Psychiatric Association’s Diagnostic and Statistical Manual (DSM-IV).[15] In developed countries, a large proportion of smokers want to stop smoking and many try to stop[16] but the corresponding proportions in developing countries are low.[17], [18], [19]Smokers who try to quit often find it difficult because of the addictive properties of nicotine.[20] Because of the low rate of quitting and the inherent difficulties in stopping, governments need to encourage smokers to quit and to provide more assistance to those who need help.
Evidence Base for Effective Intervention
The evidence base for both the effectiveness and cost effectiveness of clinical smoking cessation interventions is strong in Europe and the US.[21],[22] A similar evidentiary base is not available for developing countries.14 In the US there is also a strong evidence base for the effectiveness of community based and population based interventions such as running sustained mass media campaigns, raising tobacco prices, reducing the cost of treatment, and establishing telephone quitlines.[23],[24]
Current research from Western countries provides mixed evidence on the impact of community-based behavioral interventions without NRT on successful smoking cessation.15 However, community interventions may be more effective and more cost-effective (due to lower labor costs) in low income countries. In India, studies among 37,000 tobacco smokers and chewers found that cohorts who received health professional advice, information and cessation camps had quit rates of 9% to 17%, in contrast to 3% to 9% among cohorts who did not receive these interventions.18
Promoting smoking cessation, creating an environment supportive of non-smoking, and providing appropriate services has produced encouraging results in the UK.[25],[26],[27] Although in 2000 the WHO recommended that the treatment of tobacco dependence be considered a public health priority,[28] much more needs to be done to promote smoking cessation worldwide.
What Can Be Learned from Past/Current Research into Pharmaceutical Interventions?
Nicotine replacement Therapy-Available Technologies
In recent years, given the addictive nature of tobacco, tobacco control interventions have given an increasing importance for the tobacco addiction treatments, such as the nicotine replacement therapy products (NRTs). The recent World Bank tobacco report “Curbing the Epidemic: Governments and Economics of Tobacco Control” also addressed the importance of the NRT products as one of the efficient tobacco control policies. Moreover, the report recommends that governments include nicotine addiction treatments into tobacco control policies.
Nicotine replacement therapy (NRT) aims to replace the nicotine from cigarettes by other means of delivery nicotine skin patches, chewing-gum, lozenges, sublingual tablets, inhalators or nasal spray. NRT provides a background level of nicotine that reduces craving and withdrawal. The evidence is strong and consistent that pharmacological treatments significantly improve the likelihood of quitting, with success rates two to three times those when pharmaceutical treatments are not employed.14, 15, [29]
A recent overview suggested the 2-3% of smokers abstained at 6 months with brief clinical advice to stop. Adding NRT to such advice increased quit rates to 6%, and intensive support plus NRT raised quit rates to 8% at 6 months.
The products currently licensed in the UK listed in Table 1 (NICE 2002).
Table 1. Nicotine Replacement Therapies Technology Available in the UK
NRT / Dose/Brand/ManufacturerNicotine transdermal patches /
- 5mg, 10mg, 15 mg (Nicorette, Pharmacia)
- 7mg, 14mg, 21mg per 24 hours(NICOTINELLE TTS 10, TTS 20 &TTS 30 Novartis Consumer Health)
- 7mg, 14mg, 21mg (NiQuitin CQ, GlaxoSmithKline (GSK))
Nicotine chewing gum / 2mg, 4mg (Nicorette, Phamacia) (Nicotinell, Novartis Consumer Health)
Nicotine sublingual tablet / 2mg (Nicorette, Microtab, Pharmacia)
Nicotine lozenge / 1 mg (Nicotinell, Novartis Consumer Health)
Nicotine inhalation cartage plus mouthpiece / 10mg (Nicorette, Inhalator, Pharmacia)
Nicotine nasal spray / 0.5mg per puff metered nasal spray (Nicorette and Pharmacia
Nicotine lozenge / 2mg and 4mg (NiQuitin CQ, GSK)
While successful in treating nicotine addiction, the markets for NRT and other pharmacological therapies are highly regulated. In turn, pharmaceutical treatments are less affordable and less available than nicotine-containing tobacco products that are distributed in a relatively unrelated market. Recent evidence indicates that the demand for these products is related to economic factors, including their price.[30]Policies that decrease the cost of NRT and increase their availability, such as mandating private health insurance coverage of NRT, including NRT coverage in public health insurance programs, and subsidizing NRT for uninsured or underinsured individuals, would likely lead to substantial increases in the use of these products. Given their demonstrated efficacy in treating smoking, these policies could generate significant increases in smoking cessation and the health benefits that result from cessation.
NRT expenditures per capita vary widely between income group countries as well as between the US and other high-income countries. The US spends $2.11 per capita or $10.88 per smoker on NRT products in 1996, whereas other high-income countries on average spend $0.42 per capita or $1.63 per smoker. Middle-income countries’ expenditures on NRT are significantly less than that of other-income countries. Upper-middle income countries spend $0.03 per capita or $0.16 per smoker on NRT products. Lower-middle income countries’ spending are $0.003 per capita or $0.03 per smoker.
Nicotine Replacement Products and Government Policies
A successful tobacco control policy on addiction treatment strongly depends on smoker’s demand for NRT products and government’s policies on availability and accessibility of these products. Most smokers start smoking at an early stage of their lives and later regret that they are smokers. For example, a survey from Indonesia indicates that over 80% of smokers want to quit smoking. Moreover, most smokers who say they want to stop, their efforts to quit have failed, often despite of frequent attempts.[31]
Policies and Problems for the Availability of NRTs
Patent policies, designed to give returns to research and development expenditures, are politically charged issues. Almost all industrialized and developing countries now recognize patents on both pharmaceutical products and process- usually for 20 years.
Given the monopolistic elements of the pharmaceutical market, price control policies on drugs are commonly found in countries at all income levels. The primary objective of the price controls is to control drug prices and expenditures. With regard to NRT and such pricing policies, there is not sufficient time series data to compare the trend on NRT expenditures for countries with and without price control policies. Second, countries did not include NRT products in their essential drug lists and also there is no reimbursement system for the NRT products in any country, as they are mostly available over the counter. Therefore, NRT products are not subject to any price control policies at all.