Case Report

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A 41-year-old woman presented for treatment to a specialty tobacco clinic. She had previously quit smoking in March 2000 for 2 years using a nicotine inhaler. In March 2002, her primary care doctor felt she was becoming addicted to the inhaler and declined to continue to prescribe it. On stopping the medication, the patient quickly relapsed to smoking. She presented for treatment in July 2002 after returning to smoking for 4 months. At that time, she smoked 20 nonmenthol cigarettes per day, smoking her first cigarette of the day 1 minute after waking in the morning. Her medical history included depression, anxiety, and hyperlipidemia. She had a bachelor's degree and worked as an administrator. On examination, her exhaled carbon monoxide concentration was 21 parts per million (ppm); a typical range for a nonsmoker is 0 to 4 ppm. Her treatment plan included group behavioral treatment, a 21-mg nicotine patch worn daily, and a nicotine inhaler as needed. After successfully obtaining insurance coverage, albeit with some difficulty, she set a quit date and was successful in stopping smoking in August 2002.

The patient was reevaluated in February 2007. She had not smoked since her quit date 4.5 years earlier. She used 28 inhaler cartridges per day. Her blood nicotine level was 25 ng/mL and blood cotinine level was 390 ng/mL (both of which are in the range of a moderate regular smoker). Her exhaled carbon monoxide concentration was 0 ppm, which confirmed that she was not smoking. She reported no ill effects from the nicotine inhaler and feared that she would once again relapse to smoking if she stopped the medication. At this point, her insurance company no longer agreed to cover the medication.

Long-Term Use of Cessation Medications versus Long-Term Cigarette Smoking

Many smokers are misinformed about the safety of nicotine medications and other available cessation pharmacotherapies. Most smokers incorrectly reported that nicotine was the primary cause of cancer, and only one third correctly stated that the nicotine patch was less likely than cigarette smoking to cause a heart attack (3). In fact, NRT is safe even at high doses (4) and in high-risk populations, such as persons with existing cardiovascular disease (5). Although dependence on NRT is possible, the overall chance of addiction as reported in the literature is very low, generally under 10% (6). The optimal duration of treatment remains unclear (7), but a single, brief treatment course with NRT results in long-term abstinence in only a few smokers. Relapse is a hallmark of this chronic condition: Of persons who quit smoking by using NRT and achieve abstinence at 12 months, an estimated 30% subsequently relapse (8).

Extending the duration of NRT treatment for longer periods may be beneficial (2) and could prevent relapse (9). In clinical trials, nicotine inhaler use extended for up to 1 year increased abstinence rates at 12 months compared with placebo (10). In the Lung Health Study (11), 31% of participants continued using nicotine gum safely and effectively for over 1 year. Some participants continued gum use for up to 5 years without any serious side effects. In addition, data indicate that use of bupropion and varenicline for up to 1 year is effective and safe (12, 13). Long-term medication use in patients requiring extended courses of treatment is also supported by the updated U.S. Public Health Service Guidelines (2). Because quitters using long-term pharmacotherapy are exposed to lower levels of nicotine without the 4000 toxins found in cigarette smoke, there is a clear overall health benefit if the individual no longer smokes cigarettes (9).

Tobacco Dependence Treatment Should Be Considered the Same as Treatment of Other Chronic Medical Conditions

For some smokers, long-term pharmacotherapy is the difference between tobacco abstinence and lifelong smoking. Although long-term use of nicotine replacement therapy, as described in our case, is not typical, it is much safer than continuing to smoke cigarettes. Health care providers should remain open-minded to patients who may require a unique course of treatment. Although long-term use is considered off-label, patients should be encouraged to remain smoke-free, and if extended courses of pharmacotherapy will assist them, treatment should be continued, encouraged, and reimbursed.

Rather than considering cessation medications as a short-term aid in smoking cessation, these medications should be covered in the same manner as treatment of other long-term illnesses and conditions, such as asthma, depression, and diabetes, given the chronic, relapsing nature of tobacco dependence (Table) (14–19). The neurobiochemical effects of tobacco use are well documented and result in measurable and lasting changes in brain structure (for example, upregulation of nicotinic receptors) and brain function (for example, changes in the electroencephalogram), some of which can be objectively measured by imaging techniques, especially in the mesolimbic "reward" center (20). These biological changes are a hallmark of a chronic medical condition, and discontinuation of tobacco use results in physiologic changes within the brain and a subsequent withdrawal syndrome (2).

Pharmacotherapies have been proven effective in treating these withdrawal symptoms, but a major barrier to obtaining treatment is insurance coverage. Despite the cost-effectiveness of tobacco treatment medications compared with other commonly prescribed medical interventions, insurance carriers often do not cover proven cessation therapies or the duration of therapy is severely curtailed (2). With other serious addictions, such as heroin, proven medications (such as methadone) to prevent relapse are commonly provided long-term. This is not the case with tobacco treatment medications, even though tobacco kills far more of its users than any other addiction. Physicians and insurers view tobacco dependence like other addictions that do not garner the same respect as "medical" diagnoses—in fact, it carries a certain stigma. The reality is that tobacco use kills more people than many classic medical diseases. It should not matter whether the site of disease is in the lung with airway hyperreactivity (asthma), in the adipose tissue with insulin resistance (diabetes), or in the nucleus accumbens (tobacco dependence). The outcomes of morbidity and mortality are what should concern patients, health care providers, and payers. It is time to move beyond the antiquated categorization of tobacco use as just a bad habit and to provide effective treatment. Thus, these stakeholders should regard tobacco dependence as the chronic medical condition that it represents. With repeated assistance, our patient continued to receive the nicotine inhaler through her insurance carrier and has remained abstinent from tobacco for over 5 years. From her example and from the scientific evidence, the long-term use of medications for the treatment for tobacco dependence can result in continued abstinence and the associated reduction in negative health consequences.

In summary, the prevalence of tobacco use and death rates from smoking are higher than those of other chronic conditions, such as diabetes. Both conditions improve with comprehensive, cost-effective treatments, including combined pharmacotherapy and behavioral components. However, whereas long-term treatments for diabetes are commonly reimbursed by health insurance, those for tobacco dependence often are not. Covering both behavioral and pharmacologic measures to assist in smoking cessation will increase the demand for and accessibility to effective treatment options and has been called for in a State-of-the-Science Conference Statement by the National Institutes of Health (21). Improving the availability of these benefits will expand the number of smokers who utilize treatment and will increase smoking abstinence rates (2). Tobacco dependence should be recognized as a chronic illness that requires effective treatments as long as the condition exists.