New non-nicotine drug to help smoking cessation efforts

VOL: 103, ISSUE: 24, PAGE NO: 23

NICE has published a final appraisal determination on the use of varenicline (Champix) for smoking cessation (NICE,...

NICE has published a final appraisal determination on the use of varenicline (Champix) for smoking cessation (NICE, 2007). The draft guidance is aimed at primary care professionals, including nurse prescribers and GPs, and effectively gives them the green light to prescribe the medication - a non-nicotine drug designed to help smokers give up cigarettes.

Smoking is one of the biggest causes of premature death in the UK and the world (World Health Organization, 2007a). An estimated 12 million people in the UK smoke (Action on Smoking and Health, 2006), and an estimated 114,000 people die every year in the UK as a result of smoking.

Statistics produced from the General Household Survey of 2005 (Office for National Statistics, 2006) showed that smoking rates have fallen from 28% of the overall UK population in 1998 to 24% in 2005. The approval of another new drug to help people give up smoking will help in reaching national targets.

In December 1998 Smoking Kills - a White Paper on Tobacco was released (Department of Health, 1998). It included targets for reducing the prevalence of cigarette smoking among adults in England to 24% by 2010.

In 2004 the DH agreed a new Public Service Agreement (PSA), which revised the target - to 21% or less by 2010.

Varenicline provides another way of helping people to stop smoking alongside bupropion (Zyban) and nicotine replacement therapy (NRT). NICE has issued draft guidance on the use of varenicline for smoking cessation with final guidance expected in July (subject to any appeals against it), coinciding with England's ban on smoking in public places.

A NICE appraisal committee considered the clinical effectiveness evidence presented by the manufacturer, Pfizer. It concluded that evidence from the direct trials and systematic reviews carried out by the manufacturer and the evidence review group demonstrated that varenicline was superior to NRT and bupropion in achieving continuous abstinence.

Varenicline is available in 0.5mg and 1mg film-coated tablets. It costs £54.60 for a 56-blister pack of 0.5 or 1mg tablets. A 12-week course costs about £163.80.

The summary of product characteristics (SPC) specifies the option of an additional 12 weeks of treatment and the consideration of dose tapering. Costs, however, can vary in different settings because of negotiated procurement discounts.

The drug works by providing relief from cravings and the withdrawal symptoms experienced by smokers while also reducing the satisfaction a smoker obtains from further cigarettes, if they have a relapse.

In four randomised controlled trials carried out by Pfizer, comparisons were made of a standard 12-week course of varenicline with bupropion and NRT.

Trials of the varenicline, which is taken twice a day, carried out with 2,000 people, showed that 44% had given up smoking after a 12-week course - a better success rate than the 18% of people given a placebo and 30% of people who took bupropion.

The appraisal committee also heard from clinical specialists and patient experts including: Dr Katherine Willmer, consultant cardiologist, nominated by the British Cardiovascular Society; and Christine Owens, Head of Tobacco Control of and nominated by the Roy Castle Lung Cancer Foundation. These two groups said the success rates with varenicline made it a useful addition to the variety of interventions available in smoking cessation, particularly because many smokers need to make multiple attempts to quit.

The availability of an additional treatment choice was mentioned by the specialists and patients as beneficial to those having difficulty maintaining abstinence and avoiding relapse because it enabled them to have more control.

NICE, in its final appraisal determination, said that varenicline was 'superior to NRT and bupropion in achieving continuous abstinence' and that its use in smoking cessation was 'likely to be a cost-effective use of NHS resources'.

The drug does have reported side-effects but these caused few patients to stop using the pill during the trials. Side-effects include nausea, headache, insomnia, abnormal dreams, change in taste, dry mouth and changes in appetite.

NICE will produce tools to help NHS organisations implement the guidance. This will include a local costing template to estimate savings and costs, and audit criteria to monitor local practice.

The appraisal committee also recommended that further research be carried out into the long-term effectiveness of smoking cessation interventions, with particular reference to relapse rates after completion of treatment.

NICE is currently preparing public health programme guidance on smoking cessation services, due in November. This includes the use of pharmacotherapies in primary care, pharmacies, local authorities and workplaces, with particular reference to manual working groups, pregnant women who smoke and hard-to-reach communities.

A spokesperson for NICE has said that having looked at all the evidence, its independent committee has concluded that varenicline appears to be a good way to help people who want to quit smoking. NICE recommends that varenicline should normally be provided in conjunction with counselling and support, but if such support is not available this should not stop smokers receiving treatment with varenicline.

Some prescribers may wait until July before prescribing varenicline, but it is likely that some GPs and nurse prescribers will start recommending the drug now. The guidance means that smokers who are serious about stopping have another choice from a range of clinically proven treatments.

By combining treatments with the right support - from smoking cessation services, for example - this could significantly increase the odds of them quitting for life.

The development is timely, given England's ban on smoking in public places from 1 July, following similar bans in Scotland, Wales and Ireland.

NICE's guidance was also published in the same week as World No Tobacco Day, an initiative by WHO to promote anti-tobacco advocacy and improve health. This year's theme was to push for smoke-free environments to cut down on second-hand smoke, also called environmental tobacco smoke, and encourage smokers to quit.

Second-hand tobacco smoke is dangerous to people's health (WHO, 2007b). Over 50 of the chemicals it contains are known to cause cancer and many studies provide evidence that it causes other serious diseases, such as heart disease and asthma.

WHO says that globally 700 million children - almost half the world's children - breathe air polluted by tobacco smoke. Exposure to second-hand tobacco smoke causes 2.8% of all lung cancer.

In the EU in 2002 some 80,000 people were estimated to have died from conditions related to second-hand tobacco smoke.

WHO has argued that it is worth environments going smoke-free because, among other issues:

- Second-hand tobacco smoke kills and causes serious illnesses;

- 100% smoke-free environments fully protect workers and the public from the serious harmful effects of tobacco smoke;

- The right to clean air, free from tobacco smoke, is a human right;

- Surveys show smoking bans are widely supported by smokers and non-smokers;

- Smoke-free environments provide the many smokers who want to quit with a strong incentive to cut down or stop;

- Smoke-free environments help prevent people, especially young people, from starting to smoke.

A new smoking cessation section on nursingtimes.net is launched this week, including useful resources for nurses.

NICE DRAFT RECOMMENDATIONS

- Varenicline, within its licensed indications, is recommended as an option for smokers who have expressed a desire to quit smoking.

- It should normally be prescribed only as part of a programme of behavioural support.

- Further research should be carried out into the long-term effectiveness of smoking cessation interventions with particular reference to relapse rates after completion of treatment.