PBS subsidised with support and counselling

This document has been updated since its original release.

Evidence snapshot | PBS listing | Reason for PBS listing | What is it? | Who is it for? | Where does it fit? | How does it compare? | Safety issues | Dosing issues | Information for patients | References

Key points

A first-line pharmacotherapy Nicotine replacement therapy (NRT) increases sustained abstinence rates. One PBS-subsidised 12-week course of nicotine patches per year Nicotine gum, lozenges, tablets and inhalers are not subsidised. Refer for, or provide, support and counselling Supported therapy (e.g. Quitline) is more effective than NRT alone and is a condition of PBS subsidy. Tailor treatment to preferences and clinical suitability For example, NRT may have advantages for people with psychiatric illness. Nicotine gum or another intermittent form of NRT may be used during pregnancy or breastfeeding Nicotine is harmful to the foetus but NRT less than smoking. Consider other forms of NRT before nicotine patches. Minor side effects are common These include skin irritation or abnormal dreams with overnight use.

Evidence snapshot

What is known about this drug A meta-analysis found consistently better abstinence rates with patches compared with placebo (relative risk 1.7 [95% CI 1.5 to 1.8]), but the percentage of people abstinent at 12 months varied between trials (9–38%). The absolute benefit is greatest when used with intensive behavioural support.	Areas of uncertainty There are limited data comparing the efficacy of NRT with varenicline. Combined pharmacotherapy is not supported by evidence. The safety and efficacy of combining NRT with varenicline has not been established, and there is insufficient evidence that combining NRT with bupropion provides an additional benefit.	What does NPS say? NRT, varenicline and bupropion are all first-line choices for people who are nicotine dependent, and should be used with support and counselling (e.g. Quitline) for greatest effect. Clinical suitability and individual preferences should guide the choice of pharmacotherapy.

PBS listing

Authority required

Nicotine transdermal patches (15 mg/16 hours and 21 mg/24 hours) are listed on the Pharmaceutical Benefits Scheme (PBS) as an aid to quitting smoking for people who participate in a support and counselling program.

A maximum of 12 weeks of nicotine patches are subsidised per year. Nicotine patches are not subsidised for use at the same time as PBS-subsidised bupropion or varenicline.¹

Authority listing for Aboriginal and Torres Strait Islander people

People who identify as Aboriginal or Torres Strait Islander qualify for the existing PBS Authority listing that provides up to two courses per year of nicotine patches, each of a maximum of 12 weeks. Under this listing, participation in a support and counselling program is recommended but not mandatory. See the NPS RADAR brief item Nicotine patches for Aboriginal and Torres Strait Islander people.

Authority listing on the Repatriation Schedule

The Repatriation Schedule (RPBS) contains a further Authority listing, with each prescription providing 6 weeks' supply of patches and no limit on the number of prescriptions per year. Participation in a support and counselling program is mandatory under this listing.

May be prescribed by nurse practitioners

Authorised nurse practitioners may prescribe this medicine on the PBS. See the PBS website for more information on nurse practitioner PBS prescribing.

What is it?

Nicotine transdermal patches release nicotine over the course of 16 or 24 hours to be absorbed through the skin. Like other forms of nicotine replacement therapy (NRT), patches reduce the nicotine withdrawal symptoms associated with stopping smoking. The other types of NRT available in Australia are nicotine gum, lozenges, tablets and inhalers. Only full-strength nicotine patches (15 mg/16 hours or 21 mg/24 hours) are subsidised on the PBS.

Who is it for?

Consider smoking cessation pharmacotherapy for people who are nicotine dependent

Smokers who are nicotine dependent can roughly double the odds of successfully quitting by using a smoking cessation drug, such as NRT.³ Most studies of NRT involved people who smoked more than 15 cigarettes a day, so there is little evidence that NRT is effective for people who are not nicotine dependent.*²

People who have used NRT unsuccessfully in the past may find it useful on a repeat attempt, although the evidence to support this is limited.² Assist with a quit plan and access to suitable support and counselling. Whether or not people use pharmacotherapy, on average it takes several attempts to quit smoking successfully.⁴
See NPS Prescribing Practice Review 50 for further information about smoking cessation and the ‘5As’ approach.

*See additional online material: brief nicotine-dependence questionnaire.

NRT may be used by people with stable cardiovascular disease

Any of the three first-line smoking pharmacotherapy drugs may be used in people with stable cardiovascular disease, although evidence for safety and efficacy is most extensive for NRT. Using nicotine patches is not associated with acute cardiovascular events.^5,6 Smokers who are currently hospitalised and haemodynamically unstable should initiate NRT only under medical supervision.^7,8

NRT may be the appropriate choice for people with psychiatric illness

NRT is likely to be the preferred pharmacotherapy for people with psychiatric illness, as there are safety concerns about varenicline or bupropion. In particular, the safety and efficacy of varenicline has not been established for people with serious psychiatric illness such as schizophrenia, bipolar disorder or major depressive disorder (see the NPS RADAR brief item Varenicline (Champix) safety update: serious neuropsychiatric and dermatological adverse events).⁹ Additionally, people with a history of psychiatric illness have experienced psychotic or manic symptoms while taking bupropion (which may precipitate a manic episode in people with bipolar disorder).¹⁰

Where does it fit?

Choose NRT, varenicline or bupropion according to clinical suitability and individual preferences

Consider factors such as contraindications, adverse effects, interactions, previous experience with pharmacotherapy, convenience and cost when choosing pharmacotherapy. See Table 1 for some of the relative advantages and disadvantages of the first-line smoking cessation drugs.

NRT may be the preferred pharmacotherapy in certain populations (see Table 1). Weigh the adverse effects of pharmacotherapy against the harm of continued smoking (see Safety issues).

Table 1. Relative advantages and disadvantages of first-line smoking cessation drugs.^2,7–11

Nicotine replacement therapy	Bupropion	Varenicline
Advantages
Available without prescription in various dose forms Suitable for people with psychiatric illness Can be used by people aged 12–18 years Intermittent NRT (e.g. gum or lozenge) may be an option during pregnancy and breastfeeding	Evidence of benefit in depression	More efficacious than bupropion at 12 months and possibly NRT at 3 months
Disadvantages
Skin irritation* with patch Only patches are subsidised; other dose forms are at patient's expense	Not for people with a history of seizures Psychotic or manic symptoms reported, mainly in people with existing psychiatric illness Rash† Several significant drug interactions	Nausea* Serious neuropsychiatric symptoms reported in people with or without existing psychiatric illness Lack of safety data from people with cardiovascular disease or COPD

* Incidence > 10% in trials
^† Incidence > 1% in trials

Refer patients to support and counselling at the same time as prescribing NRT

Combining NRT with counselling is more effective than either component individually, and the absolute increase in success due to NRT is larger when used with intensive behavioural support.² Only supported use of nicotine patches is covered by the PBS listing.

Individual face-to-face support by GPs, pharmacists or practice nurses is effective.^12–15 Telephone counselling services, including Quitline, also have demonstrated effectiveness.¹⁶ Quitline staff can advise about other support options, including local quit courses and groups. Whenever possible, arrange for health professional follow-up about 1 week and 4 weeks into the quit attempt.

The benefit of combining NRT with other smoking cessation drugs is uncertain

Combinations of nicotine patches with bupropion or varenicline are not covered by the PBS listing. There is insufficient evidence that adding bupropion to NRT provides an additional long-term benefit¹⁷; individual trials have had mixed results.^18–20 The safety and efficacy of varenicline in combination with NRT has not been established and the combination may worsen adverse effects such as nausea and headache.⁹

How does it compare?

Non-drug factors may dominate efficacy differences

Trials have found differences in efficacy between the three first-line drug treatments, particularly in the short term, but non-drug factors make a large contribution to the likelihood of quitting successfully. A meta-analysis of 41 trials of nicotine patches, encompassing a wide range of treatment settings and populations, found a consistent improvement in abstinence rates compared with placebo, with a relative risk of 1.7 (95% CI 1.5 to 1.8). However, the absolute percentage of people abstinent at 12 months with nicotine patch treatment varied from trial to trial in the range 9–38%, partly because of differences in non-drug factors.² Unlike bupropion or varenicline, NRT has been shown to increase quit rates with or without counselling.²

Limited evidence for efficacy differences between NRT and other drugs

An indirect comparison between varenicline and NRT found no clear difference in efficacy.²¹ In the only direct comparison, more people using varenicline were continually abstinent after 3 months (56%) than with nicotine patches (43%). However, at 1 year the difference was no longer statistically significant (26% vs 20%, p = 0.06).²² See the NPS RADAR review of varenicline for smoking cessation for more details of the evidence regarding safety and efficacy.

There is no good evidence for a difference in efficacy between bupropion and NRT.^19,20,23

Combining patches with gum or lozenges increases efficacy

Nicotine patches maintain stable nicotine levels, while products such as gum or lozenges can be used in response to urges to smoke.

Recent trials found that optimised NRT (using both patch and lozenge) yielded greater long-term abstinence than monotherapy with nicotine patch or bupropion.^19,20 Earlier trials comparing a combination of patch and an acute dosing type with a single type found a statistically significant benefit of the combination.²

Safety issues

Most adverse effects of NRT are minor and transient. Common adverse effects include skin irritation (with patches), gastrointestinal disturbances, hiccoughs and myalgia. NRT infrequently causes tachycardia or blood pressure changes. Some symptoms may be a result of partial nicotine withdrawal when stopping smoking, such as sleep disturbance, dizziness, weight gain and headache. Abnormal dreams are common with overnight use of nicotine; that is, the 24-hour patch.²⁴

Report suspected adverse reactions to the Therapeutic Goods Administration (TGA) online or by using the 'Blue Card' distributed three times a year with Australian Prescriber. For information about reporting adverse reactions, see the TGA website.

Continued smoking during pregnancy or breastfeeding is more likely to be harmful than NRT

NRT may be considered during pregnancy and breastfeeding as smoking is more likely than NRT to cause harm.^11,25,26

Nicotine is a Category D drug under the Australian (formerly ADEC) pregnancy categorisation and can harm the foetus. Nonetheless, two studies found an increase in birth weight when women used NRT during pregnancy.^27,28 NRT results in a lower maternal exposure to nicotine than continued smoking, and avoids exposure to other harmful components of cigarette smoke.

Patches are less suitable for pregnant women than intermittent NRT formulations (gum, lozenge, inhaler, sublingual tablet) that deliver a lower total daily nicotine dose. If there is a compelling reason to use nicotine patches, they should be worn only during waking hours to minimise exposure.²⁹

Breastfeeding women should avoid using patches. Instead, an intermittent NRT formulation can be used immediately after breastfeeding, maximising the amount of time for nicotine levels to subside before the next feed.²⁵

Skin irritation is very common with nicotine patches

In trials of nicotine patches, > 10% of participants reported skin irritation. Application site reactions may take the form of redness, itch or a rash; stop using the patches if the reaction is severe. People with generalised skin disease should avoid using patches.^7,8

Reason for PBS listing

The Pharmaceutical Benefits Advisory Committee (PBAC) recommended nicotine transdermal patches for subsidy on the grounds that they are a cost-effective aid to smoking cessation when used in conjunction with a comprehensive support and counselling program. The PBAC accepted that nicotine transdermal patches are at least as efficacious as bupropion, with fewer adverse effects and a lower cost, and at the same time possibly of lower efficacy than varenicline, but with fewer adverse effects and a lower cost.³⁰

However, the PBAC considered that insufficient data had been provided to support listing for pre-quit use of nicotine patches.³¹

The PBAC noted that smoking cessation is a health priority area and has been highlighted by the national Preventative Health Taskforce.³⁰

Dosing issues

Apply patches to a non-hairy, clean dry place on the upper body or outer part of the upper arm, rotating the application site each day (sites can be reused after a few days). The 15 mg/16 hours (30 cm²) and 21 mg/24 hours (30 cm²) patches deliver nicotine at a rate of about 1 mg/hour. The 16-hour patches (i.e. Nicorette) should be applied upon waking and removed at bedtime; 24 hour patches (i.e. Nicabate P, Nicotinell Step 1) should be left in place for 24 hours.^7,8 An indirect comparison of trial results found no difference in smoking cessation rates between the 16-hour and 24-hour patch²; however, people who normally smoke shortly after waking may prefer the 24-hour patch.

Some evidence supports starting nicotine patches 2 weeks before stopping smoking

There is evidence from a few small trials that starting nicotine patches 2 weeks before the planned quit day increases the rate of cessation compared with starting on the quit day.² The rationale for pre-cessation use is that it might decrease the reinforcing or dependence-sustaining effects of the act of cigarette smoking. While there have been concerns that simultaneously smoking and using nicotine patches would increase the rate of adverse effects, especially for people with cardiovascular disease, studies have found no evidence of increased harm.^5,6

Nicotine patches are not registered in Australia for pre-quit use longer than 2 weeks (‘cut down then stop’) but gum and inhaler are approved for this indication.

Therapy for longer than 12 weeks does not appear to increase quit rates

One large trial found no benefit of prolonging a 12-week course of treatment to 28 weeks.³² This is supported by a comparison of results from trials of up to 8 weeks with those of longer trials.² A smaller, more recent trial found a benefit of 24 weeks’ treatment compared with 8 weeks, but the difference in abstinence rates at 1 year was no longer significant.³³

Nicotine patches are subsidised on the PBS for one 12-week course of treatment per patient per year. Encourage smokers who use nicotine patches unsuccessfully to discuss pharmacotherapy and support options for future quit attempts; these may include another course of NRT, depending on preferences and circumstances.

Tapering appears to be unnecessary but some people may prefer a low-strength patch

Low-strength patches (7 mg/24 hours or 14 mg/24 hours) are not available on the PBS. There is limited evidence for the efficacy of these doses and no evidence that tapering the dose is better than abrupt withdrawal.² An average cigarette delivers 1–3 mg of nicotine, so even a full-strength patch (15 mg/16 hours or 21 mg/24 hours) provides less nicotine than smoking 10 cigarettes.³⁴ Consider changing to a lower-strength patch if adverse effects (such as nausea) occur.²⁴

Information for patients

Explain that the patches often cause side effects such as dizziness, headache, nausea or sleep disturbances. These may be partly due to withdrawal from smoking and may improve with time. Abnormal dreams are common with the 24-hour patch. Patches can also irritate the area of skin where they are applied.

Advise women who are pregnant or breastfeeding how to minimise the risk of harm from NRT (see Safety issues).

Advise patients to:

• apply the patch to a non-hairy, clean dry place on the upper body or outer part of the upper arm
• wait a few days before using the same area again
• for the 16-hour patch, apply a new patch upon waking, and remove it at bedtime. The 24-hour patches should remain in place overnight
• continue treatment for up to 12 weeks (aiming for at least 8 weeks)
• keep used and unused patches out of reach of children and pets, as they can be harmful, e.g. if applied or swallowed
• dispose of the used patches carefully.

The patch packaging includes a product leaflet with detailed information about how to use, store and dispose of nicotine patches.

Resources for patients

For support, advice and information about smoking and smoking-cessation programs, call the Quitline 137848 or visit the National Tobacco Campaign website at www.quitnow.info.au.

Selected additional material available online

• Self-administered nicotine dependence tests on the websites of Quit NSW and Quit Victoria.
  
• Smoking fact sheets in community languages.
• NPS Medicine Update on varenicline for smoking cessation.
• NPS MedicinesTalk Winter 2009. Quitting is worth it.

References

1. Australian Government Department of Health and Ageing. March 2010 PBAC outcomes: positive recommendations. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-mar10-positive (accessed 24 June 2010).
2. Stead LF, Perera R, Bullen C, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2008; CD000146. [PubMed]
   
3. Reus VI, Smith BJ. Multimodal techniques for smoking cessation: a review of their efficacy and utilisation and clinical practice guidelines. Int J Clin Pract 2008;62:1753–68. [PubMed]
4. Cancer Institute NSW. New South Wales Smoking and Health Survey 2009. Sydney: Cancer Institute NSW http://www.cancerinstitute.org.au/cancer_inst/publications/pdfs/web09-287-02_nsw-smoking-and-health-survey_November-2009.PDF (accessed 10 December 2009).
5. Benowitz NL, Gourlay SG. Cardiovascular toxicity of nicotine: implications for nicotine replacement therapy. J Am Coll Cardiol 1997;29:1422–31. [PubMed]
6. Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. 2008. http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf (accessed 21 May 2010).
7. Johnson & Johnson Pacific Pty Ltd. Nicorette patch product information. 4 September 2007
8. Novartis Consumer Health Australasia Pty Ltd. Nicotinell patch product information. 20 March 2009
9. Pfizer Australia Pty Ltd. Champix product information 29 July 2009
10. GlaxoSmithKline Australia Pty Ltd. Zyban SR product information 29 January 2009
11. Zwar N, Richmond R, Borland R, et al. Smoking cessation pharmacotherapy: an update for health professionals (reviewed and updated April 2009). Melbourne: The Royal Australian College of General Practitioners, 2007. http://www.racgp.org.au/Content/NavigationMenu/ClinicalResources/RACGPGuidelines/smoking/Smoking_Cessation_Update09.pdf (accessed 10 December 2009).
12. Dent LA, Harris KJ, Noonan CW. Randomized trial assessing the effectiveness of a pharmacist-delivered program for smoking cessation. Ann Pharmacother 2009;43:194–201. [PubMed]
13. Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev 2008; CD001188. [PubMed]
    
14. Sinclair HK, Bond CM, Stead LF. Community pharmacy personnel interventions for smoking cessation. Cochrane Database Syst Rev 2004; CD003698. [PubMed]
    
15. Stead LF, Bergson G, Lancaster T. Physician advice for smoking cessation. Cochrane Database Syst Rev 2008; CD000165. [PubMed]
    
16. Stead LF, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev 2006; CD002850. [PubMed]
    
17. Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev 2007:CD000031. [PubMed]
18. Jorenby DE, Leischow SJ, Nides MA, et al. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med 1999;340:685–91. [PubMed]
19. Piper ME, Smith SS, Schlam TR, et al. A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies. Arch Gen Psychiatry 2009;66:1253–62. [PubMed]
20. Smith SS, McCarthy DE, Japuntich SJ, et al. Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics. Arch Intern Med 2009;169:2148–55. [PubMed]
21. Eisenberg MJ, Filion KB, Yavin D, et al. Pharmacotherapies for smoking cessation: a meta-analysis of randomized controlled trials. CMAJ 2008;179:135–44. [PubMed]
22. Aubin HJ, Bobak A, Britton JR, et al. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax 2008;63:717–24. [PubMed]
23. Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev 2007; CD000031. [PubMed]
    
24. Australian Medicines Handbook, 2010.
25. NSW Department of Health. National clinical guidelines for the management of drug use during pregnancy, birth and the early development years of the newborn. 2006. http://www.health.nsw.gov.au/pubs/2006/ncg_druguse.html (accessed 22 April 2010).
26. Zwar N, Richmond R, Borland R, et al. Smoking cessation guidelines for Australian general practice. Practice handbook. 2004 edition. Melbourne: The Royal Australian College of General Practitioners, 2004. http://www.health.gov.au/internet/main/publishing.nsf/content/6F8B2F83E439599BCA256F1900045114/$File/smoking_cessation.pdf (accessed 10 December 2009).
27. Oncken C, Dornelas E, Greene J, et al. Nicotine gum for pregnant smokers: a randomized controlled trial. Obstet Gynecol 2008;112:859–67. [PubMed]
28. Wisborg K, Henriksen TB, Jespersen LB, et al. Nicotine patches for pregnant smokers: a randomized controlled study. Obstet Gynecol 2000;96:967–71. [PubMed]
29. Therapeutic Guidelines: Drug use in pregnancy and breastfeeding. eTG Complete March 2010, 2010.
30. Australian Government Department of Health and Ageing. Public summary document for nicotine, transdermal patch, releasing 15 mg per 16 hours, Nicorette March 2010. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-nicotine-mar10  (accessed 24 July 2010).
31. Australian Government Department of Health and Ageing. July 2010 PBAC outcomes: positive recommendations. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-jul10-positive (accessed 16 September 2010).
32. Tønnesen P, Paoletti P, Gustavsson G, et al. Higher dosage nicotine patches increase one-year smoking cessation rates: results from the European CEASE trial. Collaborative European Anti-Smoking Evaluation. European Respiratory Society. Eur Respir J 1999;13:238–46. [PubMed]
33. Schnoll RA, Patterson F, Wileyto EP, et al. Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Ann Intern Med 2010;152:144–51. [PubMed]
34. Henningfield JE, Fant RV, Buchhalter AR, et al. Pharmacotherapy for nicotine dependence. CA Cancer J Clin 2005;55:281-99; quiz 322–3, 5. [PubMed]