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The New Zealand Medical Journal

 Journal of the New Zealand Medical Association, 03-June-2005, Vol 118 No 1216

PHARMAC and tobacco control in New Zealand: Government policy ‘up in smoke’
Shaun Holt, Matire Harwood, Sarah Aldington, Richard Beasley
Abstract
There is increasing concern amongst the medical profession in New Zealand about the adverse effect that PHARMAC has on the health of New Zealanders through restricting the availability of medications. In this article, the circumstances surrounding the restrictions limiting the availability of the smoking cessation treatment bupropion are presented. The authors conclude that the decision by PHARMAC not to fund bupropion is directly contrary to Government policy and is inconsistent with evidence-based medicine and international recommendations. It is suggested that the PHARMAC decision seriously questions the Ministry of Health’s commitment to smoking cessation and the health of disadvantaged groups in New Zealand, particularly Maori.

Drug:
Bupropion (Zyban)
Indication:
Treatment of smoking cessation
Recommended dose & duration:
Bupropion SR 150 mg daily for 3 days, then 150 mg bd for 7–12 weeks, together with behavioural therapy
Clinical efficacy:
Bupropion is an antidepressant which is an effective treatment for smoking cessation, resulting in a two-fold greater rate of smoking cessation compared with placebo.1-5
Bupropion may be more effective than nicotine replacement therapy (NRT) in achieving smoking cessation.6
Bupropion has been shown to be effective in Maori with a risk ratio for abstinence of 2.4 over 12 months.7
Rare serious adverse events such as seizures can occur, resulting in its contraindication in patients with a history of or significant predisposition to seizures.8,9
Background:
Tobacco smoking is a major public health problem in New Zealand, being the single greatest preventable cause of premature death.
In New Zealand, smoking kills around 4,500 persons per year.10
The situation is of particular concern in Maori in whom it has been estimated that one in three deaths is due to smoking.11
The rate of smoking in Maori adults is around 50%, compared with around 20% in non-Maori.12

Government policy:
The New Zealand Health Strategy highlights a reduction of smoking as one of the 13 population health objectives.13
The Ministry of Health goals for tobacco control14 are:
  • To significantly reduce the levels of tobacco consumption and smoking prevalence.
  • To reduce inequalities in health outcomes.
  • To reduce the prevalence of smoking among Maori, to at least the same level as non-Maori.
  • To reduce New Zealanders’ exposure to secondhand smoke.

In its 5 year plan for tobacco control, the Ministry of Health states14 that it will:
  • Give substantial weight to interventions for which there is strong scientific evidence of effectiveness.
  • Give weight to interventions that benefit a large proportion of the community.
  • Give weight to cost-effective interventions.
  • Strive to maximise the benefits of targeted interventions (people with the greatest health needs such as Maori and low income New Zealanders) and minimise potential adverse effects.
Current situation:
New Zealand:
Bupropion has been registered and approved for use in New Zealand since May 2000, however is not yet funded by PHARMAC.15
The National Health Committee endorsed the use of bupropion in clinical practice in 2002.15
Following a review of adverse reactions to bupropion, the Medicines Adverse Reactions Committee (MARC) recommended in 2002 that bupropion should only be considered as a second-line intervention (after unsuccessful trials with smoking cessation treatment including NRT).15

International:
In the United States and United Kingdom, bupropion is the only non-nicotine drug recommended as first-line pharmacotherapy, with strength (A) evidence as an efficacious smoking cessation treatment that patients should be encouraged to use.16,17
Nortriptyline is recommended as a second-line agent in the US Guidelines because it is not registered for smoking cessation in the US and there are more concerns about potential side effects than with first-line medications.
Access/supply:
Bupropion can be obtained through the private pharmaceutical market, on prescription. A full 7-week course costs about NZ$330.15
Nicotine replacement therapy (NRT) is subsidised by the Government.
There is evidence of efficacy with the antidepressant nortriptyline, however it was not registered for use in New Zealand as a smoking cessation adjunct until 2003. Until then nortriptyline could only be prescribed for this purpose under Section 25 of the Medicines Act 1981 which allows off-label prescribing for non-approved indications.15
Economic analysis:
Bupropion is more cost-effective than the majority of treatments currently funded by PHARMAC in terms of cost per life year saved.
Other issues:
The study demonstrating the efficacy of bupropion in Maori7 is the first randomised, double-blind, placebo-controlled trial of a pharmacotherapy in the Maori population.
Comment:
The decision by PHARMAC not to fund bupropion is directly contrary to Government policy and is inconsistent with evidence-based medicine and with US and UK guidelines. The PHARMAC decision seriously questions the Ministry of Health’s commitment to smoking cessation and the health of disadvantaged groups in New Zealand, particularly Maori.
Author information: Shaun Holt, Director, P3 Research, Wellington; Matire Harwood, Senior Research Fellow; Sarah Aldington, Senior Research Fellow; Richard Beasley, Director, Medical Research Institute of New Zealand, Wellington
Correspondence: Professor Richard Beasley, Medical Research Institute of New Zealand, PO Box 10055, Wellington. Fax: (04) 472 9199; email: richard.beasley@mrinz.ac.nz
References:
  1. Hurt RD, Sachs DPL, Glover ED et al. A comparison of sustained-release bupropion and placebo for smoking cessation. N Engl J Med. 1997;337:1195–202.
  2. Ahluwalia JS, Harris KJ, Catley D et al. Sustained-release bupropion for smoking cessation in African Americans. JAMA. 2002;288:468–74.
  3. Tonstad S, Farsang C, Klaene G, et al. Bupropion SR for smoking cessation in smokers with cardiovascular disease: a multicentre, randomised study. Eur Heart J. 2003;24:946–55.
  4. Tashkin D, Kanner R, Bailey W, et al. Smoking cessation in patients with chronic obstructive pulmonary disease: a double-blind, placebo-controlled, randomised trial. Lancet. 2001;357:1571–5.
  5. Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Tobacco Addiction Group. Cochrane Database of Systematic Reviews. 2004;1.
  6. 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.
  7. Holt S, Timu-Parata C, Ryder-Lewis S, Weatherall M, Beasley R. Efficacy of bupropion in the indigenous Maori population in New Zealand. Thorax. 2005;60:120–3.
  8. Roddy E. ABC of smoking cessation: Bupropion and other non-nicotine pharmacotherapies. BMJ. 2004;328:509–11.
  9. Richmond R, Zwar N. Review of bupropion for smoking cessation. Drug Alcohol Rev. 2003;22:203–20.
  10. Ministry of Health, Tobacco facts May 2001. Wellington: Ministry of Health; 2001. Available online. http://www.moh.govt.nz/moh.nsf/0/1c1c22b40ab9c171cc256def000ac7f6/$FILE/Tobacco_Facts_2001.pdf Accessed May 2005.
  11. Lambe J. Smoking kills 31% of Maori. NZ Med J 1998; 28th August: 327.
  12. Borman B, Wilson N, Mailing C. Socio-demographic characteristics of New Zealand smokers: results from 1996 census. NZ Med J 1999;112:460–3.
  13. Ministry of Health. The New Zealand Health Strategy. Wellington: Ministry of Health; 2001. Available online. URL: http://www.moh.govt.nz/moh.nsf/0/c024d8d149d4c168cc2569b1007679ca?OpenDocument Accessed May 2005.
  14. Ministry of Health. Clearing the smoke: a five-year plan for tobacco control in New Zealand (2004-2009). Wellington: Ministry of Health; 2004. Available online. URL: http://www.moh.govt.nz/moh.nsf/0/AAFC588B348744B9CC256F39006EB29E/$File/clearingthesmoke.pdf Accessed May 2005.
  15. Guidelines for smoking cessation. Wellington: National Health Committee on Health and Disability; 2002. Available online. URL: http://www.nzgg.org.nz/guidelines/dsp_guideline_popup.cfm?&guidelineID=25 Accessed May 2005.
  16. Fiore MC, Bailey WC, Cohen SJ et al. Treating tobacco use and dependence. Clinical Practice Guideline. Rockville, MD: US Department of Health & Human Services. Public Health Service; 2000.
  17. West R, McNeill A, Raw M. Smoking cessation guidelines for health professionals: an update. Thorax. 2000;55:987–99.


     
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