An economic case for a cardiovascular polypill? A cost analysis of the Kanyini GAP trial

Tracey-Lea Laba, Alison Hayes, Serigne Lo, David P Peiris, Tim Usherwood, Graham S Hillis, Natasha Rafter, Christopher M Reid, Andrew M Tonkin, Ruth Webster, Bruce C Neal, Alan Cass, Anushka Patel, Anthony Rodgers and Stephen Jan
Med J Aust 2014; 201 (11): 671-673. || doi: 10.5694/mja14.00266


Objective: To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease (CVD) or at similarly high cardiovascular risk.

Design: A within-trial cost analysis of polypill-based care versus usual care with separate medications, using data from the Kanyini Guidelines Adherence with the Polypill (GAP) trial and linked health service and medication administrative claims data.

Participants: Kanyini GAP participants who consented to Australian Medicare record access.

Main outcome measures: Mean health service and pharmaceutical expenditure per patient per year, estimated with generalised linear models. Costs during the trial (randomisation January 2010 – May 2012, median follow-up 19 months, maximum follow-up 36 months) were inflated to 2012 costs.

Results: Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $989 (95% CI, $648–$1331) per patient per year in the polypill arm compared with usual care (P < 0.001; adjusted, excluding polypill cost). No significant difference was shown in health service expenditure.

Conclusions: This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy. The savings will be less now than during the trial due to subsequent reductions in the costs of usual care. Nonetheless, given the prevalence of CVD in Australia, the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia.

Trial registration: Australian New Zealand Clinical Trials Registry ACTRN126080005833347.

Please login with your free MJA account to view this article in full

  • Tracey-Lea Laba1
  • Alison Hayes2
  • Serigne Lo1
  • David P Peiris1
  • Tim Usherwood3
  • Graham S Hillis1
  • Natasha Rafter4,5
  • Christopher M Reid6
  • Andrew M Tonkin7
  • Ruth Webster1
  • Bruce C Neal1
  • Alan Cass8
  • Anushka Patel1
  • Anthony Rodgers1
  • Stephen Jan1

  • 1 The George Institute for Global Health, Sydney, NSW.
  • 2 School of Public Health, University of Sydney, Sydney, NSW.
  • 3 Department of General Practice, Sydney Medical School, University of Sydney, Sydney, NSW.
  • 4 National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.
  • 5 Department of Geriatric and Stroke Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
  • 6 Centre of Cardiovascular Research and Education in Therapeutics , Monash University, Melbourne, VIC.
  • 7 Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC.
  • 8 Menzies School of Health Research, Darwin, NT.


The study was funded by a National Health and Medical Research Council (NHMRC) grant (1004623). Christopher Reid, Anushka Patel and Stephen Jan are funded by NHMRC Senior Research Fellowships. David Peiris is supported by an NHMRC Australian Primary Health Care Fellowship. Tracey-Lea Laba and Alison Hayes are funded by an NHMRC Capacity Building Grant (57132). Dr Reddy's Laboratories provided polypills free of charge for the clinical trial. Dr Reddy's Laboratories has funded the SPACE (single pill to avert cardiovascular events) Collaboration, which supports Ruth Webster and Anthony Rodgers.

Competing interests:

The NHMRC and Dr Reddy's Laboratories had no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript. The George Institute for Global Health recently secured an exclusive global licence for the polypills evaluated in the Kanyini GAP trial, after a decision by Dr Reddy's Laboratories Ltd not to proceed with taking the products to market because of existing regulatory requirements.

  • 1. Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ 2003; 326: 1419.
  • 2. Yusuf S. Two decades of progress in preventing vascular disease. Lancet 2002; 360: 2-3.
  • 3. Patel A, Cass A, Peiris D, et al. A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk. Eur J Prev Cardiol 2014; Mar 27 [Epub ahead of print].
  • 4. Thom S, Poulter N, Field J, et al; UMPIRE Collaborative Group. Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: the UMPIRE randomized clinical trial. JAMA 2013; 310: 918-929.
  • 5. Vos T, Carter R, Barendregt J, et al. Assessing cost-effectiveness in prevention (ACE-prevention): final report. University of Queensland, Brisbane; Deakin University, Melbourne, 2010.
  • 6. Bautista LE, Vera-Cala LM, Ferrante D, et al. A ‘polypill' aimed at preventing cardiovascular disease could prove highly cost-effective for use in Latin America. Health Aff (Millwood) 2013; 32: 155-164.
  • 7. Ito K, Shrank WH, Avorn J, et al. Comparative cost-effectiveness of interventions to improve medication adherence after myocardial infarction. Health Serv Res 2012; 47: 2097-2117.
  • 8. van Gils PF, Over EA, Hamberg-van Reenen HH, et al. The polypill in the primary prevention of cardiovascular disease: cost-effectiveness in the Dutch population. BMJ Open 2011; 1(2): e000363.
  • 9. Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337: a2390.
  • 10. Australian Bureau of Statistics. Consumer Price Index, Australia, Sep 2013. Table 7. Canberra: ABS, 2013.
  • 11. Doshi J, Glick HA. Economic assessments in randomized trials. Panel discussion, 7th International Conference on Health Policy Statistics; 2008; Philadelphia, PA.
  • 12. Deb P, Manning WG, Norton EC, editors. Modeling health care costs and counts. iHEA World Congress; 2013; Sydney, Australia.
  • 13. Manning WG, Mullahy J. Estimating log models: to transform or not to transform? J Health Econ 2001; 20: 461-494.
  • 14. Mihaylova B, Briggs A, O'Hagan A, et al. Review of statistical methods for analysing healthcare resources and costs. Health Econ 2011; 20: 897-916.
  • 15. Pharmaceutical Benefits Advisory Committee. Guidelines for preparing submissions to the pharmaceutical benefits advisory committee (version 4.4). Canberra: Australian Government Department of Health, 2013.
  • 16. Clarke PM, Avery AB. Evaluating the costs and benefits of using combination therapies. Med J Aust 2014; 200: 518-520. <MJA full text>
  • 17. Australian Institute of Health and Welfare. Cardiovascular disease: Australian facts 2011. Canberra: AIHW, 2011. (AIHW Cat. No. CVD 53; Cardiovascular Disease Series No. 35.)
  • 18. Webster RJ, Heeley EL, Peiris DP, et al. Gaps in cardiovascular disease risk management in Australian general practice. Med J Aust 2009; 191: 324-329. <MJA full text>


remove_circle_outline Delete Author
add_circle_outline Add Author

Do you have any competing interests to declare? *

I/we agree to assign copyright to the Medical Journal of Australia and agree to the Conditions of publication *
I/we agree to the Terms of use of the Medical Journal of Australia *
Email me when people comment on this article

Responses are now closed for this article.