Breaking new ground in switch

Breaking new ground in switch

Breaking new ground in switch: Enhancing decisions through economics

Australia currently spends around 10 per cent of its GDP on healthcare. Expenditure on medicine accounts for around 12 percent of that (i.e. $20 billion).

Initially most medicines are available by prescription only, however decision makers may later ‘switch’, 'reclassify' or ‘down-schedule’ these medicines to being available over-the-counter (OTC). Decision makers largely focus on patient risk when making these decisions.  For example, inaccurate or delayed diagnosis, inappropriate use, the incidence and severity of adverse events, and the need for advice from a medical practitioner or pharmacist.

However, there are also benefits to the patient and the healthcare system from allowing the medicine to be available OTC. It may improve patient health outcomes by reducing barriers to treatment. This may reduce the time to symptom relief, and improve treatment rates and adherence. Reducing barriers to treatment may also encourage patients to switch to more effective or safer treatments. Consequently, health-related quality of life may be improved, the onset of related diseases may be prevented, or disease progression may be delayed. Improved health outcomes may also lead to less demand for healthcare, such as diagnostic tests and hospitalisations.

While the existing framework for making scheduling decisions may not be broken, it could be improved. Indeed, a 2015 review of medicines and medical devices regulation conducted for the Federal Minister for Health recommended that the framework be reviewed. It also suggested adopting a formal risk-benefit framework might be useful.

MUCHE has developed an economic evaluation framework that can be used by regulatory bodies to assist in scheduling decisions.

This framework allows decision makers to synthesise data from a variety of sources, aggregate health outcomes into a single measure (quality adjusted life years, QALYs), consider healthcare resource use, identify areas needing further research, and explore regulatory scenarios through sensitivity analysis.

The application of the economic evaluation framework was demonstrated using two case studies: down-scheduling triptans and down-scheduling the oral contraceptive pill (OCP).

For information on this study, please contact: Bonny Parkinson or Mutsa Gumbie

This research was funded by a grant from the Australian Self-Medication Industry. The funding agreement ensured the authors’ independence in designing the economic evaluation, its inputs, interpreting results and writing the article.

Papers

Is Reclassification of the Oral Contraceptive Pill from Prescription to Pharmacist-Only Cost Effective?  Application of an Economic Evaluation Approach to Regulatory Decisions

Gumbie, M., Parkinson, B., Cutler, H., Gauld, N., Mumford, V. Is reclassification of the oral contraceptive pill from prescription to pharmacist-only cost-effective? Application of an economic evaluation approach to regulatory decisions. PharmacoEconomics (2019). https://doi.org/10.1007/s40273-019-00804-6

Abstract

Background and Objective

Unplanned pregnancies can lead to poorer maternal and child health outcomes. The Australian Therapeutic Goods Administration committee rejected reclassifying a range of oral contraceptive pills (OCPs) from prescription to pharmacist-only medicines in 2015, mainly based on safety concerns. Improving access to OCPs may encourage some women to use contraceptives or switch from other contraceptive methods. However, some adverse events may increase and some women may stop using condoms, increasing their risk of sexually transmitted infections. This study aimed to estimate the cost-effectiveness of reclassifying OCPs from prescription to pharmacist-only.

Perspective

Healthcare system.

Setting

Australian primary care.

Methods

A Markov model was used to synthesise data from a variety of sources. The model included all Australian women aged 15–49 years (N =‚ÄČ5,644,701). The time horizon was 35 years. Contraceptive use before reclassification was estimated using data from the Household, Income and Labour Dynamics in Australia (HILDA) survey, while survey data informed use after reclassification. Health outcomes included pregnancies, pregnancy outcomes (live birth, miscarriage, stillbirth, ectopic pregnancy and abortion), sexually transmitted infections, adverse events (venous thromboembolism, depression, myocardial infarction and stroke), ovarian cancer cases and quality-adjusted life-years. Costs included those related to general practitioner and specialist consultations, contraceptives and other medicines, pharmacist time, hospitalisations and adverse events. All costs were reported in 2016 Australian Dollars. A 5% discount rate was applied to health outcomes and costs.

Results

Reclassifying OCPs resulted in 85.70 million quality-adjusted life-years experienced and costs of $46,910.14 million over 35 years, vs. 85.68 million quality-adjusted life-years experienced and costs of $50,274.95 million with OCPs remaining prescription-only. Thus, reclassifying OCPs was more effective and cost saving. However, a sensitivity analysis found that more research on the probability of pregnancy in women not using contraception and not trying to conceive is needed.

Conclusion

Reclassifying OCPs is likely to be considered cost-effective by Australian decision makers.

Link to publication

Cost-Effectiveness of Reclassifying Triptans in Australia: Application of an Economic Evaluation Approach to Regulatory Decisions.

Parkinson, B., Gumbie, M., Cutler, H., Gauld, N., Mumford, V., Haywood, P. Cost-effectiveness of reclassifying triptans in Australia: application of an economic evaluation approach to regulatory decisions. Value in Health, 22(3): 293-302

Abstract

Background

Migraine is a common, chronic, disabling headache disorder. Triptans, used as an acute treatment for migraine, are available via prescription in Australia. An Australian Therapeutic Goods Administration (TGA) committee rejected reclassifying sumatriptan and zolmitriptan from prescription medicine to pharmacist-only between 2005 and 2009, largely on the basis of concerns about patient risk. Nevertheless, pharmacist-only triptans may reduce migraine duration and free up healthcare resources.

Objectives

To estimate the cost-effectiveness of reclassifying triptans from prescription-only to pharmacist-only in Australia.

Methods

The study design included decision-analytic modelling combining data from various sources. Behaviour before and after reclassification was estimated using medical practitioner and patient surveys and also administrative data. Health outcomes included migraine frequency and duration as well as adverse events (AEs) discussed by the TGA committee. Efficacy and AEs were estimated using randomized controlled trials and observational studies.

Results

Reclassifying triptans will reduce migraine duration but increase AEs. This will result in 337 quality-adjusted life-years gained at an increased cost of A$5.9 million over 10 years for all Australian adults older than 15 years (19.6 million). The incremental cost-effectiveness ratio was estimated to be A$17 412/quality-adjusted life-year gained.

Conclusions

The incremental cost-effectiveness ratio is likely to be considered cost-effective by Australian decision makers. Serotonin syndrome, a key concern of the TGA committee, had little impact on the results. Further research is needed regarding pharmacist-only triptan use by migraineurs currently using over-the-counter medicines and by nonmigraineurs, the efficacy of triptans, and the risk of cardiovascular and cerebrovascular AEs and chronic headaches with triptans.

Link to publication

*MUCHE team members highlighted in bold

Conferences

PaperActivityLocation and date
Gumbie, M.Parkinson, B.Cutler, H., Gauld, N. & Mumford, V.  (2018) Is the oral contraceptive pill Rx to OTC switch cost-effective? International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Asia Pacific 2018.(Published abstract)
[Poster] 
Tokyo, Japan 8-11 Sept. 2018                    
Parkinson, B., Gumbie, M.Cutler, H., Gauld, N., Mumford, V. & Haywood, P.  Cost-effectiveness of down scheduling triptans in Australia. International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Asia Pacific 2018.(Published abstract)
[Poster]
Tokyo, Japan 8-11 Sept. 2018

Cutler, H. Parkinson, B., Gumbie, M. ‘Is reclassifying the oral contraceptive pill to over-the-counter cost-effective?’, University of York (UK) Seminar Series

PresentationYork, United Kingdom
July 2018

Parkinson, B., Gumbie, M., Cutler, H. An economic evaluation framework to inform the scheduling of medicines in Australia, National Medicines Symposium.

PresentationCanberra, Australia    
30 May – 1 June 2018                            

Gumbie, M., Parkinson, B., Cutler, H. Should oral contraceptives be available over-the-counter?, 10th Health Services & Policy Research Conference.

PresentationSurfers Paradise, Australia
1 - 3 Nov. 2017

Parkinson, B.,  Gumbie, M. Cutler, H. An economic framework to inform the scheduling of drugs, World Self Medication Industry General Assembly Conference.

PresentationSydney, Australia
17 - 19 Oct. 2017 

Gumbie, M., Parkinson, B., Cutler, H. Should oral contraceptives be available over-the-counter? The 39th Annual Australian Health Economics Society Conference,

PresentationSydney, Australia
21 - 22 Sept. 2017 

Parkinson, B., Gumbie, M., Cutler, H. To down-schedule, or not to down-schedule, triptans in Australia? The 39th Annual Australian Health Economics Society Conference.

PresentationSydney, Australia
21 - 22 Sept. 2017

Gumbie, M., Parkinson, B., Cutler, H. Framework for oral contraceptive Rx to OTC switch in Australia, iHEA World Congress of Health Economics.

PresentationBoston, United States
8 -11 June 2017

*Presenters highlighted in bold.

Presentations

Download a copy of the presentation delivered at the World Self Medication Industry General Assembly Conference in Sydney in October 2017.

Media Coverage

   
Could The Pill save Australia $96M?Radio Adelaide3 June 2019
Over-the-counter contraceptive pill could save the health system $96m a yearSBS31 May 2019
Could an over-the-counter contraceptive pill be available in the future?Body and Soul31 May 2019
'You can't just give out a pill and expect that that's actually good medical care'Australian Journal of Pharmacy31 May 2019
S3 oral contraceptives would save Australia billions, say researchersAusDoc30 May 2019
Over-the-counter contraceptive pill could save the health system $96 million a yearThe Conversation30 May 2019
Over-the-counter oral contraceptive piilsNews Breakfast with Virginia Trioli and Paul Kennedy, ABC Television News30 May 2019
Study backs $3b+ OC pill savingPharma Infocus27 May 2019
A not so bitter pillAustralian Journal of Pharmacy23 May 2019
More than $1 Billion could be savedAustralian Journal of Pharmacy (AJP)23 Sept. 2017
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