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).
This research was funded by a grant from Consumer Healthcare Products Australia (previously known as 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.
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
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.
Australian primary care.
A Markov model was used to synthesise data from a variety of sources. The model included all Australian women aged 15–49 years (N = 5,644,701). 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.
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.
Reclassifying OCPs is likely to be considered cost-effective by Australian decision makers.
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
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.
To estimate the cost-effectiveness of reclassifying triptans from prescription-only to pharmacist-only in Australia.
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.
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.
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.
*MUCHE team members highlighted in bold
|Paper||Activity||Location 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) |
|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)|
|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
|Presentation||York, United Kingdom|
Parkinson, B., Gumbie, M., Cutler, H. An economic evaluation framework to inform the scheduling of medicines in Australia, National Medicines Symposium.
|Presentation||Canberra, 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.
|Presentation||Surfers 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.
|Presentation||Sydney, 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,
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.
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.
|Presentation||Boston, United States|
8 -11 June 2017
*Presenters highlighted in bold.
A presentation was delivered at the World Self Medication Industry General Assembly Conference in Sydney in October 2017.
|Could The Pill save Australia $96M?||Radio Adelaide||3 June 2019|
|Over-the-counter contraceptive pill could save the health system $96m a year||SBS||31 May 2019|
|Could an over-the-counter contraceptive pill be available in the future?||Body and Soul||31 May 2019|
|'You can't just give out a pill and expect that that's actually good medical care'||Australian Journal of Pharmacy||31 May 2019|
|S3 oral contraceptives would save Australia billions, say researchers||AusDoc||30 May 2019|
|Over-the-counter contraceptive pill could save the health system $96 million a year||The Conversation||30 May 2019|
|Over-the-counter oral contraceptive piils||News Breakfast with Virginia Trioli and Paul Kennedy, ABC Television News||30 May 2019|
|Study backs $3b+ OC pill saving||Pharma Infocus||27 May 2019|
|A not so bitter pill||Australian Journal of Pharmacy||23 May 2019|
|More than $1 Billion could be saved||Australian Journal of Pharmacy (AJP)||23 Sept. 2017|