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

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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 = 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.

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.

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Notes

  1. LARCs are highly effective, long-acting contraceptive methods that do not require an action to prevent pregnancy every day or every sexual encounter, and are reversible when stopped.

  2. Not using a contraceptive and not TTC, implant, intrauterine device, injection, prescription OCP, pharmacist-only OCP, withdrawal, natural safe period method, other methods, condom only, condom plus implant, condom plus intrauterine device, condom plus injection, condom plus prescription OCP, condom plus pharmacist-only OCP, condom plus other, condom plus withdrawal, female sterilisation, and male sterilisation.

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Acknowledgements

We thank Dr. Deborah Bateson for her invaluable suggestions on the manuscript prior to submission, such as including the criterion that the woman has previously been prescribed an OCP, including the impact on cancer mortality and reporting the impact on long-acting reversible contraceptive use. We also thank Rajan Sharma for research assistance, particularly conducting systematic reviews for parameter inputs. This paper uses unit record data from the HILDA Survey. The HILDA Project was initiated and is funded by the Australian Government Department of Social Services (DSS) and is managed by the Melbourne Institute of Applied Economic and Social Research (Melbourne Institute). The findings and views reported in this paper, however, are those of the authors and should not be attributed to either the DSS or the Melbourne Institute.

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Authors and Affiliations

  1. Centre for the Health Economy, Macquarie University, Sydney, NSW, 2109, Australia

    Mutsa Gumbie, Bonny Parkinson & Henry Cutler

  2. School of Pharmacy, University of Auckland, Auckland, 1023, New Zealand

    Natalie Gauld

  3. Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia

    Virginia Mumford

Authors
  1. Mutsa Gumbie
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Corresponding author

Correspondence to Bonny Parkinson.

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Funding

This study 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 or the writing of the article.

Conflict of interest

Mutsa Gumbie, Bonny Parkinson, Henry Cutler and Virginia Mumford have no conflicts of interest that are directly relevant to the content of this article. Natalie Gauld has received consulting fees from Green Cross Health for reclassifying oral contraceptives in New Zealand, has received an honorarium and expenses for attending a meeting for HRA Pharma, is a Board Member of the Pharmaceutical Society of New Zealand, and receives consulting fees, research funding and speaker’s fees relating to reclassification.

Author Contributions

BP and HC conceived the idea for the study. MG and BP developed the economic model and conducted the data analysis. NG and VM provided advice on parameter inputs. MG drafted the initial paper. All authors were involved in the interpretation of the results and revision of the manuscript.

Data Availability

All parameter inputs and the economic model are available in the ESM.

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Gumbie, M., Parkinson, B., Cutler, H. et al. Is Reclassification of the Oral Contraceptive Pill from Prescription to Pharmacist-Only Cost Effective? Application of an Economic Evaluation Approach to Regulatory Decisions. PharmacoEconomics 37, 1049–1064 (2019). https://doi.org/10.1007/s40273-019-00804-6

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