Economic Evaluation of Senshio® (Ospemifene) for the Treatment of Vulvovaginal Atrophy in Scotland

Abstract

Background

Local oestrogens, the current treatment for vulvar and vaginal atrophy (VVA), are not suitable for all women. Standard of care (SoC) consists of over-the-counter lubricants and moisturisers. Senshio® (ospemifene) provides a treatment option for postmenopausal women who are not candidates for local vaginal oestrogen therapy who would otherwise have an unmet clinical need.

Objectives

The aim of this study was to estimate the cost-effectiveness of ospemifene, a selective oestrogen receptor modulator, for the treatment of moderate to severe symptomatic VVA in postmenopausal women who are not candidates for local vaginal oestrogen therapy.

Methods

The Scottish Medicines Consortium (SMC) recently evaluated the clinical and cost-effectiveness evidence of ospemifene plus SoC compared with SoC alone. A cost-effectiveness study, from a National Health Service (NHS) Scotland perspective over a lifetime time horizon, was submitted to the SMC. The cohort-based Markov model used robust clinical evidence from two large pivotal phase III randomised controlled studies and included four health states classified by dyspareunia symptom severity: none, mild, moderate and severe. The movement of women between health states was dependent on the effectiveness of treatment in reducing dyspareunia. Extensive sensitivity analyses were undertaken to assess the level of confidence associated with the base-case results.

Results

Treatment with ospemifene was associated with an additional cost of £847 per patient and an increase in quality-adjusted life-years (QALY) of 0.06 per patient. Ospemifene had an incremental cost-effectiveness ratio of £14,138 per QALY. In the probabilistic sensitivity analysis, there was a probability of 89% that ospemifene was cost-effective at a threshold of £20,000 per QALY gained. Ospemifene remained cost-effective under all scenario analyses. The SMC reviewed the clinical and economic evidence and judged that the evidence demonstrated a robust case to support prescribing ospemifene in NHS Scotland.

Conclusion

Ospemifene is a cost-effective intervention that has recently been accepted by the SMC for the treatment of postmenopausal women with moderate to severe VVA who are not candidates for local oestrogen.

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Acknowledgements

Linda Harrison of LJH Associates Limited, UK, prepared the clinical sections of the SMC submission.

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Authors

Contributions

With the exception of Joyce Craig, all authors contributed to the study conception and design. Economic modelling-related tasks to identify data sources, and their presentation in the submission to the SMC, were performed by Amy Dymond, Heather Davies, Jessica McMaster, Hayden Holmes, and Rodolphe Perard. The project was supervised by Stuart Mealing and Rodolphe Perard. The first draft of this manuscript was written by Joyce Craig and all authors commented on subsequent versions of the manuscript. All authors read and approved the final version of the manuscript.

Corresponding author

Correspondence to Amy Dymond.

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Conflict of interest

Rodolphe Perard is an employee of Shionogi Limited, UK. Amy Dymond, Hayden Holmes, Jessica McMaster, Joyce Craig, Heather Davies, and Stuart Mealing are employees of York Health Economics Consortium, who were commissioned by Shionogi Limited to provide consultancy, develop the economic model and submission dossier, and write the manuscript.

Funding

This study was funded by Shionogi Limited, UK.

Data sharing

All data generated or analysed during this study are included or referenced in this published article (and its supplementary information files).

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Below is the link to the electronic supplementary material.

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Dymond, A., Holmes, H., McMaster, J. et al. Economic Evaluation of Senshio® (Ospemifene) for the Treatment of Vulvovaginal Atrophy in Scotland. Appl Health Econ Health Policy 19, 123–132 (2021). https://doi.org/10.1007/s40258-020-00589-2

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