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



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.


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.


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.


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.


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.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3


  1. 1.

    Bachmann GA, et al. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010;17(3):480–6.

    PubMed  Google Scholar 

  2. 2.

    DiBonaventura M, et al. The association between vulvovaginal atrophy symptoms and quality of life among postmenopausal women in the United States and Western Europe. J Women’s Health. 2015;24(9):713–22.

    Article  Google Scholar 

  3. 3.

    Nappi RE, et al. Vulvar and vaginal atrophy in four European countries: evidence from the European REVIVE Survey. Climacteric. 2016;19(2):188–97.

    CAS  PubMed  Article  Google Scholar 

  4. 4.

    Wysocki S, et al. Management of vaginal atrophy: implications from the REVIVE survey. Clin Med Insights Reprod Health. 2014;8:23–30.

    PubMed  PubMed Central  Article  Google Scholar 

  5. 5.

    Ospemifene, summary of product characteristics. Accessed 22 Oct 2019.

  6. 6.

    Portman D, et al. Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: a randomised, placebo-controlled, phase III trial. Maturitas. 2014;78(2):91–8.

    CAS  PubMed  Article  Google Scholar 

  7. 7.

    Goldstein SR, et al. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy. Climacteric. 2014;17(2):173–82.

    CAS  PubMed  Article  Google Scholar 

  8. 8.

    Healthcare Improvement Scotland/SMC. A guide to the Scottish medicines consortium. Accessed 22 Oct 2019.

  9. 9.

    National Institute for Health and Care Excellence. Menopause: diagnosis and management. Clinical Guideline (NG23); 2015. Accessed 22 Oct 2019.

  10. 10.

    Clinical Study Report 15-50821, data on file.

  11. 11.

    Clinical Study Report 15-50310, data on file.

  12. 12.

    Office for National Statistics. National life tables: Scotland. 2018.

  13. 13.

    Simon J, Portman D, Mabey RG Jr. Long-term safety of ospemifene (52-week extension) in the treatment of vulvar and vaginal atrophy in hysterectomized postmenopausal women. Maturitas. 2014;77(3):274–81.

    PubMed  Article  Google Scholar 

  14. 14.

    Ellis AK, Verma S. Quality of life in women with urinary tract infections: is benign disease a misnomer? J Am Board Family Pract. 2000;13(6):392–7.

    CAS  Article  Google Scholar 

  15. 15.

    Shingler S, et al. Utilities for treatment-related adverse events in type 2 diabetes. J Med Econ. 2015;18(1):45–55.

    CAS  PubMed  Article  Google Scholar 

  16. 16.

    National Institute for Health and Care Excellence (NICE). British National Formulary; 2018. Accessed 22 Oct 2019.

  17. 17.

    ISD Scotland. Dispenser reimbursement, remuneration and volume. Prescription cost analysis. ISD Scotland; 2018.

  18. 18.

    Curtis L, Burns A. Unit costs of health and social care 2018. Canterbury: Personal Social Services Research Unit, University of Kent; 2018.

    Google Scholar 

  19. 19.

    Information Services Division Scotland. Dispenser reimbursement, remuneration and volume. Prescription cost analysis; 2018. Accessed 22 Oct 2019.

  20. 20.

    ISD Scotland. R04opX: speciality outpatient summary. April 2017–March 2018.

  21. 21.

    Net Monetary Benefit. 2016. York: York Health Economics Consortium; 2016.

  22. 22.

    Drummond M, Barbieri M, Cook J, Glick HA, Lis J, Malik F, et al. Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force Report. Value Health. 2009;12(4):409–18.

    PubMed  Article  Google Scholar 

Download references


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

Author information




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.

Ethics declarations

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.


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).

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 13 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

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).

Download citation