Economic Evaluation of Senshio
Journal
Applied health economics and health policy
ISSN: 1179-1896
Titre abrégé: Appl Health Econ Health Policy
Pays: New Zealand
ID NLM: 101150314
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
pubmed:
12
5
2020
medline:
26
11
2021
entrez:
12
5
2020
Statut:
ppublish
Résumé
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 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.
Sections du résumé
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
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.
Identifiants
pubmed: 32390072
doi: 10.1007/s40258-020-00589-2
pii: 10.1007/s40258-020-00589-2
doi:
Substances chimiques
Tamoxifen
094ZI81Y45
Ospemifene
B0P231ILBK
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
123-132Références
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: 20032798
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.
Nappi RE, et al. Vulvar and vaginal atrophy in four European countries: evidence from the European REVIVE Survey. Climacteric. 2016;19(2):188–97.
pubmed: 26581580
Wysocki S, et al. Management of vaginal atrophy: implications from the REVIVE survey. Clin Med Insights Reprod Health. 2014;8:23–30.
pubmed: 24987271
pmcid: 24987271
Ospemifene, summary of product characteristics. https://www.medicines.org.uk/emc/product/9417/smpc . Accessed 22 Oct 2019.
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.
pubmed: 24679891
Goldstein SR, et al. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy. Climacteric. 2014;17(2):173–82.
pubmed: 23984673
Healthcare Improvement Scotland/SMC. A guide to the Scottish medicines consortium. https://www.scottishmedicines.org.uk/media/3574/20180712-a-guide-to-the-scottish-medicines-consortium.pdf . Accessed 22 Oct 2019.
National Institute for Health and Care Excellence. Menopause: diagnosis and management. Clinical Guideline (NG23); 2015. https://www.nice.org.uk/guidance/ng23 . Accessed 22 Oct 2019.
Clinical Study Report 15-50821, data on file.
Clinical Study Report 15-50310, data on file.
Office for National Statistics. National life tables: Scotland. 2018.
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: 24411556
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.
Shingler S, et al. Utilities for treatment-related adverse events in type 2 diabetes. J Med Econ. 2015;18(1):45–55.
pubmed: 25266815
National Institute for Health and Care Excellence (NICE). British National Formulary; 2018. https://bnf.nice.org.uk . Accessed 22 Oct 2019.
ISD Scotland. Dispenser reimbursement, remuneration and volume. Prescription cost analysis. ISD Scotland; 2018.
Curtis L, Burns A. Unit costs of health and social care 2018. Canterbury: Personal Social Services Research Unit, University of Kent; 2018.
Information Services Division Scotland. Dispenser reimbursement, remuneration and volume. Prescription cost analysis; 2018. https://www.isdscotland.org/Health-Topics/Prescribing-and-Medicines/Community-Dispensing/Prescription-Cost-Analysis/ . Accessed 22 Oct 2019.
ISD Scotland. R04opX: speciality outpatient summary. April 2017–March 2018.
Net Monetary Benefit. 2016. York: York Health Economics Consortium; 2016. https://yhec.co.uk/glossary/net-monetary-benefit/ .
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: 19900249