ECONOMIC EVALUATION OF ULIPRISTAL ACETATE TABLETS FOR THE TREATMENT OF PATIENTS WITH MODERATE AND SEVERE SYMPTOMS OF UTERINE FIBROIDS

Author(s)

Nagy B1, Tímár G2, Jozwiak-Hagymásy J2, Kovacs G2, Merész G2, Vámossy I3, Agh T4, László Á5, Vokó Z1, Kalo Z61ELTE, Budapest, Hungary, 2Syreon Research Institute, Budapest, Hungary, 3Gedeon Richter Plc., Budapest, Hungary, 4Semmelweis University, Budapest, Hungary, 5Bajcsy-Zsilinszky Hospital, Budapest, Hungary, 6Eötvös Loránd University, Budapest, Hungary

OBJECTIVES: Ulipristal acetate - a selective progesterone receptor modulator - was proved to be effective for 3 month pre‑operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The aim of this analysis was to assess the cost-effectiveness of ulipristal acetate 5 mg as an add-on therapy to standard pre-surgical treatment in Hungary. METHODS: A Markov state-transition economic model was developed over 10 year time horizon. Ulipristal acetate was compared to 1) pre-surgical observation, and 2) immediate hysterectomy. The model comprises mutually exclusive health states: no/mild bleeding disorder, heavy bleeding disorder, persistent heavy bleeding disorder, myomectomy, post-myomectomy with no/mild bleeding disorder, post-myomectomy with heavy bleeding disorder, hysterectomy, post-hysterectomy, post-menopausa and death. Transition probabilities and utility values were drawn from the Pearl I clinical trial and scientific literature. Resource utilisation and unit costs were derived from the consensus panel of clinical experts and National Health Insurance Fund tariffs and publications. Costs and QALYs were discounted at a yearly rate of 3.5%. RESULTS: Addition of 3 month ulipristal acetate to the standard pre-operative therapy was predicted to achieve an additional 0.019 QALYs compared to observation at an estimated incremental cost of €376, resulting an incremental cost of 20,180 €/QALY. Results were most sensitive to the utility value of post-hysterectomy, but robust to changes in further model parameters. When 3 month of therapy was compared to immediate hysterectomy without any observation period, the ICER was reduced to 6,095 €/QALY. CONCLUSIONS: The analysis suggests that adding ulipristal acetate treatment to standard pre-surgical therapy represents good value for money according to currently accepted cost-effectiveness criterion in Hungary. Inclusion of societal benefits may considerably reduce the cost-effectiveness ratio, however further evidence from observational studies is needed to capture potential benefits of ulipristal acetate therapy on fertility.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PIH24

Topic

Economic Evaluation

Topic Subcategory

Cost-comparison, Effectiveness, Utility, Benefit Analysis

Disease

Reproductive and Sexual Health

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