Real world evidence analysis of prescribing practice of medicines for the treatment of common gynecological diseases in Ukraine

Increasingly, effectiveness data obtained from RWE are required to make reimbursement decisions through coverage with evidence development schemes in line with current WHO recommendations. Due to the reforming process in Ukraine health care system, development of National Drug Policy, there is a high need to match international requirements to HTA, pricing and reimbursement practice. The study aims to outline the methodology of RWE analysis, review, examine prescribing practice, estimate costs of treatment for the inflammatory gynecological disorders, endometriosis and uterine fibroids, which rank the first place among gynecologic diseases in reproductive age women. To assess utilization and consumption of medicines for fertility treatments of out-patient care without considering ART in Ukraine we used electronic database registry of patients at Lviv Regional Reproductive Health Centre in 2015 (Lviv Region population 2,5 mln people). We analyzed 205 e-medical records of women diagnosed with inflammatory gynecological disorders, endometriosis and uterine fibroids, developed our own database for the usability and calculated average costs of medicine treatment per patient. We used the weighted average prices from Morion company database (Ukraine) on 01.12.2015 (1 USD = 23,3 UAH). We conducted integrated frequency/ABC/VEN-analysis and used National Drug Formulary of 8th edition. The costs for out-patient care were estimated from the patients’ perspective while all the payments for the prescribed medicines were out-of-pocket. The sample included 205 women with ages ranging from 19 to 68 years with a mean age of 35,5 years. 55% of women were of young reproductive age. The total number of prescriptions for antibiotics, hormones, herbal medicines, dietary supplements for the aforementioned diseases was 593,0. In 22% of cases there were no medicine’s prescriptions. In 58% of patients were diagnosed inflammatory gynecological disorders – salpingitis (5%), salpingoophoritis (7,8%), endocervicitis (5,4%), cervicitis (12%), vulvovaginitis (7,3%), bacterial vaginosis (10,2%),vaginitis (22,9%), candidiasis (1,5%). We identified 349 medicines prescriptions for these diagnoses, that included 85 brand names, which accounted of 43 INN, 18 comb drugs and 8 dietary supplements. Endometriosis was identified in 25% of women and there were found 99 medicines prescriptions, that included 55 brand names, which accounted of 28 INN, 17 comb drugs and 6 dietary supplements. We presented the alternative scenarios of endometriosis management with the use of progestins depending on costs. Uterine fibroids was diagnosed in 36% of patients. 145 medicines prescriptions were assessed and there were included 70 brand names, 39 INN, 15 comb drugs and 7 dietary supplements. We evaluated the high positive correlation between the prescriptions’ frequency and the total share of treatment costs. Due to the performed interviews with gynecologists the main goal of fertility treatment effectiveness outcome was pregnancy and childbirth. On the example of gynecological treatment schemes we outlined how real-world evidence across different therapeutic areas provides a dataset to inform health care decisions, rational reimbursement policies for state payers, private insurers and helps to develop local and national drug formularies. A usability of solutions to handle big data and analytical methods to deal with the non-randomised nature of this data are needed to be secured by IT-providers for health care systems. The decision making along with HTA use have to take into account real-world evidence in this process, in particular in the Ukrainian setting.