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.
2. The Global Strategy for Women, Children's and Adolescent's Health (2016-2030). Every woman every child United Nations, 2015 [Electronic resource]. - Access mode: http: //globalstrategy.everywomaneverychild. org / pdf / EWEC_globalstrategyreport_200915_FINAL_WEB.pdf
3. Pinyazhko O. B., Zaliska O. M. Methodical approaches to the evaluation of health technologies in Ukraine on the basis of the European model // Social Pharmacy in Public Health. - 2015. - No. 2. - P. 44-54.
4. Kaló Z., Gheorghe A., Huic M., Csanádi M. et al. HTA Implementation Roadmap in Central and Eastern European Countries // Health Economics. - 2016 - V. 25 (1). - P. 179-192.
5. Jr Garrison L. P., Neumann P. J., Erickson P., Marshall D. et al. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force Report // Value in Health. - 2007 - V. 10 (5). - P. 326-338.
6. Wilk N., Skrzekowska-Baran I., Wierzbicka N., Tomassy J. et al. Adoption of Real World Evidence in decision-making processes on public funding of drugs in Poland // JHPOR. - 2015 - V.2. - P. 23-30.
7. Wang S., Goring S. M., Lozano-Ortega G. Inclusion of real-world evidence in submission packages to health technology assessment bodies: What do current guidelines indicate? // Value in Health. - 2016 - V. 19 (3). - P. 287.
8. Berger M. L., Lipset C., Gutteridge A., Axelsen K. et al. Optimizing the leveraging of real-world data to improve the development and use of medicines // Ibid. - 2015. - V. 18 (1). - P. 127-130.
9. Parmenter L., Van Engen A. HTA and market insights, real-world evidence generation for the evolving stakeholder needs // Quintiles. - 2015 - pp. 1-10.
10. Order of the Ministry of Health of Ukraine dated 06.04.2016 № 319 "On approval and implementation of medical-technological documents on the standardization of medical care for genital endometriosis. Unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care "Tactics of management of patients with endometriosis". Ministry of Health of Ukraine, 2016 p. [Electronic resource]. - Mode of access: http://www.moz.gov.ua/ua/portal/dn_20151204_0.html#2)
11. Pinyazhko O. B., Zaliska O. M., Got N. R., Gnatyshak L. I. Analysis of pharmaceutical supply for gynecological diseases in Ukraine and the world // Pharmac. a magazine - 2013. - No. 4 (29). - P. 109-115.
12. Nemchenko A. S., Zmitslia MV, Podkolzin MV Clinical and economic analysis of medical appointments for patients with inflammatory gynecological diseases in the hospital of Kyiv / Formation of the national lycar policy in the conditions of the implementation of health insurance: issues of education , theory and practice. Maestro III Allukr. science-practice Conf., Kharkiv, March 12, 2015 / Ped. Col .: A. S. Nemchenko et al. - Kharkiv: View of the NFUU, 2015. - 272 p. [Electronic resource]. - Access mode: http://dspace.nuph.edu.ua/bitstream/123456789/6356/1/%D0%9E%D0%AD%D0%A4%2012.03.2015.pdf
13. Zalis'ka O., Piniazhko O., Vernikovskyy I., Gnatyshak L. The Prevalence and Cost of Illness in Women with Endometriosis in Ukraine // Value in Health. - 2014 - Abstracts 17 th ISPOR Annual European Congress November 8-12, Amsterdam, The Netherlands. - V. 17, N 7. - P. 158.
14. Piniazhko O., Zalis'ka O., Vernikovskyy I., Gnatyshak L. et al. Analysis of treatment costs for uterine fibroids in Ukraine // Value in Health. Abstracts 20th ISPOR Annual International Meeting May 16-20, Philadelphia, PA, USA - 2015. V. 18, N 3. - P. 106.
15. Zalis'ka O., Piniazhko O., Vernikovskyy I., Gnatyshak L. Analysis of Treatment Cost for Endometriosis in Ukraine // Value in Health. - 2014 - V. 17 (3). - P. 158.
16. Piniazhko O., Zalis'ka O., Pyrohova V. et al. Analysis of the Real-World Database: Endometriosis Treatment Practice in Ukraine // Value in Health. Abstracts 21st ISPOR Annual International Meeting May 21-25, Washington DC, USA. - 2016 - V. 19 (3). - P. A176.
17. Piniazhko O., Zalis'ka O., Pyrohova V. et al. Real-life evidence in the treatment of gynecological diseases: use in decision-making // Ibid. - 2016 - V. 19 (3). - P. A176.
18. Drug and Therapeutics Committees - A Practical Guide. WHO - 2003, pp. 1-155 [Electronic resource]. - Access mode: http://apps.who.int/medicalocs/pdf/s4882e/s4882e.pdf
19. Morozov AM, Yakovleva LV, Bezditko NV and others. Methodical recommendations for assessing the clinical and economic feasibility of the use of drugs in a health care institution (support of the formular system). - Kharkiv: View of NFUU, 2012. - 59 p.
20. Order of the Ministry of Health of Ukraine dated 14.03.2016 p. No. 183 "On approval of the eighth issue of the State Form of Medicines and ensuring its availability" [Electronic resource]. - Access mode: http://www.moz.gov.ua/ua/portal/dn_20160314_0183.html
21. Order of the Ministry of Health of Ukraine dated 15th of July 2011 № 417 "On the organization of ambulatory obstetric and gynecological care in Ukraine" [Electronic resource]. - Mode of access: http://moz.gov.ua/ua/portal/dn_20110715_417.html
22. Johnson N. P., Hummelshoj L. Consensus on current management of endometriosis // Hum Reprod. - 2013. - V. 28 (6). - P. 1552-1568.
23. Dunselman G., Vermeulen N., Nelen W. The ESHRE 2013 Guideline on the Management of Women with Endometriosis // Hum. Reprod - 2013. - V. 28, N 1. - P. 86-87.
24. Vilas G. A., Allaire C., Laberge P. Y. et al. The management of the uterine leiomyoma // Obstet Gynaecol Can. - 2015. - V. 37 (2). - P. 157-181.
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