Prostate cancer is one of the leading malignant diseases among men. With the increase in average life expectancy, an ever-growing proportion of the population is at elevated risk of developing prostate cancer. In recent years, the treatment of malignant diseases has made substantial progress, with innovative medicinal products playing a central role in achieving these outcomes.
Access to innovative therapy is a priority for the European Commission and the member states of the European Union. The aim is to reduce the incidence and mortality of malignant diseases while improving patient survival.
In Bulgaria, patients with oncological diseases experience delayed access to new medicinal therapies. This delay is due in part to the national regulatory framework and the process of including new medicinal products in the positive drug list or expanding the therapeutic indications of already reimbursed medicines. The delay in access to modern therapy for patients with prostate cancer in Bulgaria is substantial compared with many EU countries.
Feher JM, Nagy A, Flasko T. Epidemiology of prostate cancer. Magy Urol. 1994;6(3):229–32.
Mottet N, Bergh RCNVD, Vice-chair PC, Santis MD, Gillessen S, Govorov A, et al. EAU-ESUR-ESTRO-SIOG Guidelines on Prostate Cancer/ Guias Europeas. Eur Assoc Urol 2018. 2018;1–145.
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394–424.
Culp MBB, Soerjomataram I, Efstathiou JA, Bray F, Jemal A. Recent Global Patterns in Prostate Cancer Incidence and Mortality Rates. Eur Urol. 2020 Jan;77(1):38–52.
Descotes JL. Diagnosis of prostate cancer. Asian J Urol. 2019 Apr 1;6(2):129–36.
Louie KS, Seigneurin A, Cathcart P, Sasieni P. Do prostate cancer risk models improve the predictive accuracy of PSA screening? A meta-analysis. Ann Oncol Off J Eur Soc Med Oncol. 2015 May;26(5):848–64.
Grossman DC, Curry SJ, Owens DK, Bibbins-Domingo K, Caughey AB, Davidson KW, et al. Screening for prostate cancer USPreventive servicestaskforcerecommendation statement. JAMA - J Am Med Assoc. 2018;319(18):1901–13.
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229–63.
Santucci C, Carioli G, Bertuccio P, Malvezzi M, Pastorino U, Boffetta P, et al. Progress in cancer mortality, incidence, and survival: a global overview. Eur J Cancer Prev Off J Eur Cancer Prev Organ ECP. 2020 Sept;29(5):367–81.
Hanna TP, King WD, Thibodeau S, Jalink M, Paulin GA, Harvey-jones E, et al. Mortality due to cancer treatment delay : systematic review and. 2020;
Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17–48.
EFPIA [Internet]. [cited 2025 Aug 10]. European Federation of Pharmaceutical Industries and Associations. Available from: https://www.efpia.eu/about-us/who-we-are/
IMI. The Innovative Medicines Initiative (IMI) Research Agenda: Creating Biomedical R&D Leadership for Europe to Benefit the Patients and Society Revision 11 (2011).
Nikolova A, Grigorov E, Getov I, Salchev P. Study and analysis of the awareness of the health technology assessment process in Bulgaria. Bulg J Public Health. 2019 Apr 1;11(2):37–50.
Summary E. The root causes of unavailability of innovative medicines and delay in access : Shortening the wait. 2024;(June):1–41.
Todd I, Faust R, Herrero-Martinez E, Hussain N, Kawinski A, Lennard A, et al. Dynamic Regulatory Assessment: Unpacking the Process Reveals Readiness to Pilot for Europe—An EFPIA View. Clin Ther. 2023;45(11):1142–7.
Newton M, Stoddart K, Travaglio M, Troein P. EFPIA Patients W.A.I.T. Indicator 2024 Survey.
June P. Indicator 2023 Survey This year ’ s Patients W . A . I . T . indicator covers 36 countries and Indicators measure availability , limited availability and time to local authorisation dates. 2024;(June).
Kawalec P, Tesar T, Vostalova L, Draganic P, Manova M, Savova A, et al. Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review. Front Pharmacol. 2017 Dec 18;8:892.
Thanimalai S, Choon WY, Lee KKC. Stakeholder views of managed entry agreements: A literature review of national studies. Health Policy OPEN. 2021 Dec;2:100032.
Schultz NM, Flanders SC, Wilson S, Brown BA, Song Y, Yang H, et al. Treatment Duration, Healthcare Resource Utilization, and Costs Among Chemotherapy-Naïve Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Enzalutamide or Abiraterone Acetate: A Retrospective Claims Analysis. Adv Ther. 2018 Oct 1;35(10):1639–55.
Francini E, Gray KP, Shaw GK, Evan CP, Hamid AA, Perry CE, et al. Impact of New Systemic Therapies on Overall Survival of Patients with Metastatic Castration Resistant Prostate Cancer in a Hospital-based Registry. Prostate Cancer Prostatic Dis. 2019 Sept;22(3):420–7.
Vrdoljak E, Bodoky G, Jassem J, Popescu R, Pirker R, Čufer T, et al. Expenditures on Oncology Drugs and Cancer Mortality-to-Incidence Ratio in Central and Eastern Europe. The Oncologist. 2019;24(1):e30–7.
ASCO. January. 2019. Prostate Cancer: Statistics | Cancer.Net.
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