Time to access to novel anticancer drugs and the correlation with ESMO-Magnitude of Clinical Benefit Scale in Slovenia

References

• Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68:394–424.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. European medicines agency: European public assessment reports [cited 2019 Jan 27]. Available from: www.ema.europa.eu
   Google Scholar
• Mendes D, Alves C, Afonso N, et al. The benefit of HER2-targeted therapies on overall survival of patients with metastatic HER2-positive breast cancer - a systematic review. Breast Cancer Res. 2015;17:1–14.
   PubMed Web of Science ®Google Scholar
• Duruisseaux M, Besse B, Cadranel J, et al. Overall survival with crizotinib and next-generation ALK inhibitors in ALK -positive non-small-cell lung cancer (IFCT-1302 CLINALK): a French nationwide cohort retrospective study. Oncotarget. 2017;8:21903–21917.
   PubMedGoogle Scholar
• Sahni S, Valecha G, Sahni A. Role of anti-PD-1 antibodies in advanced melanoma: the era of immunotherapy. Cureus. 2018;10:1–10.
   Web of Science ®Google Scholar
• Jönsson B, Hofmarcher T, Lindgren P, et al. The cost and burden of cancer in the European Union 1995–2014. Eur J Cancer. 2016;66:162–170.
   PubMed Web of Science ®Google Scholar
• Cherny NI, Sullivan R, Torode J, et al. ESMO European consortium study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in Europe. Ann Oncol. 2016;27:1423–1443.
   PubMed Web of Science ®Google Scholar
• Cherny NI, Sullivan R, Torode J, et al. ESMO international consortium study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in countries outside of Europe. Ann Oncol. 2017;28:2633–2647.
   PubMed Web of Science ®Google Scholar
• Ades F, Senterre C, Zardavas D, et al. Are life-saving anticancer drugs reaching all patients? Patterns and discrepancies of trastuzumab use in the European Union and the USA. PLoS One. 2017;12:1–11.
   Web of Science ®Google Scholar
• Kos M, Obradovic M, Mrhar A. Accessibility to targeted oncology drugs in Slovenia and selected European countries. Eur J Cancer. 2008;44:408–418.
   PubMed Web of Science ®Google Scholar
• Vrdoljak E, Bodoky G, Jassem J, et al. Expenditures on oncology drugs and cancer mortality‐to‐incidence ratio in central and Eastern Europe. Oncologist. 2019;24:e30–e37.
   PubMed Web of Science ®Google Scholar
• Ades F, Senterre C, de Azambuja E, et al. Discrepancies in cancer incidence and mortality and its relationship to health expenditure in the 27 European Union member states. Ann Oncol. 2013;24:2897–2902.
   PubMed Web of Science ®Google Scholar
• Martinalbo J, Bowen D, Camarero J, et al. Early market access of oncologic drugs in the EU. Ann Oncol. 2016;27:96–105.
   PubMed Web of Science ®Google Scholar
• Hartmann M, Mayer-Nicolai C, Pfaff O. Approval probabilities and regulatory review patterns for anticancer drugs in the European Union. Crit Rev Oncol Hematol. 2013;87:112–121.
   PubMed Web of Science ®Google Scholar
• Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (89/105/EECOff J Eur Union; 1989. OJ L 40:8.
   Google Scholar
• EFPIA (European Federation Of Pharmaceutical Industries And Associations). Patients WAIT indicator [cited 2019 Jan 27]. Available from: www.efpia.eu
   Google Scholar
• Ades F, Senterre C, Zardavas D, et al. An exploratory analysis of the factors leading to delays in cancer drug reimbursement in the European Union: the trastuzumab case. Eur J Cancer. 2014;50:3089–3097.
   PubMed Web of Science ®Google Scholar
• Kandolf Sekulovic L, Guo J, Agarwala S, et al. Access to innovative medicines for metastatic melanoma worldwide: melanoma world society and European association of dermato-oncology survey in 34 countries. Eur J Cancer. 2018;104:201–209.
   PubMed Web of Science ®Google Scholar
• Ferrario A. Time to entry for new cancer medicines: from European Union–wide marketing authorization to patient access in Belgium, Estonia, Scotland, and Sweden. Value Heal. 2018;21:809–821.
   PubMed Web of Science ®Google Scholar
• Schnipper LE, Davidson NE, Wollins DS, et al. American society of clinical oncology statement: a conceptual framework to assess the value of cancer treatment options. J Clin Oncol. 2015;33:2563–2577.
   PubMed Web of Science ®Google Scholar
• Cherny NI, Sullivan R, Dafni U, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol. 2015;26:1547–1573.
   PubMed Web of Science ®Google Scholar
• Cherny NI, de Vries EGE, Dafni U, et al. Comparative assessment of clinical benefit using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO value framework net health benefit score. J Clin Oncol. 2019;37(4):336–349.
   PubMed Web of Science ®Google Scholar
• Davis C, Naci H, Gurpinar E, et al. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European medicines agency: retrospective cohort study of drug approvals 2009-13. BMJ. 2017;359:j4530.
   PubMed Web of Science ®Google Scholar
• Vivot A, Jacot J, Zeitoun JD, et al. Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000–2015. Ann Oncol. 2017;28:1111–1116.
   PubMed Web of Science ®Google Scholar
• Del Paggio JC, Sullivan R, Schrag D, et al. Delivery of meaningful cancer care: a retrospective cohort study assessing cost and benefit with the ASCO and ESMO frameworks. Lancet Oncol. 2017;18:887–894.
   PubMed Web of Science ®Google Scholar
• Tibau A, Molto C, Ocana A, et al. Magnitude of clinical benefit of cancer drugs approved by the US food and drug administration. J Natl Cancer Inst. 2018;110:djx232.
   Google Scholar
• Hammerman A, Greenberg-Dotan S, Feldhamer I, et al. The ESMO-Magnitude of Clinical Benefit Scale for novel oncology drugs: correspondence with three years of reimbursement decisions in Israel. Expert Rev Pharmacoeconomics Outcomes Res. 2018;18:119–122.
   PubMed Web of Science ®Google Scholar
• Cherny NI, Dafni U, Bogaerts J, et al. ESMO-Magnitude of Clinical Benefit Scale version 1.1. Ann Oncol. 2017;28:2340–2366.
   PubMed Web of Science ®Google Scholar
• European Society of Medical Oncology. Clinical practice guidelines [cited 2017 Dec 31]. Available from: https://oncologypro.esmo.org/Guidelines/Clinical-P
   Google Scholar
• Li J, Vivot A, Alter L, et al. Appraisal of cancer drugs: a comparison of the French health technology assessment with value frameworks of two oncology societies. Expert Rev Pharmacoeconomics Outcomes Res. 2019;26:1–5.
   Google Scholar