114IN - ESMO european consortium study on the availability of anti-neoplastic medicines across Europe

Date 28 September 2014
Event ESMO 2014
Session Availability of anti-neoplastic medicines across Europe: First results of the ESMO-led European Consortium Study
Topics Bioethics, Legal, and Economic Issues
Presenter Nathan I. Cherny
Citation Annals of Oncology (2014) 25 (suppl_4): iv39-iv39. 10.1093/annonc/mdu315
Authors N.I. Cherny1, A. Eniu2, R. Sullivan3, M. Saar4, J. Torode5, A. Ullrich6
  • 1Dept Medical Oncology, Shaare Zedek Medical Centre Oncology Institute, 91031 - Jerusalem/IL
  • 2-, Ion Chiricuta Oncology Institute-IOCN, 400015 - Cluj Napoca/RO
  • 3Research Oncology, Guy's and St. Thomas' Hospital NHS Trust, SE1 9RT - London/GB
  • 4Clinical Pharmacist, Tartu University Hospital, - - Tartu/EE
  • 5N/a, UICC, 1207 - Geneva/CH
  • 6N/a, World Health Organization, Cancer Control Programme, 1211 - Geneva/CH

Abstract

Body

Background:

Quality oncologic care is dependent on the availability of affordable anti neoplastic agents. Many patients in Europe either lack access to anticancer medication or have access but at a cost that is unaffordable to many persons.

Methodology:

The ESMO study on the availability and accessibility of anti-neoplastic medicines in Europe is a major initiative to evaluate the formulary availability (on and off-label), out of pocket costs and actual availability of licensed anti-neoplastic medicines across a range of common cancers. This is an ESMO project in collaborative partnership with WHO, UICC, the Kings College London Institute of Cancer Policy, and the European Society of Oncology Pharmacy. The survey tool was developed by ESMO and was peer reviewed within the ESMO framework and by the collaborating partners. Invited field reporters included the ESMO National Representatives, identified key opinion leaders, community oncologists selected by the ESMO Community Oncology Working Group and oncology pharmacists selected by the European Society for Oncology Pharmacy. 186 potential reporters were identified in 46 Countries.

Study Tool:

In addition to a range of general questions relating to health care delivery the study focuses on 7 key questions: Is it permitted to prescribe the drug for this indication? Is the drug reimbursed for this indication? Does the reimbursement require pre-authorization? Does pre-authorization delay treatment for more than 4 weeks? What is the approximate cost of the drug to the average patient? Can the patient obtain the medicine if it is prescribed? What are the barriers limiting availability? (No/unreliable supplier, No commercial motive, Parallel export, Manufacturing problems, Budget capitation). The clinical situations evaluated include breast cancer (adjuvant and metastatic), lung cancer, colorectal cancer, prostate cancer, ovarian cancer, sarcoma, pancreatic cancer, germ cell tumors, renal cell cancer, GIST, urothelial cancers, gastric and esophageal cancer, and melanoma.

Respondents:

As of June 2014, 101 responses from representatives of 14 Western European countries, 22 Eastern European countries and 6 Mediterranean countries including Israel and Turkey were submitted. 59 respondents identified themselves as oncologists and 22 as oncology pharmacists.

Health care systems:

Most Eastern Eur. countries have health care systems that do not allow for supplementary insurance in contrast to Western Eur. and Mediterranean counties in which most allow for supplementary insurance.

Formulary availability and out of pocket cost:

Across a wide range of disease settings substantial differences are seen between Eastern Europe, Mediterranean Europe and Western Europe. In Eastern Europe the range of available medications is more limited, patients are more likely to have greater out of pocket cost for medications and actual availability is more likely to be limited. These differences are most pronounced for new and expensive agents. When availability is limited the most common reasons cited for expensive agents is budget capitation and lack of reliable supplier. For inexpensive agents, lack of reliable supplier and lack of commercial motive were cited more often. Delays in preapproval for reimbursement >4 weeks were not common but when they occurred they were most prevalent in Eastern Eur. countries. Discrepancies in formulary availability, out of pocket cost and actual availability were also seen among the Western Eur. and Mediterranean Countries. Details will be presented.

Conclusions:

The ESMO survey on the availability of anti-neoplastic medicine has identified major discrepancies in accessibility and affordability of anticancer medications in different countries and regions of Europe. Access and affordability are less in Eastern Eur. and in countries which do not have provision for supplementary insurance.

Disclosure:

All authors have declared no conflicts of interest.