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Front. Public Health | doi: 10.3389/fpubh.2018.00328

Barriers for Access to New Medicines: Searching for the balance between rising costs and limited budgets

 Brian Godman1, 2, 3, 4*,  Anna Bucsics5, Patricia Vella Bonnano2,  Wija Oortwijn6,  Celia Rothe7,  Alessandra Ferrario8, Simone Boselli9, Andrew Hill10, Antony P. Martin3, 11, Steven Simoens12,  Amanj Kurdi2, 13,  Mohamed Gad14, Jolanta Gulbinovic15,  Angela Timoney2, 16,  Tomasz Bochenek7, Ahmd Salem17,  Iris Hoxha18, Robert Sauermann19, Amos Massele20, Augusto Guerra Jnr21,  Guenka I. Petrova22, Gnosia Achniotou23, Ott Laius24,  Catherine Sermet25,  Gisbert W. Selke26, Vasilios Kourafalos27,  John Yfantopoulos28,  Einar Magnusson29, 30, Roberta Joppi31, Margaret Oluka32,  Hye-Young Kwon33, Arianit Jakupi34,  Francis Kalemeera35, Joseph Fadare36, Oyvind Melien37, Magda Wladysiuk38, Vanda Marković-Peković30, 39, 40,  Ileana Mardare41, Dmitry Meshkov42, Tanja Novakovic43,  Jurij Fürst44, Dominik Tomek45,  Corinne Zara46, Eduardo Diogene47,  Johanna C. Meyer4, Rickard Malmstrom1, Bjorn Wettermark1, 48,  Zinhle C. Matsebula49, Stephen Campbell50 and  Alan Haycox3
  • 1Laboratory Medicine Clinical Pharmacology, Karolinska Institutet (KI), Sweden
  • 2Strathclyde Institute of Pharmacy and Biomedical Sciences, United Kingdom
  • 3Management School, University of Liverpool, United Kingdom
  • 4Sefako Makgatho Health Sciences University, South Africa
  • 5Universität Wien, Austria
  • 6Radboud University Nijmegen Medical Centre, Netherlands
  • 7Jagiellonian University Medical College, Poland
  • 8Harvard Medical School, United States
  • 9European Organisation for Rare Diseases (EURORDIS), France
  • 10University of Liverpool, United Kingdom
  • 11HCD Economics, United Kingdom
  • 12Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium
  • 13Hawler Medical University, Iraq
  • 14Imperial College London, United Kingdom
  • 15Vilnius University, Lithuania
  • 16NHS Lothian, University of Edinburgh, United Kingdom
  • 17IQVIA (Belgium), Belgium
  • 18University of Medicine, Tirana, Albania
  • 19Hauptverband der österreichischen Sozialversicherungsträger, Austria
  • 20University of Botswana, Botswana
  • 21Universidade Federal de Minas Gerais, Brazil
  • 22Sofia University, Bulgaria
  • 23Health Insurance Organisation (HIO), Cyprus
  • 24State Agency of Medicines, Ravimiamet, Estonia
  • 25Institut de recherche et de documentation en économie de la sant, France
  • 26Wissenschaftliches Institut der AOK - WIdO, Germany
  • 27National Organization for Healthcare Services Provision (EOPYY), Greece
  • 28National and Kapodistrian University of Athens, Greece
  • 29Ministry of Health, Indonesia
  • 30Minister of Health (Iceland), Iceland
  • 31Unità Locale Sanitaria di Verona, Italy
  • 32University of Nairobi, Kenya
  • 33Mokwon University, South Korea
  • 34A2 – Pharmaceutical Consulting, Serbia
  • 35University of Namibia, Namibia
  • 36Ekiti State University, Nigeria
  • 37Norwegian Institute of Public Health, Norway
  • 38HTA Consulting, Poland
  • 39University of Banja Luka, Bosnia and Herzegovina
  • 40Ministry of Health and Social Welfare (Republic of Srpska), Bosnia and Herzegovina
  • 41Carol Davila University of Medicine and Pharmacy, Romania
  • 42National Research Institute of Public Health named after NA Semashko, Russia
  • 43ZEM Solutions, Serbia
  • 44Health Insurance Institute of Slovenia, Slovenia
  • 45Slovak Medical University, Slovakia
  • 46Catalan Health Service, Spain
  • 47Hospital Universitari Vall d'Hebron, Spain
  • 48Stockholm County Council, Sweden
  • 49Raleigh Fitkin Memorial Hospital, Swaziland
  • 50University of Manchester, United Kingdom

Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growing prevalence of both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimise the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need.

Keywords: Managed entry, Health Policy, pharmaceutical, financing, Cancer, Orphan disease, New model

Received: 15 Aug 2018; Accepted: 26 Oct 2018.

Edited by:

Mihajlo (Michael) Jakovljevic, Department of Health Economics, Lund University, Sweden

Reviewed by:

Simon Grima, University of Malta, Malta
Magdalena Syrkiewicz-Switala, Medical University of Silesia, Poland
Jonathan Spiteri, University of Malta, Malta  

Copyright: © 2018 Godman, Bucsics, Vella Bonnano, Oortwijn, Rothe, Ferrario, Boselli, Hill, Martin, Simoens, Kurdi, Gad, Gulbinovic, Timoney, Bochenek, Salem, Hoxha, Sauermann, Massele, Guerra Jnr, Petrova, Achniotou, Laius, Sermet, Selke, Kourafalos, Yfantopoulos, Magnusson, Joppi, Oluka, Kwon, Jakupi, Kalemeera, Fadare, Melien, Wladysiuk, Marković-Peković, Mardare, Meshkov, Novakovic, Fürst, Tomek, Zara, Diogene, Meyer, Malmstrom, Wettermark, Matsebula, Campbell and Haycox. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Dr. Brian Godman, Karolinska Institutet (KI), Laboratory Medicine Clinical Pharmacology, Solna, Sweden,