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Front Public Health. 2018 Dec 5;6:328. doi: 10.3389/fpubh.2018.00328. eCollection 2018.

Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets.

Author information

1
Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.
2
Health Economics Centre, University of Liverpool Management School, Liverpool, United Kingdom.
3
Division of Clinical Pharmacology, Karolinska Institute, Karolinska University Hospital Huddinge, Stockholm, Sweden.
4
School of Pharmacy, Sefako Makgatho Health Sciences University, Pretoria, South Africa.
5
Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA), Brussels, Belgium.
6
Ecorys, Rotterdam, Netherlands.
7
Department for Health Evidence, Radboud University Medical Center, Nijmegen, Netherlands.
8
Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland.
9
Division of Health Policy and Insurance Research, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, United States.
10
EURORDIS-Rare Diseases Europe, Paris, France.
11
Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.
12
HCD Economics, The Innovation Centre, Daresbury, United Kingdom.
13
KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
14
Department of Pharmacology, College of Pharmacy, Hawler Medical University, Erbil, Iraq.
15
Global Health and Development Group, Imperial College, London, United Kingdom.
16
Department of Pathology, Forensic Medicine and Pharmacology, Faculty of Medicine, Institute of Biomedical Sciences, Vilnius University, Vilnius, Lithuania.
17
NHS Lothian, Edinburgh, United Kingdom.
18
IQVIA, Brussels, Belgium.
19
Department of Pharmacy, Faculty of Medicine, University of Medicine, Tirana, Albania.
20
Hauptverband der Österreichischen Sozialversicherungsträger, Vienna, Austria.
21
Department of Biomedical Sciences, Faculty of Medicine, University of Botswana, Gaborone, Botswana.
22
Department of Social Pharmacy, College of Pharmacy, Federal University of Minas Gerais, Av. Presidente Antônio Carlos, Belo Horizonte, Brazil.
23
SUS Collaborating Centre - Technology Assessment & Excellence in Health (CCATES/UFMG), College of Pharmacy, Federal University of Minas Gerais. Av. Presidente Antônio Carlos, Belo Horizonte, Brazil.
24
Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria.
25
Health Insurance Organisation (HIO), Nicosia, Cyprus.
26
State Agency of Medicines, Tartu, Estonia.
27
IRDES, Paris, France.
28
Wissenschaftliches Institut der AOK (WIdO), Berlin, Germany.
29
EOPYY-National Organization for the Provision of Healthcare Services, Athens, Greece.
30
School of Economics and Political Science, University of Athens, Athens, Greece.
31
Department of Health Services, Ministry of Health, Reykjavík, Iceland.
32
Pharmaceutical Drug Department, Azienda Sanitaria Locale of Verona, Verona, Italy.
33
Department of Pharmacology and Pharmacognosy, School of Pharmacy, University of Nairobi, Nairobi, Kenya.
34
Division of Biology and Public Health, Mokwon University, Daejeon, South Korea.
35
UBT - Higher Education Institute, Prishtina, Kosovo.
36
Department of Pharmacology and Therapeutics, Faculty of Health Sciences, University of Namibia, Windhoek, Namibia.
37
Department of Pharmacology and Therapeutics, Ekiti State University, Ado-Ekiti, Nigeria.
38
Norwegian Institute of Public Health, Oslo, Norway.
39
Agency for Health Technology Assessment and Tariff System (AOTMiT), Warsaw, Poland.
40
HTA Consulting, Cracow, Poland.
41
Ministry of Health and Social Welfare, Banja Luka, Bosnia and Herzegovina.
42
Department of Social Pharmacy, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.
43
Public Health and Management Department, Faculty of Medicine, "Carol Davila", University of Medicine and Pharmacy Bucharest, Bucharest, Romania.
44
National Research Institution for Public Health, Moscow, Russia.
45
ZEM Solutions, Belgrade, Serbia.
46
Health Insurance Institute, Ljubljana, Slovenia.
47
Faculty of Medicine, Slovak Medical University in Bratislava, Bratislava, Slovakia.
48
Drug Territorial Action Unit, Catalan Health Service, Barcelona, Spain.
49
Vall d'Hebron University Hospital, Fundació Institut Català de Farmacologia, Barcelona, Spain.
50
Department of Medicine Solna, Karolinska Institutet and Clinical Pharmacology Karolinska University Hospital, Stockholm, Sweden.
51
Department of Healthcare Development, Stockholm County Council, Stockholm, Sweden.
52
Raleigh Fitkin Memorial Hospital, Manzini, Swaziland.
53
Division of Population Health, Health Services Research and Primary Care, Centre for Primary Care, University of Manchester, Manchester, United Kingdom.
54
NIHR Greater Manchester Patient Safety Translational Research Centre, School of Health Sciences, University of Manchester, Manchester, United Kingdom.

Abstract

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 growth in 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 to finance new medicines 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 optimize 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:

cancer; financing; health policy; managed entry; new models; orphan diseases; pharmaceuticals

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