Pharmaceutical costs are in the front line for containing healthcare costs as payors seek to manage constrained budgets while also meeting the healthcare demands of ageing patient populations. Market access is becoming more challenging for new pharmaceuticals, especially expensive treatments that drive up drug spending. More emphasis is being placed on value for money, with economic evaluation becoming part of the equation in pricing and reimburs...
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Pharmaceutical costs are in the front line for containing healthcare costs as payors seek to manage constrained budgets while also meeting the healthcare demands of ageing patient populations. Market access is becoming more challenging for new pharmaceuticals, especially expensive treatments that drive up drug spending. More emphasis is being placed on value for money, with economic evaluation becoming part of the equation in pricing and reimbursement decisions. As payors seek to reduce uncertainty for paying for drugs for which evidence of clinical and/or economic benefits is insufficiently robust at launch, new arrangements are being made between payors and manufacturers to enable market access under conditions that limit the risk to payors. This report examines the development of market access schemes in key pharmaceutical markets and provides an analysis of the pros and cons of different types of schemes.
Introduction
This report examines the hurdles in gaining market access for new pharmaceuticals in the changing pricing and reimbursement environment and explores some of the strategies being employed by payors and manufacturers to address those hurdles. The Scope of the report includes the US, Japan and the five main European markets of France, Germany, Italy, Spain and the UK. rbhc0282
Scope of this research
• Understand what payors are looking for in proposals from manufacturers for market access agreements.
• Evaluate which types of arrangements are best suited to national pricing and reimbursement systems.
• Appreciate the pitfalls of market access schemes that fail to address key requirements of payors and providers.
• Gain an informed insight into the key drivers of arrangements with payors to gain market access for expensive new therapies.
• Prepare for negotiations with payors by incorporating relevant information in the product development plan.
Research and analysis highlights
Market access schemes can be generally classified according to whether they are essentially finance-based, in which discounts and rebates are linked to usage at patient or population level; or whether they are outcomes-based, in which reimbursement is linked to performance guarantees or the generation of further clinical evidence.
The UK and Italy are leading the way in Europe with the development of market access schemes. Italy pioneered one of the earliest risk-sharing schemes in 2000 when the government launched the Cronos project to assess the possible reimbursement of Alzheimer drugs.
Price-volume agreements are the norm in France, comparable to the situation in Australia where some 80 price-volume agreements have been developed with the Pharmaceutical Benefits Advisory Committee (PBAC), and in Canada, where price-volume agreements are almost mandatory in the major provinces.
Key reasons to purchase this research
• What are the main triggers for market access schemes and which products are subject to market access agreements in key markets?
• Which companies are most active in arranging agreements with payors to gain market access?
• What lessons can be learned from the UK risk-sharing scheme for multiple sclerosis treatments for future outcomes-based schemes?
• How can manufacturers improve their chances of gaining payor acceptance of a proposed scheme?
• What are the potential problems with performance-guarantee schemes and which types of finance-based schemes are preferred by payors?
Pharmaceutical Industry in Canada
Table of Contents
About the author 2
Disclaimer 2
The pharmaceutical P&R landscape 8
Impact of policy developments on market access 9
Evolution of market access schemes 10
Pros & cons of market access schemes 11
The role of HTA in decision-making 12
Future market access challenges and opportunities 13
Chapter 1 The pharmaceutical P&R landscape 14
Summary 14
Introduction 15
Pricing and reimbursement in the US 16
Coverage decisions 18
Pricing and reimbursement in Japan 19
Pricing and reimbursement in France 22
Pricing and reimbursement in Germany 25
IQWiG 26
Pricing and reimbursement in Italy 27
Risk-sharing schemes 30
Pricing and reimbursement in Spain 30
Internal reference pricing system 32
Pricing and reimbursement in the UK 32
PPRS 33
NICE 33
Chapter 2 Impact of policy developments on market access 37
Summary 37
Introduction 38
US healthcare reform 39
CMS review of Provenge 41
Comparative effectiveness research institute 42
Moves to improve drug lag in Japan 42
Latest developments in France 43
Economic assessments 44
Germany's pharmaceutical reforms 44
Growing use of risk-share agreements in Italy 46
Spain's regional authorities assessing cost-effectiveness 48
UK initiatives to improve access to new medicines 49
Updated TA process 49
Innovation support 50
Innovation Pass 50
New patient access pathway 50
Flexible pricing 52
Pre-licensing access scheme 52
Cancer Drugs Fund 53
Outlook for market access 53
Chapter 3 Evolution of market access schemes 54
Summary 54
Introduction 55
An international perspective 55
Australian risk-share schemes 56
Canadian listing agreements 57
Access with evidence development 58
Definitions of types of agreements 59
Definition of risk sharing 60
Case studies 63
MS risk-sharing agreement: UK 63
Velcade response scheme: UK 64
Xolair rebate scheme: UK 65
Coverage with evidence 65
Risperdal Consta: France 66
Cronos scheme: Italy 66
Actonel: US 67
Aclasta rebates: Germany/Italy 67
Diabetes drugs: US 68
Lucentis cost caps: UK/Germany 68
Sutent cost share: UK 69
Renal cancer 69
Stomach cancer 70
Stelara cost cap: UK 70
Cimzia cost share: UK 71
Avastin patient assistance: US 73
Chapter 4 Pros & cons of market access schemes 74
Summary 74
Introduction 75
Performance/outcomes-based schemes 76
Summary of pros & cons of performance/outcomes-based schemes 79
Pros 79
Cons 79
Finance-based schemes 80
Summary of pros & cons of finance-based schemes 81
Pros 81
Cons 81
Acceptance of schemes by payors 82
PAS for Avastin in metastatic colorectal cancer 82
Factors influencing PAS acceptance 84
Uptake of schemes by providers 84
Administration issues 87
Claiming for rebates 87
Transparency 88
Summary of conclusions 89
Chapter 5 The role of HTA in decision-making 90
Summary 90
Introduction 91
HTA trends 91
NICE 91
IQWiG 93
HAS 95
Towards centralized value assessment in Europe 95
US lags behind Europe 97
HTA and market access implications 99
Chapter 6 Future market access challenges and opportunities 100
Summary 100
Introduction 100
Future prospects for market access schemes 101
Specialty drugs and personalized medicine 103
International pricing implications 104
Preparation 105
Appendix 106
Primary research methodology 106
Glossary 107
Table of figures
Figure 1: Trends in pharmaceutical spending as % of total healthcare expenditure, 2004–08 15
Figure 2: P&R process in Japan 20
Figure 3: Role of IQWiG in pharmaceutical clinical and economic assessments 27
Figure 4: Algorithm for determining therapeutic innovation in Italy 29
Figure 5: Classification and number of NICE decisions 35
Figure 6: Trends in US health insurance cover (%), 2010–19 40
Figure 7: Proposed pathway for patient access schemes 52
Figure 8: Different types of market access schemes 61
Figure 9: Balancing payors' demands with need to gain market access 75
Figure 10: % Uptake of cancer drug access schemes in the NHS 86
Table of Tables
Table 1: Breakdown of US pharmaceutical spending by source ($m), 2008 17
Table 2: Price premium categories in Japan 22
Table 3: ASMR I-IV levels granted by HAS, 2007-2009 24
Table 4: Overall international rankings of drug usage 39
Table 5: Cancer drugs in risk-sharing agreements in Italy, 2006-2009 47
Table 6: Patient access schemes approved as part of NICE appraisal 51
Table 7: Examples of market access schemes 62
Table 8: Avastin cost for metastatic colorectal cancer in NHS with PAS 83
Table 9: UK survey of opinions on future management of PAS 102
