New Approaches to Gaining Market Access for Pharmaceuticals

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1 HEALTHCARE New Approaches to Gaining Market Access for Pharmaceuticals Pricing & Reimbursement, Policy Development, and the Role of HTAs by Jeanette Marchant

2 About the author Jeanette Marchant provides consultancy services to market intelligence organizations, specialist healthcare publishers and healthcare companies. She has 30 years experience in writing on international healthcare business, including 19 years at PJB Publications Ltd. She is the author of numerous market reports for the pharmaceutical, diagnostic and medical technology industries. Disclaimer Copyright 2010 Business Insights Ltd This report is published by Business Insights (the Publisher). This report contains information from reputable sources and although reasonable efforts have been made to publish accurate information, you assume sole responsibility for the selection, suitability and use of this report and acknowledge that the Publisher makes no warranties (either express or implied) as to, nor accepts liability for, the accuracy or fitness for a particular purpose of the information or advice contained herein. The Publisher wishes to make it clear that any views or opinions expressed in this report by individual authors or contributors are their personal views and opinions and do not necessarily reflect the views/opinions of the Publisher. 2

3 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 3

4 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 4

5 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 5

6 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 6

7 Table of figures Figure 1: Trends in pharmaceutical spending as % of total healthcare expenditure, 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 (%), 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), Table 2: Price premium categories in Japan 22 Table 3: ASMR I-IV levels granted by HAS, Table 4: Overall international rankings of drug usage 39 Table 5: Cancer drugs in risk-sharing agreements in Italy, 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 7

The Private Health Insurance Market in Europe

For a clearer market perspective The Private Health Insurance Market in Europe Future trends, emerging opportunities and key players Report Price Publication date 1995/ 2885/$3835 April 2010 H E A L T