藥品創新價値：針對創新治療的藥價制定及償付

Abstract

Developing, manufacturing and marketing innovative new pharmaceutical drugs is highly complex and involves significant investment. Establishing an acceptable return on investment requires generating sufficient sales revenues which in turn requires maximizing market access at the highest possible price.

Table of Contents

Executive Summary

• Introduction
• Categorizing and valuing innovation
• Region and therapy area specific considerations
• Pricing challenges for recently launched innovative therapies
• Upcoming launches of new innovative therapies

Chapter 1 Introduction

• Summary
• Introduction
• Supply-side factors
• Complexity and costs
• Market size
• Competition
• Demand-side factors
• Budget
• Unmet need
• Competition
• Valuing innovation

Chapter 2 Categorizing and valuing innovation

• Summary
• Introduction
• Categories of innovations
• New market innovations
• Redefining the category innovations
• Second generation innovations
• Incremental therapeutic innovations
• Incremental formulation innovations
• Innovative market access strategies
• Orphan drugs
• Risk-sharing

Chapter 3 Region and therapy area specific considerations

• Summary
• Introduction
• Approaches to market access in major markets
• USA
• Japan
• France
• Germany
• Italy
• Spain
• UK
• Therapy area markets for innovative therapies
• Oncology
• HIV
• Autoimmune diseases
• Diabetes
• Others

Chapter 4 Pricing challenges of recently launched innovative therapies

• Summary
• Introduction
• New market innovations
• Gardasil (human papilloma virus vaccine): changing the treatment algorithm
• Lysosomal storage diseases: pricing versus patient weight
• Redefining the category innovations
• Chantix (varenicline): redefining a therapeutic category
• Nexavar (sorafenib) versus Sutent (sunitinib): meeting an unmet need
• Second generation innovations
• Lyrica (pregabalin): a new, improved neuropathic pain drug
• Macugen vs Lucentis vs Avastin : premium pricing against off-label use
• Incremental therapeutic innovations
• Byetta vs Januvia: changing the treatment paradigm for type 2 diabetes
• Prezista vs Fuzeon: premium pricing in HIV/AIDS
• Incremental formulation innovations
• Abraxane (paclitaxel): pricing incremental convenience
• Vivitrol: market access vs premium pricing

Chapter 5 Upcoming launches of new innovative therapies

• Summary
• Introduction
• New market innovations
• Lupuzor (IPP-201101) - ImmuPharma
• Sinunase - Accentia
• Redefining the category innovations
• Bapineuzumab - Elan/Wyeth
• Multikine - CelSci
• Second generation innovations
• Arzoxifene - Eli Lilly
• Cordaptive (niacin ER/laropiprant) - Merck
• Incremental therapeutic innovations
• Naproxcinod - NicOx
• RhuDex - MediGene
• Incremental formulation innovations
• Denosumab - Amgen
• Xarelto (rivaroxaban) - Bayer/J&J
• Chapter 6 Appendix
• Research sources
• Pricing data

List of Figures

• Figure 1.1: Supply and demand factors impacting market access for innovative therapies
• Figure 2.2: Innovative drug categories by level of innovation and ease of market access
• Figure 3.3: Source of prescription drug expenditures in the US, 2005-2006
• Figure 3.4: Italian categorization for innovative new therapies
• Figure 4.5: Gardasil global sales, 2006-07 ($m)
• Figure 4.6: Selected lysosomal storage disease drugs global sales, 2006-07
• Figure 4.7: Selected lysosomal storage disease drugs pricing in the UK and US, 2008
• Figure 4.8: Smoking cessation drugs global sales, 2006-07
• Figure 4.9: Smoking cessation drugs pricing in the UK and US, 2008
• Figure 4.10: Nexavar and Sutent global sales, 2006-07
• Figure 4.11: Nexavar and Sutent pricing in the UK and US, 2008
• Figure 4.12: Selected neuropathic pain drugs global sales, 2006-07
• Figure 4.13: Selected neuropathic pain drugs pricing in the UK and US, 2008
• Figure 4.14: Age-related macular degeneration drugs global sales, 2006-07
• Figure 4.15: Age-related macular degeneration drugs pricing in the UK and US, 2008
• Figure 4.16: Selected type 2 diabetes drugs global sales, 2006-07
• Figure 4.17: Selected type 2 diabetes drugs pricing in the UK and US, 2008
• Figure 4.18: Selected HIV/AIDS drugs global sales, 2006-07
• Figure 4.19: Selected HIV/AIDS drugs pricing in the UK and US, 2008
• Figure 4.20: Taxane drugs global sales, 2006-07
• Figure 4.21: Taxane drugs pricing in the US, 2008
• Figure 4.22: Alcohol dependency drugs global sales, 2006-07
• Figure 4.23: Alcohol dependency drugs pricing in the US, 2008

List of Tables

• Table 3.1: Classification for price premium (Japanese healthcare system)
• Table 4.2: Gardasil pricing in the UK and US, 2008
• Table 4.3: Selected lysosomal storage disease drugs pricing in the UK and US, 2008
• Table 4.4: Smoking cessation drugs pricing in the UK and US, 2008
• Table 4.5: Nexavar and Sutent pricing in the UK and US, 2008
• Table 4.6: Selected neuropathic pain drugs pricing in the UK and US, 2008
• Table 4.7: Age-related macular degeneration drugs pricing in the UK and US, 2008
• Table 4.8: Selected type 2 diabetes drugs pricing in the UK and US, 2008
• Table 4.9: Selected HIV/AIDS drugs pricing in the UK and US, 2008
• Table 4.10: Taxane drugs pricing in the UK and US, 2008
• Table 4.11: Alcohol dependency drugs pricing in the UK and US, 2008
• Table 5.12: Selected innovative therapies currently in late stage development
• Table 6.13: Key UK and US pricing data for leading case studies, 2008
• Table 6.13: Key UK and US pricing data for leading case studies, 2008 (continued)