- Published: December 2011
- Region: Europe
Valuing Pharmaceutical Innovation: Pricing and Reimbursement for Innovative Therapies
- Published: August 2008
- Region: Global
- 121 Pages
- Scripp Business Insights
Developing, manufacturing and marketing innovative new pharmaceutical drugs is highly complex and involves significant investment. Market access must be maximized at the highest possible price to generate sufficient sales revenue an acceptable return on investment. However, limited payor budgets and increased competition from other therapies has increased downward pressure on drug prices across the pharma industry. Pricing strategies must be based upon potential market access, particularly in cases where a restricted market opportunity must repay significant investment.
‘Valuing Pharmaceutical Innovation: Pricing and reimbursement for innovative therapies’ is a new report published that explores the latest issues and developments surrounding innovative therapy reimbursement. The main supply and demand side factors influencing pricing, market access and reimbursement decisions across a number of major markets are closely examined and the key trends and economic requirements of major therapeutic categories are assessed.
This report also identifies the most successful pricing and market access strategies across each category of innovation with a detailed case study analysis of the pricing challenges encountered by both recently launched innovative therapies and those in late stage development. Use this report’s case study analysis to benchmark the pricing strategies of leading innovative products and evaluate the drug reimbursement environments of major markets and therapeutic categories...
Some key findings from this report...
-Market access and pricing strategies for innovative drugs are more challenging than ever. Although the US government has no direct control over pharma pricing, large agencies such as the Veteran’s Adminisration have a significant indirect influence.
-Japan and Germany have the most generous government-led reimbursement systems. The UK system follows stricter criteria while France and Italy provide 100% reimbursement for patients with chronic conditions and partial or no reimbursement for less habitual afflictions.
-Innovative risk-sharing agreements have emerged as tools to provide market access for a range of premium-priced innovative drugs with significant, but largely unproven clinical potential.
-Ensuring full market access for new market innovations will become more difficult without reference prices and established treatment protocols. However, late-stage clinical trial design can help to build market access strategies earlier in the development lifecycle.
-Payors require significant evidence of beneficial clinical and economic outcomes for truly innovative products, including cost effectiveness and budget impact models.
Top five reasons to order your copy today
-Position your upcoming products for quick access to key markets by comparing the regulatory mechanisms influencing reimbursement decisions across countries including Japan, France, Germany, Italy, Spain, the US and the UK.
-Understand the latest challenges and issues facing various categories of innovation including ‘new market’, ‘redefining the category’, ‘second-generation’, ‘incremental therapeutic’ and ‘incremental formulation’ innovations.
-Assess the innovative drug reimbursement environments of major therapeutic areas by identifying the current trends, unmet medical need and economic requirements of a range of disease categories including oncology, HIV, autoimmune diseases and diabetes.
-Leverage innovative new market access programs to protect prices for novel therapies in cost constrained reimbursement settings.
-Benchmark the reimbursement strategies of leading products by using detailed case studies of recently launched and upcoming innovative therapies across each type of innovative category.
Key issues examined in this report...
-Economic/medical trade-off. Healthcare payors are carefully prioritizing drugs for reimbursement based on their potential value to patient populations and their associated budgetary constraints.
-Incumbent treatment options. Therapies currently on the market will set the benchmark for premium-priced new and innovative drugs. Major brands must aim to convey this comparative value with quality of life adjusted years (QALY) and cost of treatment assessments.
-Non-prescription availability. Alli’s switch from Rx to OTC usage in 2007 reinvigorated the US market for obesity treatments. GlaxoSmithKline is currently pursuing a similar switch in Europe with approval expected during 2009 at the latest.
-Innovative therapy competition. The combination of high unmet need and technological feasibility within certain therapy areas has resulted in innovative therapies competing against each other at high prices. The technological complexity associated with new oncology and autoimmune treatments has caused significant price premiums over more established therapies.
Your questions answered...
-What are the key regulatory hurdles impacting on the pricing and reimbursement of innovative drugs in the major markets?
-How do cost-effectiveness and budget impact models help support pricing and reimbursement submissions for innovative new drugs?
-What innovative market access strategies are available to bring high-priced innovative therapies to market?
-How do high-priced innovative drugs affect the market dynamics of key therapeutic categories?
-To what extent do pricing and reimbursement strategies differ for different levels of innovation offered by novel therapies?
-What are the critical success factors in optimizing returns from innovative new drugs? SHOW LESS READ MORE >
Valuing pharmaceutical innovation
Executive Summary 8
Categorizing and valuing innovation 9
Region and therapy area specific considerations 10
Pricing challenges for recently launched innovative therapies 11
Upcoming launches of new innovative therapies 12
Chapter 1 Introduction 14
Supply-side factors 17
Complexity and costs 17
Market size 17
Demand-side factors 19
Unmet need 19
Valuing innovation 20
Chapter 2 Categorizing and valuing innovation 24
Categories of innovations 25
New market innovations 27
Redefining the category innovations 27
Second generation innovations 28
Incremental therapeutic innovations 29
Incremental formulation innovations 29
Innovative market access strategies 30
Orphan drugs 30
Chapter 3 Region and therapy area specific considerations 40
Approaches to market access in major markets 41
Therapy area markets for innovative therapies 62
Autoimmune diseases 64
Chapter 4 Pricing challenges of recently launched innovative therapies 70
New market innovations 71
Gardasil (human papilloma virus vaccine): changing the treatment algorithm 71
Lysosomal storage diseases: pricing versus patient weight 73
Redefining the category innovations 77
Chantix (varenicline): redefining a therapeutic category 77
Nexavar (sorafenib) versus Sutent (sunitinib): meeting an unmet need 80
Second generation innovations 82
Lyrica (pregabalin): a new, improved neuropathic pain drug 83
Macugen vs Lucentis vs Avastin : premium pricing against off-label use 86
Incremental therapeutic innovations 90
Byetta vs Januvia: changing the treatment paradigm for type 2 diabetes 90
Prezista vs Fuzeon: premium pricing in HIV/AIDS 93
Incremental formulation innovations 96
Abraxane (paclitaxel): pricing incremental convenience 96
Vivitrol: market access vs premium pricing 99
Chapter 5 Upcoming launches of new innovative therapies 104
New market innovations 106
Lupuzor (IPP-201101) – ImmuPharma 106
Sinunase – Accentia 107
Redefining the category innovations 108
Bapineuzumab – Elan/Wyeth 108
Multikine – CelSci 109
Second generation innovations 111
Arzoxifene – Eli Lilly 111
Cordaptive (niacin ER/laropiprant) – Merck 112
Incremental therapeutic innovations 113
Naproxcinod – NicOx 113
RhuDex – MediGene 114
Incremental formulation innovations 115
Denosumab – Amgen 115
Xarelto (rivaroxaban) – Bayer/J&J 116
Chapter 6 Appendix 119
Research sources 119
Pricing data 120
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 46
Figure 3.4: Italian categorization for innovative new therapies 55
Figure 4.5: Gardasil global sales, 2006-07 ($m) 72
Figure 4.6: Selected lysosomal storage disease drugs global sales, 2006-07 74
Figure 4.7: Selected lysosomal storage disease drugs pricing in the UK and US, 2008 75
Figure 4.8: Smoking cessation drugs global sales, 2006-07 78
Figure 4.9: Smoking cessation drugs pricing in the UK and US, 2008 79
Figure 4.10: Nexavar and Sutent global sales, 2006-07 80
Figure 4.11: Nexavar and Sutent pricing in the UK and US, 2008 81
Figure 4.12: Selected neuropathic pain drugs global sales, 2006-07 83
Figure 4.13: Selected neuropathic pain drugs pricing in the UK and US, 2008 84
Figure 4.14: Age-related macular degeneration drugs global sales, 2006-07 87
Figure 4.15: Age-related macular degeneration drugs pricing in the UK and US, 2008 88
Figure 4.16: Selected type 2 diabetes drugs global sales, 2006-07 91
Figure 4.17: Selected type 2 diabetes drugs pricing in the UK and US, 2008 92
Figure 4.18: Selected HIV/AIDS drugs global sales, 2006-07 93
Figure 4.19: Selected HIV/AIDS drugs pricing in the UK and US, 2008 95
Figure 4.20: Taxane drugs global sales, 2006-07 97
Figure 4.21: Taxane drugs pricing in the US, 2008 98
Figure 4.22: Alcohol dependency drugs global sales, 2006-07 99
Figure 4.23: Alcohol dependency drugs pricing in the US, 2008 100
List of Tables
Table 3.1: Classification for price premium (Japanese healthcare system) 48
Table 4.2: Gardasil pricing in the UK and US, 2008 72
Table 4.3: Selected lysosomal storage disease drugs pricing in the UK and US, 2008 75
Table 4.4: Smoking cessation drugs pricing in the UK and US, 2008 79
Table 4.5: Nexavar and Sutent pricing in the UK and US, 2008 81
Table 4.6: Selected neuropathic pain drugs pricing in the UK and US, 2008 85
Table 4.7: Age-related macular degeneration drugs pricing in the UK and US, 2008 88
Table 4.8: Selected type 2 diabetes drugs pricing in the UK and US, 2008 91
Table 4.9: Selected HIV/AIDS drugs pricing in the UK and US, 2008 94
Table 4.10: Taxane drugs pricing in the UK and US, 2008 97
Table 4.11: Alcohol dependency drugs pricing in the UK and US, 2008 100
Table 5.12: Selected innovative therapies currently in late stage development 105
Table 6.13: Key UK and US pricing data for leading case studies, 2008 120
Table 6.13: Key UK and US pricing data for leading case studies, 2008 (continued) 121