Reportlinker Adds New Approaches to Gaining Market Access for Pharmaceuticals: Pricing & Reimbursement, Policy Development, and the Role of HTAs

Oct 19, 2010, 13:24 ET from Reportlinker

NEW YORK, Oct. 19 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

New Approaches to Gaining Market Access for Pharmaceuticals: Pricing & Reimbursement, Policy Development, and the Role of HTAs

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.


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?

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



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


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

To order this report:

Pharmaceutical Industry: New Approaches to Gaining Market Access for Pharmaceuticals: Pricing & Reimbursement, Policy Development, and the Role of HTAs

Pharmaceutical Business News

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

Nicolas Bombourg



US: (805)652-2626

Intl: +1 805-652-2626

SOURCE Reportlinker