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

Date: October 22, 2010
Pages: 110
Price:
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: NFC24687737EN
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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.

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?
Table of Contents
About the author
Disclaimer
The pharmaceutical P&R landscape
Impact of policy developments on market access
Evolution of market access schemes
Pros & cons of market access schemes
The role of HTA in decision-making
Future market access challenges and opportunities

CHAPTER 1 THE PHARMACEUTICAL P&R LANDSCAPE

Summary
Introduction
Pricing and reimbursement in the US
Coverage decisions
Pricing and reimbursement in Japan
Pricing and reimbursement in France
Pricing and reimbursement in Germany
IQWiG
Pricing and reimbursement in Italy
Risk-sharing schemes
Pricing and reimbursement in Spain
Internal reference pricing system
Pricing and reimbursement in the UK
PPRS
NICE

CHAPTER 2 IMPACT OF POLICY DEVELOPMENTS ON MARKET ACCESS

Summary
Introduction
US healthcare reform
CMS review of Provenge
Comparative effectiveness research institute
Moves to improve drug lag in Japan
Latest developments in France
Economic assessments
Germany's pharmaceutical reforms
Growing use of risk-share agreements in Italy
Spain's regional authorities assessing cost-effectiveness
UK initiatives to improve access to new medicines
Updated TA process
Innovation support
Innovation Pass
New patient access pathway
Flexible pricing
Pre-licensing access scheme
Cancer Drugs Fund
Outlook for market access

CHAPTER 3 EVOLUTION OF MARKET ACCESS SCHEMES

Summary
Introduction
An international perspective
Australian risk-share schemes
Canadian listing agreements
Access with evidence development
Definitions of types of agreements
Definition of risk sharing
Case studies
MS risk-sharing agreement: UK
Velcade response scheme: UK
Xolair rebate scheme: UK
Coverage with evidence
Risperdal Consta: France
Cronos scheme: Italy
Actonel: US
Aclasta rebates: Germany/Italy
Diabetes drugs: US
Lucentis cost caps: UK/Germany
Sutent cost share: UK
Renal cancer
Stomach cancer
Stelara cost cap: UK
Cimzia cost share: UK
Avastin patient assistance: US

CHAPTER 4 PROS & CONS OF MARKET ACCESS SCHEMES 74

Summary
Introduction
Performance/outcomes-based schemes
Summary of pros & cons of performance/outcomes-based schemes
Pros
Cons
Finance-based schemes
Summary of pros & cons of finance-based schemes
Pros
Cons
Acceptance of schemes by payors
PAS for Avastin in metastatic colorectal cancer
Factors influencing PAS acceptance
Uptake of schemes by providers
Administration issues
Claiming for rebates
Transparency
Summary of conclusions

CHAPTER 5 THE ROLE OF HTA IN DECISION-MAKING 90

Summary
Introduction
HTA trends
NICE
IQWiG
HAS
Towards centralized value assessment in Europe
US lags behind Europe
HTA and market access implications

CHAPTER 6 FUTURE MARKET ACCESS CHALLENGES AND OPPORTUNITIES 100

Summary
Introduction
Future prospects for market access schemes
Specialty drugs and personalized medicine
International pricing implications
Preparation
Appendix
Primary research methodology
Glossary

TABLE OF FIGURES

Figure 1: Trends in pharmaceutical spending as % of total healthcare expenditure, 2004–08
Figure 2: P&R process in Japan
Figure 3: Role of IQWiG in pharmaceutical clinical and economic assessments
Figure 4: Algorithm for determining therapeutic innovation in Italy
Figure 5: Classification and number of NICE decisions
Figure 6: Trends in US health insurance cover (%), 2010–19
Figure 7: Proposed pathway for patient access schemes
Figure 8: Different types of market access schemes
Figure 9: Balancing payors' demands with need to gain market access
Figure 10: % Uptake of cancer drug access schemes in the NHS

TABLE OF TABLES

Table 1: Breakdown of US pharmaceutical spending by source ($m), 2008
Table 2: Price premium categories in Japan
Table 3: ASMR I-IV levels granted by HAS, 2007-2009
Table 4: Overall international rankings of drug usage
Table 5: Cancer drugs in risk-sharing agreements in Italy, 2006-2009
Table 6: Patient access schemes approved as part of NICE appraisal
Table 7: Examples of market access schemes
Table 8: Avastin cost for metastatic colorectal cancer in NHS with PAS
Table 9: UK survey of opinions on future management of PAS
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New Approaches to Gaining Market Access for Pharmaceuticals: Pricing & Reimbursement, Policy Development, and the Role of HTAs
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