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New Approaches to Gaining Market Access for Pharmaceuticals: Pricing & Reimbursement, Policy Development, and the Role of HTAs
Business Insights, Oct 2010, Pages: 110
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?
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