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Risk Sharing and Other Forms of Managed Entry Agreements for Medicines, Worldwide

Published: Feb 2013 | No Of Pages: 94 | Published By: JustPharmaReports.com
Managed entry agreements apply to an increasing number of new, innovative drugs in a growing number of markets. They are designed to share the risk between the manufacturer and the payer, consequent on uncertainties - usually at launch - about the product’s value (clinical- and cost-effectiveness), budget impact and/or utilisation to optimise performance, whilst at the same time allowing patient access. For many products considered costly they are almost essential to achieve reimbursement where health technology assessment is applied.
Risk Sharing and Other Forms of Managed Entry Agreements for Medicines, Worldwide covers all the main types of agreements (finance-based, outcome- or performance-based, and compliance-based) and their many variants in all countries that employ them. The confusing taxonomy associated with the topic (e.g. price/volume deals, budget impact schemes, cost capping, cost sharing, coverage with evidence development, money back guarantees, conditional reimbursement, listing agreements, payment for performance, payment by results) is clearly explained. 
Find out from a manufacturer’s perspective:
  • Which party should first propose an agreement and at what stage?
  • What types of agreements are possible and where?
  • Which therapeutic classes are most affected?
  • Can an agreement accepted in one country be rolled out to another?
  • Is standardisation of design likely?
  • How is monitoring conducted?
  • What types of outcome are measurable in performance-based schemes?
  • How much confidentiality surrounds finance-based deals?
  • What are the benefits of risk sharing, what are the concerns?
  • How much do schemes burden the health service?
  • Have past agreements delivered on expectations?
  • Is more of the same the way forward?
Focussing on markets with the most experience of risk sharing – Australia, Belgium, Canada, France, Italy, Portugal, Sweden and the UK – the report in total covers 24 countries across Europe, North America and Asia-Pacific. Deals where the payer is an insurer/health system at the national or local level, or an individual patient are included. Numerous brand name examples are cited by country/agreement type with 12 case studies in more detail.
Executive Summary

1. What are Risk-Sharing Agreements?
Dealing with uncertainty
Performance-based schemes
Finance-based schemes
Managed entry agreements
Industry wish list
2. Europe
Czech Republic
Price-volume agreements
Performance-based agreements
Requests by Transparency Commission
Requests by CEPS
Non-tender discount agreements
Cost-capping agreements
Compliance agreements
Performance-based agreements
AMNOG discount negotiations
Types of agreement
Case study: tyrosine kinase inhibitors in CML
Types of agreement
Scheme monitoring
Case study: Rasilez
Other managed entry agreements
Intramural care
Extramural care
Price-volume agreements
Coverage with evidence development agreements
Case studies
Risperdal Consta
Role of county councils
United Kingdom
Multiple sclerosis scheme
Principle and design of a patient access scheme
Results of patient access schemes
Case studies
Issues arising from national patient access schemes
Local patient access schemes
EU managed entry agreements project
3. North America
Industry initiatives
Provincial product listing agreements
United States
Pay for performance
Cost capping
Coverage with evidence development
Patient assistance programmes
4. Asia-Pacific
Case study: Enbrel
Other early examples
Case study: Tracleer
Process and design of Deeds of Agreement
Managed entry schemes
Current situation
New Zealand
5. Pros and Cons of Risk Sharing
For manufacturers
For providers
For payers
For patients/society
For manufacturers
For providers
For payers
For patients/society
Performance-based vs finance-based schemes
6. Conclusions
Main topics to consider
What results has risk sharing achieved?
Does it add a bureaucratic burden?
Can one scheme be applied in several countries?
Will deals remain confidential?
Strategic implications
Forms of managed entry agreements
Oncology products reimbursed in Italy under risk sharing schemes
Italy’s national oncology drug patient register
Savings from risk sharing in Italian region of Veneto
Examples of early risk-sharing schemes in UK
Positive NICE guidance after patient access schemes
Negative NICE guidance despite patient access schemes
Positive SMC guidance after patient access schemes
Average time to process a patient access scheme
Features of product listing agreements in Canada by province.
Performance-based schemes in US
Examples of Australian special pricing arrangements
Section 100 medicines subject to special pricing arrangements in Australia
Potential advantages and disadvantages of coverage with evidence development schemes
Cost sharing procedure in Italy
Risk sharing procedure in Italy
Payment by results procedure in Italy
Patient access scheme procedure in England
PAS-LU process in England
Glossary of Acronyms and Abbreviations
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