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

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

  • ID: 2396864
  • February 2013
  • Region: Global
  • 94 Pages
  • JustPharmaReports

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 READ MORE >

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List of Report Contents

Executive Summary

1. What are Risk-Sharing Agreements?

Dealing with uncertainty
Categorisation
Performance-based schemes
Finance-based schemes
Managed entry agreements
Industry wish list

2. Europe

Belgium
Czech Republic
Denmark
France
ATUs
Price-volume agreements
Performance-based agreements
Requests by Transparency Commission
Requests by CEPS
Germany
Non-tender discount agreements
Cost-capping agreements
Compliance agreements
Performance-based agreements
AMNOG discount negotiations
Hungary
Types of agreement
Case study: tyrosine kinase inhibitors in CML
Italy
Types of agreement
Examples
Scheme monitoring
Case study: Rasilez
Concerns
Savings
Other managed entry agreements
Lithuania
Netherlands
Intramural care
Extramural care
Norway
Poland
Portugal
Price-volume agreements
Coverage with evidence development agreements
Serbia
Slovenia
Spain
Sweden
Case studies
Duodopa
Acomplia
Risperdal Consta
Role of county councils
Switzerland
United Kingdom
Multiple sclerosis scheme
Principle and design of a patient access scheme
Results of patient access schemes
England
Scotland
Wales
Case studies
Velcade
Lucentis
Issues arising from national patient access schemes
Local patient access schemes
Prospects
EU managed entry agreements project

3. North America

Canada
Industry initiatives
Provincial product listing agreements
United States
Pay for performance
Cost capping
Coverage with evidence development
Patient assistance programmes

4. Asia-Pacific

Australia
Case study: Enbrel
Other early examples
Case study: Tracleer
Process and design of Deeds of Agreement
Managed entry schemes
Current situation
Japan
Korea
New Zealand

5. Pros and Cons of Risk Sharing

Advantages
For manufacturers
For providers
For payers
For patients/society
Concerns
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

List of Tables

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

List of Figures

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

References
Glossary of Acronyms and Abbreviations

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Donald Macarthur

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Note: Product cover images may vary from those shown

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