1. Payer Agreements: Splitting the Risk
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Budgets are tight. Payer funding for new products is
dwindling. And for pharmaceutical companies, market
access is more and more difficult to attain. Across the UK,
the US, Canada, Australia and parts of Europe, payer
schemes are increasingly de rigueur. Schemes advanced
by pharmaceutical companies either aim to grapple
financial issues such as price volume agreements, or they
tackle uncertainty by addressing increased data collection.
Report Overview In Payer Agreements: Splitting the Risk,
FirstWord Dossier offers a complete and concise
overview of payer schemes by definition and category.
Based on an array of expert interviews, the report
discusses the key drivers behind the evolution of payer
schemes from financial imperatives to market uncertainty.
Most importantly, the report defines—country by
country—emerging trends based on current case studies
and tackles the big question: What are the key features
that will ensure success? Key features Detailed
examination of the role of agreements in global pricing,
reimbursement and market access Discussion of the
drivers for schemes, including HTA and financial
challenges Country-by-country trends illustrated with case
studies Expert insight into the role of schemes and their
evolution Analysis of the pros and cons of agreements
Key Benefits Definitions and categories of schemes
Expert insight from key regulatory bodies Comprehensive
references to key literature Key Questions Asked What
principles should be used in designing schemes? When
should companies offer risk-sharing agreements? How
can European risk-sharing be implemented in the US?
What is the current state of play with schemes globally
What changes are likely in the future? Who Should Read
This Report Market access directors and managers Health
economics professionals Health economics professionals
Health Outcomes / Outcomes Research professionals
Pricing and Reimbursement teams Government and
regulatory affairs analysts Marketing research/business
intelligence managers Government and regulatory affairs
analysts Key quotes ―The current international
pharmaceutical pricing framework is far too rigid.
Manufacturers willing to openly differentiate the price for
a given product in line with the different ability of various

2. payers to afford a product will be punished by the
consequences of international price referencing. At the
same time, price systems are barely capable of
differentiating the price for a single product that is used in
multiple indications according to its different value
propositions.‖ – Ansgar Hebborn, Global Head, Payer and
HTA Programme Policy, Roche ―Imagine in a time where
those schemes could be really connected to one server.
Like right at the patient's bed people would enter the data
and so you would constantly be able to adjust and see
performance and see small performance even in changes
of dosing or changes or things. I know it's very difficult
but I think eventually we might get there.‖ – Ulf
Staginnus, Head of Pricing & Health Economics Europe,
Novartis and author of www.healtheconomicsblog.com
―There is a lot of difference in the governance across
Europe, which ultimately leads to quality of HTA. An
important aspect is of course the independence of the
assessment from the appraisal and ultimately the decision
on a certain price. That's very, very different country by
country and region by region.‖ – Ansgar Hebborn, Global
Head, Payer and HTA Programme Policy, Roche Expert
Views Alicia Granados: MD. Senior Director Global HTA
Strategy, GMA Genzyme Andrea Rappagliosi: Vice
President European Government Affairs & Head of
Brussels Office, GlaxoSmithKline Andrew Hobbs:
Managing Director, Pope Woodhead and Associates
Limited Ansgar Hebborn: Global Head, Payer and HTA
Programme Policy, Roche Clare McGrath: Senior
Director HTA Policy, Pfizer David Grainger: Global
Public Policy Director, Lilly Günter Harms: Market
Access & Public Affairs Director, Shire Human Genetic
Therapies Kalipso Chalkidou: Director of International
Division, National Institute for Health and Clinical
Excellence Karen Facey: Evidence based health policy
consultant and non-executive Director at NHS Forth
Valley, and Chair of the HTAi Interest Group for
Patient/Citizen Involvement in HTA Larry Gorkin:
President, Gorkin and Cheddar Consulting Mel Walker:
Senior Director Value Expert Engagement &
Collaborations, GlaxoSmithKline Robert Nauman:
Principal, BioPharma Advisors Ulf Staginnus: Head of
Pricing & Health Economics Europe, Novartis and author
of www.healtheconomicsblog.com
Table of Contents :

3. Executive summary
Current agreements with payers across Australia, Europe, Canada and the US
Introduction
Defining and categorizing schemes
Definitions from the literature
UK definition and categorization
Drivers for schemes
Financial challenges
HTA and saying no
Dealing with uncertainty
Country trends in schemes and selected case studies
Australia
Bosentan patient registry
Canada
Clozaril money-back guarantee
Denmark
No cure, no pay for Diovan
France
Risperdal refund
Germany
Aclasta refund scheme
Italy
Tarceva discount scheme
Sutent discount scheme
Serbia
Avastin, Erbitux and MabCampath rebate schemes
Sweden
Crestor and ezetimibe coverage with evidence development
UK
Multiple Sclerosis Risk Sharing Scheme
Velcade money back guarantee
Lucentis dose capping scheme
US
Proscar refund scheme
Zocor refund scheme
Januvia guarantee scheme
Sanofi and Proctor & Gamble pay for fractures scheme
Potentials and pitfalls of agreements
Fit with pricing and reimbursement environments
Pros and cons
Reality check
Conclusions
Too early to say
Maybe necessary, but not sufficient

4. Exploring uncertainty, not discounting in the future
Acknowledgements
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