IHS ECONOMICS & COUNTRY RISK
25 FEBRUARY 2015
RISK SHARING AGREEMENTS:
LESSONS FROM THE GLOBAL
EXPERIENCE
Milena Izmirlieva
Senior Manager, Life Sciences Research
+44 203 159 3378
[email protected]
© 2015 IHS
RISK SHARING / FEBRUARY 2015
Contents
‫‏‬What is risk sharing?
‫‏‬Types of risk sharing deals
‫‏‬Evolution of risk sharing
‫ ‏‬ountry preference for Payer
C
Partnerships by type
‫‏‬Game-changers for risk sharing
The future of risk sharing
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RISK SHARING / FEBRUARY 2015
What is risksharing?
• In theory, risk sharing is simply an
agreement to share the risks associated
with the introduction of a new product to
the market?
• In reality, risk sharing means different
things to payers and to pharmaceutical
companies.
• For payers: A way to share the costs.
• For pharmaceutical companies: A way to
secure market access in difficult
circumstances.
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Brief history of
risk sharing
• The first RS agreement, recorded by
IHS,‫‏‬was‫‏‬in‫‏‬2002‫‏‬and‫‏‬was‫‏‬for‫‏‬Bayer’s‫‏‬
MS drug Betaferon in the UK.
• RS are known under different names:
Patient Access Schemes (PAS) in the
UK; cost sharing agreements in some
other markets
• There are several types of risk sharing
deals, with discount-based schemes
becoming increasingly dominant.
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Growth in number of proposed risk sharing agreements
Proposed Risk Shares per Year
50
45
43
40
35
34
30
29
25
28
24
24
20
17
15
14
10
5
6
0
2005
2006
2007
2008
2009
2010
2011
2012
2013
Source: IHS Life Sciences Risk Sharing Database
(excluding 2007-08 New Zealand agreements)
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Types of risk
sharing deals
• There are several types of risk sharing
deals, with discount-based schemes
becoming increasingly dominant.
• The most popular types are financebased schemes and finance-based
discounts schemes.
• More than 15 different types of risksharing schemes are tracked regularly in
the IHS Risk Sharing database.
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Risk Sharing Deals by Class
Proposed Risk Sharing Deals by Broad Class (2002-2014)
Finance-based: discounted
scheme
Other finance-based
Dose cap
Off-label
Performance-based
Undefined/Unknown
Finance and performance
based
Source: IHS Life Sciences Risk Sharing Database
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Risk Sharing Deals by Class
Implemented Risk Sharing Deals by Broad Class (2002-2014)
Finance-based: discounted
scheme
Other finance-based
Dose cap
Off-label
Performance-based
Undefined/Unknown
Finance and performance
based
Source: IHS Life Sciences Risk Sharing Database
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Risk Sharing Deals by Class
Proposed versus Implemented Risk Sharing Deals by Broad Class (2002-2014)
Finance-based: discounted
scheme
Other finance-based
Dose cap
Off-label
Performance-based
Undefined/Unknown
Finance and performance
based
13% of proposed risk sharing deals were not implemented (mainly due to NICE
funding rejections in the UK)
Source: IHS Life Sciences Risk Sharing Database
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Risk Sharing Deals: Impact on Reimbursement Outcome
NICE Reimbursement Outcome Following PAS Proposal
NICE Reimbursement Outcome
Following PAS
2011
Recommended
2010
Rejected
2009
0
5
10
15
20
Source: IHS Life Sciences Risk Sharing Database
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Therapeutic Areas at Highest Risk of Risk Sharing Deals
Implemented Risk Sharing Deals by Therapeutic Area
Other
Respiratory
Orphan Diseases
Anfi-inflammatory and Pain
Cardiovascular
Viral (inc Hepatits B & C, HIV), vaccines
Ophthalmology
Oncology
Total
0
50
100
150
200
250
300
Source: IHS Life Sciences Risk Sharing Database
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Finance-based
schemes are
gaining popularity
• Finance-based schemes have increased
– with various permutations, including
discount-based finance schemes
• Performance-based schemes have
become somewhat less common –
mainly as a result of:
• difficulties in implementation
• new payers engaging in risk sharing deals
that are exclusively interested in discounts
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Risk Sharing as part of the manufacturers’ toolkit for
engaging with payers
Pharma companies and payers share common interests
Developed markets
Emerging markets
Improvement
in quality of
healthcare
delivery
Risk
management
Collection of
comparative
effectiveness
data
Improvement
in access to
medicines
Return on
investment
Improvement
in patient
outcomes
Improvement
in quality of
healthcare
Address
geographical
disparities
Enhance
transparency
Source: IHS Payer Partnerships study
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Acceptance of Risk Sharing Deals by Market
Predominant industry-payer partnerships: developed markets
Source: IHS Payer Partnerships study
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Acceptance of Risk Sharing Deals by Market
Predominant industry-payer partnerships: emerging markets
Source: IHS Payer Partnerships study
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Game-changers
for risk sharing
deals
• E-prescribing and the move to electronic
healthcare records.
• Market entry of expensive new drugs.
• Growing sophistication of payers
• The risk of International Reference
Pricing
• Adaptive licensing legislation in the
European Union
• Approval under Breakthrough
Designation in the US
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The Future of
Risk Sharing
• Risk sharing agreements are here to
stay, but they are a moving target.
• HCV drugs and the new drug approval
initiatives may well reshape the
environment and the type of risk sharing
payers are willing to engage in going
forward.
• Watch this space!
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