Global risk-sharing agreements between pharmaceutical companies and healthcare payers saw a leveling off between 2011-2012 according to a study by IHS Global Insight. The study found 32 new risk-sharing agreements were established during this period, consistent with prior years. However, fewer new drugs entered such agreements and most expanded existing pacts. The majority of recent deals were financial-based and focused on oncology. The UK remained the most active country for risk-sharing deals, though other European nations also participated as governments seek more cost-effective drug reimbursement.

1. Global Pharmaceutical Risk-Sharing
Agreement Trends in 2011 and 2012:
Slowing Down?
Ando G, Izmirlieva M, Honore A (IHS, London, United Kingdom)
Background • isk-sharing agreements are often accompanied by significant
R
confidentiality, and there are immediate limitations that were
With austerity measures continuing to limit healthcare budgets recognised from the outset over precisely how much information
around the world, healthcare payers are under increasing pressure and detail could be elucidated from each agreement, although
to ensure that medical technologies are utilised in the most cost- primary research was designed to capture as much information
efficient manner. This is particularly true in reimbursement as possible.
decisions and clinical guidelines for new, innovative, and
potentially expensive therapies. In this climate, pharmaceutical
companies have adopted increasingly creative strategies to Results
achieve at least some form of reimbursement for their new In the period of review (May 2011–May 2012), 32 new risk-sharing
products, including so-called “risk-sharing agreements.” agreements were found, an average of 2.6 per month, which is
roughly in line with the rate found in previous years. The total for
Risk-sharing agreements are now a well-established channel
the period January 2010–June 2011 included 45 agreements, or
through which reimbursement negotiations can be conducted in
2.5 per month.
many key markets. After a period of market expansion of these
agreements in 2005-10, there have been significant question
marks over precisely how effective they are in establishing efficient
clinical decision making.
IHS Global Insight has published ISPOR research examining the
latest global trends in pharmaceutical risk-sharing agreements
three times. This research has generally shown the expansion of
risk-sharing agreements both in terms of outcomes-based and
financial-based arrangements, and also from developed to
developing markets. This is an examination of the latest data up to
the end of May 2012.
Objectives
Whilst recognising that risks-sharing agreements represent an
important market-access strategy, the objective of this research
was to examine if the marked expansion in number of risk-sharing The number of new drugs with risk-sharing agreements attached
agreements through 2005-10 is still continuing, or if there has to them actually declined, and most new agreements are being
been a gradual levelling off across the world. negotiated for drugs that already have one in place.
The objective was subdivided to examine: The majority of agreements tend to be finance based (n=24, or
75%), although new performance-based agreements (n=7, or
• hich types of risk-sharing agreements are increasing or
W 12%) continue to emerge, including in emerging markets.
decreasing in number.
The majority of agreements (n=21, or 65%) continue to focus on
• Which therapeutic areas are most prone to these agreements. the oncology arena, with other therapeutic areas associated with
biologics, such as rheumatoid arthritis, age-related macular
• Which geographic markets are evolving in this area. degeneration, and multiple sclerosis, as well as a variety of orphan
diseases, also represented.
Methods Agreements were signed in the United Kingdom (n=20, 62%), Italy
• econdary research was conducted examining reimbursement
S (n=7), Spain, Portugal, Germany, Netherlands, and Poland.
decisions around the world, with a special focus on Australia,
Belgium, Canada, China, France, Germany, Hungary, Italy,
Netherlands, New Zealand, Poland, Spain, United Kingdom,
Conclusions
and United States. Although risk-sharing continues to be a routine part of market
access in many countries, there appears to be a notable “levelling
• ources were taken from IHS Global Insight’s Global Risk-
S off” of the rapid expansion of this strategy. This is relatively
Sharing Agreement database, as well as regulatory websites unsurprising as it reaches a natural plateau, but is still notable
around the world, academic research, press releases, news against the background of ongoing global austerity. It appears
wires, official announcements, and conference presentations. governments are forsaking more complicated pharmaco-
economic strategies in general, and risk-sharing agreements in
• his was supplemented by primary research with payers,
T
particular, as a means of cost containment. Perhaps this is
government agencies, and HTA organisations through
because of the uncertainty surrounding their efficacy in this regard.
interviews in native languages to understand the role risk-
sharing agreements have—or have not—played in their
respective markets.
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Please email: gustav.ando@ihs.com for any questions related to this poster