BackgroundWith austerity measures continuing to limit healthcare budgets around the world, healthcare payers are under increasing pressure to ensure that medical technologies are utilised in the most cost-efficient manner. This is particularly true in reimbursement decisions and clinical guidelines for new, innovative, and potentially expensive therapies. In this climate, pharmaceutical companies have adopted increasingly creative strategies to achieve at least some form of reimbursement for their new products, including so-called “risk-sharing agreements.”

Risk-sharing agreements are now a well-established channel through which reimbursement negotiations can be conducted in 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.

ObjectivesWhilst 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 agreements through 2005-10 is still continuing, or if there has been a gradual levelling off across the world.

The objective was subdivided to examine:

• Whichtypesofrisk-sharingagreementsareincreasingordecreasing in number.

•Whichtherapeuticareasaremostpronetotheseagreements.

•Whichgeographicmarketsareevolvinginthisarea.

Methods• Secondaryresearchwasconductedexaminingreimbursement

decisions around the world, with a special focus on Australia, Belgium, Canada, China, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Spain, United Kingdom, and United States.

• SourcesweretakenfromIHSGlobalInsight’sGlobalRisk-Sharing Agreement database, as well as regulatory websites around the world, academic research, press releases, news wires, official announcements, and conference presentations.

• Thiswassupplementedbyprimaryresearchwithpayers,government agencies, and HTA organisations through interviews in native languages to understand the role risk-sharing agreements have—or have not—played in their respective markets.

• Risk-sharingagreementsareoftenaccompaniedbysignificantconfidentiality, and there are immediate limitations that were recognised from the outset over precisely how much information and detail could be elucidated from each agreement, although primary research was designed to capture as much information as possible.

ResultsIn the period of review (May 2011–May 2012), 32 new risk-sharing 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 the period January 2010–June 2011 included 45 agreements, or 2.5 per month.

The number of new drugs with risk-sharing agreements attached to them actually declined, and most new agreements are being negotiated for drugs that already have one in place.

The majority of agreements tend to be finance based (n=24, or 75%), although new performance-based agreements (n=7, or 12%) continue to emerge, including in emerging markets.

The majority of agreements (n=21, or 65%) continue to focus on the oncology arena, with other therapeutic areas associated with biologics, such as rheumatoid arthritis, age-related macular degeneration, and multiple sclerosis, as well as a variety of orphan diseases, also represented.

Agreements were signed in the United Kingdom (n=20, 62%), Italy (n=7), Spain, Portugal, Germany, Netherlands, and Poland.

ConclusionsAlthough risk-sharing continues to be a routine part of market access in many countries, there appears to be a notable “levelling off” of the rapid expansion of this strategy. This is relatively unsurprising as it reaches a natural plateau, but is still notable against the background of ongoing global austerity. It appears governments are forsaking more complicated pharmaco-economic strategies in general, and risk-sharing agreements in particular, as a means of cost containment. Perhaps this is because of the uncertainty surrounding their efficacy in this regard.

Global Pharmaceutical Risk-Sharing Agreement Trends in 2011 and 2012: Slowing Down?Ando G, Izmirlieva M, Honore A (IHS, London, United Kingdom)

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