Reality Bytes

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  • 05/30/2013

Thinking personalized medicine?  Think outcomes.

The Pink Sheet reports on a new study by IMS Health shows payers globally are making more drug reimbursement decisions based on real-world evidence - including 25% of more than 100 identified case studies using biopharma industry-generated data.

IMS Health Inc. has developed a report concluding the data is increasingly influencing how payers are covering pharmaceutical products on a global basis.

The report lists more than 100 non-safety cases from around the world where real-world evidence (RWE) informed payer coverage decisions and notes that while "payers are a powerful stakeholder in setting the RWE agenda, proactive pharma engagement matters: manufacturer-generated RWE influenced over 25% of observed decisions."

The report ranks 10 countries based on their supply of real-world evidence, the demand for it and how RWE is applied. On a scoring scale with a maximum of 20, the leading country - the U.K. - scored only an 11, which reflects that "no country has ideal conditions for RWE use in a scalable manner" and "highlights RWE's infancy," the authors state. "Lower scores indicate that RWE is relatively less available or more costly to generate with less consistent or transparent use in decision making. But even in markets with lower scores, RWE is still relevant."

The U.S. is tied for third in the rankings, sharing a score of 8 with the Netherlands. Among the other countries analyzed, Sweden scored 10; France and Italy both scored 6; Denmark, 5; Canada, 4; Germany, 3 and Spain, 2.

The U.S. is unique from the other countries examined in the study in that owners of real-world data "share it without stipulating how it should be used beyond ensuring individual privacy." Most U.S. insurance companies and providers sell data and only use it to support specific analyses about their own populations," giving pharmaceutical companies broad data access that can be used all the way from clinical trial design to post-market commercial support.

But the U.S. market lacks a clear framework for sharing real-world evidence. "Successful U.S. strategies involve evidence platforms and tools that support multiple internal stakeholders. However, without clear frameworks, the channels for external engagement are more nuanced. Only selected payers engage readily on RWE, and FDA regulations on RWE dissemination are more restrictive than in [other] countries. A differentiated engagement approach is needed, requiring creative thought and investment."

In contrast, the report notes that the U.K., Sweden and the Netherlands "all have strong national [health technology assessment organizations], suggesting an impact from concentrated decision making." In these markets, "pharmaceutical companies should set high ambitions for RWE plans, demonstrating value and engaging stakeholders based on a variety of real-life views (e.g. disease, product, class, cross-care settings, long-term outcomes, payer-relevant quality of care indicators). They must fully exploit RWE beyond traditional evaluations to enable commercial strategy, leverage outcomes-based marketing and use innovative evidence tools with local health systems."

The report notes that countries such as France and Italy have significant demand for real-world data, but limited supply.

"France's bold vision includes using RWE for cost-effectiveness assessments and regular class reviews without detailing how extensive data in the health system can be accessed or levered," the authors observe. "In Italy, there is widespread use of pay-for-outcomes or coverage with evidence development (CED), but how these schemes inform coverage or pricing decisions based on the captured data remains unclear. While manufacturers can react to these limited demands for RWE, the more innovative ones might place a bet that the markets will expand RWE use over time. Pharmaceutical companies must develop some RWE capabilities for payer's current focus areas."

The four countries at the bottom of IMS' list - Denmark, Canada, Germany and Span - "may use RWE more in [the] future but face significant hurdles today," including strong data privacy rules and fragmented health care landscapes, the authors write. "In these markets, pharmaceutical companies benefit from engaging directly with selected stakeholders willing to lead on RWE. Given the limited resources of these stakeholders and the large number of manufacturers, developing a clear value proposition and local RWE capabilities are essential to becoming a preferred partner."

Outcomes talk.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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