Health data and comparative effectiveness
Peter Mansell explains why the pharma industry needs to reclaim data ownership in ways that promote both transparency and market opportunity.
By on Apr 19, 2010Peter Mansell explains why the pharma industry needs to reclaim data ownership in ways that promote both transparency and market opportunity.
Data are at the heart of the pharmaceutical enterprise: how they are generated, shaped, presented and used, not only during the long haul to marketing approval but, increasingly, throughout the product lifespan.
Accordingly, data ownership is paramount.
For brand owners, it is data exclusivity that provides the most effective bulwark against generic competition.
In a broader sense, though, data ownership is about what happens to information on a medicine in the run-up to approval and beyond, and how different stakeholders interpret those data to measure product value.
Comparative effectiveness research
The issue has taken on particular relevance with the trend towards comparative effectiveness research (CER) and other forms of health technology assessment (HTA).
Pharmaceutical companies have to think more carefully about the data they accumulate in clinical development from the perspective of pharmacoeconomic validation and value creation further down the line.
Safety, quality and efficacy are just the baseline.
Now there are more stakeholders than ever looking for real-world data on a products long-term costs and benefits.
And increasingly, these stakeholders are taking matters into their own hands.
A more proactive approach
This more proactive approach comes at a time when industry is under intense pressure to improve transparency, including the way it organizes, delivers and publicizes data from clinical trials.
While industry associations and individual companies have made high-profile commitments to put more clinical data out for public scrutiny, access to these data can still be a point of contention, whether for regulators, HTA agencies or the general public.
Industry has not been in too much of a rush to conduct, or at least publish, CER either.
A recent analysis in the Journal of the American Medical Association found that comparisons of effectiveness with existing therapies made up only 32% of studies published in six high-impact medical journals between June 2008 and September 2009.
Moreover, only 2% of the CE studies included cost-effectiveness analyses.
The growing influence of HTA
But the game is changing.
The proliferation and growing influence of HTA agencies and other arbiters of product value, exemplified by the Obama administrations $1.1 billion allocation to CER under the American Recovery and Reinvestment Act, show just how much budget holders are concerned about making fully informed choices in a healthcare marketplace characterized by selective coverage based on comparative cost and value.
Last October, for example, pharmacy benefit manager Medco Health Solutions said it was launching a head-to-head clinical trial to see whether a genetic subset of patients on Bristol-Myers Squibb/Sanofi-Aventiss blood thinner Plavix could achieve comparable outcomes to patients given Eli Lilly/Daiichis Effient.
Plavix is a blockbuster drug facing generic competition from late 2011, while Effient launched in the US in August 2009 has shown better effectiveness overall but is more expensive.
Technological advances are playing a pivotal role in constructing a new paradigm of data ownership.
The role of technology
Technology has helped industry to manage the vast amounts of data generated in clinical trials and to analyze those data to its best advantage.
At the same time, though, it is expanding the capacity of other stakeholders to mine pharmaceutical data for their own ends.
The breakneck pace of innovation in communications technology be it mobile phones, the Internet or Web 2.0 applications presents a further conundrum, one in which the new profligacy of data and information could be either industrys making or its graveyard.
The better-informed patient may be more inclined to put pressure on decision-makers for access to new therapies. On the other hand, the same patient may decide those therapies are not worth the effort.
It comes down to who has the information and what purpose that information serves.
Get back on top of the data
For industry, this should be a rallying cry of some urgency: Get back on top of the data, but in a way that skirts the old accusations of selective reporting and manipulation for short-term commercial gain.
In other words, industry needs to reclaim data ownership, but on a convincing public health platform.
As Ernst & Young notes in Progressions: Pharma 3.0, its wide-ranging review of the emerging healthy outcomes ecosystem for pharmaceuticals, the expansion in the quantity and quality of electronic health data is shifting the emphasis of product value into the post-approval space.
In the past, successful drug development stemmed from having good clinical trial data, which companies owned and controlled, the report comments. In the future, their success in the market will instead be determined by post-marketing data, of which they will no longer have sole possession.
Data management and mining
In sharpening its own data management and mining capabilities to address these challenges, industry may look to new partnerships outside its normal comfort zone for example, with data repositories or experts in predictive modelling.
Whatever the options, though, industry needs to act before the data explosion pushes it to the margins of decision-making on products that have taken years and hundreds of millions of dollars to research and develop.
As John Doyle, vice president and practice leader for Quintiles Consulting, pointed out in a report last October, pharmaceutical manufacturers also need to be actively involved in discussions about the proper design and use of CER.
They simply cannot afford to wait passively for policy-makers to dictate comparative effectiveness requirements, he warned.
Ultimately, Doyle observed, every manufacturer must communicate the value of its products to multiple stakeholders in a manner that allows for comparison with competing agents.
But this responsibility, he insisted, should be regarded as a historical market opportunity, not as a burden.