The impact of value mining on market access

Peter Mansell explains how multiple stakeholders are analyzing data to make their own determinations of medicine value.



Peter Mansell explains how multiple stakeholders are analyzing data to make their own determinations of medicine value.



Value is ultimately in the eye of the beholder.


How we cut through the white noise of available goods and services to make a purchasing decision depends on certain intrinsic qualities in those goods and services.


But it also reflects a complex weave of circumstances and influences, including cultural and brand values, self-image, price and available budget.


The pharmaceutical market, with its frequent separation of purchasers, providers and end-users, has not yet reached that level of direct consumer influence.


All the same, medicines whose value used to rest more securely on the three pillars of efficacy, safety, and quality are increasingly coming under scrutiny from multiple stakeholders with different capabilities, perspectives, and agendas.


As a result, knowledge about drug efficacy previously derived from clinical research, monopolized by pharmaceutical companies and implicitly bundled into their product prices will move into the public domain and become unbundled from the pill, according to Progressions: Pharma 3.0, a recent report by Ernst & Young.


This kind of value mining allows stakeholders other than the pharmaceutical industry to skirt the need for genetic biomarkers that predict efficacy in specific patient populations and to identify proxy variables correlated to underlying real variations in response to therapies.


Demonstrating value


The Ernst & Young report talks about a healthy outcomes ecosystem in which large volumes of information enable widespread data mining to demonstrate value in comparative effectiveness decisions.


This kind of value mining, the report suggests, will be achieved far more quickly and cheaply than biomarker identification, the Rosetta Stone of personalized medicine and of a new generation of safer, more cost-effective therapies for precisely targeted patient groups.


Stakeholders, ranging from industry itself to regulators, health systems, payors, healthcare professionals, patients and health technology assessment (HTA) agencies, all want their say in regard to what constitutes value and how much weight it should carry in the distribution of limited healthcare resources.  


This complicates enormously market access strategies for pharmaceutical companies.


At the same time, though, it opens up some new possibilities for more holistic conceptions of value that could root medicines more firmly in long-term health objectives, social ethics, and the economic challenges facing healthcare systems worldwide.


These benefits may consist of getting patients with rheumatoid arthritis or manic depression back to work; reducing reliance on expensive hospital stays; improving quality of life; taking the burden off carers in diseases like Alzheimers; or delivering incremental advances in difficult-to-treat diseases where the ensuing revenue flows keep the R&D effort moving forward.


New value paradigms


While industry works on incorporating value propositions into product lifecycles from drug discovery onwards, other stakeholders are busy constructing their own paradigms.


Industry may regard these value measures as too rigidly schematic and narrowly focused as, say, it does the National Institute for Health and Clinical Excellences influential quality-adjusted life year (QALY).


But the mechanisms are in place and companies need to deal with them, or come up with something better.


What has helped significantly to democratize value assessment in the pharmaceutical market is the explosion of information and communications technology, putting both data and data analysis tools in the hands of a much wider constituency.


In this context, industry needs not only to think more carefully about the data it generates, and to sift and tailor those data to different stakeholder needs, but also to extend the data continuum more aggressively into the post-marketing space.


This is about more than adding to the data pool that drives new indications or line extensions.


It calls for ongoing, real-life data, whether to support risk evaluation and mitigation strategies, underpin or adjust risk-sharing arrangements with healthcare payers, or to substantiate and validate conditional pricing arrangements or HTA verdicts.


The value of value mining


Value mining can play an important role.


A large hospital system could mine its data and figure out that a certain drug is more likely to work with South Asian males over the age of 55 and a history of hypertension, even if it cannot identify the genetic basis for that correlation, Ernst & Young explains.


This approach shifts data analysis and personalized medicine into the post-launch arena, to the potential exclusion of pharmaceutical interests.


Unlike biomarker identification, it doesnt involve years of bench research And since it could conceivably be done by any entity that has access to volumes of patient data, it doesnt necessarily have to be done by pharma companies alone, Ernst & Young notes.


A number of leading hospitals and payors have already been using electronic health records (EHRs) for years and are actively mining data to improve outcomes, the report adds.


The pharmaceutical industry is keen too to get a foothold in the EHR universe as a source of valuable information to inform its clinical research efforts.


But, increasingly, this will only be part of a much bigger picture in which the information flow post-launch, and the way in which real-world data are distributed, owned and interpreted, have much more bearing on long-term product uptake.


Partnering with new stakeholders


For pharmaceutical companies, that may require not just partnering with data repositories or other players outside the traditional industry sphere, but a more decisive engagement with social media, an area the industry has to date explored only tentatively, largely due to the regulatory vacuum around these interactions.


For more on pharma and social media, see To Tweet or not to Tweet? That is the pharma marketers question, The upside of social media in marketing and How the pharma sector benefits from social media.


As Ernst & Young suggests, though, emerging healthcare communities such as PatientsLikeMe could be a vital means of enriching the value equation.


Belgiums UCB saw the writing on the wall last June, when it became the first pharmaceutical company to partner with PatientsLikeMe in launching an online patient community, in this case specifically geared to epilepsy, where UCB is a market leader.


Other companies, such as Johnson & Johnson and Novartis, have gone down a similar road, sponsoring the Children with Diabetes network and the CFvoice website (for people with cystic fibrosis), respectively.


What UCB and PatientsLikeMe made clear in announcing their partnership was that the insights gained would be ploughed back into pharmaceutical R&D.


This partnership is exciting because for the first time, patients will be able to contribute their experiences and real-world data to ongoing epilepsy research, commented Roch Doliveux, chief executive officer of UCB.


For more on partnering with patient groups, see How patient advocacy groups can boost patient compliance.


Creating and sustaining value


As these initiatives suggest, pharmaceutical companies are aware of the need to cover all points in the product and disease spectrum if they are to keep a firm grip on perceptions of value, from drug discovery through to a marketplace in which these perceptions are increasingly up for grabs.


Value in medicines will continue to be in the eye of the beholder.


But what creates and sustains that value will be information from a much wider range of sources, filtered through a much broader range of stakeholders and agendas.


If pharmaceutical companies are to keep pace with this trend, they will have to make sure they know how to mine the fast-evolving data landscape to their own best advantage.