Aligning economic interests
Several tools could be used to greater effect to improve patient outcomes and lower healthcare costs, including:
- Risk sharing agreements – agreements that link drug reimbursement to outcomes achieved – enable governments to provide access to new drugs for unmet medical need more rapidly than if there are lengthy price negotiations. From the industry perspective they allow earlier market access and potentially better returns in an era when the patentable life of most new drugs is becoming shorter. Risk sharing agreements have become increasingly common in Europe.1
- Post-launch value assessments using real world data are an alternative assessment tool. These can be based on bespoke patient registries but if a coordinated, multi-country approach to a particular disease and treatment could be agreed on, the time and cost savings to all stakeholders would be significant. 2,3
- Data from patient registries are complementary to that derived from randomized controlled trials (RCTs). Patient registries offer an opportunity to evaluate cost-effectiveness because they permit longer follow-up than RCTs, represent usual standards of treatment monitoring and care, use patients who are less homogenous than in RCTs and include concomitant treatments that are chosen by physicians.
Develop companion diagnostics to reduce ineffective prescribing
The development of a companion diagnostic together with a new medicine represents an opportunity to develop a partnership with a payer to reduce inappropriate prescribing and drive better value for the payer and patient. The majority of companion diagnostic deals between pharma companies and diagnostic developers involve cancer therapies. The FDA has approved 15 companion diagnostics as of November 2012, all for cancer therapies.4 However, there are also more companion diagnostic tests that are able to determine the likely efficacy of drugs for common diseases, such as the KIF6 test for statin effectiveness. Whether this particular test is economically viable now that cheap generic statins are widely available is debatable but it does, nevertheless, allow stratification of patients at risk of coronary heart disease5 and reduce issues of co-morbidity from polypharmacy.
Improving drug compliance
Poor compliance with therapy is a major source of inadequate outcomes and it costs healthcare systems dearly: one estimate put the costs in the US at USD $290 billion, or 13 percent of total healthcare expenditures in 2009.6 The issue here is the contrast between the efficacy established in RCTs, where patients are closely monitored to ensure adherence, and real world effectiveness, which is usually lower because many patients stop taking prescribed therapies after a period of time.
Progress to improve compliance could come through smartphone apps, designed to help patients stick to medication schedules. These could also incorporate drug interaction information as well as disease awareness and lifestyle advice, depending on the view of individual country regulators.
Finding ways to help improve patient compliance with drug therapy would be one of the most effective ways of improving the value of the medicines themselves and also aligns the interests of the industry with those of the patient, healthcare professional and provider: a win for all invested parties.
IT and Big Data
Information gathering is a critical component of value convergence. Decision makers in government and other providers, as well as consumers, will undoubtedly use IT tools as part of their assessment of the value of medicines and there are clearly routes for the life sciences industry to develop IT and data partnerships.
The industry has massive repositories of marketing data, market research data, sales data and social media data. These could be used to uncover actionable insights about patients, healthcare professionals or the behavior of payers and providers that could be invaluable in supply chain analysis. The industry also has access to clinical trial data. A priori sequence analysis could be developed to predict better clinical outcomes: keyword mining techniques can reveal patterns in clinical records that may provide new treatment pathways and epidemiology trends can be better understood and used to identify underserved patient populations. The industry could use its specialist disease knowledge built over decades in certain therapeutic areas to help providers analyze their data from hospital and general practitioner records. Big Data analytics to understand market opportunities combined with cloud computing, which permits access to large datasets from anywhere, offer the chance for much greater flexibility in customer relationship management. This could further reshape the sales and marketing models that have already moved far from the share-of-voice models of the 1990s.
To date, the life sciences industry has hardly begun to impact patient access to digital information about health. Many mobile-ready websites may be just as useful as apps, particularly in developing countries where the web is accessed directly from mobile devices.7 The use of cloud computing is enabling much more flexible approaches to partnership than the industry has previously experienced.
The industry needs to adapt its model to become part of the relationship between healthcare professional and patients, and helping with adherence and involvement with electronic health records may be one route. The industry is embracing new media, albeit after a slow start: the 2012 KPMG Pharmaceutical Outlook Survey showed that pharmaceutical executives planned to use digital/social/mobile technologies over the next year, to gain customer insights (36 percent), as well as for customer facing applications (31 percent) and for recruiting and brand promotion (29 percent).
The expected publication of FDA rules on mHealth apps in 2013 should provide a much needed framework for greater use of technology in the US. The ban on direct-to-consumer advertising in the EU means companies have to focus on unbranded disease awareness apps. This may be an opportunity to partner with governments to improve health information flow to patients.
Clinical professional services units
Faced with business structures established in a different era that largely address older healthcare systems, the challenge of driving innovative business initiatives away from single product offerings is substantial. The industry could consider the creation of new business units for clinical professional services to oversee advanced data collection, information sharing, data analysis and stakeholder collaboration tools.
These new services units could:
- collate external solution requirements
- integrate internal pharma products with external partnered diagnostics, provider
- services, patient biometric input and compliance incentives
- align to payer delivery models and services
This proprietary solutions-based approach could drive increased brand value, higher margins and better business performance.
1Alexis Sotiropoulos (PDF 285.6 KB), Pricing Pharmaceuticals by Outcome (London: 2020 Public Services Trust, 2011), pg 9.
2Post-launch Value Assessment Working Group launch meeting (PDF 344 KB)
3 A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. Registries for Evaluating Patient Outcomes: A User’s Guide. 2nd edition.Gliklich RE, Dreyer NA, editors.Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Sep
4Companion Diagnostic Devices: In vitro and Imaging Tools
5 Li et al Am J Cardiol. 2010 Oct 1;106(7):994-8. doi: 10.1016/j.amjcard.2010.05.033. Epub 2010 Aug 11
6 Thinking Outside the Pillbox. NEHI August 2009
7 mHealth + HTML5 = pharma in 2012 (PDF 1.75 MB)
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