Making Personalized Medicine Value Medicine
How personalized medicine becomes functional is key to making it practical and valuable in clinical settings.
Personalized medicine involves selecting therapeutics or multi-therapeutic protocols for an individual patient, usually based on genetic, molecular, phenotypic, and sometimes behavioral data about a patient and their specific illness, interpreted relative to evidence-based insights.
How personalized medicine becomes functional is key to making it practical and valuable in clinical settings. As personalized medicine becomes practical, care teams are empowered to:
- Gain insights and reach decisions about therapeutics that might achieve the best patient outcome;
- Evaluate the therapeutic options that offer highest value to the patient and health care system – balancing economics and potential therapeutic outcomes;
- Determine how to gauge and monitor patient response to therapy relative to expectations, and validate the value for the health system.
Personalized medicine is not functional nor value-delivering until these three processes are applied in the real world.
Functionalizing personalized medicine entails using available clinical and behavioral information about specific patients to make choices regarding different therapeutic approaches, and selecting the treatment to which those patients will likely have the best clinical response. For a provider and pharmaceutical company, these are clear actions taken to give the best care for a patient population. That treatment also should be the one that the patient and provider will best adhere to in order to achieve the intended outcome.
The clinical data at the heart of the functional approach can be genetic, phenotypic and genomic. The behavioral data might include electronic patient-reported outcomes, information regarding family situations, or data from mobile apps. These data should be combined with analytics so that decisions or actions that drive value -- therapeutically or financially -- can be taken.
Insights lead to intended results
Functionalization generates insight that leads to desired results. Gaining insights requires longitudinal access to a patient's data, so that information can be studied over time, and access to an array of data, such as electronic medical records (EMRs), lab tests and genetic and genomic results, and imaging diagnostics. Functionalization focuses these data around the patient, using synthesized and codified knowledge that can be brought together around a decision or process. Applied to this information are advanced analytics, which provide key insights at the point of a decision to care providers and care managers.
When decisions regarding treatment are made, those decisions should come with the expectation that if the decisions are correct, the patient will respond in a certain way. Monitoring for responses that are consistent with these expectations is almost as important as the therapeutic decision itself.
Value interfaces with the market place
Value is becoming more important in functionalizing health care. Historically, personalized medicine involved taking data and treatment options and trying to tailor those to an individual patient. But what is the value generated by an individual therapeutic or therapeutic regimen over time and as delivered in different sites of care, for the patient and for the health care system as a whole? For instance, even though treatments may be approved by regulatory agencies, some specialty care or provider organizations may not justify including a drug in their treatment protocols because its price may be greater than competing treatments, while it has proven no more effective than those competing drugs. During a time of escalating health care costs, private providers are beginning to take on the task of rationing health care to restrain costs, especially if a drug has not proven its value. They maintain that there is not enough capacity in the system to support the expense associated with some drugs.
Some provider systems are taking on financial risk, transforming their traditional roles, and allocating care efficiently to specific patients based on the benefit they will realize, and the value of that benefit. Large payers and specialty distributors have established payment-focused pathways and episode-like (financially capped) approaches. Likewise, Medicare in the US is moving towards initial implementation of episode-based reimbursement, funding pilot programs through the Center for Medicare and Medicaid Innovation to accelerate supporting models, tools and ultimate adoption. All of these efforts drive a need for precision, assuring that innovations can provide significant therapeutic benefit, and avoiding those which offer no or limited incremental benefit over established therapies or generics.
Pharma companies must focus on how value will be perceived in the market place, as a consequence of the therapeutic approach that they are taking. Doing so affords them a market opportunity. Pricing strategies for a product will be less successful if they just focus on maximizing revenue, rather than the value they are delivering, and how they are sharing in the value realized. This in turn requires being cognizant of the value that could be created by the use of alternative products -- the competition.
A team effort required
Functional personalized medicine is a team sport. It brings together partners --life sciences companies, providers, pharmacies -- to assemble the data, insights, and analytics needed to achieve precision and personalization. These key partners must be integrated around new process and operating models to deliver the greatest benefit most efficiently.
For instance, provider systems have been historically disaggregated and distributed in terms of data and clinical approaches. But now, processes are enabling the integration of data and information around the patient. The most obvious example of this is the implementation of electronic medical records (EMRs) and the standardization of the EMR and data models within increasingly larger regional and national delivery systems. This information can be shared with pharmaceutical companies when focusing a therapy on a target patient population. This is an exceptional opportunity for life sciences companies to combine their deep capabilities in the science, translational clinical understanding, and clinical stratification with provider system clinical process design and risk management approaches.
Harnessing data-based, precise, and cross-party care delivery and management processes is the basis for implementing functional personalized medicine in the real word. The current emphasis on value and benefit of new reimbursement processes furthers the need to define clinical value from personalization.