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Defining and Delivering Value
The focus on value implies a focus that is broader than the therapeutic alone.
Throughout 2015, there was much conversation about pharmaceutical and biopharmaceutical pricing and ‘value.’ While the lightning rod for this issue was the 5000% price increase for Daraprim perpetrated by Turing Pharmaceuticals and its politically insensitive CEO, Martin Shkreli1, the debate extended far more broadly to include new therapeutics targeting the hepatitis C virus, multiple sclerosis, hypercholesterolemia and other diseases. But therapeutic pricing and value are quite different concepts.
Value as a concept integrates outcomes for the patient – clinical, ease of integrating therapy into their life, quality of life – with the population and economic outcomes realized by risk-bearing providers, health authorities, and health payers. Accenture suggests the focus should be on value as we see it and not pricing or costs to the exclusion of the outcomes realized. In fact, Accenture believes traditional notions of cost and pricing may be becoming obsolete as we see health authorities, payers, and risk-bearing providers increasingly focus on population health, patient outcomes, and overall value to the healthcare system.
Value is far bigger than therapeutics alone
Consider antidiabetic therapeutics and therapeutic insulin. These critical therapeutics are a routine part of the treatment of diagnosed diabetes patients from the earliest phase of the disease to the most advanced stages. Generally therapeutic approaches have involved therapeutic agents combined with diet modifications, exercise, and other aspects of self-care2. Adherence challenges to medical therapy and self-management aspects of the disease are numerous and largely responsible for the gap between clinical trial or controlled observational study outcomes and those seen in real-world populations3.
The focus on value implies a focus that is broader than the therapeutic alone. Value requires a focus on all aspect of how the disease is managed, from the structure of the healthcare system, point interactions between the patient and health professionals, health disparities, and critical psychosocial and personal motivational aspects.
A good example of this is the diabetes program and App, BlueStar, a mobile digital prescription therapy cleared by the FDA4. BlueStar supports patients through smart blood glucose testing, healthy diet and exercise choices, medication adherence, and quality standards of care such as A1c tests, foot exams, and blood pressure and lipid levels. Additionally, BlueStar provides the patients’ physicians with clinical decision support and enables them to efficiently extend care beyond traditional office visits5.
The clear implication is mobile and personal digital applications and therapies are capable of delivering a complementary outcome that is comparable to the therapeutics alone. Again our point is not that apps and digital therapies are alternative to therapeutics, but rather that achieving targeted outcomes is more complicated than making biological or chemical therapeutics alone available and prescribing them.
In a value-centric world, the definition of the ‘product’ itself needs to evolve to more directly address the biology of the disease in combination with structural, social, self-management requirements, and summation of health and economic benefit accruing from the combination. These are the “4S’s” of value management that Accenture has defined.
- Structural includes an understanding the health infrastructure and professional access a patient may have or be lacking. It specifically addresses how to create the information and interaction flows between a patient care provider(s) and the patient.
- Social acknowledges that disease is manifest in the individual but often impacts that individual’s family, friends and work-place relationships. The more engaged, or minimally supportive, these circles are the lower the social costs and barriers for the patient.
- Self-management recognizes that for most chronic and high acute diseases there is a significant patient self-management component that will substantially determine the outcomes. A disease may be like a second job – requiring hours per day in modified and specialized activity levels, self-testing, self-monitoring, focused diets, and managing adherence to multiple medications.
The Summation of outcomes and benefits from the combination of therapeutic intervention is critical to advancing health, population and economic outcomes most beneficially and continuously. An old adage applies here “you can’t improve what you can’t and don’t measure – making sure what you are measuring is complete.” 6
Value involves continuous insights into what can improve effectiveness, reduce the complexity of the patients' job of managing their disease state, and understand why there are differentials in outcomes across patients and patient sub-populations.
So value and outcomes in the management of a patient’s disease require a knowledge of the biology of that disease and all else required for that patient and the healthcare ecosystem supporting them to manage the totality of interventions and changes restoring health, slowing disease progression, or otherwise benefitting the patient’s health status.
Value is also a process. It involves continuous insights into what can improve effectiveness, reduce the complexity of the patients' job of managing their disease state, and understand why there are differentials in outcomes across patients and patient sub-populations – be they biological or performance across the 4S’s of value management. It is a process that should begin during the research phase of any new therapeutic program; redefine the goals for clinical development; change how regulators evaluate trial outcomes and the basis of their approvals; redefine how payers, health authorities, and life science companies engage; change our roles as patients; redefine how health providers and patients engage in pursuit of health vs. critical interventions alone; and determine the structure and resource allocation priorities for the industry’s leading innovators.
In next month’s column, we present a broad agenda for how these changes can be put in place across companies and the healthcare ecosystem.
1. http://www.theatlantic.com/health/archive/2015/09/daraprim-turing-pharmaceuticals-martin-shkreli/406546/and http://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html?_r=0
3. J Am Pharm Assoc (2003). 2013 May-Jun;53(3):267-72. doi: 10.1331/JAPhA.2013.12065 also in http://www.ncbi.nlm.nih.gov/pubmed/23699675and for self-management in doi: 10.1177/0193945914538399 West J Nurs Res October 2014 vol. 36 no. 9 1027-1029 also at http://wjn.sagepub.com/content/36/9/1027.short
6. This concept is attributed to many. Lord Kelvin proclaimed, “I often say that when you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind; it may be the beginning of knowledge, but you have scarcely in your thoughts advanced to the state of Science, whatever the matter may be. . .“ (Thomson, W. (1891). Popular Lectures and Addresses, Vol. I . London: MacMillan. p. 80. Retrieved 25 June 2012.) W. Edwards Deming and Peter Druker have variants on the theme of measurement being critical to the ability to manage to a desired outcome.
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