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Specialty pharmacy's role in shifting the existing paradigm from a transactional model to an experiential model in ways that can fuel real-world data acquisition and strategy.
Real-world outcomes are increasingly important metrics for measuring value.1 Part of this value centers on the increasing emphasis on the patient as a consumer.2 To this end, the industry needs to move beyond standard “care” or utilization data that is currently available. We must also (and perhaps more importantly) consider more deeply what data could or should be gathered if we are to develop compelling real-world evidence that truly reflects the patient experience around pharmaceutical products and services. Specifically, real-world outcomes and evidence (RWE) should be considered a critical driver of clinical innovation and optimization. Driving innovation and value means going beyond “shallow” post-marketing surveillance data or trying to squeeze insights out of administrative transactional data not intended for such use. Instead, we should proactively seek data that better reflects the patient and care context and that can impact the course and experience of illness in and outside formal treatment settings.
In this article, we discuss the unique role specialty pharmacy can play in shifting the existing paradigm from a transactional model to an experiential model in ways that can fuel real-world data acquisition and strategy. This framework provides both a conceptual and organizational structure that allows for more valuable data acquisition and insights that align specifically with patient needs and typically fall outside standard operational databases.
Specialty pharmacy services have changed and expanded in recent years as the specialty drug market itself has expanded (11.3% spending increase from 2016 to 2017 relative to a 4.3% decrease for traditional pharmaceuticals.)1 In this expanding role, specialty pharmacies are particularly well positioned to assume a critical role in filling patient care gaps that are both clinically and cost effective. This role also helps to glue or connect aspects of care that are currently experienced by most patients as disparate services.
What problem are we solving for, and to what questions do we need answers?
This question has been asked in one context in one way (drug approval process) and differently in another (go-to-market strategy). Importantly, the two can complement one another when applied throughout the product lifecycle. This requires manufacturers to view their products (and services) with a broader lens, beginning with initial drug development through approval and market launch-and including retail concepts such as loyalty.3
Real-world outcomes should in part be organized around patient needs, most of which are common across most chronic conditions. First, let’s draw on classic definitions for support,4,5 centered on three support domains well situated to contribute to a real-world strategy:
Now let’s look at the evidence-based model of chronic illness self-management developed by Kate Lorig7 at Stanford University’s Self-Management Resource Center.8 As a pioneer in patient self-management, her model centers on four primary tasks that the patient must master regardless of condition. Different patients and different conditions require different approaches to each task, and the same person with the same condition may have different needs requiring different resources over the course of care.
Rethink outcomes. Using the matrixed framework above, those designing patient support programs within specialty pharmacy can organize metrics, operations, and patient-centered programmatic design to optimize value across that spectrum of stakeholders that can expand the notion of real-world outcomes. These outcomes stem from questions and constructs that ask, “How does the illness and treatment fit in with the other demands of everyday living?”
Identify addressable patient-centered needs. If experience-based program design is to have immediate and clear patient-consumer value, then the RWD strategy must begin with identification and understand of the patient’s needs and desires and operationalizing how to identify, measure, and address these needs.
Improve the patient experience. Better understanding of patient needs lends itself to products and services that can anticipate and address those needs in ways that ease treatment understanding, access, and implementation of the treatment plan. The experience must go beyond adherence reminders.
Extend the notion of value. The pharmaceutical industry is changing such that the proximal outcome typically used in clinical trials are increasingly insufficient measures of value for key stakeholders including patients, payers, and prescribers. Nesting thoughtful metrics from within each of the above described framework cells can help extent our concept of value and provide a richer set of “in the wild” proof points.
If an experience-focused RWD strategy (as opposed to a transactional strategy) can be designed, aligned, and executed in ways that efficiently and effectively meet patient needs, it must smartly acquire the right real-world data. That begins with a framework for organizing a deeper understanding of patient needs as they relate to solving problems and providing value.
1. Hughes, B, Kessler, M., McDonnel, A. Breaking New Ground with RWE: How some pharmacies are poised to realize a $1 billion opportunity. www.quintilesims.com
3. Mahoney, D. (Mat 2016). Online Reporting of Patient Experience Outcomes: The Road to Value. Industry Edge a Press Ganey Publication
4. Schaefer, C, Coyne, JC, Lazarus RS. (1981). The health-related function of social support. J Beh Med 4(4) 381-406.
6. Turner, J, Floor, K, Kelly B. (2000). Emotional dimensions of chronic disease. West J Med 172(2) 124-128.
7. Lorig, KR, Holman, HR (2003). Self-Management Education: History, definition, outcomes and mechanism. Ann Behav Med, 26(1) 1-7.
Steven Schwartz, PhD works in Clinical Services at Diplomat Specialty Pharmacy; Gary Rice, RPh, MS, MBA, CPS, executive vice president, Operations, Diplomat Specialty Pharma; Cheryl Allen, BSPharm, MBA, VP, Business Development and Industry Relations at Diplomat Specialty Pharma.