Real World Evidence Evidence & Data Partnerships

Oct 14, 2014 - Oct 15, 2014, Bethesda

This year real patient data will change healthcare.

Patients as Partners? The Role for “Patient Centricity” in the New Healthcare Landscape

As healthcare evolves, manufacturers are engaging patients as partners earlier in product research and development. This inclusion of a patient-centric perspective helps in generating data for a value story, which resonates with these increasingly important stakeholders.



Last month, I discussed how the insurance exchange marketplace is encouraging patients to act like healthcare consumers.  This month, I want to explore this recent trend in more detail, including why manufacturers can’t ignore this important group of stakeholders, and how patients can even be valuable partners in the new healthcare landscape.

The Changing Landscape

The healthcare system – in the US and globally – is responding to the need to reduce costs and improve outcomes.  The foremost implication for manufacturers of pharmaceuticals, devices, and diagnostics is a drive to demonstrate the economic and clinical value of their products to all stakeholders including patients.  This is an extreme shift in focus for a pharma industry that has historically been very successful with a strategy of winning the favor of physicians and selling them the next blockbuster. 

As manufacturers scramble to adjust their market access and sales strategy to the shifting healthcare environment, many have focused their efforts on how to effectively market their products to relatively new stakeholders such as accountable care organizations (ACO), integrated delivery networks (IDN), and consolidated healthcare networks.  Organizations taking on this challenge are ahead of the game, and doing critical work to ensure their continued differentiation in an increasingly competitive environment.  But, while adapting your strategy for new groups of stakeholders, it is crucial to keep another core constituent group in mind – the patients who ultimately use your products.

“Patient centricity” has become another buzzword, and it means different things to different people.  The common theme is that patients should be recognized as important consumers of healthcare, and that their role as a consumer is expected to increase.  There are a number of factors contributing to patients becoming more involved in their health. 

  •  Financial: As copays increase and more patients are participating in high-deductible health plans, they are increasingly approaching their healthcare decisions from the standpoint of cost and value – driving the demand for increased transparency.

 

  • Cultural/Social:  Healthcare and wellness has become more prevalent in the media in recent decades.  While it used to be taboo to discuss health concerns with someone other than your physician, people are more open to exchanging health information with friends, family, and other non-medical professionals.  Patient advocacy groups have successfully marketed disease awareness in the forms of fundraisers, runs, internet memes, and even garnered the spotlight in national sporting events, such as the “NFL Pink” campaign for breast cancer awareness.

 

  • Technological:  The advent of the internet has made information on health and disease more readily available than ever before.  According to the Pew Research Internet Project, 87% of US adults use the internet, and 72% say they looked online for health information within the past year.   Health and wellness mobile apps, wearable fitness devices, home health monitoring, and social media are encouraging patients to monitor their health, and share their health behaviors with peers and physicians alike.  These technological trends are making patients more knowledgeable, engaged, motivated, and better equipped to do their own research and ask their physicians for treatments by name. 

 

The confluence of these trends is positioning patients as an important customer block within certain disease areas, which manufacturers can no longer afford to ignore.  In fact, the earlier in the product development process patient needs are addressed, the better. 

Patients as Partners

Manufacturers, in changing the way they think about patients as stakeholders, need to acknowledge them as healthcare decision makers.  This means identifying the types of evidence that will best resonate with patients who are later evaluating their products.  Just as manufacturers must leverage comparative effectiveness research (CER) and real world evidence (RWE) to gain favorable positioning with payers, they need to collect and demonstrate information that matters to patients in a way that makes patients listen.

This is where patients become important partners.  Patients play a dual role as both the end users of clinical research and the research subjects helping to produce the data.   Therefore, including a patient-centric perspective in early product research and development becomes critical to generating the data that will ultimately tell the patient-centric value story. Treating patients as partners will ensure both a positive patient experience during the clinical trials, as well as producing outcomes that matter.

There are two clear benefits to treating patients as partners in the new healthcare landscape:

1.    Improved patient recruitment and retention:

Identifying patient needs and expectations of the clinical trial process can lead to improved patient recruitment and decreased patient attrition – both significant research and development (R&D) costs.  A patient-centric approach to patient recruitment means developing an understanding of why a patient would be interested in participating in your trial, demonstrating respect for patients’ time and expectations, and providing both access to information and timely responses to questions.   Ultimately, treating the patient as the research partner that they are will discourage withdrawals (estimated to be up to 30% of enrollment).  In the age of social media and instant connections, fostering patient goodwill among your trial participants can also be a foundation for earning a solid reputation among patient advocacy groups.

2.    Generating the data that matters:

Clinical trials need to be designed to deliver endpoints that matter to patients (as well as regulators, payers and other stakeholders).  Recently, a physician leader at a regional cancer center put it this way:  “We know that we need to focus on outcomes.  But in oncology, is survival really the most important outcome?”  This sentiment echoes from physicians and patients alike.  Patients suffering from chronic illness may not be as interested in whether a product induces remission, as they are in whether they simply feel better!  These endpoints may challenge traditional R&D teams who are accustomed to hard endpoints like survival curves and converting to remission.

This is where patient reported outcomes (PROs) become critical.  A PRO is any outcome that is provided directly by a patient, with no clinical measurement or interpretation.  A well-constructed trial will include PROs that help in understanding patient perspectives on quality of life, activities of daily living, and goal setting, which no other kind of clinical research can provide.  In turn, these data will inform product marketing and support services that will round out a patient-centric value message.

Developing the Partnership

Manufacturers need to ensure that they have the infrastructure in place to support embedding patient considerations throughout the R&D process, as well as to translate these needs in the commercial process.  From developing patient-centric trial recruitment strategies, to establishing patient support lines and educational networks, to translating needs identified through PROs into patient support services, an entire new infrastructure must be developed with the patient at the center. Manufacturers will need to critically assess their current strengths and weaknesses in addressing patient needs, identify gaps that need to be filled, and clearly define roles and accountabilities that will lead the way to a new patient-centric focus.

Pfizer will have access to genetic mapping information for a group of 10,000 IBD patients, as well as patient outcomes reported from an online survey.  

Manufacturers are beginning to explore different ways to build their patient-centered platforms.  Recently, Pfizer announced that it will be partnering with the Google-backed consumer genomics company 23andMe to study inflammatory bowel disease (IBD).  This partnership is a prime example of the synergy that can be achieved by addressing patient needs in early research.  The social media aspect of the 23andMe website serves to attract patients that are interested in connecting with people and learning about their genetics and their illness.  Meanwhile, Pfizer will have access to genetic mapping information for a group of 10,000 IBD patients, as well as patient outcomes reported from an online survey.  This work will support current products that Pfizer is developing for treating IBD, as well as contribute to understanding the basic biology of the disease that will support continued innovation.

As manufacturers respond to the changing environment, the needs of the patient will become increasingly important to overall market access and sales strategy. Companies that take the growing importance of patients seriously, successfully develop a patient-centered R&D strategy, and integrate patient needs through the commercial business will be well positioned with this critical stakeholder group.


Numerof & Associates is a strategy consulting firm with more than 25 years of experience focused on industries in transition like healthcare.  Our unique perspective comes from working globally across the entire healthcare industry - from pharmaceutical, device and diagnostics companies to payers and major healthcare delivery organizations. 


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Real World Evidence Evidence & Data Partnerships

Oct 14, 2014 - Oct 15, 2014, Bethesda

This year real patient data will change healthcare.

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