Doctor shows patient chart
If you’ve attended a biopharma conference or industry meeting in the past 18 months you’ve probably heard companies touting the fact that they are “patient-centered.” In this increasingly patient-driven healthcare economy we all want to be patient centered – even more so as the Food and Drug Administration (FDA) embraces its “Patient-Focused Drug Development Initiative,” an effort to get patients, patient advocates and patient communities more involved in the regulatory process.

But for a lot of people “patient-centered” has become one of those phrases, like “people person” or “all natural.” It sounds good, but it doesn’t hold a lot of substance unless companies implement real changes that actually incorporate the patient’s voice into the entire lifecycle for their products – from research and development process through market delivery. That’s where a lot of companies fall short.

As the FDA and European Medicines Agency (EMA) move toward more patient-centered, value-driven decision-making as part of their drug review and approval process, biopharma companies can’t afford not to have the patient’s voice reflected in articulating the safety and efficacy of their products. I’ve had the privilege to work closely with FDA and many biopharma companies in their evolving patient-centered strategy over the years, and I’ve learned a lot about what it means to incorporate patients into the drug development lifecycle, and why it’s worth the effort. Here are some of those lessons:

Talking to clinicians and experts alone what patients want is not what being patient centered means. Indeed, it is not even the beginning. Healthcare providers in a disease area bring a vital perspective to understanding the patient’s experience. However, as a clinician (psychologist) myself, I am often focused on my understanding of the patient’s needs and priorities. While that understanding is based upon working with patients, it is not the same as directly listening to patients. I find myself focused on what I believe is most important for their well-being, given my training and experience.

To be patient-centered we have to actually listen to the patients, at every stage of the research and development process. I don’t mean talk to patients. I mean listen to patients. In these listening exercises, we have the opportunity to find out what their experience, their journey with a disease, is like from their unique perspective.  I have found such listening interviews invaluable as we plan for a product development program or post-launch activities.

You also need to listen to the nurses, technicians, caregivers, parents and other front line healthcare workers who deal with the everyday misery and triumphs of these patients. Again, listen, not talk. These listening exercises should be centered on how the healthcare workers experience of what their patients feel, how they function with their disease, and what is most important to them in the treatment of their disease.

Being truly patient centered is a smart business decision. We work in a for-profit industry where business decisions need to drive bottom line results. In this business, patients are our ultimate customers, and as in any other for-profit industry, understanding what our customer wants and communicating your value proposition to them just makes good business sense.

In my particular circumstance, I use all of these to develop patient centered outcomes. That is, we seek to reliably and validly measure the patient’s experience so that the data is robust and compelling to regulators, payers, clinicians, and the patient’s themselves! We reflect that patient’s voice in these patient-centered outcomes. And, we have been successful with regulators in having this patient centered outcome data appear on the product label.

Consider BTG’s recent FDA approval for Varithena, its injectable foam treatment to dissolve varicose veins as an alternative to surgical removal. The UK-based biopharma company included patient-centered details in its product information to demonstrate the added value of the treatment, specifically that it not only eliminates the appearance of varicose veins, it is also “proven to reduce the five symptoms patients consider most important – heaviness, achiness, swelling, throbbing, itching.” This additional patient-centric data was the basis of FDA approval in 2013, and the company now expects global sales of the treatment to reach $500 million a year.

This is just one example of how listening to patients and communicating patient-centered value propositions can help companies create better products and marketing strategies that lead to more successful bottom-line business results.
Topics in this blog post: Patient-centered, Biopharma, Triple Aim, FDA, EMA