7 Questions: Donna Cryer on raising awareness of liver diseases

pharmaphorum hears why the Global Liver Institute was established and how it is making a difference for the millions of people with liver diseases around the world.

You have played a major role in advancing patient involvement in all aspects of healthcare decision making over the last decade. What challenges remain in this respect?

Patient involvement in healthcare decision making occurs in multiple settings, but primarily at the individual and policymaking levels. The challenge for individual patient involvement is the integration of decision aids – treatment descriptions, options, side effect information – in a manner that works for both clinicians and patients in terms of format, literacy level, and timing. At the policymaking level, now that that is an accepted role for patients, the challenge is sourcing, matching, and equipping larger numbers of patients to fill, and perform well in, these new roles.

These are exciting times for patients with liver diseases, with new hope of better treatment, and even cures, as in hepatitis C. You set up the Global Liver Institute (GLI) last year. Why was this necessary and what are your main goals over the next few years?

As a liver patient for more than two decades myself, as well as someone who has worked professionally and as a volunteer in the space, I saw, and continue to see, fantastic innovations and therapies that weren’t being accessed by all patients who needed them, such as the hepatitis C cures, but also hepatitis B vaccination, liver transplantation, public health initiatives in Asia to improve early detection of paediatric liver disease and liver cancer.

A key problem is lack of awareness and understanding of these diseases, despite them affecting more than 500 million people. Overcoming these issues would mean that these patients, and the 100-plus liver diseases, are valued. I partnered with leaders in medicine, technology, finance, and other patient families in creating the GLI to change the culture around liver diseases. Our Creatives Collaborative, for example, is committed to bringing patients, caregivers and doctors together with writers, actors, producers, directors and celebrities to incorporate liver health awareness messages into TV and the media and thereby reduce stigma. We are also expanding the number and type of stakeholders involved and invested in eradicating liver diseases through our Chief Medical Roundtable for Liver Health, and redesigning health systems to better serve liver patients and prevent liver diseases through partnerships with leading academic medical centres.

As patient advocacy organisations grow bigger and more integrated into decision-making structures, how can they ensure they remain true to the spirit of representing patient interests?

One of the first questions we researched in developing the GLI was how do patient advocacy organisations stay patient-centred? We are rare in that I am both a patient and have professional experience in non-profit management. It is important to have patients and patient family members involved at every level, from the board, on staff, on advisory councils, and to establish online methods for regular, candid, grassroots communication with patients to understand a breadth of issues, challenges, and needs. Organisations which have patient experience surveys, capture patient narratives, and use other methods of qualitative and quantitative research can better represent patients.

Do you think that pharma understands patient-centricity? What are the biggest steps the industry needs to take to demonstrate its commitment to patient-centricity?

Pharma has certainly adopted the term patient-centricity, but companies have actually incorporated the concept into their actual business processes to varying degrees. Timing is one of the greatest indicators of patient-centricity – does the company involve both patients and patient advocacy organisations from the outset of the research and development process, or wait until just before a drug launch? Partnership is another key indicator of commitment – is the relationship more than transactional? Do initiatives develop because they truly meet the needs of patients in the therapeutic area and leverage the skills and capabilities of both the company and the patient community?

Access to medicines is a major issue in the richer nations, such as the US, and less well-off countries. What more needs to be done to address this? Does pharma need to do more on its prices?

Price transparency and total value provided by a medication are two pieces of information most likely to advance the access conversation and most likely to be missing. We need new formulas for pricing, purchasing, and payment of new therapeutics, particularly those that provide high value, such as the hepatitis C cures. These medications cost less than many medications that alleviate symptoms or induce remission for a short period of time, but because of the upfront cost and the current method of payer budgeting they are deemed a crisis instead of celebrated. Clearly, cases such as this need to be treated as public health issues, purchased in bulk or supported with enhanced federal matching to ensure patients and communities benefit.

Do you think that the Affordable Care Act (ACA) is here to stay? Why does that matter for US patients?

The ACA has survived multiple challenges. That, to me, is a recognition that our healthcare system was so broken and unsustainable prior to passage that going back is not an option. The ACA is important for patients – and for everyone – not only because of the coverage expansions for pre-existing conditions and the de-linking of insurance from employment, but because of other provisions such as the Patient Centered Outcomes Research Institute, which is providing comparative effectiveness information and patient-powered research networks and the Capability Maturity Model Integration (CMMI), which funded healthcare delivery system experiments, often involving care coordination or other patient-serving redesign that would not otherwise have support.

The 21st Century Cures bill looks likely to become law at some point. There are many enthusiastic supporters who believe it can accelerate medical progress, but others are concerned about it dismantling safeguards for safety and efficacy. What are your views?

If for no other reason, the 21st Century Cures initiative has succeeded in restoring trust that Congress can conduct a bi-partisan effort involving diverse stakeholders as meaningful participants and affording priority to long-term research and development infrastructure. Safety and efficacy assessments are enhanced by better funding and equipping the US FDA and creating a faster, tighter feedback loop of real-world data after a drug is approved and used by a larger and more diverse population than studied. We need to have legislation that matches the technological advances in computing, genomics, and other fields that are recognised by the bill.

About the author:

Donna Cryer is president and CEO of the Global Liver Institute, where she has channelled her personal experience as an IBD and liver transplant patient into professional advocacy.

She was the first patient to lead the American Liver Foundation in its 36-year history, serving as chair and CEO, and led CryerHealth, a healthcare consulting firm providing strategic counsel on patient engagement in health information technology, drug discovery and clinical decision making.

She was appointed by the US Government Accountability Office to serve as the patient and consumer representative on the Health Information Policy Committee, the federal advisory body to the National Coordinator for HIT and is serving her second five-year term with the US Food and Drug Administration.

She also serves on the boards of the Society for Participatory Medicine and the Personalised Medicine Coalition, and is a merit reviewer for the Patient Centered Outcomes Research Institute (PCORI).

Donna Cryer holds an undergraduate degree from Harvard/Radcliffe Colleges and a Juris Doctorate from the Georgetown University Law Center.

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