Putting patients front and center
When it comes to access, pharma can only gain by starting with the patient, says Takeda’s Liz Lewis
‘Access' and ‘patient value’ are familiar terms in the pharma industry, but so often they are used in the abstract with little sense of what they mean to people at the receiving end of healthcare.
Liz Lewis, Head of Global Oncology Patient Value, Policy, and Access at Takeda Oncology, knows better than most, and knows what these words truly mean to people living with cancer around the globe.
Her experience started in childhood. While in high school, she spent time working in the office of her physician father, gaining an understanding of how the reimbursement process worked. Her father would often discuss the differences between reimbursement in the US and his native UK.
“Working in that environment, seeing patients come in every day and what insurance coverage they have, made an impression on me as a teenager because I see the real-world implications of it,” says Lewis.
Clearly her early career as a reimbursement attorney was no accident. This broadened her understanding of the issues. “I developed an understanding of the nuances of what access means from a technical standpoint, which really helps in my current role at Takeda.”
Through the patient’s eyes
Her early work life gave her not just a deep legal and regulatory understanding of patient access and related issues, but also a feel for the on-the-ground practicalities. Getting to know patients and seeing their reactions to the reimbursement process has been invaluable. “As an attorney and access professional, you think primarily about the process and the forms. But, when you are on the ground and see it firsthand, patients quickly realize that it is not always easy or self-explanatory, and is often confusing.”
Before joining Takeda, Lewis was a partner at the Washington DC-based law firm, Epstein Becker & Green, where she represented healthcare and life science companies, ultimately becoming co-chair of the firm’s pharmaceutical practice group.
Today her role is evolving Takeda’s global strategy for securing broad patient access for the oncology portfolio, working at the intersection between policy, advocacy and access. The ultimate goal, she says, is to help change the lives of patients for the better.
“One of the ways we do that at Takeda is through leading innovation in life-saving medicine, but we also do it by taking life-changing medicine and making sure patients worldwide have access to it.”
There’s much work to be done on the latter issue. The disparity between cutting-edge medical research and antiquated approaches to access has become stark. “When it comes to drug discovery and innovation, it feels like Star Trek.Andfrom an access and reimbursement perspective, it feels like we are in the era of The Flintstones,” says Lewis citing the observation a recent speaker made at BIO.
Changing the conversation
Lewis is eager to evolve access to cancer treatments into a new age, but this will only happen by changing the conversation and working in a more collaborative manner, she says. “It is easy to point fingers and say that ‘access is a challenge due to high cost of therapies, because payers are not transparent, because PBMs are in the middle creating no value…’ and so on. But the truth, as always, is more complex. The answers lie in multi-stakeholder collaborations to develop access solutions and we welcome this engagement with others in the system.”
“We will be evolving access by having an integrated conversation to allow for better problem solving and evolution. We all need to do a better job at having all stakeholders at the table to discuss value and what that truly means to a patient. We see so much collaboration in the drug discovery phase and we have to think about developing access in the same way, keeping the patient perspective front and center.”
“I would like a future in which everyone who touches the patient along their journey, from physician to caregiver, and payer, understands the life-changing potential of new treatments and looks at how we frame them by value. Too often it is an economic discussion that does not reflect the patient experience.”
By putting the patient at the center, the concept of value can change from being just about whether something is cost-effective or not, says Lewis.
Takeda has been working to put this concept of supporting the patient throughout their journey for quite some time. Sitting down early and having conversations with patients while developing drugs is providing useful insights.
Working with them to map out the patient journey for one of the medicines that Takeda is in the early stages of developing, for example, revealed some unexpected things. “We learned that the outcomes we had considered were not those that mattered most to patients and we were able to adjust our approach accordingly,” she says.
"We refined our trial design to use these patient-centered priorities so we have quantifiable data that will flow through the registration process and give us the opportunity to have measurable outcomes.”
“By incorporating the patient voice, you have the opportunity to understand the outcomes that matter most to patients and quantify that in a meaningful way. For instance, clinicians may be focused on survival, but the patients may be more focused on adverse events and quality of life.”
At a healthcare system level, there is much that can be done to improve patient access, she adds. “Ideally, to help us get to the next phase of access, it would be encouraging to see payers publicly disclose their policies and procedures on how they listen and act with respect to incorporating the patient perspective. And regulatory bodies will become more robust about how they include patients early in the process.”
The US system has its own set of problems to work out, notably a reimbursement system that is no longer fit for purpose. “We have looked at access in a contentious, finger-pointing way, but it’s important to acknowledge that we have a system that was developed for a very different environment,” says Lewis.
The historical managed care system in service of therapies that have in the past treated millions of patients isn’t sustainable in an era of personalized medicine and cell and gene therapies. “Look at the whole rationale around patient co-pays, which was that patients needed to make an investment in their care as an incentive to choose the cheaper generics or, alternatively, pay for treatments that were not medically necessary. You can’t be a smarter consumer if you don’t have any choice.”
“No matter where you live in the world, regardless of the health system you live under, these are patients’ lives and futures. And their access challenges are real. They scramble the lives of the patients we serve. Our essential role is to change the lives of patients like these for the better.”