The 5 ‘Rs’ of Precision Oncology
Last month, the Biden Administration announced the relaunch of the Cancer Moonshot, the public-private partnership that first started in 2016.
The original initiative, in tandem with the 21st Century Cures Act, aimed to foster breakthroughs in the treatment of both common and rare cancers. The new version of the program builds upon this mission.
The Cancer Moonshot 2.0 has highly ambitious goals, including reducing the death rate from cancer by at least 50 over the next 25 years and dramatically improving the experience of being a cancer patient and caregiver during both treatment and survivorship.
To achieve these objectives, we must do more than just find new ways to shrink tumors. We also need to build infrastructure to deliver more targeted and personalized care to all patients based on their unique biological, behavioral, and socioeconomic needs.
Doing so will require concerted effort and collaboration from across the entire life sciences community. By embracing the 5 “Rs” of personalized oncology, we can architect a future patients, pharma, providers, and payers are fully aligned to maximize the potential of cutting-edge therapies.
Regulation: Creating a springboard for innovation
The Cancer Moonshot 2.0 is an important jumping off point for more personalized care. Along with the ongoing focus on precision medicine, the Moonshot will provide critical funding and policy support for promising areas of research, including CAR-Ts and other immunotherapies.
As this work unfolds, we need to ensure that regulations provide a platform, not a barrier, for innovation. We must advocate for policies that prioritize data-driven decision-making, encourage equitable and affordable access to care, and leave room for life sciences companies to creatively innovate while keeping patient safety at the core of all our efforts. For example, recent guidance from the FDA on real-world data is the type of guardrail that is needed so that all industry players have insight on what is acceptable when it comes to oncology innovation in a regulated environment.
Representation: Engaging diverse patient populations in cancer research
Just last month, JAMA shared new research that shed light on a severe lack of diversity in clinical trial participation. This study of FDA-approved vaccine trials from 2011-2020 found that 78% of participants were white. The clinical research industry has long struggled with participant diversity in clinical trials, and the pandemic has only exacerbated an already inequitable situation.
Clearly, representation matters in cancer care, and all healthcare, really. To accurately reflect real-world care scenarios and effectively personalize treatment, clinical trials must include diverse populations from the start. Researchers, clinicians, and patient advocates will need to collaborate with regulators and drug developers to increase representation in the research environment and expand clinical trial access to traditionally underserved populations.
We can do so by exploring distributed clinical trials, harnessing the power of real-world data to support synthetic control arms, and educating patients and their providers about opportunities to contribute digital and biological data during and after treatment.
Reimbursement: Realigning the financial mechanisms for personalized care
Cancer care can be extremely expensive, especially when targeted or experimental therapies are on the table. Historically, it has been difficult to create outcomes-based reimbursement structures that take this into account, especially for rare diseases and complex cases.
However, as other areas of the healthcare landscape demonstrate the viability of value-based , we can begin to adopt similar principles in oncology. The first step in this journey is to determine treatment regimens that can and should be included in bundled payment programs for sub-disease patient populations.
COTA and a large New Jersey commercial payer are doing just this with the drug Polivy (polatuzumab vedotin-piiq) for example. Evidence of Polivy’s positive effect when added to a standard first-line treatment regimen in patients with diffuse large B-cell lymphoma was published at last year’s American Society of Hematology meeting. As a result, the New Jersey payer is exploring Polivy’s inclusion in bundled payment programs and is monitoring the drug’s use with real-world data. The inclusion of this tailored treatment will likely improve outcomes for a specific group of patients while also reducing variability in cost for both the provider and payer.
By rewarding better outcomes instead of simply paying for treatments, we can encourage clinicians to focus on the patient experience and enhance incentives for high-precision, highly personalized care across the life sciences continuum.
R&D: Balancing blockbusters with targeted treatments
Pharma companies use their resources wisely, and so they typically walk a fine line between developing big blockbuster drugs that can benefit millions and crafting more targeted therapies for rare diseases. As we move forward, we must ensure that both sides of the equation receive adequate attention.
If we leverage tools like real-world data and virtual care to conduct clinical trials more quickly and effectively, we can make the development of bespoke therapies more efficient and cost-effective.
Using these strategies to improve the financial profile of treatments for rare diseases, as well as gaining additional federal support for these efforts through initiatives like the Cancer Moonshot, will allow pharma companies to engage in both categories and bring better solutions to patients with all types of cancers.
Realization: Taking collaborative action to enhance the future of cancer care
The Cancer Moonshot 2.0 invites us to reimagine a future in which every individual has access to safe, effective, affordable treatments specifically suited to their disease state. If we are to make this vision a reality, the pharma industry will have to work together in new and better ways.
We need to exchange our best ideas more freely with each other in consortiums and other collaborative settings. We need to liberate clinical data and build more robust interoperability so we can access necessary insights. And we must invest in ongoing dialogue with regulators to understand their perspectives, reduce red tape, and implement helpful guardrails for the next generation of cancer therapies.
By following these five Rs as a roadmap to build the foundation for precision oncology, we can cure more cancers while significantly improving the experiences and outcomes of current and future patients — all while moving from a Moonshot toward a monumental win for the millions of people who have been touched by cancer.