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Last week, the Cancer Moonshot Inter-Agency Task Force released its 2016 report aimed at making a decade’s worth of progress against cancer in the next five years. This report, following the Blue Ribbon Panel’s research-focused recommendations released last month, provides a policy roadmap aimed at catalyzing a “coordinated effort” to “dramatically accelerate the pace of progress in the fight against cancer.”
The Task Force report reminds us that innovation cannot survive if it does not ultimately advance the practice of medicine, and vice versa. While the report emphasizes the need to realign federally-funded research incentives, enhance prevention and screening, and share data, we need to go farther to enact policy that bridges the full spectrum of cancer research and care delivery.
Our organizations have engaged the cancer community over the past five years to explore policy solutions that support high-quality, patient-centered care, specifically in bringing new therapies to patients and improving patient access and care. What we have consistently discovered is that any effort to pursue progress against cancer on behalf of patients must take into consideration the preferences, priorities, and needs of one group — patients. Below are several suggestions for policymakers to consider as we all seek to fuel progress against cancers.
Accelerating Bringing New Therapies to Patients
Patients are the key beneficiaries of cancer innovation. Unfortunately, less than 5 percent of patients with cancer participate in clinical trials; progress against cancers is impossible without their involvement. The success of the Moonshot is incumbent upon meaningful inclusion of patients, early and often, to provide input on the clinical research process. Policymakers should support programs to elicit and include feedback from patients and patient advocates in trial design, so we have trials that not only align with the evolving science of oncology, but also reflect the needs, priorities and outcomes that matter to patients. Additionally, as we work to increase awareness of and enrollment in cancer clinical trials, policies should make patient participation in these trials easier and more affordable — clinical trial participation must be covered by value-based reimbursement models. Coverage could encourage patient participation in trials and enable meaningful generation of evidence.
Making our clinical trials process more efficient is another way to get innovation to patients more quickly. The report recognizes that trials geared toward increasing our understanding of the molecular drivers around various forms of cancer accelerate getting personalized treatments to patients. To foster this kind of innovation, however, we need policies that reduce the uncertainty around both the use and regulatory acceptance of novel clinical trial designs and outcomes measures (i.e., biomarkers and patient-reported outcomes) in the drug development and approval process. Therefore, we applaud the U.S. Food and Drug Administration’s engagement of the cancer community to create a more effective, efficient, and forward-thinking regulatory process that fully supports personalized medicine in oncology.
Improve Patient Access and Care
We need policymakers to provide guidance on coverage and reimbursement for the innovative medicines the Moonshot will undoubtedly generate, particularly as patients continue to face increasing costs for oncology care and medicines. As we move into an era defined by personalized therapy, coverage and reimbursement policies must reflect the heterogeneity of “cancer,” a term that now encompasses more than 200 unique diseases. We need policies that support patient-centered care, reimburse for evidence-based molecular diagnostics, sustain the development and utilization of personalized medicines, support informed patient decision-making and align with value-driven healthcare. Clinically significant enhancements of survival and quality of life are essential for value-based reimbursement to occur. Efforts that impose one-size-fits-all coverage standards or make blunt payment cuts to achieve cost containment will ultimately conflict with personalized medicine innovations and the goals of the Moonshot initiative.
A new era of molecular and genetic testing enables increasingly personalized decisions, which means physicians and patients must be equipped with tools to make informed decisions about treatments, based on evolving clinical evidence and patient differences. We encourage policymakers to engage and listen to all stakeholders in the oncology community, particularly patients, to support the development of these tools, sharing of real world data, and implementation of policies that support patient access to personalized therapies.
Vice President Biden has suggested that the “science is ready” in oncology; we agree. But to move the science from the bench to the bedside, we need policies that reflect not just the basic research challenges, but also the full continuum of cancer research and care delivery. The vice president has worked closely with the scientific research community in the early stages of this initiative. There is an equally passionate and dedicated community focused on translating research discoveries into innovation in practice. As we move into the next phase of the Moonshot, we encourage policymakers to leverage these voices to keep patients at the center of our efforts and make sure that they benefit from scientific innovation.
Edward Abrahams is the president of the Personalized Medicine Coalition; Gilbert S. Omenn is chair of the Health Policy Committee of the American Association for Cancer Research and director of the Center for Computational Medicine and Bioinformatics at the University of Michigan; and Marcia A. Kean is chairman of strategic initiatives for Feinstein Kean Healthcare. They are the co-conveners of the Turning the Tide Against Cancer initiative, which works with members of the cancer community to identify policies that sustain medical innovation while addressing the issue of rising health care costs.
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