Launching “Cancer Moonshot” Demands Coverage, Regulatory Progress
June 7, 2016
Vice President Joe Biden addressed oncologists, industry and medical professionals in Chicago Monday with a resounding plea: collaborate to “translate scientific discovery into meaningful treatments.” The vice president topped off the American Society of Clinical Oncology’s annual meeting, whose theme of “Collective Wisdom” dovetailed with Biden’s message.
But the aims of Biden’s National Cancer Moonshot Initiative may require something more than collaboration to launch – specifically, health coverage and regulatory structures that allow breakthrough medicines to reach cancer patients.
Established by President Barack Obama, the initiative seeks to accelerate cancer research, achieving “a decade’s worth of advances in five years.” The initiative’s $1 billion in funding is designed to:
- Enhance early detection methods
- Encourage data sharing
- Bolster clinical trials
- Speed the development of cancer vaccines.
Immuno-oncology, which harnesses the body’s immune system to fight off cancer, is a particular point of focus for the initiative. Vice President Biden announced during his ASCO address the creation of an open-access cancer research database, the Genomic Data Commons. It details the genomic make-up of cancer tumors and tracks how patients with these cancers respond to various treatments.
But significant barriers to immuno-oncology treatments remain. For instance, precision diagnostics are required to determine which immuno-oncology drug is appropriate for a given patient. Yet, as the Institute for Patient Access’ “Improving Cancer Patients’ Access to Precision Medicine” explains, physicians need more education and a better support system to determine which precision diagnostics should be administered – and when.
Likewise, regulatory structures and health plan designs must evolve to support access to immuno-oncology drugs. Otherwise, high out-of-pocket costs will likely block patients from the very innovation that could save their lives.
And the Food and Drug Administration must adapt its regulatory approach to accommodate a fundamental shift in cancer care –from a “one-size-fits-all approach” where treatments work for the “average patient” to a more personalized, targeted and data-intensive mode of treating cancer. The agency reports that it is creating “a workable regulatory platform” for targeted cancer therapies.
[Watch: “Access to Immuno-Oncology Therapies”]
Data sharing, collaborative research and breakthrough treatments are laudable, essential goals. But without viable coverage and regulatory structures too, oncologists and cancer patients might just as well be wishing on the moon.Tags: Innovation, Oncology, Regulatory Issues
Categorized in: Blog