“As the emergence of COVID-19 grips the global psych, policymakers and citizens will increasingly turn to thought leaders in health and medicine for answers about how to equip our health systems to respond to medical challenges in a new era. Proponents for personalized medicine are ready.”

Christopher J. Wells, PMC Vice President, Public Affairs, Personalized Medicine In Brief, Vol. 14, Page 8, Spring 2020 (“Newsletter”)

The Personalized Medicine Coalition (“PMC”) recently published its 2020 Spring Newsletter that examines the landscape and outlook for personalized medicine as COVID-19 prompts new discussions about the effect of COVID-19 on health care and the role of diagnostics in the future of medicine. The Newsletter highlights current advances and challenges for personalized medicine and the diagnostic industry in general. 

Policy, Education, Regulatory and Reimbursement Priorities

Cynthia A. Berns, PMC Senior Vice President, Public Policy, highlights several educational, regulatory, and reimbursement policy advances and PMC initiatives. Newsletter at pages 4-5. First among them is the newly formed Congressional Personalized Medicine Caucus (co-chaired by Rep. Eric Swalwell (D-CA), Rep. Tom Emmer (R-MN), Sen. Kyrsten Sinema (D-AZ), and Sen. Tim Scott (R-SC)). The new caucus seeks to expand support for, and knowledge of, personalized medicine by enhancing public awareness and advocating for policies in support of its advancement. 

The Food and Drug Administration (“FDA”) continues its support of personalized medicine therapies. For example, earlier this year FDA released several regulatory guidances to facilitate the efficient commercialization of cell and gene therapy. 

In response to feedback proposed by the PMC and other proponents, the Centers for Medicare and Medicaid Services (“CMS”) clarified its coverage policy for next-generation sequencing (NGS) in cancer care. Ms. Berns notes that in addition to revised national coverage of FDA-approved or-cleared NGS-based testing for genetic variants that increased susceptibility for breast and ovarian cancers, the policy also allows regional Medicare Administrative Contractors to cover non-FDA-approved tests for these and other preventive tests. Interestingly, she notes that re-testing is not covered. 

She also notes that the increased pressure on cost containment for prescription drugs could prompt legislators to adopt measures that unintentionally eliminate incentives for developing high-value personalized treatments. In addition, many investors hesitate to commercialize diagnostic tests until there is a clearly defined oversight framework for them. Newsletter at page 5.  

Increasing Clinical Integration

Daryl Pritchard, PMC Senior Vice President, Science Policy summarizes several of the expanding research and innovation initiatives that support clinical adoption of personalized medicine. Newsletter at pages 6-8. Of note is the PMC’s commissioned study that examined clinical adoption of personalized medicine practices across a wide range of health care delivering institutions across the U.S. The study found that while there was a wide variability of clinical integration across health care institutions, most had adopted some type of program indicating that personalized medicine is becoming more widely practiced, but challenges remain.

To address utility concerns and increase clinical adoption of personalized medicine, Mr. Pritchard explains that the PMC will “summarize the evidence demonstrating the importance of personalized medicine” in a new edition of its Personalized Medicine Report. Newsletter at page 7. 

In addition, the PMC is working with Illumina and other partners on a study entitled “The Utilization of Genomic Testing in the US: A Landscape Analysis” to better understand how payer coverage policies affect the utilization of genomic testing. Newsletter at page 7. 

Personalized Medicine Education

Christopher J. Wells notes that the PMC will convene its first Education Council to review and inform the public about the significance of personalized medicine in the context of global needs in health care. Newsletter at page 8. Those interested in participating on the Education Council are encourage to contact PMC staff.

As part of its educational initiative, the PMC is working on a revised Personalized Medicine Report: Opportunities, Challenges, and the Future to summarize collective evidence. The evidence will be used to support the benefits of targeted therapies for individualized health care and the allocation of health care resources. 

The PMC also is proposing the development of an online Library of Personalized Medicine to serve as a clearinghouse for available resources in personalized medicine. 

Personalized Medicine Perspectives for COVID-19 Reaction

The nation’s attention is on the COVID-19 outbreak and its impact on the health of our families, our neighbors and our world. Personalized medicine’s focus on early diagnosis and monitoring of disease can offer insights for the current health care concerns. Edward Abrahams, PMC’s President noted that personalized medicine thought leaders have been considering how the emergence of COVID-19 has influenced society in a matter of weeks. Mr. Abrahams explains: 

[L]essons learned from the emergence of COVID-19 will undoubtedly shape discussions about the future of health care in America and around the world for years to come. . . PMC is well positioned to influence those discussions, believing that personalized medicine can and will play an increasingly important role. The overwhelming influx of patients who may be infected with the new virus reminds us of the need for diagnostic tools that can help target the most intensive medical interventions to those who need them most.  

Newsletter at page 2.