Payers Weigh the Implications of Multigene Testing Coverage
Innovation in precision medicine has introduced an amalgam of testing options, of which hereditary cancer panels—multigene tests—are a major component. Additionally, the importance of inherited cancer genomics was further bolstered by former President Barack Obama’s Precision Medicine Initiative in 2015. Controversy lay, however, in the lack of formal insurance coverage policy for such tests. To expose the major roadblocks to coverage, researchers from the University of California, San Francisco (UCSF) Center for Translational and Policy Research on Personalized Medicine (TRANSPERS) and the UCSF Helen Diller Family Comprehensive Cancer Center, interviewed 11 major U.S. payers covering 160 million lives. The results of their study were published by Trosman et al in the Journal of the National Comprehensive Cancer Network.
“We believe that understanding payers’ coverage decision-making is imperative to ensuring future patient access to potentially transformative modalities and informing genetic research,” said lead author Julia R. Trosman, PhD, Adjunct Assistant Professor, TRANSPERS, UCSF Department of Clinical Pharmacy; Adjunct Assistant Professor, Northwestern University Feinberg School of Medicine; and Director at the Center for Business Models in Healthcare, an independent research organization. “We focused on private payers, as they collectively cover two-thirds of the insured U.S. population, and their coverage decisions affect public payer policy. The 11 major payers involved in our study collectively cover over 160 million enrollees in the U.S.”
Researchers also believe that payers’ hereditary cancer panel coverage considerations have implications on the Precision Medicine Initiative and its efforts to assemble more than one million volunteers to contribute genomic, clinical, and lifestyle data to advance genetic science. Based on the findings from the study, the paper discusses how the Precision Medicine Initiative design can incorporate payer feedback to ensure patient access.
Interview Findings
A majority of payers noted that novel hereditary cancer panel features present a unique appeal to patients and clinicians, but 100% of those interviewed cited that the panels do not fit within current coverage frameworks and lack necessary evidence, while more than 90% noted that the hereditary cancer panels represented departed from pedigree/family history-based testing toward genetic screening.
Payers shared not only barriers to hereditary cancer panel coverage, but also opportunities to address them. For instance, participants shared insight into how evidentiary requirements for the plans can be met, noting that, in many cases, randomized controlled trials may not be required. Rather, observational and pooled studies and registry data may be acceptable to confirm statistical significance. Some also suggested that coverage and evidence evaluation frameworks could potentially be modified to align with panel features and benefits.
In addition to clinical and evidentiary concerns, more than 80% of those interviewed expressed concern about patient engagement and understanding of the ramifications of such panels. Despite completion of the informed consent form, it remains a challenge to ensure that patients understand the emergent state of evidence for many genes in panels and express their wishes regarding being recontacted in the future when new evidence becomes available.
“We hope that our findings bring attention to the topic of insurance coverage for cancer panels and contribute to a productive dialogue among various stakeholders on framing an approach to address payers’ concerns,” stated Dr. Trosman. “Many previous studies on reimbursement for genomic technologies, including our own, were focused on barriers to coverage. We are encouraged that the present study also identified opportunities that could be pursued to mitigate barriers.”
Future Incorporation of Payer Feedback
Identified within the article are three target areas where the Precision Medicine Initiative design can incorporate payer feedback and, therefore, strengthen its impact on patients and genetic science: (1) address insurance coverage barriers to secure access to future Precision Medicine Initiative discoveries; (2) incorporate payers’ evidentiary requirements to the Precision Medicine Initiative research agenda to increase relevance of research to future coverage decisions; and (3) leverage payer recommendations and experience to keep patients informed and engaged.
“This study represents another step forward in understanding the discordant needs between health-care providers and payers with regard to coverage of hereditary cancer panels. Many of the barriers to coverage cited by the payers interviewed in this study—including gaps in evidence on gene penetrance and questionable actionability—are shared by the genetics community. The concern of the payers that availability of hereditary cancer panels will lead to ‘indiscriminant genetic screening,’ however, is likely unfounded. Instead, considerable effort on the part of the genetics community has been, and continues to be, devoted to evolving counseling models and encouraging patient participation in testing decisions to deal with the inherent uncertainties involved with genetic risk. On the other hand, it is promising that the payers support the need for pre- and post-test counseling, and they are open to the development of novel models to address the current barriers to coverage,” said Mary B. Daly, MD, Fox Chase Cancer Center, Chair, NCCN Guidelines Panel for Genetic/Familial High-Risk Assessment: Breast and Ovarian.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
