A new study published in the Journal of the National Comprehensive Cancer Network dives deeper into understanding the major roadblocks to coverage of hereditary cancer panels.
Published Online: February 15, 2017
Surabhi Dangi-Garimella, PhD
In his 2015 State of the Union speech, former President Barack Obama called for additional investment in personalized medicine, which included the announcement
of the Precision Medicine Initiative (PMI). However, discrepancies within payer policies on coverage of genetic tests was identified as a big barrier to the success of this program. A new paper published in the Journal of the National Comprehensive Cancer Network
dives deeper into understanding the major roadblocks to coverage of hereditary cancer panels (HCPs).
HCPs, which test for multiple genes and can provide information on a person’s risk for several syndromes, can have a big impact on cancer risk assessment. However, these tests lack formal coverage. Led by Julia R. Trosman, PhD, adjunct assistant professor, TRANSPERS, Department of Clinical Pharmacy, University of California, San Francisco (UCSF), the researchers interviewed 11 major US payers covering more than 160 million lives.
“We believe that understanding payers’ coverage decision-making is imperative to ensuring future patient access to potentially transformative modalities and informing genetic research,” Trosman said
. The study focused on private payers because they cover two-thirds of the US population.
The study identified the following barriers to coverage of these multigene panels:
Poor fit with coverage frameworks (100%)
Insufficient evidence (100%)
Departure from pedigree/family history–based testing toward genetic screening (91%)
Lacking rigor in the HCP hybrid research/clinical setting (82%)
Patient transparency and involvement concerns (82%)
Payers have developed different approaches to address these barriers, and they shared their ideas during the interview. They told the researchers, for example, that they would readily accept observational and pooled studies and registry data to confirm statistical significance, instead of confirmatory randomized clinical trials, which are much more rigorous to plan and conduct. Other recommendations included:
Developing evidence of actionability (82%)
Developing evidence of pathogenicity/penetrance (64%)
Creating infrastructure and standards for informing and recontacting patients (45%)
Separating research from clinical use in the hybrid clinical-research setting (44%)
Adjusting coverage frameworks (18%)
“Many previous studies on reimbursement for genomic technologies, including our own, were focused on barriers to coverage,” said Trosman. “We are encouraged that the present study also identified opportunities that could be pursued to mitigate barriers.”
The authors conclude that their study informs 3 areas that can propel the precision medicine movement forward: incorporating payers’ evidentiary requirements into PMI’s research agenda; and leveraging payers’ recommendations and experience to keep patients informed and involved.
Trosman JR, Weldon CB, Douglas MP, et al. Payer coverage for hereditary cancer panels: barriers, opportunities, and implications for the Precision Medicine Initiative. J Natl Compr Canc Netw