Challenges of coverage policy development for next-generation tumor sequencing panels: experts and payers weigh in.
BACKGROUND
Next-generation tumor sequencing (NGTS) panels, which include multiple established and novel targets across cancers, are emerging in oncology practice, but lack formal positive coverage by US payers. Lack of coverage may impact access and adoption. This study identified challenges of NGTS coverage by private payers.


METHODS
We conducted semi-structured interviews with 14 NGTS experts on potential NGTS benefits, and with 10 major payers, representing more than 125,000,000 enrollees, on NGTS coverage considerations. We used the framework approach of qualitative research for study design and thematic analyses and simple frequencies to further describe findings.


RESULTS
All interviewed payers see potential NGTS benefits, but all noted challenges to formal coverage: 80% state that inherent features of NGTS do not fit the medical necessity definition required for coverage, 70% view NGTS as a bundle of targets versus comprehensive tumor characterization and may evaluate each target individually, and 70% express skepticism regarding new evidence methods proposed for NGTS. Fifty percent of payers expressed sufficient concerns about NGTS adoption and implementation that will preclude their ability to issue positive coverage policies.


CONCLUSIONS
Payers perceive that NGTS holds significant promise but, in its current form, poses disruptive challenges to coverage policy frameworks. Proactive multidisciplinary efforts to define the direction for NGTS development, evidence generation, and incorporation into coverage policy are necessary to realize its promise and provide patient access. This study contributes to current literature, as possibly the first study to directly interview US payers on NGTS coverage and reimbursement.
From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California. From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California. From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California.
Julia R
JR
Trosman
From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California. From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California. From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California.
Christine B
CB
Weldon
From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California. From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California.
R Kate
RK
Kelley
From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California. From UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California, San Francisco (UCSF), San Francisco, California; Center for Business Models in Healthcare, Chicago Illinois; Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medicine, Division of Hematology/Oncology, UCSF, San Francisco, California; and Helen Diller Family Comprehensive Cancer Center at UCSF, San Francisco, California.
Kathryn A
KA
Phillips
D002140:California; D005104:Expert Testimony; D019538:Health Care Surveys; D059014:High-Throughput Nucleotide Sequencing / Q000191:economics; D006801:Humans; D019458:Insurance Coverage / Q000191:economics*; D008495:Medical Oncology / Q000191:economics* / Q000331:legislation & jurisprudence*; D009369:Neoplasms / Q000175:diagnosis / Q000235:genetics; D011050:Policy Making