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Published on: April 11, 2016
Challenges of coverage policy development for next-generation tumor sequencing panels: experts and payers weigh in
Julia R Trosman1, Christine B Weldon1, R Kate Kelley2
1From 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.
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.
Insights
Next-generation tumor sequencing (NGTS) faces coverage challenges with US payers due to its features not aligning with medical necessity definitions. Payer concerns about evidence and implementation may hinder positive coverage policies for this promising cancer diagnostic tool.
Area of Science:
- Oncology
- Genomics
- Health Policy
Background:
- Next-generation tumor sequencing (NGTS) panels are increasingly used in oncology.
- US payers currently lack formal positive coverage for NGTS.
- Limited coverage may impede patient access and clinical adoption.
Purpose of the Study:
- To identify challenges private payers face in covering NGTS.
- To understand payer perspectives on NGTS benefits and coverage considerations.
Main Methods:
- Semi-structured interviews were conducted with 14 NGTS experts and 10 major private payers.
- Qualitative research framework and thematic analysis were employed.
- Simple frequencies were used to describe findings.
Main Results:
- All payers recognize NGTS potential but cite coverage challenges.
- 80% find NGTS features misaligned with medical necessity definitions.
- 70% view NGTS as individual targets, not comprehensive characterization, and question new evidence methods.
- 50% have concerns that preclude positive coverage policies.
Conclusions:
- Payers see NGTS promise but current forms challenge coverage frameworks.
- Multidisciplinary efforts are needed for NGTS development, evidence, and policy integration.
- This study is among the first to directly survey US payers on NGTS coverage.
