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BUILDING THE EVIDENCE BASE FOR APPROPRIATE AND EFFICIENT IMPLEMENTATION OF EMERGING GENOMIC TESTS FOR DISEASE MANAGEMENT AND SCREENING

Award Number: R01HG011792
ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/08/2021
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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BUILDING THE EVIDENCE BASE FOR APPROPRIATE AND EFFICIENT IMPLEMENTATION OF EMERGING GENOMIC TESTS FOR DISEASE MANAGEMENT AND SCREENING - Project Summary Payer coverage and economic value continue to be critical factors in determining whether genomic medicine is appropriately and efficiently implemented into clinical care and health policies. However, genomic tests are now emerging that present particularly difficult challenges for coverage and value determinations because they (a) will be used for screening and early detection in asymptomatic populations in addition to disease management in patients with a condition, and (b) use less-transparent methods, such as algorithmic scores, to establish linkages between genetic markers and disease. Our objective is to assess payer coverage decisions and the economic value of two types of emerging genomic tests for disease management and screening: cell-free DNA tests (cfDNA) and tests based on polygenic risk scores (PRS). The Specific Aims are: Aim 1: Examine which cfDNA and PRS tests are covered and why using (a) systematic evidence reviews of payer coverage policies and (b) structured interviews with payers on how they consider evidence and make coverage decisions. Aim 2: Understand the economic value of cfDNA and PRS tests by taking a patient-centered approach, addressing key methodological challenges, and identifying gaps in evidence. Aim 3: Compare evidence needs for payer coverage (Aim 1) and economic value assessment (Aim 2) across clinical scenarios and generalize our findings on evidence needs to other emerging clinical scenarios, considering patient access and stakeholder perspectives. This study will provide unique insights by examining multiple clinical scenarios and both coverage and economic value. All Aims will be framed around the implications of our findings for patient access and disparities and consideration of stakeholder perspectives within a rapidly changing health care policy and delivery ecosystem. Study outcomes will identify key factors that determine positive coverage, what evidence is needed and how it can be prioritized to develop appropriate coverage and value assessments, how patient- centered and advanced modeling approaches can be applied across clinical scenarios, and how coverage and value assessments can take into account patient access and disparities and diverse stakeholder perspectives. Study findings will contribute to the overarching objectives of systematic development of practices and policies that are appropriate, efficient, and equitable irrespective of whether the tests are covered or shown to have economic value. Our findings will be useful across stakeholders and will facilitate the development of policies and practices that will help patients have appropriate, efficient access to testing.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $852,472 )
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Human Genome Research	000	5	4/25/2025	NON-COMPETING CONTINUATION	$852,472
														Subtotal = $852,472

Issue Date FY: 2024 ( Subtotal = $918,686 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Human Genome Research	001	4	5/29/2024	NON-COMPETING CONTINUATION	$74,995
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Human Genome Research	000	4	4/24/2024	NON-COMPETING CONTINUATION	$843,691
														Subtotal = $918,686

Issue Date FY: 2023 ( Subtotal = $937,434 )
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Human Genome Research	000	3	4/24/2023	NON-COMPETING CONTINUATION	$937,434
														Subtotal = $937,434

Issue Date FY: 2022 ( Subtotal = $937,434 )
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Human Genome Research	000	2	4/22/2022	NON-COMPETING CONTINUATION	$937,434
														Subtotal = $937,434

Issue Date FY: 2021 ( Subtotal = $953,132 )
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Human Genome Research	000	1	7/8/2021	NEW	$953,132
														Subtotal = $953,132

Grand Total All Awards = $4,599,158

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BUILDING THE EVIDENCE BASE FOR APPROPRIATE AND EFFICIENT IMPLEMENTATION OF EMERGING GENOMIC TESTS FOR DISEASE MANAGEMENT AND SCREENING

Award Number: R01HG011792

ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/08/2021

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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