The coreNASH: Multi- stakeholder Consensus on Core Outcomes (COS) for Decision Making About Nonalcoholic Steatohepatitis Treatment has announced publication of the work of the coreNASH panel. The publication is led by Elizabeth Clearfield. Elizabeth is an epidemiologist with experience in methodology, surveillance, data analysis, Cochrane systematic reviews and large-scale literature reviews, manuscript preparation, and field investigation, in government, consulting, and academic positions. Elizabeth is based at the Center for Medical Technology Policy, Baltimore, Maryland, United States. The paper is published in Hepatology Communications which is a peer-reviewed, online-only, open access journal for fast dissemination of high quality basic, translational, and clinical research in hepatology.
coreNASH was an initiative to develop a COS for NASH using a modified Delphi consensus process with a multi‐stakeholder voting panel. A candidate outcome list was created based on a literature review and key informant interviews. Leonardo Ruiz-Casas, Principal Health Economist, at HCD Economics is a member of the panel and as such contributed to the work reported in the publication.
Research funding for the initiative reflects the commitment being made by the pharmaceutical industry in the discovery of improved NASH treatments. Research fund contributors included Sanofi, GENFIT, Intercept Pharmaceuticals, Pfizer, AstraZeneca, NGM Biopharmaceuticals, Allergan, Novartis, Boehringer Ingelheim, Novo Nordisk, NuSirt Biopharma.
The increasing prevalence and burden of nonalcoholic steatohepatitis (NASH) has spurred the development of new treatments and a need to consider outcomes used for NASH treatment decision making. A consensus‐based COS has been developed that can be used across the life cycle of NASH treatments. Outcomes included can contribute to decision making for regulatory, market access, and on‐market decision making. Including the coreNASH COS in clinical development programs will facilitate improved comparisons and help decision makers assess the value of new products.
Development of a NASH core outcome set (COS) can help prioritize outcomes of highest importance by incorporating the perspectives from a variety of decision makers . The coreNASH Delphi panel included 53 participants (7 patients, 10 clinicians and researchers, 7 health technology assessors, 22 industry representatives, 2 regulators, and 5 payers) who considered outcomes for two NASH‐related COS: one for NASH without cirrhosis (F2‐F3) and one for NASH with cirrhosis (F4). The initial candidate outcome list for both disease stages included 86 outcomes. The panel agreed on including two core outcomes for NASH without cirrhosis and nine core outcomes for NASH with cirrhosis in the COS.
HCD Economics entered the field of NASH research, with a multi-centre global burden of illness study (the GAIN study - https://www.jhep-reports.eu/article/S2589-5559(20)30076-8/fulltext), Leo was a study lead for HCD Economics and participated in the GAIN publication. Future investment in NASH research is planned by HCD Economics all of which is directed towards improving the evidence and understanding of core outcomes in NASH.
For further information on the HCD Economics portfolio of current and planned NASH research projects, please contact Alison Rose – firstname.lastname@example.org
For a personal insight into the work of the coreNASH panel, please contact email@example.com