The U.S. House Appropriations Committee said its budget proposal for the Department of Health and Human Services includes $24.4 billion in emergency spending, and $47 billion for the NIH, an increase of $5.5 billion over the enacted level for the current fiscal year. The allocation for the NIH would include $5 billion to improve capacity at the NIH’s institutions and $240 million for research into a universal flu vaccine. The $8 billion directed toward the CDC is more than $230 million above the enacted level for fiscal 2020, but the CDC would also receive a $9 billion emergency supplemental that would enable the agency to make preparations for public health emergencies. Public health data and surveillance activities at the CDC would receive $50 million, while $700 million would be applied toward preparedness cooperative agreements. The Biomedical Advanced Research and Development Authority would receive $3.5 billion for development of advanced manufacturing technologies for vaccines and therapeutics, and another $500 million for next-generation vaccine manufacturing facility enhancements. BioWorld will cover the committee’s hearing for the budget proposal in a future edition.
The Institute for Clinical and Economic Review (ICER) posted a draft scoping document outlining its planned review of the comparative clinical effectiveness and value of treatments for high cholesterol in the setting of heterozygous familial hypercholesterolemia or secondary prevention of atherosclerotic cardiovascular disease. The therapies include inclisiran (Novartis AG), bempedoic acid (Nexletol, Esperion Therapeutics Inc.) and bempedoic acid/ezetimibe (Nexlizet, Esperion). Inclisiran is currently undergoing FDA review, with a decision expected by year-end 2020. Bempedoic acid received FDA approval in February 2020. ICER encouraged stakeholders to submit comments and suggested refinements to the scope of its review no later than July 24, 2020, by emailing firstname.lastname@example.org.