Latest From Cathy Kelly
Letter from department’s general counsel responds to request from the company for a pre-enforcement advisory opinion. Despite the letter, Lilly maintains its ‘limited distribution program is fully consistent with applicable laws and regulations.’
Center for American Progress suggests pricing reforms for the 'next Administration' in lieu of legislation.
Effectiveness can be evaluated more quickly because researchers won’t have to wait for the second dose, company executive notes during briefing on the launch of the Phase III study.
Bipartisan congressional letters seek relief from HHS but the Trump Administration has taken aim at 340B providers itself and may not be inclined to help.
Value-based contracting in the US is moving toward high-cost drugs for rare disease and away from lower cost chronic treatments as payers plan for the coming pipeline of cell and gene therapies. Marketed gene therapies all have some kind of risk sharing deal in place but further progress on the most innovative payment models is hampered by regulatory and operational challenges. The Centers for Medicare and Medicaid Services has taken a first step toward addressing regulatory obstacles but there is a long way to go.
Results of an analysis published in JAMA could undercut arguments against legislative proposals establishing inflation penalties in Medicare.