Three generics firms – Aurobindo, Cipla and Viatris’s Mylan – have signed licensing agreements with the Medicines Patent Pool that will allow them to produce versions of ViiV Healthcare’s long-acting cabotegravir treatment for HIV pre-exposure prophylaxis.

Lilly execs caution that even if FDA approves donanemab in 2023, no uptake of any significance is expected until 2024 and beyond. An accelerated approval would essentially preclude Medicare reimbursement, and a CMS policy change or more persuasive trial data could take some time.

Stakeholders differ on whether the rapid growth in spending is to be expected, given the realities in health care and specialty drug costs, or that the data underscores the need for oversight and reform of the 340B program.