Risk-averse decision-making climate at CMS and a likely unwillingness to commit the resources needed probably means that innovative payment arrangements for cell and gene therapies may have to start in the commercial insurance sector, Demetrios Kouzoukas suggests.

CMMI payment demonstrations are viewed as way of skirting statutory obstacles to experimenting with new approaches to reimbursement and could lead to significant drug pricing reforms if legislative efforts fail. However, HHS is not signaling an intent to pursue transformational new models at this point.

Industry chiefs and experts, including Sandoz' global head of biopharmaceuticals, deliberated at the recent AAM meeting the status of biosimilars adoption in Europe and trends and opportunities to generate savings for both the US federal government and payers.