As part of its new cell and gene therapy access tool, HHS' first focus is improving access to sickle cell disease therapies, which can cost millions of dollars for a one-time dose.
Sickle cell disease is an extremely painful condition that affects more than 100,000 Americans and disproportionately affects Black patients, HHS said in a Jan. 31 news release. Historically, there were limited therapies available for sickle cell patients, but recent approvals have broadened their options.
The list prices for some of these new drugs, such as Casgevy (exagamglogene autotemcel) and Lyfgenia (lovotibeglogene autotemcel), respectively cost $2.2 million and $3.1 million, though. At least nine hospitals are authorized to administer Casgevy, and some Blue Cross Blue Shield companies cover both of them.
HHS' cell and gene therapy access model will negotiate with the manufacturers of sickle cell drugs for outcomes-based agreements. The negotiations are scheduled for 2024 with the goal of increasing access in 2025.
The access model aims to lower drug costs and reduce health disparities and access barriers, according to an HHS fact sheet.