Gene therapy may be the next revolution in healthcare. The opportunity to cure diseases through the modification of the genome was once considered science fiction, but no longer. The United States has seen a few approvals in this area, including the approval of voretigene neparvovec for a rare form of blindness. In addition, CAR-T agents, two of which are available, have demonstrated alternative ways to treat disease by manipulating genes of different cells.
According to a report, the Institute for Clinical and Economic Review (ICER) is considering offering a service, for a fee, to pharmaceutical manufacturers whereby ICER would provide guidance on clinical trial design.
Imagine your company just received FDA approval of a new pharmaceutical, the result of years of clinical research and difficult regulatory scrutiny. The product is being manufactured and is shipping to distributors and wholesalers. Providers and patient advocacy groups seem excited for the launch, and sales goals are considered aggressive. However, one key variable remains: coverage.
In 2015, an estimated $107 billion was spent globally on oncology therapeutics, a year-over-year increase of 11.5 percent. Drug spend reports from leading U.S. pharmacy benefit managers and payers found similar trends in 2016.