The Institute for Clinical and Economic Review, a U.S. pricing watchdog, has proposed changing its evaluation process to better account for CAR-T and gene therapy prices, according to an S&P Global Market Intelligence report.
The gene and CAR-T therapies on the market come with high price tags, but also offer the potential for a one-time treatment, which complicates the evaluation process, according to the report.
The institute's current framework evaluates drugs based on their effectiveness over time. It assigns a value, or price, it deems acceptable based on the number of years and quality of the years the drug offers the patient. But this framework is not as accurate for one-time treatments like gene therapies and cell therapies, the institute said.
The organization is proposing changes that would incorporate new factors into its cost-effectiveness framework to account for the single and short-term therapies on the market.
The institute is considering establishing new effectiveness threshold and standardizing methods to tackle uncertainty arising from the current lack of evidence from the therapies.
The institute said it also would look at shared savings opportunities and how the high costs are being dispersed throughout healthcare organizations.
"Many of these therapies are introduced with much higher levels of uncertainty about their long-term safety and effectiveness than standard treatments, and patients and insurers are being asked to pay extremely high prices up front for the promise of a long-term benefit," ICER President Steven Pearson told S&P Global . "These tensions raise important questions for how best to adapt health technology assessment methods to ensure that all aspects of the value of these treatments are fully evaluated and the uncertainty put into perspective for decisionmakers."
The proposed changes are open to public comment until Sept. 6.