On December 21st, Novartis’ Kymriah and Kite’s Yescarta have received NICE’s green light and are accessible to UK patients. These decisions come 3 months after initial negative draft guidances earlier this year. In the final guidances, NICE confirmed that the two CAR-Ts do not appear to meet the usual cost-effectiveness thresholds, mainly due to uncertainty on magnitude and duration of effect. Still, the two treatments are going to be reimbursed in the EMA approved indications. These positive decisions are possible thanks to a particular type of innovative access agreements, usually called Coverage with Evidence Development (CED) or conditional reimbursement and are a signal NICE bodies are taking new approaches in dealing with cell and gene therapies. Under these agreements, NICE and the relevant companies will collect evidence of effect of the two drugs over the next 3 to 5 years and will run new HTA assessments at the end of these periods. Access to Kymriah and Yescarta will be funded without restrictions through the UK Cancer Drugs Fund (CDF).

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