Last week the CieBOM in the Netherlands proposed new criteria for clinical relevance in oncology therapies studied in non-randomized clinical trials. An increasing number of treatments achieve EMA registration based on non-randomized trials, especially in rare indications. CieBOM currently does not evaluate these therapies as it only decides on therapies that were studied in an RCT. However, a positive CieBOM advice is needed for a positive reimbursement decision from the Dutch HTA agency in therapies for solid tumors. The proposed criteria are made up of a combination of (conditional) EMA registration, indication and treatment specific conditions and a combination of response rate and duration of response. These criteria could close the gap between an EMA registration and patient access for these therapies.
Read the full-text article on the proposed criteria here (in Dutch):