The evaluation process for the pilot subscription reimbursement scheme will be undertaken by NICE over the next 12 months. The output of these evaluations will inform the subscription payment price the company will receive for its product. It is anticipated that Fetcroja will be made available to patients via a subscription-based payment model from early 2022 .
Fetcroja has been selected for inclusion in a pilot subscription reimbursement scheme, launched by NICE and NHSE&I. The scheme will pilot a model that reimburses pharma companies for antimicrobials based on a health technology value assessment of their value to the NHS, as opposed to the volumes of the drug used. This pilot is intended to encourage drug developers to resume and increase research and development into new antibiotic medications, given that this area is lacking in innovation due to the economic challenges associated with it. This is due in large part to the fact that the newest antibiotic drugs are reserved as last-line treatments, and are often only used when all other treatment options have been exhausted .
PIII CREDIBLE-CR study (n=152) reports cefiderocol had similar clinical and microbiological efficacy to best available therapy (pre-specified before randomisation and maximum of three drugs) in this population .
PIII CREDIBLE-CR study (NCT02714595) still recruiting with a primary completion date of May 19 .
Study NCT02714595 still recruiting with a primary completion date of Sept 18 .
NCT02714595 - primary data due Dec 17
PIII trial initiated in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens (CREDIBLE-CR; NCT02714595; 1424R2131). The randomised, open-label trial has initiated recruitment of approximately 150 patients in the US, and will expand to Croatia, Germany, Israel, Italy, Japan, South Korea and Taiwan .