Roche Disappointed By English Funding Rejection For Gavreto But Will Not Appeal
Health technology assessment institute NICE said that uncertainty in the clinical evidence for Gavreto means that cost-effectiveness estimates are also uncertain for the drug, which is approved for treating RET fusion-positive advanced non-small cell lung cancer and is reimbursed in 10 European countries.
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Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.
Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.
France is set to become the first country in Europe to fund Imcivree for a second – and as yet unapproved – indication. Meanwhile, England has agreed to reimburse the drug for its approved indication as did Germany earlier this year. Reimbursement discussions are underway in the rest of Europe.