Sanofi Genzyme Korea said Monday that Evoltra (Ingredient: Clofarabine), a treatment for pediatric patients with refractory or relapsed acute lymphoblastic leukemia (ALL), will continue to receive reimbursement.
The approval comes after the drug satisfied the condition of coverage with evidence development (CED) under the risk sharing agreement (RSA). Evoltra is the first therapy listed as reimbursable under the RSA in 2013 and is also the only CED-approved therapy under the RSA.
The CED is a merit-based evaluation scheme associated with therapies’ clinical outcome after the Ministry of Health and Welfare decides on whether to maintain a therapy to be reimbursable based on clinical studies’ results during the contract period. Evoltra satisfied the evidence development coverage at the time of RSA approval, thereby passing re-evaluation for drug reimbursement.
Analyses of patients’ clinical data collected confirmed that the response rate for Evoltra exceeded the initial goal set when the company applied for the RSA approval. Therefore, the drug will become reimbursable at not only clinical study sites but every clinic and hospital across the country from this month, the company said.
“The decision to keep Evoltra reimbursable is very encouraging in that it improves medical accessibility for adolescents and young adults with ALL and at the same time confirms clinical effects of Evoltra on local patients,” Sanofi Genzyme Korea General Manager Christine Park said.