NovoCure (NVCR) said that the German Federal Joint Committee (Gemeinsamer Bundesausschuss or G-BA) has published a decision to support a clinical trial to study the effects of Optune on newly diagnosed glioblastoma.
The proposed trial design will examine the benefit of combining Optune with radiation therapy and temozolomide prior to the initiation of maintenance temozolomide in accordance with the German Healthcare Provision Act.
This decision by the G-BA is a first step in Novocure’s process to secure national reimbursement for Optune in Germany, NovoCure said. And while the costs of the clinical trial will ultimately be shared by Novocure and G-BA, the positive decision to initiate a clinical trial does not imply immediate funding.
The company noted that before the trial can begin, the G-BA subcommittee for assessment of new methods must issue a final directive for approval by the German Ministry of Health which could take up to 18 months or longer. In the interim, Novocure said it will continue to bill German healthcare payers for individual cases.