On September 5, 2017 Novocure (NASDAQ: NVCR) reported that the German Federal Joint Committee, (Gemeinsamer Bundesausschuss or G-BA), has published its decision to support a clinical trial studying Optune for the treatment of newly diagnosed glioblastoma (GBM) (Press release, NovoCure, SEP 5, 2017, https://www.novocure.com/german-federal-joint-committee-announces-decision-to-support-a-clinical-trial-to-study-optune-for-the-treatment-of-newly-diagnosed-glioblastoma/ [SID1234520373]).1 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 Section 137e of the German Healthcare Provision Act. The G-BA decision is an important first step in Novocure’s process to secure national reimbursement for Optune in Germany.
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The trial design as proposed would enroll 933 patients. Novocure and the G-BA will share the costs for the conduct of the clinical trial. The statutory health insurance funds will reimburse treatment costs, including the cost of Optune for trial patients.
"The decision by the G-BA to study Optune in combination with radiation therapy for the treatment of newly diagnosed GBM will provide valuable data on the benefits of initiating therapy earlier in the course of GBM treatment," said Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "We are excited to understand the possible impact of earlier initiation of Optune in newly diagnosed GBM and are pleased to partner with the G-BA for this pivotal trial."
The positive decision to initiate a clinical trial does not imply immediate funding. 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. The German Ministry of Health approval process and subsequent initiation of the clinical trial is anticipated to take up to an additional 18 months, and could take longer. In the interim, Novocure will continue to bill German healthcare payers for individual cases. Each case is evaluated individually on its merits and under the payer’s specific rules for such cases.
1 G-BA decision available at: View Source
Approved Indications
In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial GBM following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
In Europe, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.
In Europe, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at [email protected] in Europe.