On June 26, 2019 Novocure (NASDAQ: NVCR) reported that the German Institute for Quality and Efficiency in Healthcare, or IQWiG, has published its rapid report concluding that, based on a review of Novocure’s EF-14 phase 3 pivotal trial, patients with newly diagnosed glioblastoma (GBM) lived longer when treated with Optune in addition to standard chemotherapy, without affecting quality of life (Press release, NovoCure, JUN 26, 2019, View Source [SID1234537278]). This positive conclusion is an important step in Novocure’s process to secure national reimbursement for Optune in Germany.

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In November 2018, the German Federal Joint Committee, or G-BA, commissioned IQWiG to prepare its report, which IQWiG did in an accelerated procedure, known as a rapid report. IQWiG sent this rapid report to the G-BA in May 2019. G-BA should now continue the process toward a national reimbursement decision for Optune in Germany. According to its published timeline, a directive is expected no later than October 2020. As the review process advances in Germany, Novocure will continue to bill payers for individual cases. Each case is evaluated individually on its merits and under the payer’s specific rules for such cases.

IQWiG’s evaluation was based on the EF-14 phase 3 pivotal trial data published in JAMA in December 2017. EF-14 demonstrated that patients with newly diagnosed GBM who added Optune to standard chemotherapy, temozolomide, had a greater opportunity to live longer than those who used chemotherapy alone. Patients treated with Optune plus temozolomide experienced overall survival of 20.9 months versus 16 months for patients treated with temozolomide alone. Two and five-year survival rates were better with Optune with 13 percent of patients treated with Optune plus chemotherapy alive at five years versus 5 percent of patients treated with chemotherapy alone. Patients treated with Optune were also able to maintain their mental, emotional and physical well-being longer than those on chemotherapy alone.