Novocure wins CMS review of Optune glioblastoma Tx

NovoCure (NSDQ:NVCR) said today that the durable medical equipment Medicare Administrative Contractors accepted a new local coverage determination reconsideration request for the treatment of newly diagnosed glioblastoma with its Optune system.
The St. Helier, Jersey-based company said it plans to “take steps to publish a final LCD for newly diagnosed GBM,” and per the Centers for Medicare and Medicaid Services and Medicare policy, both DEM MAC’s will issue a single joint policy for all DME regions.
The DME MACs plan to assemble a Contractor Advisory Committee prior to publishing the proposed LCD for Optune. The LCD will be subject to a 45-day public comment period before publication, according to a press release.
Novocure said that the DME MACs did not provide a specific timeline, but confirmed they “confirmed that they are working diligently on the process for Optune,” according to a press release.
Last month, NovoCure said that it inked a $15 million licensing agreement with Shanghai-based biopharma company Zai Lab to offer its Optune technology on the Chinese market and accelerate clinical trial enrollment in the region.
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Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Optical/Ophthalmic Regulatory/Compliance NovoCure Source Type: news