Neurosurgery ·
FDA grants priority review to neurosurgically delivered Huntington gene therapy; CMS pauses global surgery data collection; Contour matches WEB
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The Food and Drug Administration accepted uniQure's application for ifezuntirgene inilparvovec, a Huntington disease gene therapy given by MRI-guided stereotactic neurosurgery, for priority review, the company said Nov. 2.
The Centers for Medicare & Medicaid Services (CMS) paused global surgery data collection in its final 2027 physician fee schedule, and a propensity-matched study in Neurosurgery found comparable occlusion with the Contour and Woven EndoBridge intrasaccular devices.
THE DETAILS
- FDA Nov 2, 2026uniQure said the Food and Drug Administration (FDA) accepted its biologics license application for ifezuntirgene inilparvovec under the accelerated approval pathway, with priority review and a target action date of May 1, 2027. The one-time therapy is given through MRI-guided, convection-enhanced stereotactic neurosurgical delivery into the caudate and putamen, according to the company. The application compares phase 1/2 data with a propensity score-matched external control from the Enroll-HD database, and 51 patients have been dosed.Sources: uniQure, NeurologyLive
- Payment Nov 4, 2026The Centers for Medicare & Medicaid Services (CMS) finalized its proposal to pause the global surgery data collection required under the Medicare Access and CHIP Reauthorization Act, saying its data show post-operative visits during the global period are not occurring and the requirements may be causing undue burden. CMS said it will keep assessing how to use the data and solicited comment on ways to improve global surgery payment accuracy. The same-day visit reduction applies only to 0-day global procedures, not 10- or 90-day ones as proposed. The nonqualifying alternative payment model conversion factor is $32.63, down 2.31%.Sources: CMS, Medical Economics
- Technology Nov 2, 2026A propensity score-matched study in Neurosurgery compared the Contour Neurovascular System with the Woven EndoBridge (WEB) device, using WorldWideWEB Consortium data and a European Contour registry. Complete occlusion did not differ (odds ratio 1.01; 95% CI 0.67 to 1.52; P = .971), nor did a modified Rankin Scale score of 0 to 2 at last follow-up (odds ratio 0.48; 95% CI 0.21 to 1.02; P = .064). The authors said the devices had comparable clinical and angiographic outcomes in the multicenter study.Sources: Neurosurgery, PubMed
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