BRIEF—ICER outlines plans to assess sickle cell disease drugs

The USA’s Institute for Clinical and Economic Review (ICER) on Friday posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value treatments for crizanlizumab and voxelotor, both of which will be indicated for sickle cell disease.

Crizanlizumab, a P-selectin inhibitor, is currently under Food and Drug Administration review with an anticipated decision expected in the first half of 2020, is being developed by Swiss pharma giant Novartis, and was accepted for priority review by the FDA in July this year.

US biotech firm Global Blood Therapeutics is planning to initiate and complete a rolling New Drug Application (NDA) for voxelotor, an HbS polymerization inhibitor, before the end of 2019, according to the ICER.

Global Blood Therapeutics’ shares were down 1.54% at $45.98 by close of trading on Friday.

All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to  publiccomments@icer-review.org and must be received by 5 PM ET on September 20, 2019. All comments submitted must meet ICER’s formatting specifications.