Posted by Michael Wonder on 18 Jul 2016
ICER releases addendum to draft scoping document for MS review
18 July 2016 - The ICER has released an addendum to the draft scoping document on disease-modifying therapies for multiple sclerosis.
The addendum will be subject to a special public comment period of four weeks to provide stakeholders the opportunity to comment on the modifications.
With this addendum, ICER has expanded the draft scope to include the use of ocrelizumab and rituximab for patients with primary-progressive multiple sclerosis (PPMS). Previously, the scope was limited to include only relapsing-remitting multiple sclerosis (RRMS).
The decision to expand the scope of the MS review reflects feedback from patients, clinicians, and other stakeholders that an analysis of all DMTs for MS would be of greatest utility, as well as the FDA June 27th announcement that it had granted Priority Review Designation to ocrelizumab for both PPMS and RRMS indications. An approval decision is expected in December 2016.
