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ofatumumab

Last Updated: March 1, 2021
Result type: Reports
Project Number: SR0657-000
Product Line: Reimbursement Review

Generic Name: ofatumumab

Brand Name: Kesimpta

Manufacturer: Novartis Pharmaceuticals Canada Inc.

Therapeutic Area: Multiple Sclerosis, relapsing

Indications: For the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.

Manufacturer Requested Reimbursement Criteria1: For the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.

Submission Type: Initial

NOC Status at Filing: Pre NOC

Project Status: Active

Companion Diagnostics: No

Date Recommendation Issued: February 25, 2021

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input open July 27, 2020
Call for patient input closed September 16, 2020
Clarification:

- Patient input submission received from MS Society of Canada

Submission received August 25, 2020
Submission accepted September 09, 2020
Review initiated September 10, 2020
Draft CADTH review report(s) provided to sponsor for comment November 24, 2020
Deadline for sponsors comments December 03, 2020
CADTH responses on draft review report(s) provided to sponsor January 08, 2021
Expert committee meeting (initial) January 20, 2021
Draft recommendation issued to sponsor February 03, 2021
End of embargo period February 18, 2021
Final recommendation issued to sponsor and drug plans February 25, 2021
Final recommendation posted March 01, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) March 11, 2021
CADTH review report(s) posted -