mepolizumab


( Last Updated : August 11, 2022)
Generic Name:
mepolizumab
Project Status:
Active
Therapeutic Area:
Severe chronic rhinosinusitis with nasal polyps
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
Nucala
Project Line:
Reimbursement Review
Project Number:
SR0735-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Initiation Criteria - Add on to standard of care for adult patients (18 and plus) with severe nasal polyps inadequately controlled by intranasal corticosteroids (INCS) alone defined as: Documented diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) through either CT or endoscopy; and Symptoms persisting for at least 8-12 weeks despite treatment with INCS Administration Criteria - Patient must be managed by a physician experienced in the treatment of CRSwNP (allergist, ENT, respirologist) - Prior to initiating Nucala, baseline assessment of patient reported symptoms and/or quality of life (i.e. SNOT-22 or VAS) Renewal Criteria - Clinical response should be assessed after 1 year Improvement in patient reported symptoms based on baseline assessment (i.e. SNOT-22, VAS) if in the first year of treatment, or maintenance of this improvement if in subsequent years of treatment
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Nucala is indicated as add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone.
  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/clinician input open12-Apr-22
Call for patient/clinician input closed06-Jun-22
Clarification:

- Patient input submission received from Asthma Canada and British Columbia Lung Association & Lung Groups

Submission received11-May-22
Submission accepted26-May-22
Review initiated27-May-22
Draft CADTH review report(s) provided to sponsor for comment11-Aug-22
Deadline for sponsors comments22-Aug-22
CADTH review report(s) and responses to comments provided to sponsor16-Sep-22
Expert committee meeting (initial)28-Sep-22
Draft recommendation issued to sponsorOctober 11, 2022
To
October 13, 2022
Draft recommendation posted for stakeholder feedback20-Oct-22
End of feedback period03-Nov-22