Last Updated : February 27, 2023
Details
FilesGeneric Name:
mepolizumab
Project Status:
Complete
Therapeutic Area:
Severe chronic rhinosinusitis with nasal polyps
Manufacturer:
GlaxoSmithKline Inc.
Brand Name:
Nucala
Project Line:
Reimbursement Review
Project Number:
SR0735-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | April 12, 2022 |
|---|---|
| Call for patient/clinician input closed | June 06, 2022 |
| Clarification: - Patient input submission received from Asthma Canada and British Columbia Lung Association & Lung Groups | |
| Submission received | May 11, 2022 |
| Submission accepted | May 26, 2022 |
| Review initiated | May 27, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | August 15, 2022 |
| Deadline for sponsors comments | August 24, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | September 16, 2022 |
| Expert committee meeting (initial) | September 28, 2022 |
| Draft recommendation issued to sponsor | October 11, 2022 |
| Draft recommendation posted for stakeholder feedback | October 20, 2022 |
| End of feedback period | November 03, 2022 |
| Final recommendation issued to sponsor and drug plans | November 16, 2022 |
| Final recommendation posted | December 02, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 30, 2022 |
| CADTH review report(s) posted | February 28, 2023 |
Files
Last Updated : February 27, 2023