mepolizumab

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Generic 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
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:
  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 openApril 12, 2022
Call for patient/clinician input closedJune 06, 2022
Clarification:

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

Submission receivedMay 11, 2022
Submission acceptedMay 26, 2022
Review initiatedMay 27, 2022
Draft CADTH review report(s) provided to sponsor for commentAugust 15, 2022
Deadline for sponsors commentsAugust 24, 2022
CADTH review report(s) and responses to comments provided to sponsorSeptember 16, 2022
Expert committee meeting (initial)September 28, 2022
Draft recommendation issued to sponsorOctober 11, 2022
Draft recommendation posted for stakeholder feedbackOctober 20, 2022
End of feedback periodNovember 03, 2022
Final recommendation issued to sponsor and drug plansNovember 16, 2022
Final recommendation postedDecember 02, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 30, 2022
CADTH review report(s) postedFebruary 28, 2023