Last Updated : January 20, 2021
Details
FilesGeneric Name:
indacaterol /mometasone furoate
Project Status:
Complete
Therapeutic Area:
Asthma maintenance (adults, children 12 or older)
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Atectura Breezhaler
Project Line:
Reimbursement Review
Project Number:
SR0646-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease. Atectura Breezhaler should be prescribed for patients not adequately controlled on a long-term asthma control medication, such as ICS or whose disease severity clearly warrants treatment with both a LABA and an ICS.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease. Atectura Breezhaler should be prescribed for patients not adequately controlled on a long-term asthma control medication, such as ICS or whose disease severity clearly warrants treatment with both a LABA and an ICS.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient input open | March 31, 2020 |
| Call for patient input closed | May 21, 2020 |
| Clarification:
- Patient input submission received from Asthma Canada and Lung Health Foundation |
|
| Submission received | May 19, 2020 |
| Submission accepted | June 02, 2020 |
| Review initiated | June 03, 2020 |
| Draft CADTH review report(s) provided to sponsor for comment | August 18, 2020 |
| Deadline for sponsors comments | August 27, 2020 |
| CADTH responses on draft review report(s) provided to sponsor | October 08, 2020 |
| Expert committee meeting (initial) | October 21, 2020 |
| Draft recommendation issued to sponsor | November 03, 2020 |
| End of embargo period | November 17, 2020 |
| Final recommendation issued to sponsor and drug plans | November 24, 2020 |
| Final recommendation posted | November 26, 2020 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | December 08, 2020 |
| CADTH review report(s) posted | January 20, 2021 |
Files
Last Updated : January 20, 2021