Last Updated : February 23, 2023
Details
FilesGeneric Name:
dalbavancin
Project Status:
Complete
Therapeutic Area:
Acute bacterial skin and skin structure infections
Manufacturer:
Paladin Labs Inc.
Brand Name:
Xydalba
Project Line:
Reimbursement Review
Project Number:
SR0728-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Paladin Labs Inc. is requesting for Xydalba (dalbavancin for injection) to be reimbursed for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin susceptible strains).
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Xydalba (dalbavancin for injection) is indicated for: treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin susceptible strains).
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 | February 28, 2022 |
|---|---|
| Call for patient/clinician input closed | April 22, 2022 |
| Clarification: - No patient input submission received | |
| Submission received | April 11, 2022 |
| Submission accepted | April 29, 2022 |
| Clarification: - Submission was not accepted for review on 26 Apr 2022 | |
| Review initiated | May 02, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | August 03, 2022 |
| Deadline for sponsors comments | August 12, 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 12, 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 23, 2023 |
Files
Last Updated : February 23, 2023