dalbavancin

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Generic 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

Biosimilar:

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:

November 16, 2022

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
Milestones title	Date
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

Recommendation and Reasons View PDF

Clinical and Pharmacoeconomic Combined Report View PDF

Stakeholder Feedback on Draft Recommendation View PDF

Last Updated : February 23, 2023