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Canada’s Drug Agency | Drugs, Health Technologies and Systems.

sotatercept

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Generic Name:
sotatercept
Project Status:
Active
Therapeutic Area:
Pulmonary arterial hypertension (WHO group 1)
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Winrevair
Project Line:
Reimbursement Review
Project Number:
SR0828-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As an add-on to optimal background therapy, for the treatment of adult patients with PAH who are not at low risk. Low risk is defined as: FC I or II and; 6MWD 440 m and; NT-proBNP 300 ng/L or BNP 100 ng/L Optimal background therapy is defined as: patients receiving optimal number and doses of therapies according to clinical guidelines. Patients may be on double or triple therapy depending on contraindications and/or tolerability of available PAH therapies. This medication should be prescribed under the direction of a specialist in PAH. Diagnosis must be confirmed by right heart catheterization.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III.
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open23-Feb-24
Call for patient/clinician input closed22-Apr-24
Clarification:

- Patient input submission received from the Pulmonary Hypertension Association of Canada

Submission received08-Apr-24
Submission accepted22-Apr-24
Review initiated23-Apr-24
Draft CADTH review report(s) provided to sponsor for comment09-Jul-24
Deadline for sponsors comments18-Jul-24
CADTH review report(s) and responses to comments provided to sponsor16-Aug-24
Expert committee meeting (initial)28-Aug-24
Draft recommendation issued to sponsor12-Sep-24
Draft recommendation posted for stakeholder feedback19-Sep-24
End of feedback period04-Oct-24
Final recommendation issued to sponsor and drug plans21-Oct-24
Final recommendation posted06-Nov-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)04-Nov-24
CADTH review report(s) posted-

Files

Recommendation and Reasons View PDF
Patient and Clinician Group Input View PDF
Last Updated : December 16, 2024