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
Performance Metric:
Achieved
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 openFebruary 23, 2024
Call for patient/clinician input closedApril 22, 2024
Clarification:

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

Submission receivedApril 08, 2024
Submission acceptedApril 22, 2024
Review initiatedApril 23, 2024
Draft CADTH review report(s) provided to sponsor for commentJuly 09, 2024
Deadline for sponsors commentsJuly 18, 2024
CADTH review report(s) and responses to comments provided to sponsorAugust 16, 2024
Expert committee meeting (initial)August 28, 2024
Draft recommendation issued to sponsorSeptember 12, 2024
Draft recommendation posted for stakeholder feedbackSeptember 19, 2024
End of feedback periodOctober 04, 2024
Final recommendation issued to sponsor and drug plansOctober 21, 2024
Final recommendation postedNovember 06, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 04, 2024
CADTH review report(s) posted-