Last Updated : April 23, 2024
Details
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:
TBC
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:
For the treatment of adults
with pulmonary arterial hypertension (PAH, World Health Organization [WHO]
Group 1) to increase exercise capacity, provide clinical improvement, improve
WHO functional class (FC), and delay disease progression, including to reduce
the risk of death and hospitalization for PAH.
- 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.
| Call for patient/clinician input open | February 23, 2024 |
|---|---|
| Call for patient/clinician input closed | April 22, 2024 |
| Clarification: - Patient input submission received from the Pulmonary Hypertension Association of Canada | |
| Submission received | April 08, 2024 |
| Submission accepted | April 22, 2024 |
| Review initiated | April 23, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | July 09, 2024 |
| Deadline for sponsors comments | July 18, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | August 16, 2024 |
| Expert committee meeting (initial) | August 28, 2024 |
| Draft recommendation issued to sponsor | September 10, 2024 To September 12, 2024 |
| Draft recommendation posted for stakeholder feedback | September 19, 2024 |
| End of feedback period | October 04, 2024 |
Last Updated : April 23, 2024