Last Updated : December 23, 2021
Details
FilesGeneric Name:
macitentan and tadalafil
Project Status:
Complete
Therapeutic Area:
Pulmonary arterial hypertension
Manufacturer:
Janssen Inc.
Brand Name:
Opsynvi
Project Line:
Reimbursement Review
Project Number:
SR0690-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease. OPSYNVI should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.
Submission Type:
Initial
Fee Schedule:
Schedule C
Indications:
For the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease. OPSYNVI should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | 22-Apr-21 |
| Call for patient/clinician input closed | 11-Jun-21 |
| Clarification: - No patient input submission received | |
| Submission received | 20-May-21 |
| Submission accepted | 04-Jun-21 |
| Review initiated | 07-Jun-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 09-Sep-21 |
| Deadline for sponsors comments | 20-Sep-21 |
| CADTH responses on draft review report(s) provided to sponsor | 15-Oct-21 |
| Expert committee meeting (initial) | 27-Oct-21 |
| Draft recommendation issued to sponsor | 08-Nov-21 |
| Draft recommendation posted for stakeholder feedback | 18-Nov-21 |
| End of feedback period | 02-Dec-21 |
| Final recommendation issued to sponsor and drug plans | 14-Dec-21 |
| Final recommendation posted | 07-Jan-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 05-Jan-22 |
| CADTH review report(s) posted | 18-Feb-22 |
Files
Last Updated : December 23, 2021