macitentan and tadalafil


( Last Updated : November 18, 2021)
Generic Name:
macitentan and tadalafil
Project Status:
Active
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

Details


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.
  1. 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.

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Key Milestones

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