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macitentan and tadalafil

Last Updated: April 22, 2021
Result type: Reports
Project Number: SR0690-000
Product Line: Reimbursement Review

Generic Name: macitentan and tadalafil

Brand Name: TBC

Manufacturer: Janssen Inc.

Therapeutic Area: Pulmonary arterial hypertension

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 either idiopathic or heritable or associated with connective tissue disease or congenital heart disease. Macitentan and tadalafil can be used in patients who are currently treated concomitantly with macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.

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 either idiopathic or heritable or associated with connective tissue disease or congenital heart disease. Macitentan and tadalafil can be used in patients who are currently treated concomitantly with macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.​

Submission Type: Initial

Project Status: Pending

Call for patient/clinician input open: April 22, 2021

Call for patient/clinician input closed: June 11, 2021

Anticipated Date: May 20, 2021

Fee Schedule: Pending

  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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