Macitentan With TadalafilOPSYNVI

7.1 The PBAC recommended the Section 100 (Highly Specialised Drug Program) Authority Required (Telephone/Online) listing of macitentan 10 mg with tadalafil 40 mg (Opsynvi®, herein referred to as MAC+TAD) fixed dose combination (FDC) for the continuing treatment of pulmonary arterial hypertension (PAH) in patients who are on stable doses of macitentan and tadalafil as combination therapy.PSD · Nov 2024

7.2 The PBAC noted that the intention of the proposed listing is that only patients that are stable on macitentan 10 mg and tadalafil 40 mg (as two 20 mg tablets) doses are eligible for MAC+TAD FDC. The PBAC considered that it was appropriate for treatment criteria for MAC+TAD FDC initiation to be added so that a patient must have been taking macitentan 10 mg and tadalafil 40 mg (as dual therapy, or as part of triple therapy) for at least 6 months …PSD · Nov 2024

6.9 The submission presented a cost-minimisation approach versus combination therapy of one macitentan 10 mg tablet with two 20 mg tadalafil tablets.PSD · Nov 2024

6.10 The equi-effective doses were estimated as MAC+TAD FDC 10 mg/40 mg daily and macitentan 10 mg tablet with two 20 mg (40 mg) tadalafil tablets daily. This was reasonable and based upon the TGA’s advice on bioequivalence.PSD · Nov 2024

6.6 The submission claimed that MAC+TAD FDC 10 mg/40 mg was non-inferior in terms of efficacy and safety compared to the use of one 10 mg macitentan tablet and two 20 mg tadalafil tablets as combination therapy. The ESC considered that this claim was 12PSD · Nov 2024

6.7 The submission claimed that the reduced pill burden of 1 tablet compared to 3 that MAC+TAD FDC presents could improve adherance resulting in improved health outcomes for PAH patients. The submission presented studies and literature reviews which supported the claim that adherence to treatment for patients with PAH resulted in improved clinical outcomes5.PSD · Nov 2024

6.2 The PBAC noted and welcomed the input from one organisation via the Consumer Comments facility on the PBS website. The Lung Foundation Australia discussed the health, financial and social cost for people living with PAH in Australia. The organisation was supportive of the proposed listing and stated that MAC+TAD FDC can potentially reduce pill burden and costs for these patients.PSD · Nov 2024

6.4 The submission stated that the AC-077-103 study proved that the FDC and the individual components were bioequivalent. With the addition of the other clinical studies, AC-077-101 and 67896062PAH1006, the TGA Delegate considered there was sufficient evidence that the MAC+TAD FDC was bioequivalent to treatment with macitentan and tadalafil as individual tablets.PSD · Nov 2024