TadalafilAdcirca
Treatment of pulmonary arterial hypertension (PAH), specifically a new 60-tablet pack size to align treatment supply duration with combination endothelin receptor antagonist therapies.
Decisions on record
- Meeting Mar 2024 Recommended Pulmonary arterial hypertension (PAH)
- Meeting Nov 2011 Recommended Pulmonary arterial hypertension
Access path
- TGA registered · Adcirca
TGA label narrower than the PBS population
- Nov 2011Recommended · restricted
Evidence: RCT → Meta-analysis
- Nov 2011Recommended · restricted
Evidence: RCT → Meta-analysis
- Mar 2024Recommended
Comparator changed: sildenafil → Tadalis 56-tablet pack
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of a new pack size (60 tablets) of tadalafil 20 mg for the treatment of PAH at the same cost per tablet as the currently listed pack size (56 tablets).PSD · Mar 2024
6.2 The PBAC noted that the maximum quantity of 60 tablets is consistent with the likely use of the proposed medicine for one month of therapy between each dispensing by the pharmacist.PSD · Mar 2024
5.2 The PBAC noted and welcomed the input from an individual, the Pulmonary Hypertension Society of Australia and New Zealand, and Lung Foundation Australia, via the Consumer Comments facility on the PBS website. The input expressed support for listing Tadalis 60-tablet pack for the treatment of PAH. JustificationsPSD · Mar 2024
5.3 The submission noted that Tadalis is often taken in combination therapy with an endothelin receptor agonist such as bosentan, selexipag, ambrisentan and/or macitentan. The submission noted that when a patient uses Tadalis in combination with these drugs, the patient would finish the Tadalis and the brand of combination therapy in 28 and 30 days, respectively; and require a new prescription after 168 and 180 days, respectively.PSD · Mar 2024
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the new pack size is therapeutically equivalent to the existing 56-tablet pack on a per-tablet basis.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because the new form of tadalafil is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity over the currently listed form, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 for Pricing Pathway A were not met. PBAC · 2024
Decision context
PopulationPatients with pulmonary arterial hypertension treated with tadalafil in combination with endothelin receptor antagonists.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended | Tadalis 56-tablet pack | — | Cost-minimisation · Cost-minimisation |
| Nov 2011 | Recommended · restricted | sildenafil | — | RCT · 6MWD |
| Nov 2011 | Recommended · restricted | sildenafil | — | Meta-analysis · 6MWD |
Consumer voice
An individual, the Pulmonary Hypertension Society of Australia and New Zealand, and Lung Foundation Australia expressed support for listing Tadalis 60-tablet pack for PAH treatment. Consumer input highlighted concerns about treatment burden, medication adherence, and access difficulties for elderly and rural patients when different combination therapies require prescriptions at different intervals
finishing the supply of one medicine earlier than the other could result in confusion or anxiety Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients receiving tadalafil combined with endothelin receptor antagonists; TGA label permits tadalafil monotherapy.