The PBS has signalled a move to subsidise dual combination therapy for patients with pulmonary arterial hypertension (PAH).
A recommendation to subsidise combination therapy with an endothelin receptor antagonist (ERA) and phosphodiesterase-5 (PDE-5) inhibitor for patients with WHO Functional Class III and IV PAH was accepted by the Pharmaceutical Benefits Advisory Committee (PBAC) at its November 2018 meeting.
The move away from the current restriction to monotherapy for PAH patients is long overdue and will bring PBS subsidies some way towards alignment with evidence-based guidelines, according to Dr Edmund Lau, respiratory physician at the Royal Prince Alfred Hospital, Sydney.
He told the limbic that dual combination therapy had been the standard of care for most patients with PAH for about four to five years.
The lack of PBS subsidy means that patients with PAH currently had to purchase their medications for combination therapy on private prescription or rely on compassionate access programs, he said.
“I’m very pleased that the PBS will be funding combination therapy, at least for patients with class III and IV disease,” said Dr Lau.
However he noted that recent trials such as the AMBITION study had shown that patients with less severe disease – functional class II – had better outcomes with first-line combination therapy compared to monotherapy.
“There are very few situations that would arise [with PAH] where we would not use combination therapy – I’d say about 80-90% of patients in our clinics are now using it,” he said.
The new recommendations also fail to address the needs of patients with more severe disease who require triple therapy, he added.
They are a response to a report from a post market review of PAH medicines that started in 2015.
The committee said it accepted the key findings presented in the report and was “of a mind to recommend initial combination therapy with PBS subsidised ERA and PDE-5 inhibitor medicines for patients with WHO FC III/IV symptoms with increased risk factors, and sequential combination therapy with ERA and add on PDE-5 inhibitor medicine for patients with WHO FCIII/IV symptoms with demonstrated inadequate response to monotherapy.
It also recommended removing the current PBS restriction for patients to ‘have failed to respond to six or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists’ .
However there is as yet no timeline for when the PBAC recommendations will be included in the PBS schedule.