7 May 2019

Cost barrier to new GCA drug may be lifted

Clinical Giant-cell arteritis

The crippling effects of steroid treatment in older women with giant-cell arteritis could soon be eased, with the Pharmaceutical Benefits Advisory Committee (PBAC) deciding to push a biologic along to the next stage of the PBS approval process.

Actemra (tocilizumab) recently received a positive recommendation by PBAC, which means patients might soon have affordable access to the medication.

The biologic makes it possible to taper steroid treatment in some patients with giant-cell arteritis (GCA).

GCA patients are usually women aged in their 60s and 70s. In these patients, the toxic effect of steroids can lead to osteoporosis and fractures.

The benefits of Actemra for GCA were demonstrated in a clinical trial of around 250 patients, published in the NEJM in 2017 (the GiACTA study).

Around half of the patients on Actemra and a prednisone taper were still in remission after one year, compared with  around 14 to 18% of patients in the placebo group.

“The trial suggests that this drug may reduce the rate of relapse and allow us to more rapidly go to steroid-free remission,” said Professor Stephen Hall, a rheumatologist at Cabrini Medical Centre in Melbourne and the director of Emeritus Research.

Actemra is an expensive anti-IL-6 receptor biologic that is currently listed on the PBS for RA and JIA.

But, even if Actemra did get listed on the PBS, it might not be funded for long-term use, Professor Hall said.

This could be problematic as the trials show that around 50% of patients with GCA relapsed when the drug was stopped after one year, he said.

“We are still waiting on the two-year figures, the second year of the GiACTA study, which I’ve heard on the grapevine is due to be release at EULAR in June,” he said.

Stuart Knight, the managing director of Actemra maker Roche Pharma Australia, said Rochewas “dedicated to bringing innovative medicines to Australian patients, particularly in areas where there is significant unmet medical need”.

“There had been no proven treatments or clinical advances in giant cell arteritis beyond that of corticosteroids for 60 years,” he said.

“Roche will continue to work with the Department of Health and the PBAC to progress this recommendation to a future PBS listing for Actemra in GCA,” the company said in a statement.