Rare diseases

Tocilizumab on the PBS for GCA

Tocilizumab (Actemra) will be added to the PBS from August 1 for the treatment of giant cell arteritis (GCA).

When announcing the new indication, the Federal Health Minister Greg Hunt said subsidised access for the monoclonal antibody would benefit about 852 patients with GCA per year, who would pay over $10,200 per course of treatment.

The Pharmaceutical Benefits Advisory Committee (PBAC), who recommended the listing at its March meeting, said there was a high unmet clinical need for effective treatments for GCA.

As reported in the limbic in 2017, weekly injections of the IL-6 inhibitor have been shown in a randomised controlled trial to extend sustained remission in patients tapering from prednisone.

Rheumatologist and clinical pharmacologist Dr David Liew, from the Austin Hospital, told the limbic that access to an effective steroid-sparing agent for GCA patients was very exciting.

“This disease is one of the few where for a long time we’ve just accepted that our patients are going to get this terrible burden of steroid toxicity.”

“We see our patients get Cushingoid, they put on weight, they notice mood changes, they can’t sleep, they get cataracts – all these things are happening in front of our eyes and we haven’t been able to do anything about it.”

Dr Liew said rheumatologists who already used tocilizumab for patients with severe rheumatoid arthritis were fairly comfortable with the safety profile of the monoclonal antibody.

“I don’t think we expect to see the safety profile be any different to what we have seen in rheumatoid arthritis and as long as we take the right precautions I think it will be fine.”

He noted tocilizumab had only been approved for 52 weeks of therapy.

“We’ve seen data … in which not all patients who had success after 52 weeks with tocilizumab were able to stay in remission when they were taken off tocilizumab.”

“We’re not really sure what will happen but even if it means that patients might need some other therapies after that – they might need steroids or methotrexate or more tocilizumab – they have still been able to get enormous benefit from that period of time when they were able to get off steroids.”

He said rheumatologists were also waiting for long-term data from the key registration trial as to whether or not tocilizumab can prevent the long-term complications of GCA.

“I don’t think tocilizumab will work for everyone with GCA but I think it will work for a lot of people,” he said.

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