New hep c drugs just days away from PBS listing

Medicines

By Amanda Shepherd

24 Feb 2016

Liver clinics around Australia are expected to bear the brunt of pent-up demand for PBS access to four new hepatitis C drugs, even though GPs will be able to prescribe the drugs from next week.

The antivirals – sofosbuvir and ledipasvir (Harvoni®; sofosbuvir (Sovaldi®); daclatasvir (Daklinza®); and ribavirin (Ibavyr®) – are lauded as the new hope in achieving a high cure rate for patients.

According to Hepatitis Australia, these drugs have a cure rate of 90%, can be taken orally with few side effects and for as little as 8-12 weeks, and do not require the use of peg-interferon as part of the regimen.

From March 1, the four drugs will be listed on the PBS, making them accessible to some 230,000 Australians living with hep C. On the private market, the health department has revealed the drug costs up to $100,000 per patient, however the cost to the PBS is expected to be significantly less than this.

Prescribing rights will not be limited to specialists. In a bid to ensure the drugs are available to all patients, GPs will also be able to prescribe them, although they will have to obtain consent from a gastroenterologist, hepatologist or infectious diseases physician.

This is likely to create some barriers, at least in the early days, said Professor Alex Thompson, director of the Department of Gastroenterology at St Vincent’s Hospital, Melbourne and NHMRC Research Fellow of the University of Melbourne.

But he said the PBS listing was “terrific news” that would make a huge difference to many thousands of patients.

“I’m very excited, it’s going to be fantastic,” he said.

He said the Australian Liver Association was in the process of developing educational material to assist GPs with the process, and there were still discussion about the role community pharmacies will play in the supply of the drugs.

“It’s certainly not going to be immediately straightforward to walk into a GP, get a script and go around the corner and get their drugs,” he said.

He said patients who wanted to access the drugs could expect to attend their GP several times for assessment, review and commencement of treatment, and GPs would need to have a process for requesting consent from the specialist.

“It’s not going to be like going to your GP for a script for antibiotics for a chest infection,” Professor Thompson said.

In the meantime, he said he expected hospital-based liver clinics would be prescribing the bulk of the drugs at least in the early days, with supply coming from hospital pharmacies. Many clinics had been preparing for months so they would be ready to go come March 1.

“I think from the first of March the people who are ready to go will be jumping in to get the drugs,” he said. “We have 200 pre-identified patients (at our liver clinic) who are suitable for treatment. The big liver clinics will have similar numbers – we will all treat a lot of people this year.”

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