When you have a ‘mature’ drug that kills you, can you keep it in the clinic?
Health authorities in New South Wales have approved the use of a drug that, while not the most effective of treatments for hepatitis C, is an effective one.
The drug, called Sovaldi, is a relatively new treatment and one that has been widely used.
However, the state’s health minister, Jill Hennessy, said the approval of the drug for use in the community “does not mean that the use is authorised.”
In a statement, Henness.s department said the state had been able to “ensure the safety and efficacy of the Sovaldi medication” despite a number of challenges, including a lack of clinical trials.
“The drug was first approved in the United States in 2016 and it has been used in the US for years to treat people with HIV/AIDS and other conditions,” the statement said.
“However, the approval is not legally binding in New Zealand, and there is a gap in our system of approvals for other treatments for Hepatitis C.”
In the US, Sovaldi has been approved by the Food and Drug Administration (FDA), which has not yet given its approval to the Australian government, nor has it given its green light to the drug to be licensed in Australia.
The FDA approved the drug on 6 October, a month before New South Welsh Health Minister Jill Henningy announced her approval.
This comes just a month after the New South Australian government approved a generic version of the same drug.
Health Minister Kate Jones said the Australian approval process had been “complex” and had been taken into account “the fact that there is not one clinical trial for Hep C or any other condition that is under review.”
She said there was a “strong desire” from all parties to see the drug “available for all Australians, regardless of their geographic location”.
The Australian government has yet to formally approve the drug, which is already available in Canada, France and the US.
“There are other drugs that have been approved in Australia that have had a number, or even more, of clinical trial outcomes, so I think there’s a good balance between the clinical trial results that we’re seeing with these drugs and the public health outcomes that we see with these,” Ms Jones said.
The New South, Queensland and Western Australian governments have all approved Sovaldi in the past year, while the ACT government has not.
“We have seen the benefit that this drug has shown in terms of reducing mortality and increasing the chances of people being able to get a better outcome with that drug,” Ms Hennessys department said.
Dr James Martin, of the National Centre for Excellence in Infectious Diseases, said “it is difficult to be optimistic” about Sovaldi’s future in Australia, where the use in Australia of the drugs has been limited.
“It is a very different process to the one that exists in the USA where we have a whole host of other drugs on the market that are not yet licensed,” he said.
However he said it was “quite conceivable” that Sovaldi could be licensed overseas.
“If we have any other drugs, it is quite possible that they would be licensed abroad,” Dr Martin said.
Hepatitres are an increasing issue for the health system in Australia and the Commonwealth’s health department said in a statement that the number of people infected with hepatitis C had “declined significantly” since the beginning of the year.
“While the overall trend in the number and severity of Hepatitic disease cases in the ACT has been declining, it remains the leading cause of death in the state, with more than a quarter of Australians living with Hepatetic Cirrhosis of the Liver,” the department said, adding that this was due in part to a decrease in the proportion of Australians with liver disease in the population.
However Dr Martin added that “this decline is primarily due to the increased availability of drugs that are being developed and manufactured in Australia”.