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Hep C cure comes with $3 billion price tag

Thousands of Australians living with hepatitis C are a step closer to a cure after the Commonwealth’s chief medicines adviser recommended they be given subsidised access to a hugely expensive but effective drug credited with eliminating the disease in the majority of patients.

But the Pharmaceutical Benefits Advisory Committee (PBAC) has warned that, at its current price tag of around $110,000 for a 12-week course, subsidising the drug for around 62,000 chronic hepatitis C patients would cost the country more than $3 billion over five years.

Nonetheless, in recommending that sofosbuvir (marketed under the name Sovaldi) be listed on the Pharmaceutical Benefits Scheme for the treatment of chronic hepatitis C, the PBAC said there was a “high clinical need” for such a treatment to be available on the PBS.

The Therapeutic Goods Administration approved the use of Sovaldi as part of a combination antiviral treatment for chronic hepatitis C last year, raising hopes of improved outcomes for the estimated 233,000 people living with the disease.

But the medicine’s huge price tag means it will have to be subsidised through the Pharmaceutical Benefits Scheme if it is to be put within financial reach for many patients.

In its initial assessment of the drug in late 2014, the PBAC recommended against listing on the PBS, cautioning that doing so would have “a high financial impact on the health budget”, warning that estimates of its cost to taxpayers were probably understated given the likelihood of a jump in demand.

But in its latest assessment, the PBAC took a more expansive view.

It said “it was appropriate for the new all-oral treatment to be listed in the General Schedule, rather than Section 100 Highly Specialised Drug Program, to facilitate the longer term objectives for access to treatment, increase treatment rates and better outcomes with a view to treat all patients with CHC [chronic hepatitis C] over time”.

However, the Committee said the drug was not cost-effective at the price proposed by the manufacturer, and warned that the expense of providing subsidised access through the PBS would come at “a large opportunity cost to the health care system”.

While viral hepatitis has become increasingly common – the Kirby Institute estimates more than half a million Australians now live with either hepatitis B or C – treatment rates are low.

Fewer than 5 per cent of those with hepatitis B receive treatment, and only around 1 per cent of those with chronic hepatitis C.

Unsurprisingly, in this environment, Sovaldi is regarded as something of a wonder drug.

Manufacturer Gilead Sciences said hepatitis C patients can be cured of the disease in as little as 12 weeks, eliminating the lifetime burden of an otherwise chronic infection.

Director of gastroenterology at Melbourne’s St Vincent’s Hospital, Professor Alex Thompson, told the Herald Sun last year that Sovaldi was a major advance on current hepatitis C treatments.

“This is a game-changing medicine,” Professor Thompson said. “This disease could become rare or non-existent, you could be talking about eradication.”

Hepatitis Australia has warned that hepatitis C could become a major health burden for the country unless urgent action is taken.

Viral hepatitis damages the liver and, without effective treatment, it can lead to liver cirrhosis, cancer and failure – currently around 1000 a year die from hepatitis-related liver cancer, according to the Institute.

“Without urgent investment in rigorous treatment programs, Australia will continue to fail in its efforts to halt escalating rates of serious liver disease due to chronic hepatitis B or C,” Hepatitis Australia said.

It said hepatitis B and C infections had continued to spiral despite national strategies aimed at curbing their growth, showing that “Australia needs to redouble its efforts and investment in prevention”.

“We know what works – educating the community on the risks of infection and improving access to hepatitis B vaccinations and needle and syringe programs for vulnerable populations,” the group said. “It’s now time for the investment to make it happen.”

Clinical trials of Sovaldi evaluated by the TGA demonstrated that the hepatitis C virus was undetectable in up to 90 per cent of patients 12 weeks after completing therapy.

Professor Gregory Dore, Head of the Kirby Institute’s Viral Hepatitis Clinical Research Program, hailed the drug as “a major advance” in the treatment of hepatitis C because it was able to achieve results more quickly than existing treatments, and with fewer side effects.

But humanitarian organisation Medicins Sans Frontieres has complained that the high cost of the medicine puts it out of the reach of most of the world’s poor.

The medical charity said drugs such as Sovaldi had the potential to revolutionise treatment of hepatitis C, but not at current prices.

Sovaldi, is Gilead’s trade name for sofosbuvir, which in the United States costs $US84,000 ($A90,000) for a 12-week course of treatment – roughly $US1000 a pill. Even in Thailand, its costs $US5000 for a course.

“The price Gilead says it will charge for sofosbuvir in developing countries is still far too high for people to afford,” said MSF Director of Policy and Advocacy Rohit Malpani. “When you’re starting from such an exorbitant price in the US, the price Gilead will offer middle-income countries like Thailand and Indonesia may seem like a good discount, but it will still be too expensive for many of these countries to scale up treatment.”

Adrian Rollins