Menu
Access to the new generation direct acting antiviral (DAA) hepatitis C drugs has been at the forefront of HFA’s work on hepatitis C this year.
These new treatments have been described as “game changers”. They are part of the new wave of far more effective hepatitis C treatments that many people with bleeding disorders have been waiting for.
In clinical trials they have had very high success rates – over 90% for most – with few side-effects, and shorter treatment courses. Most will be available in all-oral interferon-free combinations. Some will also be ribavirin-free regimes, which is good news for those who can’t tolerate ribavirin. Some have had encouraging results even with people who previously had unsuccessful treatment or who have advanced liver disease, such as cirrhosis. Most of these treatments are already available in other countries.
To speed up the approval process, the new treatments have been going before the Therapeutic Goods Administration (TGA) to be approved for use in Australia at the same time as the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS). Listing these new treatments on the PBS would mean they are subsidised by government and would allow Australians to access them at an affordable cost.
Several of the new treatments went before the PBAC in March 2015. HFA made a substantial submission to the PBAC including the comments of community members – thanks to the community members who completed the HFA survey on new hepatitis C treatments last year. Your responses were vital to the HFA submission.
We were very pleased that in March 2015 the PBAC recommended that these hepatitis C treatments should be added to the PBS for the treatment of chronic hepatitis C:
In its decision, the PBAC explained that the “new treatments for HCV were very effective” and would offer options for treating people with genotypes 1 to 6.
The PBAC also recommended that the new all oral treatments should be listed in the General Schedule, rather than the Section 100 Highly Specialised Drug Program. This would mean that prescribing these treatments would no longer be limited to specialist clinics.
However, clearly the PBAC was not satisfied with the proposed treatment prices and advised that the Australian Health Minister should negotiate lower prices for them to be cost-effective.
"Government funding is needed urgently for these medicines to be listed on the PBS so they are affordable to Australians with hepatitis C," said Gavin Finkelstein, HFA President.
The next step in the process is for the Australian government to consider the PBAC recommendations and make decisions about funding. We hope the cost of these drugs can be negotiated successfully with the pharmaceutical companies without delay. Access to these medicines is critical.
Disappointingly, the Health Minister did not include the new hepatitis C drugs in the pre-Budget announcement of $1.3 billion to subsidise high-cost medicines. However, the pricing agreements for these hepatitis C drugs would need to be finalised with the pharmaceutical companies before they could be listed and this process is no doubt still underway.
“The good news is that the Minister confirmed that the Abbott Government is committed to listing approved drugs as fast as possible,” commented Helen Tyrell, CEO of Hepatitis Australia in a recent press release. “Minister Ley made it clear that other high-cost medicines – which we assume means the hepatitis C therapies – are now being considered for a government subsidy.”
HFA continues to follow up with further representation to government about access to these treatments.
It is very important that the current range of new DAAs be made available as quickly as possible to people with hepatitis C, particularly those with long-term infection who are at risk of advanced liver disease.
At the recent European Association for the Study of the Liver (EASL) Congress in Vienna, a large US study confirmed the detrimental effects of delaying treatment with the new DAAs until the person has advanced liver disease. “The benefits of treatment are diminished if treatment is delayed. If you treat too late it is not going to be as effective,” noted the researchers.1
This is particularly relevant in Australia, where access to the new treatments off clinical trial has been limited only to the sickest patients through special access schemes provided by the pharmaceutical companies. Australian hepatitis specialists have been very concerned about the potential impact of delaying access to treatment with DAAs. In a letter to the Medical Journal of Australia they used a modelling approach to demonstrate that if treatment access was delayed by 1 or 2 years, it would result in many new cases of liver cancer, advanced liver disease and liver-related deaths.2
People with bleeding disorders and hepatitis C in Australia have been living with hepatitis C infection for more than 20 years now – many for much longer. Treatment to cure their hepatitis C and prevent further liver damage is urgently needed. Many have waited a long time for a treatment that is likely to be successful and they can’t wait any longer. HFA continues to pursue every avenue possible around access to these new treatments for affected members.
Other new DAAs are continuing to work their way through the treatments pipeline. In July 2015 another new combination treatment will go before PBAC for PBS listing:
Paritaprevir with ritonavir, ombitasvir and dasabuvir, with or without ribavirin (Viekira Pak®) – for the treatment of chronic hepatitis C genotype 1.
At the recent EASL Congress, researchers reported on the next generation of experimental hepatitis C drugs. The current range of interferon-free DAA treatment combinations can cure most people with hepatitis C genotype 1 in 12 weeks. Now researchers are trialling new drugs to work against multiple genotypes ('pan-genotypic') and that aim to cure patients with shorter treatment courses, eg 6 weeks. However, in the experimental treatments presented at EASL, people who had previously had unsuccessful treatment or had cirrhosis still needed longer treatment courses to achieve a cure and the next round of studies are investigating this.3
In comparison to previous studies, which took years to complete, clinicians expect that these clinical trials will produce results much more quickly as the treatment courses are quite short. With the current pace of hepatitis C research, we are likely to see a very different hepatitis C treatment landscape in the next few years.
In the meantime – if you have hepatitis C and a bleeding disorder, remember that you would need to have your liver health assessed before you could be considered for treatment:
Haemophilia Foundation Australia acknowledges the Traditional Owners and Custodians of Country throughout Australia, the land, waters and community where we walk, live, meet and work. We pay our respects to Elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples.
Sign up for the latest news, events and our free National Haemophilia magazine