No 191 September 2015

Hep C News

Several new generation direct acting antiviral (DAA) hepatitis C treatments have now been approved for use in Australia, but Australia still lags behind the rest of the world in affordable access to the treatments.

NEW APPROVALS

We were pleased that in July 2015 the Pharmaceutical Benefits Advisory Committee (PBAC) recommended adding Viekira PAK® to the Pharmaceutical Benefits Scheme (PBS) for the treatment of chronic hepatitis C genotype 1.

In line with the new process 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.

Another treatment for hepatitis C, a combination of simeprevir/sofosbuvir, also went before the PBAC in July 2015, but is waiting on TGA approval for the PBAC outcome to be made public.

HFA made a substantial submission to the PBAC in support of these treatments, including comments of community members from HFA surveys.

GREAT NEED FOR EFFECTIVE NEW TREATMENT

The PBAC undertook a thorough evaluation of treatments and was clear that all the approved new treatments for hepatitis C are very effective - both Viekira PAK and the other hepatitis C treatments approved in March 2015. They recognised that there is a high clinical need for all-oral interferon-free hepatitis C treatments to be made available on the PBS.

Viekira PAK® (paritaprevir with ritonavir, ombitasvir, and dasabuvir, with or without ribavirin) would be another option for treating genotype 1 – as effective as treatment with Harvoni® (Ledipasvir with sofosbuvir).

These new all-oral treatments would be easier to manage, and the PBAC recommended listing them in the General Schedule so that prescribing these treatments would no longer be limited to specialist clinics. Infrastructure would need to be built to support this but in the longer term it would mean wider access to treatment, including in regional areas.

NEW HEP C TREATMENTS APPROVED BY PBAC IN 2015

  • Daclatasvir (Daklinza®) in combination with Sofosbuvir (Sovaldi®)

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  • Ledipasvir with sofosbuvir (Harvoni®)

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  • Sofosbuvir (Sovaldi®)

  • Viekira PAK® (paritaprevir with ritonavir, ombitasvir, and dasabuvir, with or without ribavirin)

ACCESS DELAYS

However, once again the PBAC did not accept the proposed treatment prices.

There are now four new hepatitis C treatment combinations that have been approved by the PBAC and none are available yet on the PBS. These treatments are already available in many other countries.

"Access to these treatments is critical for Australians with hepatitis C. My community members with bleeding disorders and hepatitis C have been waiting for these treatments for too long. Every delay puts their health and their lives more at risk," said Gavin Finkelstein, HFA President, in a recent media release. “Government funding is needed urgently to list these medicines on the PBS. These treatments can cure hepatitis C – and if they are not on the PBS, these treatments are just not affordable for most Australians with hepatitis C.”

The next step in the process is for the Australian government to consider the PBAC recommendations and make decisions about funding. It is important that the cost of these drugs is negotiated successfully with the pharmaceutical companies without further delay.

HFA is continuing to make representation to government about access to these treatments for people with bleeding disorders.

AND IF YOU HAVE HEP C?

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:

  • Make sure you have your liver health checked regularly
  • If you don’t know where to start, ask your Haemophilia Centre for a referral
  • Stay in touch with your hepatitis clinic about what’s new
  • Don’t forget to go to your appointment with the hepatitis clinic after your liver health check, even if the fibroscan shows your liver health is stable at the moment
  • And for comprehensive care, let your Haemophilia Centre know about your liver test results or how your treatment is going to make sure they stay in the loop.
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