Emicizumab (Hemlibra) is expected to be available free of charge for people with haemophilia A by December 2020.
The treatment, which without subsidy costs around over $675,000 per year, will be available for prophylaxis through the National Blood Authority (NBA) under a joint funding agreement between Federal and state governments.
About 800 patients are expected to benefit each year from the addition of emicizumab to the National Product List, according to the National Blood Authority.
The NBA says emicizumab has been found to be more effective than current clotting factor injections in reducing the incidence of bleeding events for patients, and also reduced the need for the use of additional blood products when patients have problems with inhibitors.
It also has the advantage of being easier to administer by less intrusive subcutaneous administration either once per week, every two weeks, or every four weeks.
“Hemlibra will be prescribed by a specialist clinician in a recognised Haemophilia Treatment Centre, which will continue to provide coordinated access consistent with the current framework for access to therapies for haemophilia,” it says.
“Clinical guidance for the use of Hemlibra, taking into account MSAC recommendations, will be provided by the Australian Haemophilia Centre Director’s Organisation (AHCDO). The Clinical Advisory Group of AHCDO will be available to provide peer advice to Haemophilia Treatment Centre clinicians considering the transition of relevant patients to emicizumab.”
The NBA adds that it is important for patients to continue using the MyABDR App to record data on the use of Hemlibra for the Australian Bleeding Disorders Registry (ABDR).
The move was welcomed by Haemophilia Australia, which notes that emicizumab is currently only available to patients via clinical trial or compassionate access.
“The new funding means that every individual with severe FVIII deficiency will have the option to switch to Hemlibra or remain on their current treatment,” it said.
“This is a very significant step forward. It will provide as much protection for people with haemophilia from the risk of bleeding as current treatments and it will be much easier to administer, without the need for regular intravenous injections and we hope to see a similar product for haemophilia B in the near future.”
The National Blood Authority is currently finalising supply arrangements with Roche, with 63% of costs to be funded by the Australian Government, and 37% by states and territories.