Extended half life clotting factor products now reimbursed for haemophilia A and B

People with haemophilia now have subsidised access to two Extended Half-Life (EHL) replacement treatments that will reduce their need for frequent infusions.

From 1 July, efmoroctocog alfa (Eloctate and Adynovate) and eftrenonacog alfa (Alprolix) will be reimbursed for people with haemophilia A and B respectively, by the National Blood Authority.

“This means that there is funded access to extended half life factor VIII for all people with haemophilia A and an extended half life factor IX for all people with haemophilia B where they and their treating doctor at their Haemophilia Treatment Centre consider it for their treatment,” the NBA said in a statement.

The recombinant EHL factor replacement therapies require less frequent dosing compared to existing Standard Half-Life (SHL) factor replacement therapies because they are have a lower clearance from the blood stream. The half-life of some recombinant factor VIII products is 8–12 hours, so patients need several injections a week to maintain an effective concentration of factor VIII, whereas the half-life of efmoroctocog alfa is 19 hours.

According to manufacturer Sanofi, efmoroctocog  and eftrenonacog can be infused regularly to prevent bleeding episodes (prophylaxis therapy), or can be used to stop or reduce bleeding that has already started (on-demand therapy).

A recent study conducted by the Australian Haemophilia Centre Directors Organisation (AHCDO) found that switching to EHL factor VIII therapy for haemophilia A resulted in resulted in decreased injection frequency (3 to 2 per week), improved ‘reduced adherence’ rates (18% to 7%), decreased median annualised bleeding rate (ABR; 2.0 to 0.0) and increased proportion of patients with zero bleeds (44% to 64%). It also showed that factor utilization increased by 4 IU/kg/wk on Eloctate.

For haemophilia B, switching to EHL FIX resulted in decreased injection frequency (2 to 1 per week), improved ‘reduced adherence’ rates (35% to 11%), decreased median ABR (3.0 to 2.0) and increased proportion of patients with zero bleeds (31% to 46%). Actual factor utilization decreased by 4 IU/kg/wk.

The NBA says it has consulted with the AHCDO, Haemophilia Foundation Australia (HFA) and Australian Haemophilia Nurses Group (AHNG), on transition arrangements for relevant patients to commence using extended half-life products. However, due to COVID-19 and some other local reasons there may be some delays to access.

The new supply arrangements will apply for a period of up to five years and replace the limited interim arrangements for supply of extended half-life clotting factor products previously introduced by the NBA in March 2018.

The Haemophilia Association of Australia (HFA) noted that the announcement does not include a decision about government funding for Hemlibra (emicizumab) which is registered in Australia for the treatment of people with severe and moderate haemophilia A with and without inhibitors.

“Hemlibra is not on the National Product List. HFA will continue to advocate for Hemlibra to be funded as well as the products on this list for our community,” it said.

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