Australia Adds Takhzyro to Its Benefits Scheme on Dec. 1

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Starting on Dec. 1, people with hereditary angioedema (HAE) in Australia will have access to Takhzyro (lanadelumab), an under-the-skin injection to prevent HAE swelling attacks, through Australia’s Pharmaceutical Benefits Scheme (PBS).

“Without this PBS subsidy, Australian patients are paying around $241,000 per year for this treatment,” Greg Hunt, Australia’s minister for health and aged care, said in a press release. “From 1 December, they’ll pay $41.30 per script or $6.60 with a concession card.”

Hunt noted that this new listing is expected to help more than 100 people in Australia every year. The decision follows a recommendation from Australia’s Pharmaceuticals Benefit Advisory Committee announced earlier this year, which was applauded by HAE Australasia.

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“Since 2013, the Coalition Government had approved more than 2,700 new or amended listings on the PBS,” Hunt said. “This represents an average of around 30 listings or amendments per month — or one each day — at an overall investment by the Government of $13.9 billion.”

HAE is caused by mutations that result in the overproduction of a signaling molecule called bradykinin, which drives the sudden bouts of swelling that characterize HAE.

Takhzyro, which is marketed by Takeda, works by inhibiting the activity of a protein called kallikrein, which normally helps to regulate the production of bradykinin. By blocking kallikrein and lowering bradykinin levels in the body, Takhzyro is thought to reduce the frequency of swelling attacks.

Results from a Phase 3 clinical trial called HELP (NCT02586805) showed that preventive treatment with Takhzyro outperformed a placebo at reducing the number of swelling attacks experienced by people with HAE, even in the early phases of treatment.

Takhzyro was also well-tolerated, with no serious side effects related to treatment reported. The most common side effects associated with treatment included pain and redness at the injection site, headache, and viral infections in the upper respiratory tract.

Based on these findings, Takhzyro was approved in the U.S. and European Union in 2018. It has also been approved in Brazil, Canada, and Switzerland and is up for approval in Japan.