The anti-CD20 monoclonal antibody is now subsidised for eligible patients with active lupus nephritis, cutting thousands of dollars from treatment costs.
Australians with severe lupus nephritis have gained subsidised access to obinutuzumab after the B-cell-targeting therapy joined the Pharmaceutical Benefits Scheme on 1 September.
The move comes six months after the Pharmaceutical Benefits Advisory Committee backed the listing of obinutuzumab (Gazyva, Roche Products) and is expected to benefit about 3500 Australians.
It will see the cost of treatment fall from around $4300 a month to a maximum PBS co-payment of $25, or $7.70 for concession cardholders.
The PBS listing covers patients with active class III or IV lupus nephritis, with or without class V disease, who are receiving standard therapy with mycophenolate mofetil and corticosteroids.
The Pharmaceutical Benefits Advisory Committee recommended the listing at its March meeting, as reported in Rheumatology Republic, citing the high clinical need for more effective treatments for lupus nephritis.
The committee particularly acknowledged the burden of the disease among young women, First Nations people and people of Asian and African ancestry, noting that First Nations Australians experienced more severe disease, morbidity, and mortality.
The PBAC accepted that adding obinutuzumab to standard therapy was more effective than standard therapy alone at improving kidney outcomes, including rates of complete kidney response. It also noted higher rates of adverse events including infections and infusion-related reactions in the phase 3 REGENCY trial.
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As reported by RR in March this year, results of that trial, published in the New England Journal of Medicine, supported this.
Lupus Voice Australia welcomed the listing, saying additional treatment choices were particularly important for a patient population that had historically faced limited options.
“For people living with lupus, this is about hope,” said Lupus Voice Australia vice-chair Melinda Barrett.
“For too long, our community has lived with limited treatment options. Every new option means more choice for patients and their doctors.
“Our community has waited a long time for progress, and we are finally beginning to see it.”
Obinutuzumab is being funded through the PBS Section 100 Highly Specialised Drugs Program. See the product information here.
