Autoimmune diseases

Unrestricted PBS listing for rituximab dermatology prescriptions


Australians living with autoimmune and inflammatory skin diseases will have easier access to affordable rituximab, with the easing of PBS criteria from 1 September.

The listing change to unrestricted benefit for specialist prescribing opens up access to the monoclonal antibody biologic for patients living with rare conditions such as pemphigus vulgaris, ANCA vasculitis, neuromyelitis optica and immune thrombocytopenic purpura.

The change on September 1 means rituximab now moves from “authority required” listing to “unrestricted benefit” within the S100 highly specialised drugs program. It was recommended by the Pharmaceutical Benefits Advisory Committee last September.

“The PBAC considered that changing the rituximab listings to unrestricted would provide subsidised access to treatment for patients with conditions where there are no alternative PBS listed medicines,” the PBAC found. “The PBAC considered the expanded use would be cost effective given the price reductions to rituximab to date.”

Rheumatologist Peter Nash, a Professor in the School of Medicine at Griffith University and a Director of the Rheumatology Research Unit on the Sunshine Coast, said the open listing would be very helpful in immune-mediated rheumatic diseases that were driven by a pathologic antibody.

He said these included SLE nephritis, haemolytic anaemia, thrombocytopaenia, dermatomyositis and antibody-positive inclusion body myositis, HMG myositis, AAV and other vasculitis, cryoglobulinaemia rheumatoid arthritis plus malignancy, or vasculitis Scleroderma ILD, rapidly progressive.”

“[These are] uncommon conditions that could never apply individually for indication approval and reimbursement,” he said. “Previously we had to apply individually to public hospital committees for approval and hospital budgets to pay for the drug.”

He said the Australian Rheumatology Association had been trying “for years” to streamline the use of biologics, especially for continuation therapies.

Clinical immunologist Dr Daman Langguth said rituximab could be used for a wide range of applications.

“There are a huge number of conditions,” he said. “This is kind of a first as it is not a drug that is just used by one specialty. This is a game-changer for patients.”

Dr Langguth, head of immunology at Sullivan Nicolaides Pathology in Brisbane, said rituximab would likely be prescribed by dermatologists as well as rheumatologists, haematologists and  neurologists.

One of the leading voices calling for the expansion of its use under the PBS, Dr Langguth also credited a group letter from patient members of the Australian and New Zealand vasculitis society and the Australasian Society of Clinical Immunology and Allergy and the Australian Rheumatologists Association, for advocating for the change.

“This was doctors and patients getting together to change funding in Australia for rare diseases,” he said.

Dr Langguth said it was previously used for three groups of conditions, ANCA-positive vasculitis, rheumatoid arthritis, and various types of lymphoma.

Now, people who live with pemphigus vulgaris, for example, would be able to access the medication as required, at low or no cost.

“Often we have to transition through other drugs,” he said. “Internationally, rituximab is considered the standard of care and we really should use it first line in almost all patients.”

He noted, however, the increased risk of immunosuppression for patients on rituximab, especially amid the COVID-19 pandemic.

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