With today's PBS schedule change, prominent rheums reflect on how general schedule listing changes practice.
As of 1 September 2022, PBS listings for all listed brands of rituximab have changed from authority required to unrestricted benefit listings under the S100 Highly Specialised Drugs program.
The PBAC recommended the change at its September 2021 intracycle meeting.
This is the first immunomodulatory biologic to be made available without restriction on the PBS, and potentially opens the door to subsidised treatment for patients with conditions that are currently not adequately catered for.
We asked rheumatologists how they thought it would affect their practice and patients, and Australian rheumatology more broadly.
“This is game changing for Australians”, said Perth rheumatologist Associate Professor Helen Keen. “It will improve access to a potentially lifesaving drug for people with chronic, incurable, systemic inflammatory diseases.
“It means access for people who don’t meet the previous narrow criteria and provide equity of access for people outside of the major public hospital systems, so those in private, or rural and remote areas,” said Professor Keen, who is also a member of the Rheumatology Republic editorial board.
Sydney rheumatologist Dr Tony Sammel agreed it is a positive outcome for patients.
“This is excellent news for patients with rare autoimmune conditions and a long time coming. Australians with ANCA-associated vasculitis in particular will now have access to PBS-funded maintenance therapy which is standard of care in the UK, Europe and the USA.
Under the authority required listing, indications for rituximab were rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, as well as lymphoma and leukaemia. Among the expected beneficiaries of the unrestricted listing are patients with SLE and, as Dr Sammel noted, ANCA-associated vasculitis.
Many orphan diseases rely on rituximab treatment, and these would otherwise have had little chance of obtaining the evidence required for a specific indication on the PBS. Until now, patients with these conditions were reliant on compassionate access, public hospital funding, or private payment to gain access to the costly drug.
Professor Peter Nash of Griffith University said that the relaxation of indication restrictions will make a big difference therapeutically.
“For example, any disease driven by a pathological antibody is a candidate, including SLE nephritis, haemolytic anaemia, thrombocytopaenia; dermatomyositis, especially Ro52 positive and IBM (antibody positive) and HMG antibody positive myositis; progressive systemic sclerosis with lung involvement, rapidly progressive skin disease (antibody positive); vasculitis – AAV; and appropriate RA.
“Outside of rheumatology, there is also thyroid eye disease and myasthenia gravis; and immune-mediated inflammatory disease plus vasculitis or lymphoma,” added Professor Nash.
Dr Claire Barrett noted that it will be beneficial for patients who don’t fulfil PBS criteria for RA but for whom RIX would be the treatment of choice – “such as a patient who has liver cirrhosis hence MTX precluded but recent history of malignancy, so rituximab might be treatment of choice. The current PBS eligibility requirement is mandatory MTX so they can’t have it prescribed on the PBS.
“Or the SLE/other CTD patient where their condition is not included in a PBS indication and hence they cannot access the medication,” said Dr Barrett, pointing out that currently such patients care is transferred to the public system where the hospital carries the cost.
Apart from opening up treatment for a broader range of indications, it may help ease administrative burden and red tape, as well as reduce hospital costs.
“It’s good news that rituximab access will be easier imminently,” said Associate Professor Alberta Hoi of Monash Health.
“I think this can only be positive to eliminate some of the red tape and allow clinicians to utilise this drug for many forms of autoimmune diseases that do not otherwise have approved therapeutic options.”
However, Dr Barrett was not convinced it would make much difference in terms of admin, although saw benefits for reducing hospital costs.
“The administrative burden seems unlikely to change too much; before today, rituximab was an authority streamlined, which was not too challenging — I mean we’ve put up with it for leflunomide and that has been on the PBS since the late 1990s,” said Dr Barrett.
“Until the ‘rules’ come out, and it seems likely there will be some ‘rules,’ it is unclear how many patients will have improved access but it seems likely that [certain patients] are likely to be ‘winners’ – or at least the public hospitals who have until now paid for the medication.”
Meanwhile, Professor Graeme Jones was concerned about injudicious use.
“Rituximab is an important therapy option for many of the autoimmune diseases we treat where there are no approved or even effective options,” said Professor Jones.
“I welcome it being available although I think it would be prudent for it to be streamline authority for rheumatologists only as this would lead to better decision making and safety. It is best used in severe disease.”
Professor Hoi noted that she’d welcome more quality data regarding ways to use rituximab safely, with Professor Nash suggesting, “OPAL should collect the indications outcomes and safety ramifications”.
As for the future, “Hopefully this is the first cab off the rank for unrestricted PBS access for off-patent biologics, including TNF inhibitors for orphan diseases which currently don’t attract government support,” Dr Sammel said,
Currently listed products are biosimilars Riximyo (Sandoz), Truxima (Celltrion) and Ruxience (Pfizer). The reference brand MabThera was delisted from the PBS last year by its manufacturer, Roche.
“Today’s move to unrestricted authority for the biosimilar rituximab is good news for Australian patients and health care providers as it will mean less paperwork for physicians/prescribers and more clinical time for patients,” said Guy Strong, general manager of Sandoz Australia.
“Biosimilars represent a great opportunity for the future of Australian healthcare. Out of the 10 drugs that represented the highest Government cost in 2021, eight were biologics and of those four have biosimilars available or will have them in the next five years,” Mr Strong said.
