We reflect on 2022, where regulatory changes in prescribing, rheumatologist workforce issues and covid prevention dominated headlines.
2022 told through our most-read stories.
Regulatory changes in prescribing, rheumatologist workforce issues and covid prevention and treatment dominated the headlines in 2022 and featured among our top-rating stories.
The most-read article for this year was breaking news arising from the March 2022 PBAC meeting recommendations released in April, which flagged a major PBS biologics approval shakeup. The changes, which are being enacted in stages, promise to slash the paperwork burden rheumatologists have long faced for targeted agents.
Patients on biosimilars for RA and AS can get their initial script via phone or online approval, with all continuing scripts good to go with a streamline code.
Meanwhile, RA and AS patients getting any targeted agent, except for upadacitinib, will come under the approval process biosimilars are in now. This change means streamline subsequent continuing scripts for all biologics, including originator TNF inhibitors Humira, Enbrel and Remicade, as well as JAK inhibitors tofacitinib and baricitinib.
Another big regulatory story was all PBS-listed brands of rituximab changing from authority required to unrestricted benefit listings on 1 September under the S100 Highly Specialised Drugs program.
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.
“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 provides equity of access for people outside of the major public hospital systems, so those in private, or rural and remote areas,” she added.
The finding that metformin reduced the need for total knee replacements in patients with diabetes by slowing the progression of knee osteoarthritis has highlighted the drug’s potential for modifying osteoarthritis.
Professor Flavia Cicuttini told Rheumatology Republic that, depending on the findings of further research, metformin could have a profound impact on the otherwise costly treatment of knee osteoarthritis, as it is a “low-cost, well-tolerated, easy-to-use medication that could be readily translated into clinical care”.
People with polymyalgia rheumatica (PMR) are usually treated with glucocorticoids, which are highly effective but often needed for several years. To avoid associated adverse events, effective steroid-sparing agents are still needed, and this latest study on tocilizumab has added to the promise shown in small and uncontrolled trials.
And in another study investigating steroid-sparing options, this time in giant cell arteritis (GCA), Mayo Clinic researchers conducted a small prospective, open-label proof-of-concept study of baricitinib. Only one of the 14 patients relapsed during the study period, with the other patients able to taper then discontinue glucocorticoids and remain in remission for 52 weeks.
With a recent update to the Australian Living Guideline for the pharmacological management of inflammatory arthritis conditionally recommending triple therapy as initial therapy in RA, Associate Professor Helen Keen reflected on triple therapy in the treatment of RA.
The guideline has drawn a strong reaction from the Australian rheumatology community, and the ARA hosted a debate to address the issue in June.
Professor Lyn March presented the pro case, addressing the evidence of efficacy and patient preferences. Ben Horgan, a consumer, then reminded rheumatologists to talk to their patients.
Dr Helen Cooley present the negative argument, addressing practicalities, tolerability, cost to the patient and feasibility. Horgan again reminded rheumos to talk to their patients. The reality is that triple therapy is about 37 tablets a week, as opposed to two with MTX monotherapy, and that is a hard sell.
The 2021 rheumatology workforce survey revealed there were 380 adult rheumatologists, a number that fell slightly short of the 400 rheumatologists needed to fulfil the estimated ideal number, based on two rheumatologists per 100,000 adults. The shortage plagues both adult and paediatric practice.
However, most survey respondents indicated they were not doing a full-time clinical rheumatology load, and based on reported clinical workload the current numbers equated to just 231 full-time-equivalent positions.
The survey also found that while 10% of rheumatologists were considering increasing their work hours, 38% were considering reducing their workload temporarily or permanently, mostly within the next two years. The ARA said it would advocate for increased advanced training positions.
The good news was that work satisfaction was high, with 80% satisfied or very satisfied with their work.
Skilled migration was a feature of the 2022-23 federal budget, but if recruiting rheumatologists from overseas seems like one way to address the shortage, the experience of two practitioners originally from Brazil is sobering. And a rheumatologist from Sri Lanka responded with an account of her experience, which left her questioning whether there’s any need – or desire – for OTPs.
The big stories in covid this year related to treatments and (non-vaccine) prevention, especially for rheumatology and other immunocompromised people who may not respond to vaccines. So the TGA’s provisional approval of Australia’s first covid pre-exposure prevention therapy, tixagevimab + cilgavimab (Evusheld, AstraZeneca), was very welcome.
Associate Professor Philip Robinson, a senior rheumatology specialist at the Royal Brisbane and Women’s Hospital, said the treatment would be a “substantial advantage” for immunocompromised and immunosuppressed patients, who were “terrified” of getting covid.
Early supply issues were resolved, and eligible patients are able to receive Evusheld at no cost through the National Medical Stockpile. Evusheld was up for consideration at the PBAC September intracycle meeting for listing on the PBS for pre-exposure prophylaxis in immunocompromised people aged 12 years and older. However, this first attempt didn’t get the green light.
In a thought-provoking editorial piece in The Lancet Rheumatology, authors from Johns Hopkins University and the University of Queensland’s Associate Professor Phillip Robinson have proposed that sulfasalazine may be a risk factor for severe covid based on its action as a type 1 interferon inhibitor.
This, in turn, suggests it could be a useful treatment for autoimmune diseases where type 1 interferon production plays a role in immunopathogenesis. This includes systemic lupus erythematosus (SLE), dermatomyositis and Sjögren’s syndrome – conditions in need of effective and affordable therapeutics.
Vitamin D supplements don’t prevent bone fractures in healthy adults, according to an ancillary analysis from the US-based VITamin D and OmegA-3 TriaL (VITAL) study.
Despite being widely recommended by health professionals, and widely taken by consumers, vitamin D supplements did not show any benefit in reducing bone fractures in healthy adults over the five-year study period.
This comes on top of earlier VITAL analyses which found vitamin D supplementation had no effect on incident risk of falls or changes in bone mineral density or structure.
The latest findings led experts to call for a major re-evaluation of the approach to vitamin D testing and supplementation in the general population.
