Editors note: This story was originally published on Tuesday 24 November but removed temporarily so that it could include a response from the Australian Rheumatology Association and other groups involved in the Targeted Therapies Alliance (TTA) consortium.
A government-funded program that is targeting rheumatologists’ prescribing of bDMARDS is unnecessary and being perceived as “Big-Brotherish”, a leading rheumatologist claims.
Rheumatologists are the first target of the NPS MedicineWise led Value in Prescribing bDMARDs Program which is encouraging them to consider down-titrating patients’ drug doses. Dermatologists and gastroenterologists prescribing bDMARDs will also be targeted in coming months.
Last month, 450 rheumatologists and immunologists were sent PBS Practice Reports giving individualised data on their prescribing of bDMARDS and other rheumatology drugs with comparisons to average prescribers, encouraging them ”reflect” on their prescribing behaviour.
Dr Mona Marabani, a Sydney-based rheumatologist and former president of the Australian Rheumatology Association, said she had “serious misgivings” about the value of the bDMARDs program.
“I think this program is all about saving money, not about quality use of medicines,” she said, adding that the program was funded under a 2018-19 Federal Budget measure that aimed to deliver savings to the PBS.
Dr Marabani said she was not sure if the data in her PBS Practice Review report accurately reflected her practice, and a number of other rheumatologists had also raised concerns with her about their reports.
“Some have said it doesn’t capture all my patients, and others think the opposite” she told the limbic. “Not everybody is comfortable that it is an accurate reflection of their practice.”
While many rheumatologists would ignore the reports, she said the initiative was perceived by some rheumatologists as “a bit Big Brother-ish”.
“There is a level of disquiet as to why rheumatologists are being targeted in this way.
“Rheumatologists are the experts in prescribing of these medicines and have the breadth and depth of knowledge … is there any evidence to suggest that biologics and targeted synthetic drugs are being misused or overused or that Australian rheumatologists use them more than comparable countries?” she asked.
Health and economic outcomes
The program, launched last month, is run by the Targeted Therapies Alliance (TTA), a consortium of nine organisations led by NPS MedicineWise and including the Australian Rheumatology Association (ARA), Arthritis Australia, the Australian and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network and Arthritis Australia, among others.
The NPS said the program aimed to get the “best health and economic outcomes” for use of the expensive drugs, and a plethora of resources have been released focused on prescribing of b/tsDMARDS. They include a down-titration algorithm for rheumatoid arthritis and living guidelines —currently out for public consultation – that recommend prescribers consider down-titration of the drugs for people with rheumatoid arthritis or axial spondyloarthritis who are in remission or have low disease activity.
However, Dr Marabani said the evidence for de-prescribing of bDMARDs was still evolving.
“We have to be very careful not to get ahead of the evidence and potentially put patients at risk for the sake of saving money for the system,” she said. “I am concerned we are being pushed into doing something that may be not that appropriate for everyone and not well supported by a sufficient body of evidence.”
Dr Marabani said current PBS restrictions on bDMARD prescribing ensured the drugs were used appropriately, and rheumatologists already worked with their patients to reduce medication use wherever possible while maintaining control of disease.
“There is no doubt these expensive drugs are a significant item of expenditure for the government and it is perfectly reasonable to ensure medicines are used appropriately, but I think the whole process of the highly specialised drug application process and restrictions on who can receive them [on the PBS] is enough,” she said.
“I’m not questioning the motives of those involved in the program, but I don’t think the implications for individual patients have been sufficiently considered. Loss of disease control, and the potential recording of a ‘strike’ in the context of a lifetime limit of five advanced drugs for RA [on the PBS] is a serious risk for patients.”
TTA members respond
However these claims have been challenged by members of the Targeted Therapies Alliance consortium.
Professor Catherine Hill, President of the Australian Rheumatology Association and Chair of the Consortium Leadership Committee of the Targeted Therapies Alliance, on behalf of the Targeted Therapies Alliance, made this statement to the limbic:
“The Targeted Therapies Alliance Value in Prescribing bDMARDs program aims to optimise the use of bDMARDs and other specialised medicines to achieve better health outcomes. Quality use of medicines is at the centre of the program. The vision is greater than cost saving, it is about achieving best possible patient care in a complex environment with rapidly evolving evidence.”
“The PBS Practice Review reports were sent to rheumatologists and clinical immunologists to provide insights on their practice, for personal interpretation and reflection, but not regulatory auditing processes. Experience in general practice programs over many years has shown that GPs value seeing how their practice compares with their peers. The data used in the reports is strictly confidential. While these reports underwent thorough quality assurance and testing with rheumatologists, the limitations in using real-world data from the PBS dataset is acknowledged and feedback is encouraged via [email protected].
“The Targeted Therapies Alliance is developing valuable tools and resources with and for consumers to help them better understand and manage their medicines to improve their health outcomes, and to empower consumers to take part in shared decision making with their health professionals.”
Professor Rachelle Buchbinder, Chair of the Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network and Deputy Chair of the Consortium Leadership Committee of the Targeted Therapies Alliance, on behalf of the Targeted Therapies Alliance made this statement:
“A key foundation of the program is An Australian Living Guideline for the Pharmacological Management of Inflammatory Arthritis. The guidelines are living, evidence-based, and developed in consultation with rheumatologists, other health professionals and people living with inflammatory arthritis. The guidelines are currently out for public consultation ahead of NHMRC endorsement and we encourage feedback from rheumatologists as well as patients and others who care for people with these conditions.”
“To date we have made conditional recommendations to consider down titration of b/tsDMARDs for people with rheumatoid arthritis and axial spondyloarthritis, but only if certain preconditions are met. In contrast a conditional recommendation was made against down titration in people with psoriatic arthritis. These recommendations are living and may or may not change as further evidence is published. Other recommendations are also being made to support the quality use of medicines including for opioids and glucocorticoids.”
The Targeted Therapies Alliance is funded by the Australian Government Department of Health through the Value in Prescribing – Biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) Program Grant, and led by NPS MedicineWise, members of the Targeted Therapies Alliance include:
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- Arthritis Australia
- Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network
- Australian Rheumatology Association
- Cochrane Musculoskeletal
- Council of Australian Therapeutic Advisory Groups
- NPS MedicineWise
- Pharmaceutical Society of Australia
- Quality Use of Medicines and Pharmacy Research Centre (University of South Australia)
- Society of Hospital Pharmacists of Australia.