PBS approval reform starts, with RA and AS changes to follow.
In good news for rheumatologists and their patients with giant cell arteritis, new prescription approval processes mean a faster turnaround time with potential for better communication and education about using the medication.
While not as seamless as streamlined authority, for many it represents a major improvement on the current system and could lead to better patient outcomes.
From 1 July 2023, real-time assessment of authority requests for tocilizumab for GCA are available through Services Australia’s Online PBS Authorities (OPA) system, via Health Professional Online Services (HPOS). The change applies to initial and continuing treatment.
The initiative is part of the Department of Health and Aged Care’s digital transformation of Authority Required (Written) PBS listings.
Providing that eligibility criteria are met, prescribers can obtain immediate authority approval online, without having to submit paper forms, prescriptions and test results, or upload copies of these to Services Australia for assessment. Once approved, patients can leave the consultation with the prescription for their medicine.
Postal applications for authority to prescribe can still be used.
Sydney-based rheumatologist and vasculitis specialist Dr Tony Sammel is delighted with the new, faster approval process and what it means for patients.
“Once a decision is made to use tocilizumab, the key thing is really to get going quickly so you can wean patients off prednisone faster than you would otherwise be able to do,” said Dr Sammel.
“I would typically try and start tocilizumab as soon as a diagnosis is confirmed, and that historically has meant doing the paperwork.”
Dr Sammel said that depending on how the paperwork is submitted – through the PRODA system versus by mail – it can take anywhere from one hour to one month.
“I would typically get an approval back within a few days, though it can be up to a week or so. But if I’m concerned about a patient and I call them up, they’ll usually process that within an hour or two.
“Some of my colleagues, for logistical reasons, are still posting the paperwork down to Tasmania, and then waiting for the script to get sent back to patients, which can take up to a month. In that case, it’s obviously going to limit the ability to taper prednisone rapidly.
“I think that the old systems were impossible, but they’re just more obtuse than being able to do it in this new system.
Apart from faster turnaround, Dr Sammel said the new system provides the opportunity for better communication and education during the consultation.
“If we’re getting the prescription ready at that point of care, we can then go through the logistics of administering the medication. It will also prevent some complexity and uncertainty in some patients who get confused with these medications – when a script arrives two weeks later, what do they do with it?”
One concern is the time it takes to complete the application, which would ideally happen while the patient is there so they can take the prescription away with them.
“It’s probably going to take at least five minutes to run through the process of logging in, answering all the questions and submitting – then you get an approval. So that needs to be taken into consideration as part of the consultation,” said Dr Sammel.
There’s also good news for the juvenile idiopathic arthritis (JIA) community, with initial authority to prescribe adalimumab, etanercept and tocilizumab now able to be made in real time online or by phone (continuing treatment is already streamlined authority). The same applies to tocilizumab prescriptions for systemic JIA.
Prescriptions for rheumatoid arthritis and ankylosing spondylitis are reported to be next in line for real time approvals, which were first announced by PBAC in April last year.
Patients on biosimilars for RA and AS will be able to get their initial script via phone or online approval, with all continuing scripts good to go with a streamline code.
Meanwhile, RA patients getting any targeted agent except for upadacitinib will come under the approval process biosimilars are in now. This change will mean streamline subsequent continuing scripts for all biologics, including originator TNF inhibitors Humira, Enbrel and Remicade, as well as JAK inhibitors tofacitinib and baricitinib.
