Saxagliptin with dapagliflozin will move from streamlined authority to phone or electronic authority required in February.
Doctors looking to prescribe dual DPP-4 inhibitor/SGLT-2 inhibitor medication Qtern 5/10 (saxagliptin and dapagliflozin, AstraZeneca) can expect to get very familiar with the PBS authority hotline from next year.
On Thursday, the PBS formally took up suggestions from a November 2022 PBAC drug utilisation sub-committee to move the restriction type for the combination drug up from streamlined authority.
Australian Diabetes Society CEO Associate Professor Sof Andrikopoulos saidthat while saxagliptin and dapagliflozin was not necessarily as useful of a combination as the yet-to-launch sitagliptin and dapagliflozin combination, he took issue with the principle of restricting access to the therapy.
“We need to be able to personalise medicine treat people for type 2 diabetes and we need to make it easy for prescribers to be able to do that,” he told The Medical Republic.
“They are putting in this barrier, this extra step, and it doesn’t make sense to do it.”
The 2022 PBAC sub-committee report found that around 15% of patients were being supplied an SGLT2 inhibitor or DPP4 inhibitor without concurrent metformin, a sulfonylurea, or insulin and in contravention of the PBS restrictions.
“The PBAC considered that a price reduction of at least 15% in the cost of DPP4 inhibitors and SGLT2 inhibitors would be appropriate to account for the proportion of use outside the restrictions for which cost-effectiveness has not been considered,” the report said.
It went on to foreshadow the PBAC’s intention to recommend a change to the restriction type to “reduce use outside the PBS restrictions” if sponsors did not agree to a price reduction.
Professor Andrikopoulos questioned why the PBS response would be to make the process more difficult for the 85% of prescribers who were already following the PBS rules.
“This is going to ultimately affect the patient with diabetes,” he said.
“This is what I’m concerned about.
“If you make it difficult, then will the prescriptions of SGLT2 and DPP4 inhibitors fall, and is that a good thing for the person with diabetes?
“I would think not.”
RACGP specific interests diabetes chair Dr Gary Deed was similarly miffed.
“It’s part of the current [type 2 diabetes treatment plan] that’s presented by the Australian Diabetes Society and supported by the Royal Australian College of General Practitioners,” he said.
Dr Deed told The Medical Republic that the move to phone and online authority was “reactive, rather than proactive”.
“Rather than have these reactive responses, I’d really call for a more proactive system than what they currently have,” he said.
“It penalises the prescriber and the patient at the same time.
“One way [to be more proactive] would be to work with software developers for prescribing to allow gatekeeping so … you just can’t prescribe it unless there’s evidence that previous drug combinations were utilised.”
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There are many potential reasons why doctors may not be following the PBS restrictions, he said.
“General practitioners and other specialists are utilising these medications because of the increasing evidence of clinical utility, not just in lowering glucose, but also other off-glycaemic effects, such as protection of against chronic kidney disease progression … but also heart disease as well,” Dr Deed said.
“But the trouble is, I think, in trying to manage people with diabetes, [doctors] are quickly utilising drugs without necessarily reading the fine print of the PBS requirements.”
Saxagliptin with dapagliflozin therapy will still be available via streamlined authority until 1 February 2025.
