Table 1 – Types of vertigo (non-exhaustive list)[/caption]
Vomiting
In older people, dizziness significantly increases the risk of falls.7 Implementing appropriate interventions to address modifiable risk factors such as dizziness is of paramount importance. In cases of drug-induced dizziness, deprescribing can be considered if the medicine can be safely reduced, discontinued or substituted to prevent inappropriate prescribing cascades of potentially inappropriate medicines (PIM), especially in the context of older people.29
Yesterday (19 August), it was announced that Ozempic (semaglutide 1.0 mg) has received approval from the Therapeutic Goods Administration (TGA) for an expansion of indication to reduce the risk of kidney disease progression in patients with type 2 diabetes and chronic kidney disease (CKD).
It’s estimated that around 2.7 million Australians are living with indicators of CKD, including both diagnosed and undiagnosed cases.
Of these, diabetes is the leading cause of end stage kidney disease (ESKD) – accounting for over a third (38%) of new cases. Of an estimated 333,000 Australians living with both CKD and diabetes, approximately 10,000 are expected to progress to kidney failure.
If not managed appropriately and in serious cases, CKD may also lead to kidney failure, heart disease and stroke, and in some cases, premature death, said Professor Vlado Perkovic, nephrologist and Provost at the University of New South Wales.
‘Early intervention can help with slowing disease progression,’ he said.
‘This approval represents a step forward in addressing the multifaceted needs of individuals living with type 2 diabetes and CKD,’ added Dr Ana Svensson, Vice President of Clinical, Medical and Regulatory at Novo Nordisk Oceania.
What does the evidence say?
The FLOW (Evaluate Renal Function with Semaglutide Once Weekly) trial is a large multinational study that assessed the effects of once-weekly semaglutide 1.0 mg in adults with type 2 diabetes and CKD.
Participants who received semaglutide had a 24% reduction in risk of major kidney events, slower decline in estimated glomerular filtration rate, and decreased albuminuria – compared to placebo. They also experienced improvements in cardiovascular outcomes and all-cause mortality – with the safety profile consistent with previous studies.
To date, the TGA has not released specific dosing guidance related to the new CKD indication.
Will Ozempic be PBS listed for CKD?
Semaglutide (Ozempic) for CKD is currently not subsidised under the Pharmaceutical Benefits Scheme (PBS).
That means the out-of-pocket costs will not be subsidised, compared to around $31.60 for general patients using the medicine under existing PBS criteria.
‘While it is not specifically reimbursed for kidney disease risk reduction, Novo Nordisk continues to engage with government stakeholders to explore opportunities for broader access to our medicines for Australians living with chronic conditions,’ a spokesperson for Novo Nordisk told Australian Pharmacist.
With Ozempic no longer in shortage, will access open up?
Last month (18 July), the TGA officially removed Ozempic from its medicine shortages list, with previous supply restrictions now lifted. Now that Ozempic stocks have returned to a sufficient level, new patients can be initiated on the medicine. But Ozempic prescribed for weight loss is still off-label, with no update to the indication for weight loss. So the PBS criteria on this front also remain unchanged, and it’s uncertain if this will change any time soon.
‘We have semaglutide 2.4 mg (Wegovy) available – it is indicated for the treatment of patients with obesity or overweight and established cardiovascular disease,’ the Novo Nordisk spokesperson said.
But experts hope that subsidy and accessibility will improve over time as demand and evidence grow.
‘There’s no doubt that both cost and availability present a barrier to the more widespread use of semaglutide at the moment,’ Prof Perkovic said. ‘But I’m sure that over time that situation will change and the drugs will become more widely available.’
