Ozempic sales boom as PBAC calls for more hurdles

The PBAC wants it to be harder for GPs to start patients on GLP-1 RAs, recommending a switch to written or phone approval.

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GPs will find it harder to initiate prescriptions for glucagon-like peptide 1 receptor agonists (GLP-1 RAs) via the PBS, if the government takes the PBAC’s latest advice.

Following their last meeting, the PBAC has recommended that GPs wanting to start their patients on GLP-1 RAs will be required to get written or phone approval from Services Australia or the Department of Veterans Affairs before prescribing.

“In making this recommendation, the PBAC considered the high use of GLP-1 RAs outside of the PBS restrictions, their high cost versus comparator treatments, and the administrative burden on prescribers associated with telephone/electronic authorities,” said the PBAC.

“Continuing access [to GLP-1 RAs] should be via a streamlined authority.”

The news comes as Ozempic sales are booming globally. Novo Nordisk, the drug’s manufacturer, is predicting a 23% growth in the drug’s sales to $112.5 billion in 2023, 54% greater than its closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8 billion.

“In 2022, US sales of Ozempic contributed to 65% of global sales; this is expected to continue, with the US market forecast to continue capturing the majority of sales, generating $71 billion between 2023 and 29. It is forecast that Ozempic will sustain its sales growth over the next five years, with an expected annual sales figure of $17 billion in 2029,” said a spokesperson for GlobalData.

“This represents a significant 83% increase in sales during 2022–29, demonstrating a compound annual growth rate (CAGR) of 9%.”

The PBAC also recommended that “the use of GLP-1 RAs in all type 2 diabetes mellitus indications be restricted to patients who are contraindicated, intolerant or inadequately responsive to sodium glucose cotransporter 2 (SGLT2) inhibitors”, partly because of cost.

“The PBAC noted that both SGLT2 inhibitors and GLP-1 RAs were PBS-listed based on a series of non-inferiority comparisons originating from insulin … [and] that the price reduction to SGLT2 inhibitors in 2015 meant that SGLT2 inhibitors were now more cost-effective than GLP-1 RAs,” the PBAC recommendation says.

“Relevant clinical groups [should] be consulted on the proposed T2DM medicines restriction wording prior to implementation to ensure the restrictions are simple and clear.”

Professor Jenny Gunton, chair of medicine at the University of Sydney, told TMR the Endocrine Society of Australia and the Australian Diabetes Society were preparing formal comments in response to the recommendation, but they were not yet ready for public release.

Quoted in newsGP, Dr Gary Deed, chair of the RACGP’s diabetes specific interest group, said the new recommendations aligned with the Living Evidence in Diabetes Guidelines, which suggest the prioritisation of SGLT2 inhibitors before considering a GLP-1 RA.

“The new proposed listing also means we are not using sulphonylureas as a comparator, plus there would be more effort to prescribe them with the need for telephone authority,” he said.

“This is a bit of a change for GPs as there was a push to consider GLP-1 RA as early therapy choices after metformin failure, especially for subgroups such as those with significant issues of weight impacting their diabetes.

“However, some of the PBAC response aligns to their observations that even on the prior restrictions, GLP-1 RA scripts were not aligned to necessary PBS criteria on a significant number analysed.

“The change will mean more work and education for GPs about these authority restrictions and also what place GLP-1 RAs have in diabetes management.”

TMR has previously reported that GLP-1 RAs such as semaglutide (Ozempic) and liraglutide (Saxenda) are being prescribed off-label for weight loss by online portals on the back of a simple questionnaire.

Increasing demand for the drugs as weight loss aids has also led to shortages in supply.