29 April 2022 - Wegovy was the first discrete medicine to have a stakeholder meeting before its consideration by the PBAC; it seems it didn't help that much.

The PBAC did not recommend the PBS listing of semaglutide for the treatment of obesity.

While the PBAC agreed with the submission that semaglutide 2.4 mg should be used as a later-line therapy, in conjunction with diet and exercise, the submission had poorly justified the population access it had requested (chronic use in patients with BMI ≥ 35 kg/m2 and at least one weight-related comorbidity but who do not have diabetes). In addition, although the trial data showed that semaglutide plus diet and exercise was superior to diet and exercise alone in terms of weight loss, HbA1c and other biomarkers and quality of life, these benefits were only demonstrated over the short term and whilst on treatment, and it was unlikely they would be fully realised in Australian practice without the intensive diet and exercise counselling co-administered in the trial program.

One would have thought these issues would have been discussed extensively at the stakeholder meeting.

Moreover, the submission’s modelled reduction in co-morbidities over a lifetime was highly uncertain given that no longer term data was presented in this submission. In addition, the PBAC noted that there were several issues with the modelled economic evaluation that limited its reliability, and that semaglutide was not cost effective at the proposed price. 

Furthermore, the PBAC considered that pharmacotherapy was only one aspect of the public health response to obesity in Australia, but the proposed PBS listing of semaglutide would require an extremely high investment (an average of >$1 billion annually over 6 years) with very uncertain implications for the PBS and broader health budget.

The PBAC has a history of rejecting new medicines for obesity. The PBAC rejected sibutramine hydrochloride (Reductil) four times between 2006-2008.  

The PBAC has never considered a submission for:

• Orlistat (Xenical)
• Liraglutide (Saxenda)
• Naltrexone hydrochloride with bupropion hydrochloride (Contrave)

All of these medicines have been approved by the TGA for the treatment of obesity.

NICE is yet to conduct an assessment of semaglutide (Wegovy) for obesity; a submission for Wegovy is under review by CADTH.