The PBAC has once again knocked back a bid to list semaglutide on the PBS for severe obesity, declaring the treatment remains economically unviable at prices being asked by Novo Nordisk.

But there was better news for patients with osteoporosis, with the committee backing funding of generic and branded teriparatide in multi-dose pre-filled pens (details below).

It’s the second rejection in as many years for semaglutide obesity-indicated product Wegovy from the PBAC, which has previously estimated an obesity listing would cost at least $1 billion annually, carrying “very uncertain implications for the PBS and broader health budget”.

At its March 2022 meeting, it also argued that while the drug had engendered significant weight loss in trial participants, this was unlikely to be replicated in a broader Australian context.

“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,” it said at the time.

“Moreover, the submission’s modelled reduction in comorbidities over a lifetime was highly uncertain given that no longer term data was presented in this submission.”

Novo Nordisk returned to the committee for a second attempt at PBS listing in November last year, this time refining its proposal to a more limited population of patients with severe obesity and certain comorbidities.

In this case, telephone/online authority would be required for all prescriptions, with patients only eligible for the treatment of severe obesity with prior participation in an appropriate lifestyle-based weight management intervention.

But the expert committee remained unmoved, declaring there was “no strong clinical rationale for the proposed obesity comorbidities selected for inclusion”, nor any detail on which patients were most likely to experience relatively large weight-loss or long-term benefits.

“No new clinical trial evidence was presented in this resubmission to support benefits of longer-term use, although the committee noted that new randomised controlled trial data highlighting potential benefits in reducing cardiovascular events was announced by the sponsor in a press release after the resubmission was received,” it said in an outcome statement (link here).

“The PBAC considered this information would be informative in defining eligible patients who would obtain downstream health benefits of weight loss.”

Moreover, the committee said it would be “unreasonable” for patients currently eligible for semaglutide 1 mg once-weekly (Ozempic) for Type 2 diabetes, who had severe obesity, to not be able to access the higher dose of semaglutide 2.4 mg once-weekly (Wegovy).

This group should be included for future consideration, it said.

The committee added: “The PBAC considered semaglutide was not cost-effective at the price proposed, noting although only short-term weight loss benefits were modelled, there were multiple issues with the utility values applied.”

As a result, a risk sharing arrangement would be required given the “extremely high estimated expenditure and the criteria for defining the patient population”, it said.

The PBAC nominated the facilitated resolution pathway for the item, pointing to the “high added therapeutic value of semaglutide and outstanding issues for resolution in defining the patients in whom treatment would reduce downstream consequences of obesity, be cost-effective, and appropriate for the significant government expenditure”.

In its official response, Novo Nordisk said it was disappointed with the outcome, but would continue its efforts to attract PBS listing for the product.

“Novo Nordisk remains committed to continuing to work collaboratively with the PBAC to ensure Australians living with obesity, especially high-risk and vulnerable patients, have government-funded access to Wegovy,” it said.

Osteoporosis treatment supported

Also at the November 2023 meeting, the PBAC recommended generic and Terrosa brand of teriparatide injection 250 micrograms per mL, 2.4 mL (teriparatide 250 mcg) in multi dose pre-filled pen.

This should be on a cost minimisation basis and under the same conditions as the currently listed pre-filled cartridges, the PBAC said.

Medroxyprogesterone acetate 150 mg/mL (Depo-Provera) was supported for funding in pre-filled syringe form under the same circumstances as the already listed vials.