PBAC backs funding of novel therapies from AstraZeneca, BMS, Roche, Amgen, UCB and Organon

The Pharmaceutical Benefits Advisory Committee (PBAC) has handed down its latest recommendations from its May meeting, supporting several new and expanded listings on the Pharmaceutical Benefits Scheme (PBS) across oncology, ophthalmology, dermatology and gynaecology.

Among the notable decisions, the PBAC backed the listing of AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) – known as the STRIDE regimen – for patients with advanced, unresectable Barcelona Clinic liver cancer (BCLC) Stage B or C hepatocellular carcinoma (HCC) who are either treatment naïve or intolerant to prior tyrosine kinase inhibitors (TKIs). While acknowledging uncertainties in comparing the STRIDE regimen to the combination of Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab), the PBAC concluded it was “likely to be similarly effective and safe” for this indication.

In melanoma, the PBAC endorsed a broadened listing for Bristol Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab), enabling their use in stage III disease as per the neoadjuvant protocol used in the NADINA trial. The trial demonstrated improved 12-month event-free survival and 18-month distant metastases-free survival when Opdivo and Yervoy were used as neoadjuvant therapy, compared to Opdivo alone in the adjuvant setting. The Committee requested the Department of Health ensures clear communication of the updated listings to dermatologists and oncologists, particularly the Melanoma Institute of Australia (MIA).

In lung cancer, the PBAC recommended the listing of BMS’ Augtyro (repotrectinib) for adults with stage IIIB or IV ROS1-positive non-small cell lung cancer (NSCLC). While acknowledging heterogeneity and uncertainty in the clinical comparisons, the Committee concluded that “on balance it was likely repotrectinib provided similar health outcomes to [Roche’s Rozlytrek] entrectinib.” The recommendation assumes cost minimisation to Rozlytrek.

Also in NSCLC, Roche’s Alecensa (alectinib) was supported for listing in the adjuvant treatment of resected ALK-positive tumours ≥4 cm or node-positive. The PBAC recognised the significant unmet need in this rare NSCLC subtype and noted the therapy’s potential to delay disease recurrence. Although survival benefit was uncertain, the PBAC found Alecensa to be cost-effective, especially with revised pricing and updated economic modelling. It advised that, consistent with other high-cost adjuvant therapies, “re-treatment in the metastatic setting should not be permitted”.

In ophthalmology, Amgen’s Tepezza (teprotumumab) was recommended for PBS listing in active, moderate-to-severe thyroid eye disease. The PBAC reaffirmed the high clinical need and found that Tepezza “is more effective in improving proptosis and diplopia compared to current standard of care, which may also lead to a reduction in eye surgery.” Despite some economic uncertainties, changes in the resubmission, including a proposed Risk Sharing Arrangement, were deemed to have sufficiently addressed earlier concerns raised at the March meeting.

The PBAC also supported listing for UCB’s IL-17A and IL-17F inhibitor, Bimzelx (bimekizumab), for moderate to severe hidradenitis suppurativa (HS), conditional on cost minimisation to either Novartis’ Cosentyx (secukinumab) or Humira (adalimumab). HS is a chronic, systemic and often painful skin disease, marked by recurring boil-like nodules that can rupture into open wounds, leading to irreversible scarring.

In reproductive health, Organon’s NuvaRing (etonogestrel with ethinylestradiol) received a recommendation for unrestricted PBS listing. The PBAC welcomed consumer input highlighting how listing would improve access and affordability, and acknowledged NuvaRing’s comparable efficacy and safety to existing PBS-listed contraceptive options. While the submission proposed limiting access to specific patient groups, the PBAC favoured a broader listing, stating that NuvaRing “could provide an additional contraceptive option for a wider population.”

Pricing negotiations between the sponsor and the Department of Health will influence the next steps, with the average time from a positive PBAC recommendation to PBS listing typically ranging from 6 to 9 months.

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