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News & Trends - Pharmaceuticals

Positive PBAC recommendations announced

Health Industry Hub | June 20, 2022 |

Pharma News: The outcomes from the May 2022 Pharmaceutical Benefits Advisory Committee (PBAC) meeting are now available and indicate positive recommendations for Janssen, Roche and Kyowa Kirin therapies.

Janssen’s Darzalex (daratumumab) subcutaneous (SC) in combination with CyBorD has been recommended for listing for the treatment of patients with newly diagnosed systemic amyloid light-chain (AL) amyloidosis. There are currently no treatments on the PBS available specifically for this condition, and it considered that the addition of this medicine will offer a high added therapeutic value. The PBAC considered that the revised economic analysis which included more conservative assumptions, and a risk sharing arrangement based on reduced financial estimates which also accounted for the overlap between patients with AL amyloidosis and multiple myeloma, were acceptable.

The PBAC recommended the listing of Kyowa Kirin’s Crysvita (burosumab) for the treatment of patients with X-Linked Hypophosphataemia (XLH). The PBAC noted the high clinical need and the ongoing strong consumer support for the listing of treatments for this condition. The PBAC considered that the incremental cost-effectiveness ratios for both the paediatric and adult populations were acceptable at the proposed price and that the proposed risk sharing arrangement was adequate to manage the risks associated with the uncertainties relating to the estimated financial impact to the PBS.

Call for a horizon scanning framework that is future proof, agile and moves with the age of precision medicine

Roche’s Vabysmo (faricimab) for neovascular (wet) age-related macular degeneration (nAMD) and for the treatment of patients with visual impairment due to diabetic macular oedema (DMO) has also been recommended for PBS listing.

The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of Vabysmo would be acceptable if it were cost-minimised to PBS-listed anti-VEGFs such as Bayer’s Eylea (aflibercept) and Novartis’ Lucentis (ranibizumab). The PBAC supported a 2-year time horizon for the cost-minimisation calculation, and suggested equi-effective doses for both indications.

In nAMD, the PBAC considered that there should be no extra cost to government given the PBAC’s acceptance of Vabysmo administration frequency in the first year of treatment, derived from the average doses in the first 48 weeks of treatment in the TENAYA and LUCERNE trials (6.4 mean administrations through to week 48, average treatment duration of 46.2 weeks) apportioned to a 52 week estimate, and the Eylea administration frequency using PBS data.

In DMO, the PBAC considered the proposed cost savings with listing Vabysmo to be overestimated, in particular noting that the cost savings estimated in the submission depends on the assumed dose frequencies, which may differ in clinical practice. The PBAC considered that there should be no extra cost to government given the PBAC’s acceptance of Vabysmo administration frequency based on the RHINE/YOSEMITE trials and of Eylea administration frequency using PBS data.


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