Darolutamide to be listed on the PBS for mHSPC

GU cancer

By Siobhan Calafiore

17 Nov 2023

Darolutamide (Nubeqa, Bayer) will become the first androgen-receptor inhibitor to be listed on the Pharmaceutical Benefits Scheme for use in triple therapy for men with metastatic hormone-sensitive prostate cancer (mHSPC) from 1 December.

It will form part of a three-pronged treatment, used alongside chemotherapy (docetaxel) and hormone therapy (androgen deprivation therapy or ADT).

Through the PBS, eligible patients will pay $7.30 (concession) or $30.00 (general) each month for darolutamide, which would have otherwise cost them more than $42,000 each year in addition to the cost of the other anti-cancer medicines.

It is estimated about 5,000 men will meet the criteria.

The TGA registered the non-steroidal androgen receptor antagonist as a combination therapy for advanced prostate cancer earlier this year, based on promising results from the international phase III ARASENS trial [link here].

“The risk of death was 32.5% lower in the darolutamide group than in the placebo group (hazard ratio, 0.68; 95% confidence interval, 0.57 to 0.80; P<0.001),” the trial said.

Improvements with darolutamide were also observed in key secondary end points including time to castration-resistant prostate cancer, time to pain progression, time to first symptomatic skeletal event, time to initiation of subsequent systemic antineoplastic therapy, and symptomatic skeletal event–free survival.

The study also found rates of adverse events were generally comparable with the triplet versus dual therapy.

The drug is already subsidised for castration resistant non-metastatic prostate cancer.

Genesis Care medical oncologist Dr Laurence Krieger welcomed the listing.

“Sadly, prostate cancer remains the second greatest cancer killer of Australian men. New treatment options are desperately needed,” he said in a statement.

Metastatic prostate cancer kills more than 3,700 Australian men each year.

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