DarolutamideNUBEQA
Treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) and docetaxel.
Decisions on record
- Meeting May 2023 Recommended Metastatic hormone sensitive prostate cancer (mHSPC) no PSD
- Meeting Nov 2022 Deferred Metastatic hormone-sensitive prostate cancer
- Meeting Jul 2021 Recommended Non-metastatic castration resistant prostate cancer
- Meeting Mar 2021 Not recommended Non-metastatic castration resistant prostate cancer
- Meeting Jul 2020 Not recommended Prostate cancer
Access path
- TGA registered · NUBEQA
TGA label narrower than the PBS population
- Jul 2020Recommended · restricted
vs watchful waiting (standard of care) with ongoing androgen…
- Mar 2021Not recommended
Comparator changed: watchful waiting (standard of care) with ongoing androgen deprivation…
- ↻ resubmittedJul 2021Recommended · restricted
ICER dropped $55,000 → $45,000 (-18%)
- May 2023Recommended · restricted
Comparator changed: watchful waiting (standard of care) with ongoing androgen deprivation…
- PBS listing · Authority Required
From the public summary
The PBAC deferred its decision on whether to recommend darolutamide for the treatment of mHSPC. The PBAC was of a mind to recommend darolutamide, pending advice from the TGA Delegate and, in the circumstance where apalutamide is not PBS listed for mHSPC, revised financials estimates and parameters for a risk sharing arrangement (RSA) are provided.PSD · Nov 2022
However, the PBAC considered that, in order to increase clinical choice, the PBS restriction for darolutamide should mirror that previously recommended for apalutamide and allow use as dual therapy in combination with ADT or as triple therapy in combination with docetaxel and ADT. The PBAC considered that darolutamide, in combination with docetaxel and ADT, provides a moderate clinical benefit for patients with mHSPC compared with docetaxel + ADT.PSD · Nov 2022
The submission presented a stepped economic evaluation (cost-utility analysis) based on the ARASENS trial, using a partitioned survival model to estimate costs and outcomes for darolutamide versus placebo in mHSPC.PSD · Nov 2022
Table 10 summarises the key components of the economic evaluation. 18PSD · Nov 2022
The submission described darolutamide as superior in terms of effectiveness compared with placebo and “comparable” in terms of safety compared to placebo.PSD · Nov 2022
The ESC considered that the effectiveness claim was adequately supported by the evidence presented in the submission which demonstrated a significantly higher OS in the darolutamide arm compared to placebo, and superior efficacy for other secondary outcomes.PSD · Nov 2022
The PBAC noted and welcomed the input from individuals (21), health care professionals (2), consumer group organisations (3) and medical organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with the combination of darolutamide with chemotherapy and androgen deprivation therapy, including improved efficacy in terms of delaying disease progression and increasing overall survival.PSD · Nov 2022
The PBAC noted that input was received from the Prostate Cancer Foundation of Australia, Prostate Heidelberg and the Geelong Prostate Support Group which supported the proposed listing. The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the darolutamide submission, categorising it as one of the therapies of “highest priority for PBS listing” on the basis of the ARASENS trial.PSD · Nov 2022
Cost-effectiveness
ICER values are redacted/not stated in the publicly available text; the document indicates commercially sensitive pricing information.
The revised base case incremental cost-effectiveness ratio (ICER) was $35,000 to < $45,000 per quality adjusted life year (QALY). PSD · 2021
Decision context
PopulationPatients with metastatic hormone-sensitive prostate cancer (mHSPC) suitable for treatment with docetaxel, including de novo and relapsed patients, with ECOG performance score of 0 or 1.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2023 | Recommended · restricted | Placebo in combination with ADT and docetaxel | — | RCT · OS |
| Jul 2021 | Recommended · restricted | watchful waiting (standard of care) with ongoing androgen deprivation therapy; near-market comparators: apalutamide, enz | $35k–45k | RCT · OS |
| Mar 2021 | Not recommended | watchful waiting / standard of care (SOC) with ongoing ADT | $45k–55k | RCT · MFS |
| Jul 2020 | Recommended · restricted | watchful waiting (standard of care) with ongoing androgen deprivation therapy | — | RCT · PFS |
Clinical evidence
Consumer voice
Consumer input from 21 individuals, 2 healthcare professionals, 3 consumer organisations, and 1 medical organisation supported PBS listing of darolutamide with chemotherapy and ADT, emphasising improved efficacy in delaying disease progression and increasing survival, while highlighting the importance of effective treatment for quality of life and concerns about disease progression, cancer pain, s
The comments described a range of benefits of treatment with the combination of darolutamide with chemotherapy and androgen deprivation therapy, including improved efficacy in terms of delaying disease progression and increasing overall survival. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ECOG 0–1 performance status and first-line use; TGA label specifies neither restriction.