Radium-223 Dichloride
Treatment of castration resistant metastatic carcinoma of the prostate in patients with symptomatic bone metastases and no known visceral metastatic disease.
Access path
- Nov 2017Recommended · restricted
vs abiraterone
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of radium 223Ra dichloride (223Ra) for the treatment of castration resistant metastatic carcinoma of the prostate, on a cost- minimisation basis with abiraterone.PSD · Nov 2017
6.2 The PBAC primarily relied on the MSAC’s prior (April 2014) consideration of 223Ra to recommend to the Minister that 223Ra should be made available on the PBS under a Section 100 special arrangement for radiopharmaceuticals.PSD · Nov 2017
5.16 The submission presented a cost minimisation analysis against abiraterone. The PBAC agreed this was a reasonable approach. 7PSD · Nov 2017
5.17 The equi-effective doses for the purposes of the cost-minimisation analysis against abiraterone are considered by the submission to bePSD · Nov 2017
5.2 There PBAC noted and welcomed the input from individuals (9), health care professionals (3) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with 223Ra including the improvement of quality of life (QOL), increased mobility, reduced pain, fewer side effects and a reduction in hospital visits.PSD · Nov 2017
5.3 The Medical Oncology Group of Australia (MOGA) also expressed its support for the 223Ra submission, on the basis of improved PFS, OS and improved QOL. The PBAC noted that the MOGA presented the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) for 223Ra, which was 5 (out of a maximum of 5, where 5 and 4 represent the grades with substantial improvement)1], based on a comparison with abiraterone and cabazitaxel.PSD · Nov 2017
5.28 The submission acknowledges that Risk-Sharing Arrangements (RSA) exist for cabazitaxel, abiraterone and enzalutamide.PSD · Nov 2017
5.29 The submission states that the sponsor would be willing to work with the Department of Health to establish an appropriate RSA for 223 Ra. However, Bayer requests a separate RSA for 223Ra and that any rebates over the cap take into account the higher costs incurred by Bayer for distributing 223Ra.PSD · Nov 2017
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated by design
Decision context
PopulationCastration resistant metastatic prostate cancer patients with ≥2 skeletal metastases, WHO performance status ≤2, who have failed or are unsuitable for docetaxel, and have not received prior abiraterone or enzalutamide or have developed intolerance to these agents
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Recommended · restricted | abiraterone | — | Meta-analysis · Cost-minimisation |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ALSYMPCA | Ph 3 | 921 | Overall Survival | completed |
Consumer voice
Consumer input from individuals, healthcare professionals, and organisations described benefits of 223Ra treatment including improved quality of life, increased mobility, reduced pain, fewer side effects, and reduced hospital visits. Organisations urged urgent access to this MSAC-approved treatment, highlighting inequity of international availability.
The comments described a range of benefits of treatment with 223Ra including the improvement of quality of life (QOL), increased mobility, reduced pain, fewer side effects and a reduction in hospital visits. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ≥2 skeletal metastases, WHO PS ≤2, docetaxel failure/unsuitability, and prior abiraterone/enzalutamide experience.