TamoxifenGenox
Primary prevention of breast cancer in women at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).
Decision on record
- Meeting Mar 2016 Recommended Prevention of breast cancer
Access path
- TGA registered · Genox
TGA label equal than the PBS population
- Mar 2016Recommended · restricted
vs watchful waiting
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended a Restricted Benefit listing of tamoxifen for the reduction of breast cancer risk in patients at moderate to high lifetime risk of breast cancer, on the basis of acceptable cost-effectiveness compared to watchful waiting.PSD · Mar 2016
7.2 The PBAC noted the proposed restriction in the submission and the suggestions by the Secretariat. The PBAC also noted that DUSC considered that more frequent review may assist in detection and management of adverse events and encourage compliance.The PBAC advised that the PBS restriction wording should be finalised after completion of the registration of this drug by the TGA and the entry in the Australian Registry of Therapeutic Goods is known.PSD · Mar 2016
Methods used to A state transition model was used to generate the results by modelling participants generate results based primarily on the Cuzick 2013 meta-analysis. - Moderate/high risk of breast cancer. - ER+ breast cancer. Health states - Other breast cancer. - Death (absorbing state). - Adverse events (transient states). Cycle length 1 year. Transition to the breast cancer health states:PSD · Mar 2016
General population age-based breast cancer risk estimates (AIHW) multiplied by a constant relative risk increase (1.84; AIHW and Cuzick et al.) and a time-dependent relative risk reduction for tamoxifen (Cuzick et al.). Transition to the adverse events health states:PSD · Mar 2016
6.11 The submission described tamoxifen as clinically superior to placebo in reducing the incidence of breast cancer and inferior to placebo in terms of comparative safety.PSD · Mar 2016
Clinical superiority was adequately supported in terms of the incidence of breast cancer but not in terms of survival.PSD · Mar 2016
Cost-effectiveness
The document states a cost-utility analysis was provided but does not present numeric ICER values in the public text.
Decision context
PopulationWomen at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average) of developing breast cancer.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2016 | Recommended · restricted | watchful waiting | — | Meta-analysis · ORR |
Consumer voice
Breast Cancer Network Australia (BCNA) highlighted that tamoxifen for breast cancer risk reduction provides an important alternative to surgery, particularly for younger women who wish to preserve fertility. The Medical Oncology Group of Australia (MOGA) also supported PBS listing of tamoxifen for breast cancer prevention.
the use of tamoxifen for the reduction of breast cancer risk provides an important alternative option to surgery including removal of breasts and sometime ovaries, the latter being unacceptable to younger women who may wish to have a family. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — TGA label and PBAC recommendation both specify the same two risk categories for primary breast cancer prevention.