← The record

Anastrozole, Everolimus, Exemestane, Goserelin, Letrozole

Recommended OncologyRestricted

Breast cancer in male and female patients. The submission sought to amend PBS restrictions to allow males with breast cancer equitable access to these five hormone therapies, which were previously restricted to post-menopausal women.

1
Submissions
2014–14
On the record
ICER range
Not modelled
Cost basis

Access path

1 submission · public record
  1. Nov 2014
    Recommended
  2. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
3.1 The PBAC agreed with the MOGA view that the small number of male patients requiring treatment for breast cancer should not be denied PBS subsidised access to effective treatments based on their gender. The PBAC considered that a similar equity in access issue also occurs for the paediatric population and that this is often circumvented by recommending restrictions which do not necessarily preclude use in that certain patient population.PSD · Nov 2014

Cost-effectiveness

No economic evaluation submitted; this was a restriction amendment request for equity of access based on gender.

Decision context

PopulationMale and female patients with breast cancer (hormone receptor positive); previously the restrictions explicitly limited subsidy to post-menopausal women.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Nov 2014 Recommended Cost-minimisation

Similar precedents

By decision profile

Regulatory · TGA

Label broader than PBS population — TGA label restricts to post-menopausal women; PBAC recommended inclusion of males and pre/peri-menopausal females, expanding beyond registered indication.