inavolisib (Itovebi)

following a full submission assessed under the end of life and orphan equivalent medicine process:

inavolisib (Itovebi®) is not recommended for use within NHSScotland.

Indication under review: in combination with palbociclib and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER) positive, HER2 negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.

Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence.

In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.

In a randomised, double-blind, phase III study, inavolisib plus palbociclib and fulvestrant significantly improved progression-free and overall survival compared with placebo plus palbociclib and fulvestrant (a relevant comparator). Indirect evidence against the two other relevant comparators has limitations which raise uncertainty.

The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.