palbociclib (Ibrance)

following a full submission considered under the end of life and orphan equivalent assessment process:

palbociclib (Ibrance®) is accepted for use within NHSScotland.

Indication under review: for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:

- in combination with an aromatase inhibitor;
- in combination with fulvestrant in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

This submission relates to use in combination with fulvestrant in women who have received prior endocrine therapy.
In a phase III study palbociclib plus fulvestrant, compared with fulvestrant, prolonged progression-free survival in women with HR-positive HER2-negative locally advanced or metastatic breast cancer who had received prior endocrine therapy.

This SMC advice takes account of the benefits of Patient Access Schemes (PAS) that improve the cost-effectiveness of palbociclib and fulvestrant. This advice is contingent upon the continuing availability of these PAS in NHSScotland or list prices that are equivalent or lower