Scottish Medicines Consortium palbociclib (Ibrance)

following a full submission considered under the end of life process:

palbociclib (Ibrance®) is accepted for restricted use within NHS Scotland.

Indication under review: 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 peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

SMC restriction: in combination with an aromatase inhibitor for first-line treatment of HR-positive HER2-negative locally advanced or metastatic breast cancer.

In an open label phase II study and a double-blind, placebo-controlled phase III study, palbociclib in combination with letrozole increased progression-free survival when compared with letrozole alone in patients with oestrogen receptor-positive, HER2-negative advanced breast cancer.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of palbociclib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.