pertuzumab (Perjeta)

following a second resubmission assessed under the orphan medicine process:

pertuzumab (Perjeta®) is accepted for use within NHSScotland.

Indication under review: for use in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2 positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.

In a phase II study conducted in women with locally advanced, inflammatory, or early HER2 positive breast cancer, in the neoadjuvant setting, the addition of pertuzumab to trastuzumab plus chemotherapy resulted in a significantly higher proportion of patients achieving pathological complete response in the breast.

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

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.