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trastuzumab emtansine (Kadcyla)

Advice

following a resubmission assessed under the orphan equivalent and end of life process: 

trastuzumab emtansine (Kadcyla ®) is accepted for use within NHS Scotland.

Indication under review: as a single agent, for the treatment of adult patients with human epidermal growth factor type 2 (HER2)-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: 
    • Received prior therapy for locally advanced or metastatic disease, or 
    • Developed disease recurrence during or within six months of completing adjuvant therapy.

In a randomised phase III open-label study, trastuzumab emtansine (Kadcyla®) conferred a significant survival benefit compared with an active comparator.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of trastuzumab emtansine (Kadcyla®). 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.

Drug Details

Drug Name: trastuzumab emtansine (Kadcyla)
SMC Drug ID: 990/14
Manufacturer: Roche
Indication: As a single agent, for the treatment of adult patients with human epidermal growth factor type 2 (HER2)-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: • Received prior therapy for locally advanced or metastatic disease, or • Developed disease recurrence during or within six months of completing adjuvant therapy.
BNF Category:
Sub Category: 8.1 Cytotoxic drugs
Submission Type: Resubmission
Status: Accepted
Date Advice Published: 10 April 2017

Archived Advice

Full submission 13 October 2014

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