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.
Download detailed advice208KB (PDF)
Medicine details
- Medicine name:
- trastuzumab emtansine (Kadcyla)
- SMC ID:
- 990/14
- 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.
- Pharmaceutical company
- Roche
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Resubmission
- Status
- Accepted
- Date advice published
- 10 April 2017