Download Trastuzumabemtansine_CohortProforma_Jun17_v0.2

TRA1_ver2.2 – National Cancer Drugs Fund Application Form – Trastuzumab Emtansine (Kadcyla) - For the
treatment of HER2-positive locally advanced/unresectable or metastatic (Stage IV) breast cancer who previously
received trastuzumab and a taxane, separately or in combination
Patient NHS No:
Trust:
Patient Hospital No:
Practice Code:
Patient's Initials and DoB:
GP Postcode:
Choose Consultant:
Consultant Name:
*
Other Contact Details:
Notification Email Address:
*
(@NHS.net account ONLY)
Treatment Start Date:
BY TICKING THESE BOXES AND SUBMITTING THE APPLICATION THE CLINICIAN IS CONFIRMING THE PATIENT
MEETS ALL THE CRITERIA BELOW. IT SHOULD BE NOTED THAT THE SACT DATASET WILL BE USED TO
MONITOR THAT THESE CRITERIA ARE BEING MET:
Please indicate whether patient meets the following criteria:
1. I confirm that an application has been made and the first cycle of systemic anti -cancer therapy will be
prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer
therapy.
Please tick
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
2. I confirm that the patient has HER2-positive locally advanced or metastatic breast cancer
3. I confirm progression during or after the most recent treatment for advanced stage disease or within 6
months of completing treatment for early stage disease
4. I confirm that the patient has received previous treatment with a taxane
5. I confirm that the patient has received previous treatment with trastuzumab
6. I confirm that the patient has a performance status of 0, 1 or 2.
7. I confirm that the patient has left ventricular ejection fraction of 50% or more
8. I note that trastuzumab emtansine is not to be used beyond first disease progression outside the CNS.
Do not discontinue if disease progression is within the CNS alone.
9. I confirm that no planned treatment breaks of more than 4 weeks beyond the expected cycle length are
allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve).*
*Requests for continuation of treatment after unplanned treatment breaks over this duration should be
made via the treatment break approval process.
10. I confirm that trastuzumab emtansine will otherwise be used as set out in its Summary of Product
Characteristics (SPC).
11. What is the acquisition cost of the drug including VAT (if applicable)?
£ per month:
Commissioners will complete if cost not known as this will allow us to ensure budgets are
allocated appropriately.
NOTE: To minimise the risk of errors due to the similarity of the product name trastuzumab emtansine
(Kadcyla) with that of trastuzumab the recommendations in the Risk Minimisation Plan educational
material from the manufacturer should be followed when prescribing, dispensing and administering the
product.
Yes
No