Download Trastuzumab Emtansine for Unresectable Locally Advanced or

Eligibility Form
Trastuzumab Emtansine for Unresectable Locally Advanced or
Metastatic Breast Cancer as Third or Subsequent Line of
Treatment (Time-Limited*)
*For patients who have initiated or completed at least two lines of HER2 targeted therapy
prior to the implementation of this temporary funding (October 17, 2014)
This form must be completed before the first dose is dispensed.)
1. Patient Profile
* Surname:
* Given Name:
* OHIN:
* Chart Number:
* Postal Code:
* Height (cm):
* Weight (kg):
2
* BSA (m ):
* Gender:
Male
Female
* Date of Birth:
Day
Month
Year
* Site:
* Attending Physician (MRP- Most Responsible Physician):
Requested Prior Approval
Specify Trial:
ALLTO MAC13
Yes
* Patient on Clinical Trial
Yes
MA.34
MA.31
NSABP B-40
NSABP B-41
OTHER
Geron CP 14B014
W020697
Synta 9090-08
NCIC CTG IND.213
MARIANNE
Peruse
NCT01966471 (KAITLIN)
Other (specify):
Specify Arm:
Standard of care arm
Experimental arm
No
Other
Request prior approval for enrolment
* Justification for Funding
* Anticipated date of first treatment
Day
Month
Year
2. Eligibility Criteria
1. Trastuzumab emtansine is used for patients:
With HER2-positive, unresectable locally advanced or metastatic breast
cancer with an ECOG performance status of 0 or 1,
AND
Who have initiated or completed at least two lines of HER2 targeted
therapy prior to the implementation of this temporary trastuzumab
emtansine funding (October 17, 2014), and who have not received
trastuzumab emtansine in any prior line of therapy.
Yes
2. Patient had previously been enrolled in the following HER2 targeted therapies:
Adjuvant/Neoadjuvant trastuzumab + chemotherapy
If yes, specify funding source
Yes
No
NDFP
EBP
Third Party
First line:
Adjuvant/Neoadjuvant trastuzumab + chemotherapy (NDFP)
Adjuvant/Neoadjuvant trastuzumab + chemotherapy (EBP)
Adjuvant/Neoadjuvant trastuzumab + chemotherapy (Third Party)
Pertuzumab-trastuzumab + taxanes (NDFP)
Pertuzumab-trastuzumab + taxanes (Third Party)
Trastuzumab + chemotherapy (NDFP)
Trastuzumab + chemotherapy (Third Party)
Other
If other, specify drug and funding source (i.e. NDFP):
Second line:
Pertuzumab-trastuzumab + taxanes (NDFP)
Pertuzumab-trastuzumab + taxanes (Third Party)
Trastuzumab + chemotherapy (NDFP)
Trastuzumab + chemotherapy (Third Party)
Lapatinib-capecitabine (EAP)
Lapatinib-capecitabine (EAP)
Lapatinib-capecitabine (Third Party)
Other
If other, specify drug and funding source (i.e. NDFP):
Third line:
Trastuzumab + chemotherapy (NDFP)
Trastuzumab + chemotherapy (Third Party)
Lapatinib-capecitabine (EAP)
Lapatinib-capecitabine (Third Party)
Eribulin (NDFP)
Eribulin (Third Party)
Other
N/A: This enrolment is for third-line use
If other, specify drug and funding source (i.e. NDFP):
Fourth line:
Eribulin (NDFP)
Eribulin (Third Party)
Other
N/A: This enrolment is for third-line use
N/A: This enrolment is for fourth-line use or higher
If other, specify drug and funding source (i.e. NDFP):
3. Funded Dose
Trastuzumab emtansine 3.6mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
4. Notes
a. Reimbursement of trastuzumab emtansine under the NDFP, according to the clinical criterion
outlined above, is effective on October 17, 2014 and ends on October 16, 2017. Patients enrolled prior
to the end date may continue to receive funding for treatments beyond October 16, 2017, until
disease progression or unacceptable toxicity. Enrolments submitted on October 17, 2017 and later
will not be considered.
b. For this policy, the following documents may be requested:
Pathology report confirming date of biopsy, Tumour Node Metastases (TNM) staging information and
positive HER2 test results
c. There is a risk of medication errors between trastuzumab emtansine and trastuzumab. Do not substitute
trastuzumab emtansine for or with trastuzumab. Do not exceed the recommended trastuzumab emtansine
dose (i.e., 3.6 mg/kg IV every 3 weeks). The trastuzumab emtansine dose should not be re-escalated after a
dose reduction is made.
d. It is recommended that the left ventricular ejection fraction (LVEF) be greater than or equal to 50% prior to
initiation of therapy. It is also recommended that LVEF be assessed (via MUGA or ECHO) prior to the
initiation of trastuzumab emtansine and at regular intervals (e.g., every 3 months) during treatment. If, at
routine monitoring, the LVEF is ≤ 40%, or is 40-45% with a 10% or greater absolute decrease below the pretreatment value, withhold the trastuzumab emtansine and repeat the LVEF assessment within approximately
3 weeks. Trastuzumab emtansine should be permanently discontinued if the LVEF has not improved or has
declined further.
6. Supporting Documents
To ensure reimbursement of your claim, both the completed enrolment form and a copy of the required
documentation (where applicable) must be submitted through CCO e-Claims.
Signature of Attending Physician (MRP-Most Responsible Physician):
16
10
2014
Day
Month
Year