For patients with metastatic basal cell carcinoma or locally advanced basal cell carcinoma who are inappropriate for surgery and radiation therapy and who have ECOG 0-2.
A BCCA “Compassionate Access Program” request with appropriate clinical information for each patient must be approved prior to treatment.

For the treatment of metastatic basal cell carcinoma (BCC) or locally advanced BCC (including patients with basal cell nevus syndrome, i.e., Gorlin syndrome) in patients who meet the following criteria:
– patients must have measurable metastatic disease or
locally advanced disease; AND
– patients’ disease must be considered inoperable or
inappropriate for surgery; AND
– patients’ disease must be considered inappropriate
for radiotherapy, AND
– patient is 18 year of age or older, AND
– patient has an EGOG≤2 Dose is 150 mg orally once
daily taken until disease progression or unacceptable toxicity. Physicians must provide rationale for why surgery AND radiation cannot be considered
– must include a surgical consult note that provides a preoperative/surgical evaluation why surgery is not appropriate for the patient; AND
– a consult note as to why radiation therapy is not appropriate for the patient: AND
– both of the above evaluations must come from a physician who is not the ordering physician, AND
– the chart must include confirmation that the patient has been discussed at a multi-disciplinary cancer conference (MCC) or equivalent.
Note: considered inoperable or inappropriate for surgery for at least ONE of the following reasons:
– technically not possible to perform surgery due to size/location/invasiveness of BCC (either lesion too large or can be several small lesions making surgery not feasible) OR
– recurrence of BCC after two or more surgical
procedures and curative resection unlikely; OR
– substantial deformity and/or morbidity anticipated from surgery Note: considered inappropriate for radiation for at least ONE of the following reasons:
– contraindication to radiation (e.g. Gorlin syndrome) OR – prior radiation lesion: OR
– suboptimal outcomes expected due to
size/location/invasiveness of BCC
Note: patients preference for oral therapy will not be
considered * Prescribing limited to named physicians
WHO ARE REGISTERED IN EPPP PROGRAM WITH A
SPECIFIC PRESCRIBER ID NUMBER.

Approved for the following indications:
• Treatment of metastatic basal cell cancer (BCC) in patients with ECOG ≤2
• Treatment of locally advanced BCC (including basal cell nevus syndrome or Gorlin syndrome, 18 years of age or older) in patients with ECOG ≤2, who are inappropriate for surgery or radiotherapy, based on a multi-disciplinary team decision that included surgeons, dermatologi

For patients with metastatic basal cell carcinoma (BCC) or with locally advanced BCC (including patients with basal cell nevus syndrome, ie. Gorlin syndrome) who have measurable metastatic disease or locally advanced disease, which is considered inoperable or
inappropriate for surgery and inappropriate for radiotherapy AND

– With measurable disease (at least one lesion > 10 mm) that is considered inoperable or inappropriate for surgery or radiation, as determined and documented by at least two specialist physicians AND
– Patients 18 years of age or older AND
– Patient has ECOG = or < 2

Initial Requests:
For patients with metastatic basal cell carcinoma (BCC) or with locally advanced BCC (including patients with basal cell nevus syndrome, i.e. Gorlin syndrome) who have measurable metastatic disease or locally advanced disease, which is considered inoperable or inappropriate for surgery* AND inappropriate for radiotherapy**;
AND
-Patient 18 years or age or older; AND
-Patient has ECOG ≤ 2 Dose: 150 mg orally once daily taken until disease progression or unacceptable toxicity. Approval Duration: 1 year Physicians must provide rationale for why surgery AND radiation cannot be considered
• The request must include a surgical consult note that provides a preoperative/surgical evaluation why surgery is not appropriate for the patient; AND

• A consult note as to why radiation therapy is not appropriate for the patient
• Both of the above evaluations must come from a physician who is not the requesting physician.
• Please confirm this patient has been discussed at a multi-disciplinary cancer conference (MCC) or equivalent

*Considered inoperable or inappropriate for surgery for one of the following reasons:
Provincial Funding Summary – Vismodegib (Erivedge) for Advanced Basal Cell Carcinoma Date Posted: January 30, 2015
© 2015 pCODR | PAN-CANADIAN ONCOLOGY DRUG REVIEW 4 PROVINCE STATUS DECISION DATE FUNDING CRITERIA
– Technically not possible to perform surgery due to size/location/invasiveness of BCC (either lesion too large or can be several small lesions making surgery not feasible)
– Recurrence of BCC after two or more surgical procedures and curative resection unlikely
– Substantial deformity and/or morbidity anticipated from surgery
**Considered inappropriate for radiation for one of the following reasons:
– Contraindication to radiation (e.g. Gorlin syndrome)
– Prior radiation to lesion – Suboptimal outcomes expected due to size/location/invasiveness of BCC
Note: Patient preference for oral therapy will not be
considered

Vismodegib may be used for the treatment of llocally advanced BCC (including basal cell nevus syndrome i.e. Gorlin syndrome who are 18 years of age and older) in patients with ECOG PS≤2 who are inappropriate for surgery and radiotherapy based on a discussion/evaluation with other members of the multi-disciplinary team.

Initial Requests: For patients with metastatic basal
cell carcinoma (BCC) or with locally advanced BCC
(including patients with basal cell nevus syndrome,
i.e. Gorlin syndrome) who have measurable
metastatic disease or locally advanced disease, which
is considered inoperable or inappropriate for surgery1
AND inappropriate for radiotherapy2 AND
• Patient 18 years or age or older; AND
• Patient has ECOG ≤ 2
• Patient preference for oral therapy will not be
considered Information Required Physicians must
provide rationale for why surgery1 AND radiation2
cannot be considered
• The request must include a surgical consultation
report that provides a preoperative/surgical
evaluation why surgery is not appropriate for the
patient; AND
• A consultation report as to why radiation therapy is
not appropriate for the patient
• Both of the above evaluations must come from a
physician who is not the requesting physician
• Confirmation that the patient has been discussed at
a multi-disciplinary cancer conference or equivalent
(e.g. Regional Tumour Board).
Renewal criteria: The physician has confirmed that
the patient has not experienced disease progression
while on Erivedge therapy.
Clinical Notes:
1Considered inoperable or inappropriate for surgery
for one of the following reasons:
– Technically not possible to perform surgery due to
size/location/invasiveness of BCC (either lesion too
large or can be several small lesions making surgery
not feasible)
– Recurrence of BCC after two or more surgical
procedures and curative resection unlikely
– Substantial deformity and/or morbidity anticipated
from surgery
2Considered inappropriate for radiation for one of the following reasons:
– Contraindication to radiation (e.g. Gorlin syndrome)
– Prior radiation to lesion o Suboptimal outcomes
expected due to size/location/invasiveness of BCC Dose: 150mg orally once daily taken until disease progression or unacceptable toxicity.
Claim Notes:
• Initial approval duration: 1 year
• Renewal approval duration: 1 year

For patients with metastatic basal cell carcinoma (BCC) or with locally advanced BCC (including patients with basal cell nevus syndrome, i.e. Gorlin syndrome) who have measurable metastatic disease or locally advanced disease, which is considered inoperable or
inappropriate for surgery and inappropriate for radiotherapy; AND
• Patient 18 years or age or older; AND
• Patient has ECOG ≤ 2