Alberta Regulation 18/2005

Cancer Programs Act

CANCER PROGRAMS AMENDMENT REGULATION

Filed: February 22, 2005

For information only: Made by the Minister of Health and Wellness (M.O. 9/2005)

on February 17, 2005 pursuant to sections 16 and 22 of the Cancer Programs Act.

1 The Cancer Programs Regulation (AR 242/98) is

amended by this Regulation.

2 The

Schedule is repealed and the following

Schedule is

substituted:

Schedule

Drug

Group

Dosage

Form

Criteria

13 Cis-RETINOIC ACID

capsules

Pediatrics

- restricted to the treatment

of advanced stage

neuroblastoma following

POG/CCG Protocols

- prescribing limited to

written authorization by

physicians recommended by

the pediatric tumour program

ALL-TRANS RETINOIC ACID

capsules

- restricted to treatment of

acute promyelocytic

leukemia

- prescribing limited to

written authorization by

physicians recommended by

the hematology/lymphoma

tumour program or the

pediatric tumour program

AMSACRINE

injectable

ANAGRELIDE

capsules

- for thrombocytosis due to

myeloproliferative disorder

- prescribing limited to

written authorization by

physicians recommended by

the hematology/lymphoma

tumour program

ANASTROZOLE

tablets

- for post-menopausal

patients with receptor-

positive, metastatic breast

cancer who have progressed

or have experienced severe

side effects on prior hormone

therapy

tablets

Breast Cancer Adjuvant

- for adjuvant use in invasive

breast cancer patients who

are post-menopausal,

hormone receptor positive in

whom tamoxifen is

contraindicated or not

tolerated

- prescribing limited to

written authorization by

named physicians as

recommended by the breast

tumour program

ASPARAGINASE

injectable

BCG

injectable

- bladder carcinoma

BICALUTAMIDE

tablets

- restricted to patients who

are intolerant to Nilutamide

or Flutamide

- approved dosage is 50 mg

daily

BLEOMYCIN

injectable

pump

BUSERELIN

injectable

- prostate cancer

- Restricted to:

Stage II (T2a-T2c):

Neoadjuvant use pre RT (2

months pre and during RT).

Neoadjuvant use pre radical

prostatectomy (4 months pre)

Stage III (T3a-T4b):

Neoadjuvant use pre RT (2

months pre and during RT).

Adjuvant use (3 years post

RT)

Stage IV (N1-N3)

(M1-M1c): As monotherpy

in medical castration.

In total androgen blockade

(medical castration and

nonsteriodal antiandrogen)

- Guidelines for LHRH use

in the above stated stages

include: LHRH agonists are

indicated for use in patients

at risk of thromboembolic

disease, strokes (CVA),

myocardial infarction and

also for consideration in

patients with dyslipidemia,

hypertension, diabetes

mellitus or where a patient is

considered intolerant to

cyproterone acetate or

megestrol acetate

BUSULFAN

tablets

CAPECITABINE

oral

- metastatic or advanced

breast cancer (with or

without prior anthracycline

exposure)

- prescribing limited to

written authorization by

physicians recommended by

the breast tumour program

oral

- option in first line

treatment of advanced or

metastatic colorectal cancer

- prescribing limited to

written authorization by

named physicians as

recommended by the GI

tumour program

oral

- adjuvant treatment of colon

cancer

- prescribing limited to

written authorization by

named physicians as

recommended by the GI

tumour program

CARBOPLATIN

injectable

CARMUSTINE

injectable,

topical

CHLORAMBUCIL

tablets

CISPLATIN

injectable

CLADRIBINE

injectable,

subcutane-

ous

- restricted to treatment of

hairy cell leukemia

- Waldenstrom's

macroglobulinemia

- hematologic malignancies

(histocytosis-X, cutaneous

T-cell lymphoma, systemic

mast cell disease)

- prescribing limited to

written authorization by

physicians recommended by

the hematology/lymphoma

tumour program

injectable

POG Protocol 9720

prescribing limited to written

authorization by physicians

recommended by the

pediatric tumour program

CLODRONATE

oral

- treatment of osteolytic

bone lesions in metastatic

breast cancer

CYCLOPHOSPHAMIDE

injectable,

tablets

CYPROTERONE

tablets

CYTARABINE

injectable

CYTARABINE LIPOSOMAL

injectable

- for intrathecal management

of neoplastic meningitis due

to solid tumours or

lymphoma

DACARBAZINE

injectable

DACTINOMYCIN

injectable

DAUNORUBICIN

injectable

DEXAMETHASONE

injectable,

tablets

- antiemetic use NOT

covered

DOCETAXEL

injectable

- treatment of metastatic

breast cancer after failure of

any previous chemotherapy

regimen

- as a single agent or in

combination, as an option for

first line treatment of

metastatic breast cancer

- only one taxane is to be

administered to any one

patient

- prescribing limited to

written authorization by

named physicians as

recommended by the breast

tumour program

injectable

Breast Neoadjuvant

- following a neoadjuvant

anthracycline containing

regimen in locally advanced

(Stage IIIA or IIIB) breast

cancer

- prescribing limited to

written authorization by

named physicians as

recommended by the breast

tumour program

injectable

Breast Adjuvant

- (with doxorubicin and

cyclophosphamide (TAC))

for adjuvant treatment of

node positive breast cancer

- prescribing limited to

written authorization by

named physicians as

recommended by the breast

tumour program

injectable

- 2nd line therapy in patients

with advanced or metastatic

non-small cell lung cancer

with good performance status

(ECOG 0-2) and no

symptomatic or uncontrolled

brain metastases

- prescribing limited to

written authorization by

named physicians as

recommended by the lung

tumour program

injectable

Prostate Cancer

- Docetaxel (with

prednisone) as first-line

treatment of hormone

refractory prostate cancer

- prescribing limited to

written authorization by

named physicians as

recommended by the tumour

program

DOXORUBICIN

injectable

DOXORUBICIN LIPOSOMAL

injectable

- Kaposi's sarcoma

injectable

- 2nd or 3rd line treatment of

ovarian cancer, fallopian tube

carcinoma and primary

peritoneal neoplasms

- prescribing limited to

written authorization by

named physicians as

recommended by the

gynecology tumour program

EPIRUBICIN

injectable

Breast Cancer

- adjuvant (node positive)

and neoadjuvant (stage II and

III) treatment of pre- and

post-menopausal breast

cancer patients

- adjuvant treatment of high

risk (as defined by current

Alberta Breast Cancer

Program Guidelines), lymph

node negative breast cancer

- prescribing limited to

written authorization by

named physicians as

recommended by the breast

tumour program

injectable

Esophagogastric Cancer

- used (in combination with

cisplatin and fluorouracil) in

the treatment of locally

advanced or metastatic

esophagogastric cancer in

patients with good

performance status

injectable

NCIC MA21 Trial

- use as adjuvant treatment

in NCIC MA21 Trial

- prescribing limited to

written authorization by

clinical trial principal

investigator(

s) or co-

investigators

ESTRAMUSTINE

capsules

ETOPOSIDE

injectable,

capsules

EXEMESTANE

oral

- for post-menopausal

patients with

receptor-positive,

advanced/metastatic breast

cancer that have progressed

or have experienced severe

side effects on prior hormone

therapy

FLUDARABINE

injectable,

tablets

- previously treated or

untreated chronic

lymphocytic leukemia

- low grade lymphoma

- Waldenstrom's

macroglobulinemia

- prescribing limited to

written authorization by

physicians recommended by

the hematology tumour

program

FLUOROURACIL

injectable,

cream

pump

FLUTAMIDE

tablets

- prostate cancer

GEMCITABINE

injectable

Advanced or metastatic

non-small cell lung cancer

- prescribing limited to

written authorization by

physicians recommended by

the lung tumour program

injectable

Bladder Cancer

- Gemcitabine/Cisplatin as

first line chemotherapy in

locally advanced/metastatic

bladder cancer

- prescribing limited to

written authorization by

physicians recommended by

the GU tumour program

injectable

Pancreas

- locally advanced or

metastatic adenocarcinoma

of the pancreas

- prescribing limited to

written authorization by

physicians recommended by

the GI tumour program

injectable

Hematology

- Gemcitabine,

Dexamethasone, Cisplatin

for relapsed or refractory

Hodgkins or Non-Hodgkins

Lymphoma (GDP regimen)

- prescribing limited to

written authorization by

named physicians as

recommended by the

hematology/lymphoma

program

injectable

Breast Cancer

- Gemcitabine/Paclitaxel for

treatment of metastatic breast

cancer

- prescribing limited to

written authorization by

named physicians as

recommended by the breast

tumour program

injectable

Hematology

- Gemcitabine with

Vinorelbine for recurrent or

refractory Hodgkins

Lymphoma (Pediatric COG

Study Protocol AHOD0321)

- prescribing limited to

written authorization of

named physicians as

recommended by the

pediatric tumour program

GOSERELIN

injectable

- prostate cancer

- Restricted to:

Stage II (T2a-T2c):

Neoadjuvant use pre RT (2

months pre and during RT).

Neoadjuvant use pre radical

prostatectomy (4 months pre)

Stage III (T3a-T4b):

Neoadjuvant use pre RT (2

months pre and during RT).

Adjuvant use (3 years post

RT)

Stage IV (N1-N3)

(M1-M1c): As monotherpy

in medical castration

In total androgen blockade

(medical castration and

nonsteriodal antiandrogen)

- Guidelines for LHRH use

in the above stated stages

include: LHRH agonists are

indicated for use in patients

at risk of thromboembolic

disease, strokes (CVA),

myocardial infarction and

also for consideration in

patients with dyslipidemia,

hypertension, diabetes

mellitus or where a patient is

considered intolerant to

cyproterone acetate or

megestrol acetate

injectable

- breast cancer. 2nd line

hormonal therapy for

recurrent or metastatic

disease in either or both

estrogen and progesterone

receptor positive pre and

perimenopausal patients after

tamoxifen failure

- prescribing limited to

written authorization by

physicians recommended by

the breast tumour program

injectable

- breast cancer adjuvant

- Goserelin, with or without

Tamoxifen, as first line

adjuvant treatment in pre or

peri-menopausal patients

with early hormone receptor

positive breast cancer in

whom chemotherapy is

contraindicated

- prescribing limited to

written authorization by

named physicians as

recommended by the breast

tumour program

HYDROCORTISONE SODIUM

SUCCINATE

injectable

- intrathecal use only

HYDROXYUREA

capsules

IDARUBICIN

injectable

POG Protocol 9720

- prescribing limited to

written authorization by

physicians recommended by

the pediatric tumour program

IFOSFAMIDE

injectable

pump

IMATINIB

capsules

- for surgically unresectable

or metastatic gastrointestinal

stromal tumour (GIST)

- prescribing limited to

written authorization by

named physicians as

recommended by the tumour

program

capsules

Hematology

- Philadelphia-chromosome

positive leukemia (including

disease situations such as

first chronic phase chronic

myelogenous leukemia

(CML), accelerated phase

CML, blast crisis phase

CML, acute lymphoblastic

leukemia, or other leukemias

that have the characteristic

t(9;22) translocation detected

by cytogenetics, FISH

analysis, or PCR-positive for

bcr-abl oncogene)

- prescribing limited to

written authorization by

named physicians as

recommended by the

hematology/lymphoma

program

INTERFERON alpha 2b

injectable

- cladribine-resistant hairy

cell leukemia

- Kaposi's sarcoma

- chronic myelogenous

leukemia

- metastatic renal cell

carcinoma

injectable

- mycosis fungoides and

sezary syndrome (cutaneous

T-cell lymphomas)

- prescribing limited to

written authorization by

physicians recommended by

the hematology/lymphoma

tumour program

injectable

- basal cell carcinoma

- adjuvant treatment of high

risk melanoma

injectable

Superficial Bladder Cancer

- Interferon alone - second

line treatment or first line in

those with a documented

intolerance or

contraindication (i.e.,

immunosuppression or other)

to BCG

- Interferon in combination

with BCG - second line

treatment

injectable

- treatment of patients with

malignant carcinoid and

neuroendocrine

gastroenteropancreatic

tumours not amenable to

surgical extirpation

- prescribing limited to

written authorization by

physicians recommended by

the GI and endocrine tumour

programs

injectable

- maintenance therapy in

multiple myeloma patients

who have achieved complete

remission after high dose

chemotherapy and

autologous stem cell

transplant

- follicular lymphoma and

need for therapy as indicated

by any of: mass >7 cm or 3

sites >3 cm, Bsx,

splenomegaly @ umbilicus,

compression syndromes (GI,

GU, orbit), effusions

cytopenias, Age