Schedule of cancer drugs, appendix b, m.o. 71/2012

M.O. 71/2012
WHEREAS it is desirable to provide cancer drugs for the treatment of cancer; WHEREAS Ministerial Order 49/2012 established the Conditions for the Use of Cancer Drugs and the Schedule of Cancer Drugs; and WHEREAS based on the recommendations of the Alberta Health Services Cancer Drug Evaluation Committee and endorsed by Alberta Health Services Drugs and Therapeutics Committee, and at the request of Alberta Health Services, it is desirable to revise the Schedule of Cancer Drugs; THEREFORE, I, MARCIA NELSON, Deputy Minister of Health, pursuant to section 8(1) of the Government Organization Act, hereby repeal Ministerial Order 49/2012 and establish: the Conditions for the Use of Cancer Drugs, as set out in the attached Appendix A; and the Schedule of Cancer Drugs, as set out in the attached Appendix B. DATED at Edmonton, Alberta this 17th day of M.O. 71/2012
(REPEALS M.O. 49/2012)
APPENDIX B
SCHEDULE OF CANCER DRUGS
-for patients with metastatic, castration-resistant prostate cancer who have previously received docetaxel therapy. -Prescribing limited to written authorization by named physicians as recommended by the genitourinary (GU) tumor program. fludarabine for patients previously treated for CLL. Prescribing limited to written authorization by named physicians as recommended by the hematology tumor group. - for post-menopausal patients with receptor-positive, metastatic breast cancer who have progressed or have experienced severe side effects on prior hormone therapy breast cancer patients who are post-menopausal, hormone receptor positive in whom tamoxifen is contraindicated or not tolerated M.O. 71/2012
(REPEALS M.O. 49/2012)
- in combination with chemotherapy in the treatment of advanced colorectal cancer (indicated for first-line therapy, or if bevacizumab naïve, second-line therapy). -prescribing limited to written authorization by named physicians as recommended by the GI Tumor Group. - relapsed multiple myeloma - prescribing limited to written authorization by physicians recommended by the Hematology Tumour Program -first line treatment of previously untreated multiple myeloma who are not candidates for autologous stem cell transplantation (HDT-ASCT) -prescribing limited to written authorization by named physicians as recommended by the Hematology tumor program combination treatment for relapsed or refractory mantle cell lymphoma. M.O. 71/2012
(REPEALS M.O. 49/2012)
written authorization by named physicians as recommended by the hematology tumor program. - 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) (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 - used in combination with prednisone for patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel containing regimen. - prescribing limited to written authorization by named physicians as recommended by the genitourinary (GU) tumor program - metastatic or advanced breast cancer (with or without prior anthracycline M.O. 71/2012
(REPEALS M.O. 49/2012)
exposure) - prescribing limited to written authorization by physicians recommended by the breast tumour program -(instead of 5-Fluorouracil and Leucovorin) in combination with Oxaliplatin in metastatic colorectal cancer patients (performance status 0-2) who have had treatment failure with irinotecan or have a contraindication to irinotecan. -prescribing limited to written authorization by named physicians as recommended by the GI tumour program - in combination with a platinum-based regimen as first line palliative chemotherapy for patients with locally advanced or metastatic cancer of the esophagus, gastroesophageal junction or stomach -prescribing limited to written authorization by named physicians as recommended by the GI tumour program -patient has locally or regionally advanced squamous cell carcinoma of the head and neck without M.O. 71/2012
(REPEALS M.O. 49/2012)
distant metastases, and - have Karnofsky Performance score >90,and -is used in combination with curative radical radiotherapy -prescribing is limited to written authorization by named physicians as recommended by the head and neck tumor program Hematology -for treatment of adults with chronic, accelerated or blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate. -for adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia whose disease is resistant to imatinib-containing chemotherapy (patient must have tried 600 mg/day) or have experienced grade 3 non-hematologic toxicity, or grade 4 hematologic toxicity persisting for more than 7 days to imatinib -prescribing limited to written authorization by named physicians as recommended by the hematology tumor program - as first line treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase M.O. 71/2012
(REPEALS M.O. 49/2012)
(CML-CP) - prescribing limited to written authorization by named physicians as recommended by the hematology tumor program. - 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 - following a neoadjuvant anthracycline containing regimen in locally advanced (Stage IIIA or IIIB) breast cancer (either preceding or following surgery). - prescribing limited to written authorization by named physicians as recommended by the breast tumour program Breast Adjuvant -For the adjuvant treatment of lymph node positive breast cancer patients and for the adjuvant treatment of lymph node negative (intermediate or high-risk) breast cancer patients. - prescribing limited to written authorization by named physicians as recommended by the breast tumour program M.O. 71/2012
(REPEALS M.O. 49/2012)
- 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 - for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and whose EGFR expression status is positive or unknown -cannot have received Gefinitib first line - prescribing limited to written authorization by named physicians as recommended by the lung tumour program M.O. 71/2012
(REPEALS M.O. 49/2012)
-for treatment of patients with metastatic renal cell carcinoma (mRCC) after failure of initial treatment with VEGF-receptor TKIs, sunitinib or sorafenib. -prescribing limited to written authorization by named physicians as recommended by the genitourinary (GU) tumor group. -restricted to use in patients hypersensitive to E. Coli asparaginase for remission in acute lymphoblastic leukemia -prescribing limited to written authorization by named physicians as recommended by the pediatric and hematology/ lymphoma programs. M.O. 71/2012
(REPEALS M.O. 49/2012)
- first line treatment of epidermal growth factor receptor (EGFR) sensitizing mutation positive non-small cell lung cancer (NSCLC) - Prescribing limited to written authorization by named physicians as recommended by the lung tumor program Intravesical (for bladder instill-ations) - 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) (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 breast cancer. As first line treatment in pre- and post-menopausal patients with metastatic breast cancer prescribing limited to written authorization by named physicians as M.O. 71/2012
(REPEALS M.O. 49/2012)
- breast cancer adjuvant: pending clinical trial confirmation, treatment with ovarian suppression along with GnRH agonists is not generally indicated in the adjuvant setting, however may be considered an adjuvant treatment option for pre-menopausal patients who have had hormone receptor positive breast cancer, and are eligible for adjuvant chemotherapy but either: a) decline chemotherapy, or b) where chemotherapy is contraindicated, or c) have a contraindication to adjuvant tamoxifen. - prescribing limited to written authorization by named physicians as recommended by the breast tumour program -for the treatment of advanced melanoma (unresectable Stage III and Stage IV melanoma) in patients who have received prior systemic therapy. -prescribing limited to written authorization by named physicians as recommended by the cutaneous tumor program. - for surgically unresectable or metastatic gastrointestinal stromal tumour (GIST) - prescribing limited to written authorization by named physicians as recommended by the tumour program M.O. 71/2012
(REPEALS M.O. 49/2012)
- for the adjuvant treatment of patients who are at high risk of relapse following complete resection of KIT (CD117) positive GIST. written authorization by named physicians as recommended by the musculoskeletal tumor program. 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 treatment of patients with advanced/metastatic breast cancer whose tumors overexpress ErbB2 (HER2) after prior taxane and trastuzumab exposure. -prescribing limited to written authorization by named physicians as recommended by the Breast tumor program. M.O. 71/2012
(REPEALS M.O. 49/2012)
-for multiple myeloma after at least one prior therapy. -prescribing limited to written authorization by named physicians as recommended by the Hematology tumor program. -as an adjuvant treatment in postmenopausal, hormone receptor positive breast cancer high risk (node positive, high and intermediate risk node negative, stage IIB/III) cancer patient who has completed primary surgery and chemotherapy (where appropriate) (or other aromatase inhibitor if intolerant to letrozole) - 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) (M1-M1c): As monotherpy in medical castration. In total androgen blockade (medical castration and M.O. 71/2012
(REPEALS M.O. 49/2012)
- 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 NOTE: 3rd line for bladder cancer indication Metastatic Breast Cancer -for patients who have had severe acute infusion reactions with paclitaxel or docetaxel considered by the treating physician to be due to the vehicle of the taxanes (cremophor and polysorbate80); or patients who have experienced severe toxicity from previous administration of other taxanes* (*severe toxicity could be due to the pre-medications for the administration of the taxane or due to the taxane itself). -prescribing limited to written authorization by named physicians as recommended by the Breast tumor group M.O. 71/2012
(REPEALS M.O. 49/2012)
for Imatinib resistant or intolerant, or Dasatinib intolerant CML patients - prescribing limited to written authorization by named physicians as recommended by the hematology tumor group. - as first line treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia Chronic Phase (CML-CP). -prescribing limited to written authorization by named physicians as recommended by the hematology tumor program. - first line in patients with metastatic adenocarcinoma of the pancreas (as a component of FOLFIRINOX) - prescribing limited to written authorization by named physicians as recommended by the GI tumor program M.O. 71/2012
(REPEALS M.O. 49/2012)
treatment of patients with metastatic/advanced colorectal carcinoma with non-mutated (wild-type) K-RAS after failure of fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy regimens. Recommended dosing is 6 mg/kg every 2 weeks until progression. -Prescribing limited to written authorization by names physicians as recommended by the gastrointestinal tumor program. -for treatment of patients with advanced or metastatic clear cell renal carcinoma who, based on the mutual assessment of the treating physician and the patient, are unable to tolerate ongoing use of an effective dose of Sunitinib. -prescribing limited to written authorization by named physicians as recommended by the genitourinary (GU) tumor program. - Pemetrexed (in combination with Cisplatin) for use in patients with malignant mesothelioma - prescribing limited to written authorization of named physicians as recommended by the lung tumour program -second line treatment of patients with non-small cell lung cancer -prescribing limited to written authorization by named physicians as recommended by the Lung tumor program treatment of patients with advanced non-small cell lung cancer (NSCLC) of non-squamous histology following four cycles of palliative platinum-doublet chemotherapy. M.O. 71/2012
(REPEALS M.O. 49/2012)
-prescribing limited to written authorization by named physicians as recommended by the lung tumor program - Rituximab plus chemotherapy for patients with follicular, mantle cell, and other CD20 positive indolent histology non-Hodgkin’s lymphoma who have had no prior treatment with rituximab - relapsed or refractory, low grade or follicular, CD 20 positive, B-cell, non-Hodgkin’s lymphoma - prescribing limited to written authorization by physicians recommended by the lymphoma tumour program - in combination with chemotherapy for aggressive histology B-cell CD20 positive non-Hodgkin’s lymphoma (any stage or age) - prescribing limited to written authorization by named physicians as recommended by the hematology/lymphoma tumour program -maintenance for Follicular Lymphoma patients who are in remissions (CR or PR) following chemotherapy +/- Rituxan induction -prescribing limited to written authorization by named physicians as recommended by the M.O. 71/2012
(REPEALS M.O. 49/2012)
-as extended maintenance therapy for 8 doses in patients with indolent CD-20(+)B cell lymphomas who have recently (within 3 months) responded to systemic therapy and have never previously received maintenance Rituximab. written authorization by named physicians as recommended by the Hematology tumor program chemotherapy (including high dose therapy and ASCT) for patients with CD-20(+) large B cell lymphomas who are in first relapse after at least a 6 month remission following initial Rituximab containing chemotherapy, and who are considered potential candidates for high dose therapy and autologous stem cell transplantation (no serious co-morbidities, no CNS lymphoma). -prescribing limited to written authorization by named physicians as recommended by the Hematology tumor program. chemotherapy as first-line treatment of chronic Lymphocytic leukemia -prescribing limited to written authorization by names physicians as recommended by the Hematology Tumor Program - IV q2months as maintenance rituximab for transplant ineligible mantle cell lymphoma (MCL) patients (remission) after induction chemotherapy until (disease) progression. -Prescribing limited to written authorization by named physicians as recommended by the M.O. 71/2012
(REPEALS M.O. 49/2012)
-as second line treatment (after failure of cytokine therapy) for advanced/ metastatic renal cell carcinoma -prescribing limited to the written authorization by named physicians as recommended by the genitourinary tumor program Metastatic or Unresectable Gastrointestinal Stromal Tumour (GIST) -after disease progression on or after intolerance to Imatinib -prescribing limited to written authorization by named physicians as recommended by the musculoskeletal tumour program. -First line in advanced/ metastatic renal cell carcinoma or second line after interferon failure/ intolerance -prescribing limited to written authorization by named physicians as recommended by the GU tumor program first line treatment of recurrent glioblastoma multiforme and M.O. 71/2012
(REPEALS M.O. 49/2012)
anaplastic astrocytoma - first line concurrent (with RT)/adjuvant treatment for malignant glioma - prescribing limited to written authorization by physicians recommended by the neuro oncology tumour program For dose intensive RESCUE protocol for relapsed malignant gliomas Group 2 - Prescribing limited to written authorization by named physicians as recommended by the neuro oncology tumor program temozolamide in children with recurrent neuroblastoma (protocol ANBL0421) -prescribing limited to written authorization by named physicians in the pediatric tumor program -first line treatment of patients with poor prognosis (multiple risk factors) metastatic renal cell carcinoma, independent of histology -prescribing limited to written authorization by named physicians as recommended by the genitourinary tumor program - restricted to the treatment of metastic breast cancer, HER 2 protein overexpression (+3) by IHC, or HER 2 amplification by FISH - prescribing limited to written authorization by physicians recommended by the breast tumour program M.O. 71/2012
(REPEALS M.O. 49/2012)
Adjuvant/Neoadjuvant treatment of Stage 1-3, Her-2 positive breast cancer - for use with or following chemotherapy - prescribing limited to written authorization by physicians recommended by the breast tumour program breast cancer when used in combination with chemotherapy after previous exposure to trastuzumab-based treatments in the metastatic setting. used in conjunction with Cisplatin and either 5-Fluarouracil or Capecitabine as palliative treatment for advanced adenocarcinoma of the stomach and gastroesophageal junction that demonstrates HER2 over-expression (immunohistochemistry score 3+ or 2+ with in situ hybridization positivity). Prescribing limited to written authorization by named physicians as recommended by the Gastrointestinal (GI) tumor program. -for treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. -prescribing limited to written authorization by named physicians as recommended by the cutaneous tumor group. M.O. 71/2012
(REPEALS M.O. 49/2012)

Source: http://www.health.alberta.ca/documents/MO-71-2012-Cancer-Drugs.pdf