Drug Formulary. Apr 13, 2018

Transcription

1 Drug Apr 13, 2018 Disclaimer: The Saskatchewan Cancer Agency Drug is an information-only resource that identifies the funding status of cancer treatment drugs and some supportive drugs used to care for cancer patients in Saskatchewan. This information is intended to be for informational purposes only and is current as of the date listed on the Drug. It is not intended to constitute medical advice.

2 Saskatchewan Cancer Agency Drug Apr 13, 2018 Abemaciclib Verzenio Abiraterone Zytiga Abraxane Paclitaxelnanoparticle albumin-bound (nab) (tradename used to minimize confusion with Paclitaxel) Acalabrutinib Calquence Acitretin Soriatane Afatinib Giotrif Oral (tablets) 50 mg, 100 mg, 150 mg, 200 mg 250 mg, 500 mg 100 mg 100 mg 10 mg, 25 mg 20 mg, 30 mg 40 mg access access Amebaciclib is not commercially available in Canada Prostate Metastatic, Castration-Resistant Completion of the SCA Treatment Evaluation Program () registration form for each patient is required prior to treatment initiation Treatment of symptomatic metastatic castration-resistant prostate cancer (in combination with Prednisone) in patients who have received prior chemotherapy with Docetaxel or who are not candidates for treatment with Docetaxel Treatment of metastatic castration-resistant prostate cancer (in combination with Prednisone) in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy who have not received prior chemotherapy Note: Patients are not eligible for Abiraterone if they have previously received Enzalutamide in any treatment setting Not funded for treatment of hormone naïve metastatic prostate cancer or for patients with castrationresistant prostate cancer without evidence of metastases (e.g., biochemical only recurrence/relapse) Breast Cancer - Metastatic Patients who have experienced previous anaphylaxis or anaphylactoid reactions with standard Paclitaxel or Docetaxel infusions where further use of a taxane is desirable Patients who have significant contraindications to the pre-medications for taxanes (e.g. uncontrolled diabetes) Pancreas Cancer Locally Advanced or Metastatic Completion of the SCA Treatment Evaluation Program () request form for each patient is required for treatment approval In combination with Gemcitabine as first line treatment of patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas who have an ECOG performance status of 0 to 2 Note: Patients are not eligible for Abraxane with Gemcitabine therapy in the second line setting for locally advanced unresectable or metastatic pancreas cancer if they previously received FOLFIRINOX as first line therapy and experienced disease progression If patients exhibit intolerance to FOLFIRINOX therapy initiated in the first line setting without disease progression, a first line switch to Abraxane with Gemcitabine therapy is approved Acalabrutinib is not commercially available in Canada Treatment of refractory cutaneous T-cell lymphoma (e.g. mycosis fungoides) Non-Small Cell Lung Cancer (NSCLC) - Advanced First line treatment of patients with EGFR mutation positive advanced or metastatic adenocarcinoma of the lung with an ECOG performance status of 0 or 1 Note: Use of Afatinib precludes the use of any other EGFR inhibitor as a subsequent line of therapy Page 1

3 Saskatchewan Cancer Agency Drug Apr 13, 2018 Aflibercept Zaltrap Aldesleukin Interleukin-2, IL-2 Proleukin Alectinib Alecensaro Alemtuzumab MabCampath All-trans Retinoic Acid ATRA, Tretinoin, Vesanoid Amifostine Ethyol Amsacrine Amsa P-D Anagrelide Anastrozole 100 mg/4 ml 200 mg/8 ml 22 MU 150 mg 30 mg/1 ml 10 mg 500 mg Injection (ampoule) 75 mg/1.5 ml 0.5 mg 1 mg Intralesional treatment of unresectable in-transit metastatic melanoma (e.g., in patients with rapidly developing in-transit metastases after surgery or patients who present with multiple in-transit metastases unsuitable for surgical resection) Alemtuzumab is no longer commercially available in Canada as of Sep 4, 2012, and is only accessible through the MabCampath Distribution Program of Genzyme Canada for patients who meet certain eligibility criteria See Tretinoin Amifostine is no longer commercially available in Canada as of Dec 31, 2007, and is not currently accessible from AstraZeneca/MedImmune outside of a clinical trial, or through Health Canada s Special Access Program Induction of remission in adult acute leukemia refractory to conventional therapy Note: Amsacrine is not routinely stocked by the Cancer Centre Pharmacies and sufficient notice for purchase must be provided Treatment of essential thrombyotosis or polycythemia vera with elevated platelets after failure or intolerance of Hydroxyurea Note: Anagrelide also has full listing on the Saskatchewan Prescription Drug Plan (SPDP) Breast Cancer - Metastatic Endocrine therapy in post-menopausal women with hormone-receptor positive breast cancer. Not approved after failure with Letrozole Breast Cancer - Adjuvant Endocrine therapy in post-menopausal women with hormone-receptor positive disease either initially for 5 to 10 years (upfront strategy), for 2 to 3 years following 2 to 3 years of treatment with Tamoxifen for a total of 5 years (switch strategy), or for up to 5 years following 5 years of treatment with Tamoxifen (extended strategy) Endocrine therapy in post-menopausal women with hormone-receptor positive ductal carcinoma in-situ (DCIS) for up to 5 years Breast Cancer Neoadjuvant Endocrine therapy in post-menopausal women with hormone receptor positive, locally advanced disease, not eligible for chemotherapy Page 2

4 Saskatchewan Cancer Agency Drug Apr 13, 2018 Ancestim Stemgen Apalutamide Erleada Aprepitant Emend (also see Fosaprepitant) Arsenic Trioxide Trisenox Asparaginase (E.Coli) Kidrolase Asparaginase (Erwinia) Crisantaspase 1,875 mcg/5 ml 60 mg 125 mg 80 mg Injection (ampoule) 10 mg/10 ml 10,000 units 10,000 units/1 ml Ancestim is no longer commercially available in Canada Apalutamide is not commercially available in Canada Primary prevention of acute and delayed nausea and vomiting for patients receiving highly emetogenic chemotherapy [e.g. single day Cisplatin regimens >40 mg/m 2, women with breast cancer receiving an anthracycline and Cyclophosphamide (e.g., AC, FE100C), and regimens containing Carmustine, Mechlorethamine, Streptozocin or high dose single day Dacarbazine (e.g., >850 mg/m 2 )] in combination with a 5-HT3 antiemetic (e.g., Ondansetron) and Dexamethasone Secondary prevention of acute and delayed nausea and vomiting for patients receiving multi-day Cisplatinbased chemotherapy (e.g., BEP), ABVD and CHOP like regimens where emesis (vomiting) is experienced despite treatment with a combination of a 5-HT3 antiemetic (e.g. Ondansetron) and Dexamethasone in a previous cycle Primary or secondary prevention of acute and delayed nausea and vomiting in patients >12 years old who are >40 kg and can swallow capsules, and are receiving chemotherapy of high emetogenic risk Approved for acute promyelocytic leukemia (APL) in the following clinical settings: In combination with all trans-retinoic acid (ATRA) as first-line induction and/or consolidation therapy in patients with low to intermediate risk APL characterized by t(15;17) translocation and/or PML/RAR-α (promyelocytic leukemia, retinoic acid receptor-alpha) gene expression As consolidation therapy after induction therapy (ATRA plus chemotherapy) in patients with high risk APL characterized by t(15;17) translocation and/or PML/RAR-α (promyelocytic leukemia, retinoic acid receptoralpha) gene expression In the relapsed/refractory APL setting as induction and/or consolidation therapy in: a) patients who have relapsed after completion of first-line therapy, including prior therapy with arsenic trioxide, b) patients with t(15;17) translocation and/or PML/RARα gene expression who are refractory to nonarsenic trioxide based treatment Treatment of acute lymphoblastic leukemia (ALL) Approved for use in the following indications: Pediatric patients who are actively enrolled on a COG protocol Pediatric patients where a COG protocol is being followed off study Patients with acute lymphoblastic leukemia (ALL) who have experienced prior hypersensitivity to other forms of L-asparaginase Page 3

5 Saskatchewan Cancer Agency Drug Apr 13, 2018 Asparaginase-PEG Pegaspargase Oncaspar Atezolizumab Tecentriq Avelumab Bavencio Axicabtagene ciloleucel Yescarta Axitinib Inlyta Azacitidine Vidaza BCG Vaccine Bacillus Calmette-Guerin OncoTICE Belinostat Beleodaq 3,750 units/5 ml 1,200 mg/20 ml 200 mg/10 ml Suspension for intravenous formulation 1 mg, 5 mg 100 mg Intravesical (vial) 1 x 10 8 CFU s (colony forming units) 500 mg Pegaspargase is not marketed in Canada and drug supply is either obtained through a clinical trial or Health Canada s Special Access Program (SAP) and Shire. Approved for use in the following indications: Pediatric patients who are actively enrolled on a COG protocol (a separate COG study supply must be ordered) Pediatric patients where a COG protocol is being followed off study (a separate Health Canada Special Access Program approval and supply required) Patients with acute lymphoblastic leukemia (ALL) who have experienced prior hypersensitivity to other natural forms of L-asparaginase Axicabtagene ciloleucel is not commercially available in Canada Approved for use in the following indication: Renal Cell Carcinoma Metastatic (mrcc) As a second line treatment option for patients with metastatic clear cell (or clear cell component) renal carcinoma (mrcc) where sequencing a TKI in the second line setting after progression on first line TKI therapy (Sunitinib or Pazopanib) is the preferred therapeutic approach, or a second line treatment switch for patients who do not have disease progression, but are unable to tolerate ongoing use of an effective dose with second line Everolimus therapy Note: Patients are only eligible for either Axitinib or Everolimus in the second line setting Treatment of myelodysplastic syndrome (MDS) of intermediate-2 or high risk type according to the International Prognostic Scoring System (IPSS) Treatment of chronic myelomonocytic leukemia (CMML) with 10-29% blasts Treatment of acute myeloid leukemia (AML) with 20-30% blasts Intravesical treatment of superficial bladder cancer Belinostat is not marketed in Canada Page 4

6 Saskatchewan Cancer Agency Drug Apr 13, 2018 Bendamustine Treanda 25 mg, 100 mg Approved for use in the following indications: Indolent non-hodgkin s lymphoma (NHL) and Mantle Cell Lymphoma (MCL) Treatment of patients with indolent non-hodgkin s lymphoma (NHL) including follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma and non-transplant eligible patients with mantle cell lymphoma, in combination with Rituximab (B-R) for a maximum of 6 cycles as a first line option or as one line of therapy in the relapsed setting in patients eligible for Rituximab re-treatment (e.g., in patients with progressive disease or relapse > 6 months after last Rituximab dose) Bevacizumab Avastin (continued on next page) 100 mg/4 ml 400 mg/16 ml access Access Notes: Maintenance Rituximab therapy following B-R given in the induction setting is approved for patients who achieve a partial response or greater; B-R is not approved in patients with mantle cell lymphoma who are transplant eligible Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Completion of the SCA Treatment Evaluation Program () registration form for each patient undergoing chemotherapy with anti-cd20 therapy In combination with Rituximab (BR) for patients with CLL/SLL who are either previously untreated, previously treated but have not received any anti-cd20 therapy, or who have received prior anti-cd20 therapy with a treatment free interval of greater than 3 years since the last dose of anti-cd20 therapy First line treatment of patients with CLL/SLL as a single agent for a maximum of 6 cycles in patients medically unfit for chemotherapy in combination with anti-cd20 therapy Note: Bendamustine as a single agent is not approved for patients who have received previous treatment for CLL/SLL Blood and Marrow Transplant (BMT) As part of the BeEAM conditioning regimen prior to autologous stem cell transplant Colorectal Cancer Metastatic (Unresectable Stage IV) First line treatment in combination with Irinotecan or Oxaliplatin-based chemotherapy (e.g., FOLFIRI, CAPIRI, FOLFOX, CAPOX) In combination with chemotherapy (e.g., FOLFIRI or FOLFOX) for borderline resectable disease and conversion therapy In combination with a fluoropyrimidine (Capecitabine or Fluorouracil/Leucovorin) for the first-line treatment of patients with advanced or metastatic colorectal cancer for whom combination chemotherapy with Oxaliplatin or Irinotecan is unsuitable, and who have an ECOG performance status of <2 Carcinoma of the Cervix Completion of the SCA Treatment Evaluation Program () request form for each patient is required for treatment approval In combination with platinum and Paclitaxel for the treatment of patients with metastatic (Stage IVb), persistent, or recurrent carcinoma of the cervix of all histologic subtypes, except small cell, and who have an ECOG performance status of 0 or 1. Bevacizumab is approved at a dose of 15 mg/kg for treatment until disease progression, unacceptable toxicity or complete response. Page 5

7 Saskatchewan Cancer Agency Drug Apr 13, 2018 Bevacizumab Avastin (continued from previous page) Bexarotene Targretin 100 mg/4 ml 400 mg/16 ml 75 mg Access access Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Front-Line) Completion of the SCA Treatment Evaluation Program () request form for each patient is required for treatment approval In combination with platinum and Paclitaxel for the front-line treatment of patients with epithelial ovarian, fallopian tube or primary peritoneal cancer who are at high risk of relapse [Stage III suboptimally debulked ( 1 cm residual disease), Stage III unresectable or Stage IV] and who have an ECOG performance status of 2. Bevacizumab is approved at a dose of 7.5 mg/kg for 5 cycles (if chemotherapy is initiated 4 weeks from surgery) or for 6 cycles (if chemotherapy is initiated > 4 weeks from surgery), then for up to 12 additional cycles, or until disease progression Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Platinum-Resistant) Completion of the SCA Treatment Evaluation Program () request form for each patient is required for treatment approval In combination with Paclitaxel, Topotecan, or pegylated liposomal Doxorubicin (Caelyx ) for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC) who have received no more than two prior anticancer regimens; AND who have good performance status, no contraindications to bevacizumab and whose disease is not primary platinum refractory Notes: o Eligible patients must have measurable/assessable ovarian cancer that has progressed less than 6 months after completing at least 4 cycles of platinum-based therapy and be carefully reviewed for risk of GI perforation o Patients remain eligible for Bevacizumab for PROC if they have received more than two lines of platinum-based treatments, where all treatments were in the setting of platinum-sensitive disease o Patients who were previously treated with Bevacizumab in the front-line setting for high risk Stage III disease are not eligible to receive Bevacizumab again in the platinum-resistant setting o Patients who are currently receiving treatment with Caelyx, Paclitaxel or Topotecan for platinumresistant ovarian cancer, and would have met the criteria for Bevacizumab eligibility at the start of treatment, may have Bevacizumab added to their therapy provided they are still responding to their therapy, or Bevacizumab may be initiated with their next line of therapy for PROC, providing they have not shown resistance to all the chemotherapy options that may be used with Bevacizumab o Patients with PROC who have been previously treated and experienced disease progression on all approved chemotherapy options with Bevacizumab (Caelyx, Paclitaxel and Topotecan) are not eligible to receive Bevacizumab with another chemotherapy treatment o Treatment should continue until disease progression or unacceptable toxicity. Bevacizumab is not funded as a single agent if chemotherapy is interrupted or held for any reason Bexarotene is not commercially available in Canada, and not available through the Health Canada Special Access Program. Page 6

8 Saskatchewan Cancer Agency Drug Apr 13, 2018 Bicalutamide Bleomycin Blinatumomab Blincyto 50 mg 15 units 35 mcg Prostate Cancer Prevention of flare reaction at initiation of LHRH analog therapy Treatment of prostate cancer in patients who have had an orchiectomy or are receiving GnRH agonist or antagonist therapy as part of a combined androgen blockade strategy In combination with Dutasteride for prostate volume reduction prior to permanent implant prostate brachytherapy Note: Dutasteride is provided by patient s retail pharmacy through Drug Plan eligibility criteria and benefits Acute Lymphoblastic Leukemia (ALL) - Philadephia Chromosome Negative (Ph-) Treatment of adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) who have had at least two prior lines of therapy Page 7

9 Saskatchewan Cancer Agency Drug Apr 13, 2018 Bortezomib Bosutinib Bosulif 3.5 mg 100 mg, 500 mg access Multiple Myeloma (including amyloidosis) Treatment of multiple myeloma in patients who are refractory to or have relapsed after at least one prior line of therapy, or have completed at least one full treatment regimen and are experiencing intolerance to their current therapy First line treatment for multiple myeloma as part of an approved regimen (e.g., CyBorD, CyBorP, VMP, Bortezomib/Dexamethasone) For patients eligible for their first autologous stem cell transplant (ASCT) as part of the RVD regimen (Lenalidomide, Bortezomib, Dexamethasone) for the following indications: o 2 to 4 cycles as first-line induction therapy for patients with plasma cell leukemia and high risk multiple myeloma, defined as del 17p, t(4:14), or t(14:16) o 2 cycles as salvage induction therapy in patients who did not achieve an adequate response (i.e. did not achieve a 50% disease response) after 3 or 4 cycles of CyBorD induction therapy; if a response after 2 cycles of RVD was achieved, but a deeper response is still required, an additional 1 or 2 cycles may be separately requested o 2 cycles as post-transplant consolidation therapy in patients with multiple myeloma and 17p deletion who achieve a VGPR or better when an upfront tandem transplant is not planned Note: RVD is not funded in patients who are not eligible for transplant; as salvage therapy in the relapsed/refractory setting; or as induction or consolidation therapy in conjunction with a second transplant Step-down maintenance for up to 2 years in patients not proceeding to transplant who have only achieved stable disease after use of a Bortezomib containing protocol in the first line setting Maintenance treatment for patients with newly diagnosed multiple myeloma with 17p deletion, t(4:14), or t(14:16) following autologous stem cell transplant (ASCT), in patients with stable disease or better, with no evidence of disease progression; treatment may be continued for up to 2 years, unless discontinued due to patient intolerance Note: Maintenance Bortezomib is not funded after a second ASCT; patients that start maintenance Bortezomib in this setting are not eligible for treatment with maintenance Lenalidomide Maintenance treatment for patients with newly diagnosed multiple myeloma without a 17p deletion, t(4:14), or t(14:16) following autologous stem cell transplant (ASCT)n patients who develop intolerance to Lenalidomide maintenance in this setting Mantle Cell Lymphoma Monotherapy for treatment of patients with relapsed or refractory mantle cell lymphoma after failure of at least 1 prior therapy Chronic Myelogenous Leukemia (CML) - Philadephia Chromosome Positive (Ph+) Treatment of patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who have resistance/disease progression or intolerance to prior tyrosine kinase inhibitor (TKI) therapy Note: Second generation TKI s (Dasatinib, Nilotinib, Bosutinib) are not funded as options after Ponatinib Page 8

10 Saskatchewan Cancer Agency Drug Apr 13, 2018 Brentuximab vedotin Adcetris Brigatinib Alunbrig Buserelin acetate Suprefact Busulfan Busulfex (injection) Myleran (oral) Cabazitaxel Jevtana Caelyx Pegylated Liposomal Doxorubicin (tradename used to minimize confusion with Doxorubicin) Calcitonin Calcimar 50 mg 30 mg, 90 mg Injection (depot syringe) 6.3 mg (2 month) 9.45 mg (3 month) 60 mg/10 ml 2 mg 60 mg/1.5 ml 20 mg/10 ml 50 mg/25 ml 400 units/2 ml Treatment of patients with Hodgkin s lymphoma who have relapsed disease following autologous stem cell transplant and who have ECOG performance status of 0 or 1 Treatment of patients with systemic anaplastic large cell lymphoma who have failed at least one prior multiagent chemotherapy regimen and who have an ECOG performance status of 0 or 1 Brigatinib is not commercially available in Canada Injection approved for the following indication: Use in the Blood and Marrow Transplant (BMT) program as part of the conditioning regimen prior to allogeneic transplant Oral approved for the following indication: Treatment of chronic myelogenous leukemia (CML) when alternative treatments are not suitable Prostate Advanced, Castration-Resistant Treatment of metastatic castration-resistant prostate cancer in combination with Prednisone in patients who have received prior chemotherapy with Docetaxel Second or third line treatment as a single agent for advanced epithelial ovarian cancer, fallopian tube carcinoma, and primary peritoneal neoplasms in patients with platinum intolerance, resistant disease or refractory disease Second line treatment in combination with Carboplatin for advanced epithelial ovarian cancer, fallopian tube carcinoma, and primary peritoneal neoplasms in patients with platinum sensitive disease In combination with Bevacizumab for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC) First line treatment of advanced AIDS-related Kaposi s sarcoma (KS) in patients with extensive mucocutaneous or visceral disease Page 9

11 Saskatchewan Cancer Agency Drug Apr 13, 2018 Capecitabine Caphosol Supersaturated calcium phosphate 150 mg 500 mg Oral (ampoules) Calcium solution 15 ml Phosphate solution 15 ml Breast Cancer - Metastatic One line of therapy as a single agent or in combination with Docetaxel, Vinorelbine, Lapatinib or Trastuzumab Colon and Rectal Cancer - Neoadjuvant and Adjuvant Neoadjuvant treatment of stage II or stage III rectal cancer as a single agent prior to radiotherapy and/or concurrent with radiotherapy Adjuvant treatment of stage II or stage III rectal cancer as a single agent and/or concurrent with radiotherapy Adjuvant treatment of stage II (high risk) or stage III colon cancer as a single agent Adjuvant treatment of stage III colon or rectal cancer as part of the CAPOX regimen as an alternative to infusional therapy with Fluorouracil in the FOLFOX regimen Colon and Rectal Cancer - Metastatic First line treatment as an alternative to combination chemotherapy Alternative to infusional therapy with Fluorouracil in the CAPIRI and CAPOX regimens In combination with Bevacizumab for the first-line treatment of patients with advanced or metastatic colorectal cancer for whom combination chemotherapy with Oxaliplatin or Irinotecan is unsuitable, and who have an ECOG performance status of <2 Gallbladder/Cholangiocarcinoma - Adjuvant Alone or concurrently with radiotherapy as adjuvant treatment following resection Gallbladder/Cholangiocarcinoma - Unresectable or Metastatic One line of therapy as a single agent Gastro-Esophageal Cancer - Locally Advanced or Metastatic First line treatment as a single agent or in combination with Epirubicin and Cisplatin in the ECX regimen, or in combination with Cisplatin Head and Neck Cancer - Advanced One line of therapy as a single agent for advanced head and neck cancer Pancreas Cancer Second line single agent treatment after failure of Gemcitabine Concurrent with radiotherapy for treatment of locally advanced disease In combination with Gemcitabine as adjuvant treatment following resection for patients with newly diagnosed pancreatic adenocarcinoma Blood and Marrow Transplant (BMT) Program Prevention and treatment of oral mucositis resulting from high dose Melphalan chemotherapy in stem cell transplantation conditioning protocols as an adjunct to standard oral care for a maximum therapy duration of 4 weeks Page 10

12 Saskatchewan Cancer Agency Drug Apr 13, 2018 Carboplatin 50 mg/5 ml 150 mg/15 ml 450 mg/450 ml 600 mg/60 ml Carfilzomib Kyprolis Carmustine BCNU, BiCNU Ceritinib Zykadia Cetuximab Erbitux Chlorambucil Leukeran Cisplatin Cladribine 2-CDA 10 mg, 30 mg, 60 mg 100 mg 150 mg 100 mg/50 ml 200 mg/100 ml 2 mg 50 mg/50ml 100 mg /100mL 10 mg/10 ml Colorectal Cancer - Metastatic As monotherapy or in combination with Irinotecan for treatment of patients with non-mutated (wild type) RAS (KRAS or NRAS) after failure of at least 2 prior lines of therapy, including regimens containing a fluoropyrimidine, Oxaliplatin and Irinotecan Head and Neck Cancer - Locally or Regionally Advanced First line treatment in combination with radiation therapy for patients with locally or regionally advanced squamous cell head and neck cancer without distant metastases who are deemed unsuitable for Cisplatin Treatment of hairy cell leukemia Clodronate Ostac, Bonefos 400 mg Treatment of symptomatic, lytic bony lesions in advanced breast cancer as an oral alternative to Pamidronate Clofarabine Clolar 1 mg/ml Page 11

13 Saskatchewan Cancer Agency Drug Apr 13, 2018 Cobimetinib Cotellic Cortisone acetate Crisantaspase Asparaginase Erwinia Erwinase Crizotinib Xalkori Cyclophosphamide Cyproterone acetate CPA Cytarabine Cytosine Arabinoside, ARA-C 20 mg 5 mg, 25 mg 10,000 units/1 ml 200 mg, 250 mg 1 g, 2 g 25 mg, 50 mg 50 mg 100 mg/1 ml 500 mg/5 ml 1 g/10 ml 2 g/20 ml Melanoma - Advanced (Unresectable or Metastatic) In combination with Vemurafenib, for the treatment of patients with previously untreated BRAF V600 mutationpositive unresectable stage Ill or stage IV melanoma who have a good performance status Notes: o Previously untreated patients will be interpreted as BRAF-targeted therapy naïve. Patients who received prior checkpoint inhibitor immunotherapy will be eligible for combination BRAF-MEK inhibitor therapy. Previous use of any other BRAF-targeted therapy precludes the use of the combination of Cobimetinib and Vemurafenib. o If brain metastases are present, patients should be asymptomatic or have stable symptoms. o Treatment should continue until unacceptable toxicity or disease progression. o In the clinical setting of toxicity to the combination of Cobimetinib and Vemurafenib, but without disease progression, treatment may be continued, as clinically appropriate, with Vemurafenib monotherapy, or switched to alternate BRAF-targeted therapy with the combination of Dabrafenib and Trametinib, or monotherapy with either Dabrafenib or Trametinib. o Use of the combination of Cobimetinib and Vemurafenib precludes the use of any other BRAF targeted therapy as a subsequent line of therapy following disease progression. Approved only for the following indication: Replacement therapy when required for patients treated with Mitotane See Asparaginase Erwinia Second line treatment of patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) with an ECOG performance status 2 who have received one prior chemotherapy regimen, until disease progression or unacceptable toxicity First line treatment of patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) with an ECOG performance status of 2, until disease progression or unacceptable toxicity Page 12

14 Saskatchewan Cancer Agency Drug Apr 13, 2018 Cytarabine Liposomal DepoCyt Dabrafenib Tafinlar Dacarbazine DTIC Dactinomycin Actinomycin D, Daratumumab Darzalex Darbepoetin alfa Aranesp Intrathecal (vial) 50 mg/5 ml 50 mg, 75 mg 200 mg 600 mg 0.5 mg vial 100 mg/5 ml 400 mg/20 ml Injection (prefilled syringe) 100 mcg/1 ml 200 mcg/1 ml 500 mcg/1 ml Melanoma Advanced (Unresectable or Metastatic) First line BRAF targeted therapy (i.e. patients may be treatment naïve or previously treated with checkpoint inhibitor immunotherapy and/or chemotherapy) as a single agent in patients with BRAF V600 mutation positive unresectable or metastatic melanoma who have an ECOG performance status of 0 or 1 and stable brain metastases (if present) First line BRAF targeted therapy (i.e. patients may be treatment naïve or previously treated with checkpoint inhibitor immunotherapy and/or chemotherapy) with the combination of Dabrafenib and Trametinib in patients with BRAF V600 mutation positive unresectable or metastatic melanoma who have an ECOG performance status of 0 or 1 and stable brain metastases (if present). Notes: o Dabrafenib or the combination of Dabrafenib and Trametinib is not approved in patients who have progressed on prior BRAF targeted therapy o Use of the combination of Dabrafenib and Trametinib precludes the use of any other BRAF targeted therapy as a subsequent line of therapy following disease progression (e.g., combination of Vemurafenib and Cobimetinib, or monotherapy with either Dabrafenib, Trametinib, or Vemurafenib) o In the clinical setting of toxicity to combination therapy, but without disease progression, treatment may be continued with either Dabrafenib or Trametinib as monotherapy if clinically appropriate, or switched to other BRAF targeted agents (e.g. Vemurafenib monotherapy or the combination of Vemurafenib and Cobimetinib Gynecology As single agent therapy, or part of combination chemotherapy treatment for gestational trophoblastic neoplasia Soft Tissue Sarcomas (STS) As part of combination chemotherapy and/or multi-modality treatment for Wilms tumor, rhabdomyosarcoma and Ewing s sarcoma Myelodysplastic Syndrome (MDS): Management of patients with IPSS low-risk or intermediate-1 myelodysplastic syndrome (MDS) with symptomatic anemia for a therapeutic trial of 12 weeks if the serum erythropoietin level < 500 units/l and/or receiving < 2 units of RBC transfusions per month Page 13

15 Saskatchewan Cancer Agency Drug Apr 13, 2018 Dasatinib Sprycel Daunorubicin Daunomycin 20 mg, 50 mg 70 mg, 80 mg 100 mg, 140 mg 20 mg Chronic Myelogenous Leukemia (CML) - Philadephia Chromosome Positive (Ph+) Second line treatment in chronic phase, accelerated phase or blast crisis with primary or acquired resistance to Imatinib First line treatment switch in patients with chronic phase, accelerated phase or blast crisis who were initiated on Imatinib, but are experiencing a suboptimal response by not meeting established therapeutic milestones according to the Canadian Hematology Society (CHS) or European LeukemiaNet (ELN) guidelines Subsequent line of treatment in patients who are resistant to or experiencing toxicity to other second generation TKI therapies (e.g. Nilotinib or Bosutinib) First line treatment in patients with accelerated phase or blast crisis Note: Second generation TKI s (Dasatinib, Nilotinib, Bosutinib) are not funded as options after Ponatinib Acute Lymphoblastic Leukemia (ALL) - Philadephia Chromosome Positive (Ph+) First or second line treatment for induction and maintenance therapy in patients with Ph+ ALL Decitabine Dacogen 50 mg/20 ml Defibrotide Defitelio Degarelix Firmagon 200 mg/2.5 ml 240 mg (as 2 x 120 mg) 80 mg Prostate Cancer Treatment of patients with prostate adenocarcinoma who are suitable candidates for an every 4 week administration schedule in whom androgen deprivation therapy is warranted for testosterone suppression Note: Degarelix is a gonadotrophin-releasing hormone (also known as a luteinizing hormone- releasing hormone or LHRH) antagonist There is no role for the use of a GnRH (LHRH) antagonist in patients who have had a bilateral orchiectomy Denosumab Xgeva Dexamethasone 120 mg/1.7 ml 20 mg/5 ml 0.5 mg, 2 mg 4 mg Dexrazoxane Zinecard, Totect 250 mg 500 mg Reducing (preventing) the incidence and severity of cardiotoxicity associated with the use of Doxorubicin for the treatment of metastatic breast cancer Treatment of extravasation resulting from IV anthracycline chemotherapy Page 14

16 Saskatchewan Cancer Agency Drug Apr 13, 2018 Docetaxel (continued on next page) 20 mg 80 mg 160 mg access Approved for use in the following indications: Breast Cancer - Metastatic One line of therapy as a single agent or as part of combination chemotherapy in patients who are taxane naïve or have recurrent disease greater than 1 year after receiving a taxane in the adjuvant setting Breast Cancer - Adjuvant or Neoadjuvant Treatment with approved adjuvant regimens: o FEC100 (3 cycles) followed by Docetaxel (3 cycles), o Docetaxel and Cyclophosphamide (TC x 4 to 6 cycles) o Docetaxel, Carboplatin, Trastuzumab (TCH x 6 cycles) Treatment with approved neoadjuvant therapy regimens: AC or FEC100 (4 cycles) followed by Docetaxel (4 cycles) TAC x 6 cycles, with G-CSF support, is not funded Gastro-Esophageal Cancer (Advanced) Second line treatment for locally advanced, locally recurrent, or metastatic gastric or esophageal adenocarcinoma not curable with surgery or radiation Gastro-Esophageal Cancer (Early Stage - Perioperative) Completion of the SCA Treatment Evaluation Program () registration form for each patient is required before initiating the FLOT regimen As part of the FLOT regimen for perioperative therapy for patients with resectable gastric or gastroesophageal junction adenocarcinomas Gynecology Alternative to Paclitaxel in patients who have experienced a hypersensitivity reaction In combination with Gemcitabine for treatment of metastatic uterine leiomyosarcoma Head and Neck Cancer - Neoadjuvant Induction treatment in combination with Fluorouracil and Cisplatin prior to radiation therapy Head and Neck Cancer - Metastatic Treatment of recurrent or metastatic head and neck cancer as a single agent Non-Small Cell Lung Cancer (NSCLC) - Advanced First line treatment in combination with platinum (may be used as second line therapy in combination with platinum if prior treatment with an EGFR tyrosine kinase inhibitor as first line treatment) Single agent treatment after failure of any non-docetaxel containing platinum based therapy Prostate Cancer Advanced Treatment of metastatic castration-resistant prostate cancer in combination with Prednisone Treatment of metastatic hormone-sensitive prostate cancer in patients with high volume disease and good performance status (ECOG < 2) Sarcoma: Second line treatment for advanced sarcoma in combination with Gemcitabine after failure of Ifosfamide and Doxorubicin based therapy Page 15

17 Saskatchewan Cancer Agency Drug Apr 13, 2018 Docetaxel (continued from previous page) Dolasetron Doxorubicin Doxorubicin Liposomal (see Myocet ) Doxorubicin Pegylated Liposomal (see Caelyx ) Dronabinol Delta-9- tetrahydrocannabinol Marinol Durvalumab Imfinzii Elotuzumab Empliciti Enasidenib Idhifa Enzalutamide Xtandi 20 mg 80 mg 160 mg 50 mg, 100 mg 10 mg/5 ml 50 mg/25 ml 200 mg/100 ml 50 mg 20 mg/10 ml 50 mg/25 ml 2.5 mg, 5 mg, 10 mg 120 mg/2.4 ml 500 mg/10 ml 300 mg 400 mg Oral (tablets) 50 mg, 100 mg 40 mg access Urothelial Cancer Advanced Second line treatment after progression on or after a platinum containing regimen See Myocet See Caelyx Elotuzumab is not commercially available in Canada Enasidenib is not commercially available in Canada Prostate Metastatic, Castration-Resistant Completion of the SCA Treatment Evaluation Program () registration form for each patient is required prior to treatment initiation Treatment of symptomatic metastatic castration-resistant prostate cancer in patients with good performance status (ECOG <2) who have progressed on Docetaxel based chemotherapy or who are not candidates for treatment with Docetaxel Treatment of patients with metastatic castration-resistant prostate cancer (mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy who have not received prior chemotherapy Note: Patients are not eligible for Enzalutamide if they have previously received Abiraterone in any treatment setting Page 16

18 Saskatchewan Cancer Agency Drug Apr 13, 2018 Epirubicin Pharmorubicin Epoetin alfa Eprex Eribulin Halaven Erlotinib Estramustine Emcyt Etoposide VP-16 Etoposide Phosphate Etopophos 10 mg/5 ml 50 mg/25 ml 200 mg/100 ml Injection (prefilled syringe) (various strengths) 1 mg/2 ml 25 mg,100 mg 150 mg 140 mg 100 mg/5 ml 1 g/50 ml 50 mg 100 mg Breast Cancer As part of approved regimens for adjuvant, neoadjuvant and metastatic therapy Gastro-Esophageal Cancer - Advanced First line treatment as part of the ECF or ECX regimen Breast Cancer - Metastatic Treatment of metastatic or incurable locally advanced breast cancer in patients with a good performance status (ECOG <2) who have had previous treatment with a taxane and an anthracycline, who have had at least two chemotherapy regimens for metastatic or locally recurrent disease, and who have progressed after their last therapy Non-Small Cell Lung Cancer (NSCLC) - Advanced Monotherapy for treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen in patients who have not received prior EGFR inhibitor therapy, and whose EGFR mutation status is positive Monotherapy for first line treatment of patients with locally advanced (stage IIIB, not amenable to curative therapy) or metastatic (stage IV) non-small cell lung cancer (NSCLC) with EGFR activating mutations Note: Use of Erlotinib in the first line setting precludes the use of any other EGFR inhibitor as a subsequent line of therapy Etopophos is not commercially available in Canada Page 17

19 Saskatchewan Cancer Agency Drug Apr 13, 2018 Everolimus Afinitor 2.5 mg, 5 mg, 10 mg Access Access Renal Cell Carcinoma Metastatic (mrcc) Treatment of patients with metastatic renal cell carcinoma (mrcc) after failure of initial treatment with either of the VEGF-receptor TKI s Sunitinib or Pazopanib Note: Patients are only eligible for treatment with either Everolimus or Axitinib in the second line setting Patients are not eligible for Everolimus after disease progression on Nivolumab Gastrointestinal Pancreatic Neuroendocrine (pnet) Completion of the SCA Treatment Evaluation Program () request form for each patient is required for treatment approval Treatment of patients with progressive, unresectable, well or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors (pnet) with good performance status (ECOG 0-2) Note: Patients whose disease progresses on Everolimus are not eligible for SCA funded treatment with Sunitinib for pnet Neuroendocrine Tumors Gastrointestinal or Lung Origin (NET GIL) Completion of the SCA Treatment Evaluation Program () request form for each patient is required for treatment approval Treatment of unresectable, locally advanced or metastatic, well-differentiated, non-functional neuroendocrine tumours (NETs) of gastrointestinal or lung origin (GIL) in adults with documented radiological disease progression within six months and with a good performance status; treatment should continue until confirmed disease progression or unacceptable toxicity Breast Cancer - Metastatic In combination with Exemestane for treatment of hormone-receptor positive, HER2 negative, advanced breast cancer in post-menopausal women with good performance status (ECOG <2) after recurrence or progression following a non-steroidal aromatase inhibitor (Anastrozole or Letrozole) Notes: o Patients that had breast cancer progression while previously receiving Exemestane will not be eligible for Everolimus o Patients will be eligible for EITHER Palbociclib with Anastrozole or Letrozole in the first line setting OR Everolimus with Exemestane as a subsequent line of therapy, not both therapies Page 18

20 Saskatchewan Cancer Agency Drug Apr 13, 2018 Exemestane Filgrastim G-CSF (Granulocyte Colony Stimulating Factor) 25 mg Neupogen 300 mcg /1 ml 480 mcg /1.6 ml Injection (pre-filled syringe) Grastofil 300 mcg/0.5 ml 480 mcg/0.8 ml Breast Cancer - Metastatic Endocrine therapy in post-menopausal women with hormone-receptor positive breast cancer. May be used after failure of a non-steroidal aromatase inhibitor (either Anastrozole or Letrozole) In combination with Everolimus for treatment of hormone-receptor positive, HER2 negative, advanced breast cancer in post-menopausal women with good performance status (ECOG <2) after recurrence or progression following a non-steroidal aromatase inhibitor (Anastrozole or Letrozole) Breast Cancer - Adjuvant Endocrine therapy in post-menopausal women with hormone-receptor positive disease either initially for 5 to 10 years (upfront strategy), for 2 to 3 years following 2 to 3 years of treatment with Tamoxifen for a total of 5 years (switch strategy), or for up to 5 years following 5 years of treatment with Tamoxifen (extended strategy) Endocrine therapy in post-menopausal women with hormone-receptor positive ductal carcinoma in-situ (DCIS) for up to 5 years Breast Cancer Neoadjuvant Endocrine therapy in post-menopausal women with hormone receptor positive, locally advanced disease, not eligible for chemotherapy Filgrastim (G-CSF) is approved to prevent or mitigate neutropenic complications resulting from cancer treatment according to the following indications: Primary prophylaxis in patients receiving an SCA approved regimen where the documented or expected incidence of febrile neutropenia has been identified as 20% or higher. Secondary prophylaxis in patients receiving curative intent therapy following at least a 1 week dose delay due to neutropenia or an episode of febrile neutropenia and where further treatment delays and/or dose reductions may result in inferior outcomes Acute Myelogenous Leukemia (AML): following induction therapy in patients age 55 or older to reduce the duration of antibiotic administration and hospital admission; after completion of consolidation therapy in patients of any age with AML in remission to reduce the duration of neutropenia As required by protocol in pediatric patients and within the Blood and Marrow Transplant program Not approved in the following clinical scenarios: In afebrile patients during neutropenia in an attempt to more quickly increase granulocyte counts As adjunct therapy for the treatment of uncomplicated fever and neutropenia defined as: fever of less than or equal to 10 days in duration; no evidence of pneumonia, cellulitis, abscess, sinusitis, hypotension, multi-organ dysfunction (sepsis syndrome) or invasive fungal infection; and no uncontrolled malignancies In patients with aplastic anemia Page 19

21 Saskatchewan Cancer Agency Drug Apr 13, 2018 Fludarabine Fludrocortisone acetate Florinef Fluorouracil 5-FU Flutamide Fosaprepitant Emend IV (also see Aprepitant) Fulvestrant Faslodex Gefitinib 50 mg 10 mg 0.1 mg 5 g/100 ml 250 mg 150 mg Injection (prefilled syringe) 250 mg/5 ml 250 mg Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) First or second line treatment as a single agent or in combination therapy Low Grade Lymphoma Treatment of low grade lymphoma, including lymphoplasmacytic lymphoma (Waldenstrom s macroglobulinemia) Blood and Marrow Transplant Program As part of approved conditioning regimens Approved only for the following indication: Replacement therapy when required for patients treated with Mitotane Approved for the following indications when Bicalutamide cannot be used: Prostate Cancer Prevention of flare reaction at initiation of LHRH analog therapy Treatment of advanced prostate cancer in patients who have had an orchiectomy or are receiving GnRH agonist or antagonist therapy as part of a combined androgen blockade strategy Primary prevention of acute and delayed nausea and vomiting for patients receiving highly emetogenic chemotherapy [e.g. single day Cisplatin regimens >40 mg/m 2, women with breast cancer receiving an anthracycline and Cyclophosphamide (e.g., AC, FE100C), and regimens containing Carmustine, Mechlorethamine, Streptozocin or high dose single day Dacarbazine (e.g., >850 mg/m 2 )] in combination with a 5-HT3 antiemetic (e.g., Ondansetron) and Dexamethasone Secondary prevention of acute and delayed nausea and vomiting for patients receiving multi-day Cisplatinbased chemotherapy (e.g., BEP), ABVD and CHOP like regimens where emesis (vomiting) is experienced despite treatment with a combination of a 5-HT3 antiemetic (e.g. Ondansetron) and Dexamethasone in a previous cycle Non-Small Cell Lung Cancer (NSCLC) - Advanced First line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology who have activating mutations of the epidermal growth factor receptor (EGFR) tyrosine kinase (TK) Note: Use of Gefitinib precludes the use of any other EGFR inhibitor as a subsequent line of therapy Page 20

22 Saskatchewan Cancer Agency Drug Apr 13, 2018 Gemcitabine Gemtuzumab Mylotarg 200 mg 1 g, 2 g 5 mg Approved for use in the following indications: Breast Cancer - Metastatic One line of therapy either as a single agent or in combination with Paclitaxel or platinum Bladder Cancer Neoadjuvant, Adjuvant, Locally Advanced or Metastatic First line treatment in combination with platinum Gallbladder/Cholangiocarcinoma - Unresectable or Metastatic One line of therapy in combination with platinum, or as a single agent Gynecology Treatment of recurrent or progressive epithelial ovarian, fallopian tube or primary peritoneal cancer as part of one line of therapy In combination with Docetaxel for treatment of metastatic uterine leiomyosarcoma Head and Neck Cancer - Metastatic Treatment of recurrent or metastatic head and neck cancer as a single agent Hematology Treatment of relapsed or refractory Hodgkin s or non-hodgkin s lymphoma in combination with Cisplatin and Dexamethasone as part of the GDP regimen Non-Small Cell Lung Cancer (NSCLC) - Advanced First line treatment in combination with platinum or Vinorelbine, or as a single agent as one line of therapy Pancreas Cancer Single agent adjuvant treatment following macroscopic complete resection First line single agent treatment of metastatic or unresectable disease In combination with Capecitabine as adjuvant treatment following resection for patients with newly diagnosed pancreatic adenocarcinoma Sarcoma Second line treatment for advanced sarcoma in combination with Docetaxel after failure of Ifosfamide and Doxorubicin based therapy Page 21

23 Saskatchewan Cancer Agency Drug Apr 13, 2018 Glucarpidase Voraxaze 1,000 units Glucarpidase is not marketed in Canada and drug supply is only available through Health Canada s Special Access program (SAP) and BTG International Inc. for the following indication: Emergency treatment of toxic plasma Methotrexate concentrations (>1 micromol/l) in patients with delayed Methotrexate clearance due to impaired renal function as recommended in a COG protocol Note: Glucarpidase is not indicated for use in patients who exhibit expected clearance of Methotrexate (plasma concentrations of Methotrexate within 2 standard deviations of the mean Methotrexate excretion curve specific for the last dose of Methotrexate administered) or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to Methotrexate Glucarpidase is not routinely stocked in the cancer centre pharmacies or hospitals; once an emergency SAP request is initiated, drug can be shipped for on-site delivery within 24 hours Goserelin acetate Zoladex Granisetron Injection (depot syringe) 3.6 mg (1 month) 10.8 mg (3 month) 1 mg/1 ml 4 mg/4 ml access Prostate Cancer Neoadjuvant and/or adjuvant therapy for prostate cancer with a maximum therapy duration of 3 years Treatment of metastatic prostate cancer Note: There is no role for the use of a GnRH (LHRH) analog in patients who have had a bilateral orchiectomy Breast Cancer - Metastatic Endocrine therapy for pre-menopausal patients with hormone-receptor positive disease after failure of Tamoxifen Breast Cancer Adjuvant Completion of the SCA Treatment Evaluation Program () request form for each patient is required for treatment approval In combination with an aromatase inhibitor for up to 5 years of adjuvant endocrine therapy for pre-menopausal women with early stage (I-III), high risk, lymph node negative or lymph node positive, endocrine receptor positive breast cancer to achieve ovarian suppression in women where use of GnRH agonist therapy would be the preferred choice over surgical oophorectomy (e.g., younger age, preservation of fertility, not a surgical candidate) o The results of subgroup analyses suggest that patients with sufficiently higher risk breast cancer that warranted chemotherapy administration and were less than 35 years of age derived the most benefit from the combination of ovarian suppression and an aromatase inhibitor o If adjuvant or neo-adjuvant chemotherapy is prescribed, Goserelin may be initiated at any time in relation to chemotherapy (e.g., at the start, during or after), but within 8 months following completion of chemotherapy o Aromatase inhibitor therapy should start after completion of chemotherapy, and at least 6 to 8 weeks after initiation of Goserelin to allow time for ovarian suppression to occur 1 mg Page 22