10:00 Antineoplastic Agents

10:00.00 ANTINEOPLASTIC AGENTS

ABIRATERONE ACETATE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage

For the treatment of metastatic castration resistant prostate cancer patients (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) and who have not received prior chemotherapy if they meet the following criteria:

  • used in combination with prednisone; and
  • patient has an ECOG performance status of 0 or 1.

For the treatment of metastatic castration resistant prostate cancer patients (mCRPC) who progressed on docetaxel-based chemotherapy if they meet the following criteria:

  • used in combination with prednisone; and
  • patient has an ECOG performance status ≤ 2; and
  • abiraterone is not used as an add-on therapy to enzalutamide (Xtandi); and
  • abiraterone has not been used in the pre-docetaxel setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression

Table: ABIRATERONE ACETATE
Drug strength and dosage form DIN Brand name Manufacturer code
250MG Tablet 02371065 ZYTIGA JSO
500MG Tablet 02457113 ZYTIGA JSO

AFATINIB DIMALEATE

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC) who meet all of the following criteria:

  • first line treatment of patients; and
  • EGFR mutation positive; and
  • advanced or metastatic adenocarcinoma of the lung; and
  • an ECOG performance status of 0 or 1.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Use of afatinib precludes the use of any other EGFR inhibitor as a subsequent line of therapy.

Table: AFATINIB DIMALEATE
Drug strength and dosage form DIN Brand name Manufacturer code
20MG Tablet 02415666 GIOTRIF BOE
30MG Tablet 02415674 GIOTRIF BOE
40MG Tablet 02415682 GIOTRIF BOE

ALECTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC); or

Second-line treatment of patients with locally advanced not amenable to curative therapy or metastatic NSCLC who have disease progression on or intolerance to crizotinib;

and

  • to be used as monotherapy; and
  • disease is anaplastic lymphoma kinase (ALK)-positive; and
  • patient has a good performance status.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: ALECTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Capsule 02458136 ALECENSARO HLR

ANASTROZOLE

Table: ANASTROZOLE
Drug strength and dosage form DIN Brand name Manufacturer code
1MG Tablet 02351218 ACH-ANASTROZOLE ACC
1MG Tablet 02395649 ANASTROZOLE PDL
1MG Tablet 02442736 ANASTROZOLE SAN
1MG Tablet 02374420 APO-ANASTROZOLE APX
1MG Tablet 02224135 ARIMIDEX AZC
1MG Tablet 02392488 BIO-ANASTROZOLE BMI
1MG Tablet 02339080 JAMP-ANASTROZOLE JMP
1MG Tablet 02379562 MAR-ANASTROZOLE MAR
1MG Tablet 02379104 MED-ANASTROZOLE GMP
1MG Tablet 02393573 MINT-ANASTROZOLE MIN
1MG Tablet 02417855 NAT-ANASTROZOLE NPH
1MG Tablet 02320738 PMS-ANASTROZOLE PMS
1MG Tablet 02328690 RAN-ANASTROZOLE RBY
1MG Tablet 02392259 RIVA-ANASTROZOLE RIV
1MG Tablet 02338467 SANDOZ ANASTROZOLE SDZ
1MG Tablet 02365650 TARO-ANASTROZOLE TAR
1MG Tablet 02394898 TEVA-ANASTROZOLE TEV

APALUTAMIDE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of non-metastatic castration-resistant prostate cancer patients (nmCRPC) who meet all the following criteria:

  • used in combination with androgen deprivation therapy (ADT); and
  • have no detectable distant metastases by either CT, MRI or technetium-99m bone scan; and
  • are at high risk* of developing metastases; and
  • have no risk factors for seizures; and
  • have a good ECOG performance status (0 or 1)

* High risk is defined as a prostate-specific antigen doubling time of ≤ 10 months during continuous ADT

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

Table: APALUTAMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
60MG Tablet 02478374 ERLEADA JSO

AXITINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the second-line treatment of patients with advanced or metastatic clear cell renal carcinoma after failure of prior therapy with a first-line agent.

Patients are only eligible for either everolimus or axitinib in the second-line setting, but not sequential use of both agents except in cases of intolerance.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: AXITINIB
Drug strength and dosage form DIN Brand name Manufacturer code
1MG Tablet 02389630 INLYTA PFI
5MG Tablet 02389649 INLYTA PFI

BICALUTAMIDE

Table: BICALUTAMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Tablet 02325985 ACH-BICALUTAMIDE ACC
50MG Tablet 02296063 APO-BICALUTAMIDE APX
50MG Tablet 02184478 CASODEX AZC
50MG Tablet 02357216 JAMP-BICALUTAMIDE JMP
50MG Tablet 02275589 PMS-BICALUTAMIDE PMS
50MG Tablet 02311038 PRO-BICALUTAMIDE PDL
50MG Tablet 02371324 RAN-BICALUTAMIDE RBY
50MG Tablet 02270226 TEVA-BICALUTAMIDE TEV

BOSUTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

Patients has Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML); and

  • patient has an ECOG performance status of 0 to 2;
  • and
  • documented resistance/disease progression to at least one prior oral tyrosine kinase inhibitor [TKI] (imatinib, dasatinib or nilotinib); or
  • documented intolerance to one prior oral TKI (imatinib, dasatinib or nilotinib) where subsequent treatment with an alternative oral TKI is not clinically appropriate.

Criteria for renewal every 12 months:

Confirmation from the clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so and has not developed unacceptable toxicities.

Table: BOSUTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Tablet 02419149 BOSULIF PFI
500MG Tablet 02419157 BOSULIF PFI

BUSERELIN ACETATE

Table: BUSERELIN ACETATE
Drug strength and dosage form DIN Brand name Manufacturer code
6.3MG/IMPLANT Implant 02228955 SUPREFACT DEPOT 2 MONTHS CHE
9.45MG/IMPLANT Implant 02240749 SUPREFACT DEPOT 3 MONTHS CHE
1MG/ML Solution 02225166 SUPREFACT CHE
1MG/ML Solution 02225158 SUPREFACT (NASAL) CHE

BUSULFAN

Table: BUSULFAN
Drug strength and dosage form DIN Brand name Manufacturer code
2MG Tablet 00004618 MYLERAN ASP

CABOZANTINIB (CABOZANTINIB MALATE)

Limited use benefit (prior approval required).

Initial coverage for 4 months:

For the treatment of patients with advanced renal cell carcinoma (RCC) who have received at least one prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.

  • patient has good performance status with an ECOG of 0 to 2

Criteria for renewal every 4 months:

There is no objective evidence of disease progression.

*NIHB coverage is only provided for one of axitinib (Inlyta) or cabozantinib (Cabometyx) in the third-line setting for intermediate or poor risk patients treated with nivolumab (Opdivo) and ipilimumab (Yervoy) first-line and VEGF TKI secondline.

Table: CABOZANTINIB (CABOZANTINIB MALATE)
Drug strength and dosage form DIN Brand name Manufacturer code
20MG Tablet 02480824 CABOMETYX IPS
40MG Tablet 02480832 CABOMETYX IPS
60MG Tablet 02480840 CABOMETYX IPS

CAPECITABINE

Table: CAPECITABINE
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Tablet 02426757 ACH-CAPECITABINE ACC
150MG Tablet 02421917 SANDOZ CAPECITABINE SDZ
150MG Tablet 02457490 TARO-CAPECITABINE TAR
150MG Tablet 02400022 TEVA-CAPECITABINE TEV
150MG Tablet 02238453 XELODA HLR
500MG Tablet 02426765 ACH-CAPECITABINE ACC
500MG Tablet 02421925 SANDOZ CAPECITABINE SDZ
500MG Tablet 02457504 TARO-CAPECITABINE TAR
500MG Tablet 02400030 TEVA-CAPECITABINE TEV
500MG Tablet 02238454 XELODA HLR

CERITINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

Second-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have disease progression on or intolerance to crizotinib; and

  • to be used as monotherapy; and
  • disease is anaplastic lymphoma kinase (ALK)-positive; and
  • patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: CERITINIB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Capsule 02436779 ZYKADIA NVR

CHLORAMBUCIL

Table: CHLORAMBUCIL
Drug strength and dosage form DIN Brand name Manufacturer code
2MG Tablet 00004626 LEUKERAN ASP

COBIMETINIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the first-line treatment of patients with metastatic or unresectable melanoma in combination with vemurafenib (Zelboraf).

And for patients who meet the following criteria:

  • patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; and
  • patient does not have brain metastases or brain metastases are asymptomatic or stable; and
  • patient has an ECOG performance status of 0 to 1.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: COBIMETINIB
Drug strength and dosage form DIN Brand name Manufacturer code
20MG Tablet 02452340 COTELLIC HLR

CRIZOTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

First-line treatment of patients with advanced non-small cell lung cancer (NSCLC); or

Second-line treatment of patients with advanced NSCLC who have received one prior chemotherapy regimen.*; and

  • patient is anaplastic lymphoma kinase (ALK)-positive; and
  • patient has an ECOG performance status of 0 to 2.

*Patients who have progressed during or following first-line therapy with crizotinib are not eligible to receive crizotinib as a second-line therapy.

Criteria for renewal every 12 months:

The patient has experienced a hematologic and/or cytogenic response to crizotinib and is expected to continue to do so.

Table: CRIZOTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
200MG Capsule 02384256 XALKORI PFI

CYCLOPHOSPHAMIDE

Table: CYCLOPHOSPHAMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
25MG Tablet 02241795 PROCYTOX BAX
50MG Tablet 02241796 PROCYTOX BAX

DABRAFENIB

Limited use benefit (prior approval required).

1. First-line treatment of patients with metastatic or unresectable melanoma.

Criteria for initial 6-month coverage:

for the first-line treatment of patients with metastatic or unresectable melanoma as monotherapy; or

for the first-line treatment of patients with metastatic or unresectable melanoma in combination with trametinib (Mekinist)

And for patients who meet the following criteria:

  • patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; and
  • patient does not have brain metastases or brain metastases are asymptomatic or stable; and
  • patient has an ECOG performance status of 0 to 1; and
  • patient is previously untreated.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

2. Adjuvant treatment of patients with cutaneous melanoma.

Criteria for maximum 12-month coverage:

  • in combination with trametinib for the adjuvant treatment of patients with stage IIIA (limited to lymph node metastases of >1 mm) to stage IIID (8th edition of the American Joint Committee on Cancer Staging System) cutaneous melanoma; and
  • patient has documented BRAF V600 mutation cutaneous melanoma; and
  • disease must be completely resected including in-transit metastases*; and
  • patient has an ECOG performance status of 0 to 1.

Maximum duration of therapy is 12 months.

* Presence of regional lymph nodes with micrometastases after sentinel lymph node biopsy alone is allowed.

Table: DABRAFENIB
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Capsule 02409607 TAFINLAR NVR
75MG Capsule 02409615 TAFINLAR NVR

ENZALUTAMIDE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are/have:

asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) who have not received prior chemotherapy; and

  • have an ECOG performance status of 0 or 1 with no risk factors for seizures; or
  • progressed on docetaxel-based chemotherapy with an ECOG performance status ≤2 and no risk factors for seizures; and
  • would be an alternative to abiraterone for patients in the post-docetaxel setting but would not be an add-on therapy to abiraterone treatment.

Patients previously treated with abiraterone would not be eligible for enzalutamide unless unable to tolerate abiraterone.

Use of enzalutamide in the post-docetaxel setting is not permitted if previously used in the pre-chemotherapy setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

or

Criteria for initial 12-month coverage:

For the treatment of non-metastatic castration-resistant prostate cancer patients (nmCRPC) who meet all the following criteria:

  • used in combination with androgen deprivation therapy (ADT); and
  • are at high risk* of developing metastases; and
  • have no risk factors for seizures; and
  • have a good ECOG performance status (0 or 1).

* high risk is defined as a prostate-specific antigen doubling time (PSADT) of ≤ 10 months during continuous ADT.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: ENZALUTAMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Capsule 02407329 XTANDI AST

ERLOTINIB HYDROCHLORIDE

Limited use benefit (prior approval required).

Treatment of non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown.

Table: ERLOTINIB HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
25MG Tablet 02461862 APO-ERLOTINIB APX
25MG Tablet 02483912 NAT-ERLOTINIB NPH
25MG Tablet 02269007 TARCEVA HLR
25MG Tablet 02377691 TEVA-ERLOTINIB TEV
100MG Tablet 02461870 APO-ERLOTINIB APX
100MG Tablet 02454386 PMS-ERLOTINIB PMS
100MG Tablet 02269015 TARCEVA HLR
100MG Tablet 02377705 TEVA-ERLOTINIB TEV
150MG Tablet 02461889 APO-ERLOTINIB APX
150MG Tablet 02454394 PMS-ERLOTINIB PMS
150MG Tablet 02269023 TARCEVA HLR
150MG Tablet 02377713 TEVA-ERLOTINIB TEV

ETOPOSIDE

Table: ETOPOSIDE
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Capsule 00616192 VEPESID CHE

EVEROLIMUS

Limited use benefit (prior approval required).

For the treatment of:

  • advanced breast cancer according to established criteria.
  • advanced or metastatic renal cell carcinoma (mRCC) according to established criteria.
  • progressive, unresectable, well or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors (pNet) according to established criteria.
  • non-functional neuroendocrine tumors (Nets) of gastrointestinal or lung origin (GIL) according to established criteria.

(Please refer to Appendix A).

Table: EVEROLIMUS
Drug strength and dosage form DIN Brand name Manufacturer code
2.5MG Tablet 02369257 AFINITOR NVR
2.5MG Tablet 02463229 TEVA-EVEROLIMUS TEV
5MG Tablet 02339501 AFINITOR NVR
5MG Tablet 02463237 TEVA-EVEROLIMUS TEV
10MG Tablet 02339528 AFINITOR NVR
10MG Tablet 02463253 TEVA-EVEROLIMUS TEV
2MG Tablet For Suspension 02425645 AFINITOR DISPERZ NVR
3MG Tablet For Suspension 02425653 AFINITOR DISPERZ NVR
5MG Tablet For Suspension 02425661 AFINITOR DISPERZ NVR

EXEMESTANE

Table: EXEMESTANE
Drug strength and dosage form DIN Brand name Manufacturer code
25MG Tablet 02390183 ACT EXEMESTANE TEV
25MG Tablet 02419726 APO-EXEMESTANE APX
25MG Tablet 02242705 AROMASIN PFI
25MG Tablet 02407841 MED-EXEMESTANE GMP
25MG Tablet 02408473 TEVA-EXEMESTANE TEV

FLUDARABINE PHOSPHATE

Table: FLUDARABINE PHOSPHATE
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Tablet 02246226 FLUDARA SAC

FLUTAMIDE

Table: FLUTAMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
250MG Tablet 02238560 FLUTAMIDE AAP
250MG Tablet 02230104 PMS-FLUTAMIDE PMS

GEFITINIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who meet all of the following criteria:

  • first-line treatment; and
  • EGFR mutation positive; and
  • patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: GEFITINIB
Drug strength and dosage form DIN Brand name Manufacturer code
250MG Tablet 02468050 APO-GEFITINIB APX
250MG Tablet 02248676 IRESSA AZC
250MG Tablet 02487748 SANDOZ GEFITINIB SDZ

HYDROXYUREA

Table: HYDROXYUREA
Drug strength and dosage form DIN Brand name Manufacturer code
500MG Capsule 02247937 APO-HYDROXYUREA APX
500MG Capsule 00465283 HYDREA BMS
500MG Capsule 02242920 MYLAN-HYDROXYUREA MYL

IBRUTINIB

Limited use benefit (prior approval required).

For the treatment of:

  • previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (first-line) according to established criteria.
  • chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (second-line) according to established criteria.
  • relapsed/refractory mantle cell lymphoma (MCL) according to established criteria.

(Please refer to Appendix A).

Table: IBRUTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
140MG Capsule 02434407 IMBRUVICA JSO

IDELALISIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

  • for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab. Treatment should continue until unacceptable toxicity or disease progression.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: IDELALISIB
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Tablet 02438798 ZYDELIG GIL
150MG Tablet 02438801 ZYDELIG GIL

IMATINIB MESYLATE

Limited use benefit (prior approval required).

For the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase; or

For the treatment of patients with gastrointestinal stromal tumour; or

For newly diagnosed adult patients with Philadelphia chromosome-positive (CML); or

For the treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Table: IMATINIB MESYLATE
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Tablet 02355337 APO-IMATINIB APX
100MG Tablet 02253275 GLEEVEC NVR
100MG Tablet 02397285 NAT-IMATINIB NPH
100MG Tablet 02431114 PMS-IMATINIB PMS
100MG Tablet 02399806 TEVA-IMATINIB TEV
400MG Tablet 02355345 APO-IMATINIB APX
400MG Tablet 02253283 GLEEVEC NVR
400MG Tablet 02397293 NAT-IMATINIB NPH
400MG Tablet 02431122 PMS-IMATINIB PMS
400MG Tablet 02399814 TEVA-IMATINIB TEV

LENALIDOMIDE

Limited use benefit (prior approval required).

For the treatment of:

  • myelodysplastic syndrome (MDS)
  • refractory/relapsed multiple myeloma after one prior therapy (MM-AOPT)
  • newly diagnosed multiple myeloma for patients who are not eligible for autologous stem cell transplant (MM-TNE)
  • maintenance treatment for newly diagnosed Multiple Myeloma post-autologous stem cell transplant (NDMM post-ASCT)

(Please refer to Appendix A).

Table: LENALIDOMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
2.5MG Capsule 02459418 REVLIMID UNK
5MG Capsule 02304899 REVLIMID UNK
10MG Capsule 02304902 REVLIMID UNK
15MG Capsule 02317699 REVLIMID UNK
20MG Capsule 02440601 REVLIMID UNK
25MG Capsule 02317710 REVLIMID UNK

LENVATINIB

Limited use benefit (prior approval required).

1. Unresectable Hepatocellular Carcinoma (HCC):

Criteria for initial 4-month coverage:

For the first-line treatment of adult patients with unresectable HCC; and

  • patient has a Child-Pugh A liver function status; and
  • patient has an ECOG performance status of 0 to 1; and
  • patient meets the inclusion criteria of the REFLECT trial:
  • patient does not have ≥50% of liver occupation;
  • patient does not have clear invasion of the bile duct or portal vein at the main portal branch;
  • patient does not have a history of or current brain or subdural metastases.

Criteria for renewal every 4 months:

There is no objective evidence of disease progression.

2. Differentiated thyroid cancer (DTC)

Criteria for initial 4-month coverage:

Used as monotherapy for treatment of patients with locally recurrent or metastatic, progressive DTC; and

  • DTC is refractory to radioactive iodine treatment; and
  • have an ECOG performance status of ≤ 2;and
  • patient meets the eligibility criteria of the SELECT trial as follows:
  • pathologically confirmed differentiated thyroid cancer (patients with anaplastic or medullary thyroid cancer are not eligible)
  • evidence of iodine-131 refractory disease according to at least one of the following criteria:
  • at least one measurable lesion without iodine uptake on any iodine-131 scan
  • at least one measurable lesion that had progressed according to RECIST criteria within 12 months after iodine-131 therapy despite iodine-131 avidity at the time of treatment
  • total lifetime radioactive iodine dose greater than 600 mCi (millicurie)
  • radiologic evidence of progression within the previous 13 months
  • no prior therapy with a tyrosine kinase inhibitor or have received one prior treatment regimen with a tyrosine kinase inhibitor

Criteria for renewal every 4 months:

There is no objective evidence of disease progression.

Table: LENVATINIB
Drug strength and dosage form DIN Brand name Manufacturer code
4MG Capsule 02484056 LENVIMA EIS
8MG Capsule 02468220 LENVIMA EIS
10MG Capsule 02450321 LENVIMA EIS
12MG Capsule 02484129 LENVIMA EIS
14MG Capsule 02450313 LENVIMA EIS
20MG Capsule 02450305 LENVIMA EIS
24MG Capsule 02450291 LENVIMA EIS

LETROZOLE

Table: LETROZOLE
Drug strength and dosage form DIN Brand name Manufacturer code
ST2.5MG Tablet 02338459 ACH-LETROZOLE ACC
2.5MG Tablet 02358514 APO-LETROZOLE APX
2.5MG Tablet 02392496 BIO-LETROZOLE BMI
2.5MG Tablet 02231384 FEMARA NVR
ST2.5MG Tablet 02373009 JAMP-LETROZOLE JMP
ST2.5MG Tablet 02402025 LETROZOLE PDL
2.5MG Tablet 02373424 MAR-LETROZOLE MAR
2.5MG Tablet 02322315 MED-LETROZOLE GMP
ST2.5MG Tablet 02421585 NAT-LETROZOLE NPH
2.5MG Tablet 02309114 PMS-LETROZOLE PMS
ST2.5MG Tablet 02372282 RAN-LETROZOLE RBY
2.5MG Tablet 02398656 RIVA-LETROZOLE RIV
2.5MG Tablet 02344815 SANDOZ LETROZOLE SDZ
ST2.5MG Tablet 02343657 TEVA-LETROZOLE TEV
2.5MG Tablet 02378213 ZINDA-LETROZOLE UNK

LEUPROLIDE ACETATE

Table: LEUPROLIDE ACETATE
Drug strength and dosage form DIN Brand name Manufacturer code
10.5MG/VIAL Powder For Suspension 02248239 ELIGARD SAC
22.5MG/VIAL Powder For Suspension 02248240 ELIGARD SAC
30MG/VIAL Powder For Suspension 02248999 ELIGARD SAC
45MG/VIAL Powder For Suspension 02268892 ELIGARD SAC

LOMUSTINE

Table: LOMUSTINE
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Capsule 00360430 CEENU BMS
40MG Capsule 00360422 CEENU BMS

MEGESTROL ACETATE

Table: MEGESTROL ACETATE
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Tablet 02195917 MEGESTROL AAP
160MG Tablet 02195925 MEGESTROL AAP

MELPHALAN

Table: MELPHALAN
Drug strength and dosage form DIN Brand name Manufacturer code
2MG Tablet 00004715 ALKERAN ASP

MERCAPTOPURINE

Table: MERCAPTOPURINE
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Tablet 02415275 MERCAPTOPURINE RAX
50MG Tablet 00004723 PURINETHOL TEV

METHOTREXATE SODIUM

Table: METHOTREXATE SODIUM
Drug strength and dosage form DIN Brand name Manufacturer code
7.5MG Solution 02320029 METOJECT UNK
7.5MG Solution 02454823 METOJECT SUBCUTANEOUS UNK
10MG Solution 02454831 METOJECT SUBCUTANEOUS UNK
10MG/0.4ML Solution 02422174 METHOTREXATE PMS
10MG/ML Solution 02182947 METHOTREXATE PFI
12.5MG Solution 02454750 METOJECT SUBCUTANEOUS UNK
15MG Solution 02454858 METOJECT SUBCUTANEOUS UNK
15MG/0.6ML Solution 02422182 METHOTREXATE PMS
17.5MG Solution 02454769 METOJECT SUBCUTANEOUS UNK
20MG Solution 02454866 METOJECT SUBCUTANEOUS UNK
20MG/0.8ML Solution 02422190 METHOTREXATE PMS
22.5MG Solution 02454777 METOJECT SUBCUTANEOUS UNK
25MG Solution 02454874 METOJECT SUBCUTANEOUS UNK
25MG/ML Solution 02419173 JAMP-METHOTREXATE JMP
25MG/ML Solution 02099705 METHOTREXATE TEV
25MG/ML Solution 02182777 METHOTREXATE PFI
25MG/ML Solution 02182955 METHOTREXATE PFI
25MG/ML Solution 02398427 METHOTREXATE SDZ
25MG/ML Solution 02417626 METHOTREXATE MYL
25MG/ML Solution 02422166 METHOTREXATE PMS
25MG/ML Solution 02422204 METHOTREXATE PMS
2.5MG Tablet 02182963 APO-METHOTREXATE APX
2.5MG Tablet 02170698 PMS-METHOTREXATE PMS
10MG Tablet 02182750 METHOTREXATE PFI

MIDOSTAURIN

Limited use benefit (prior approval required).

Criteria for 12-month coverage:

  • patient has newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML); and
  • patient's FLT3-mutation status has been confirmed; and
  • midostaurin is being used in combination with standard cytarabine and daunorubicin (or idarubicin) induction and cytarabine consolidation chemotherapy; and
  • patient has an ECOG performance status of 0 to 2.
Table: MIDOSTAURIN
Drug strength and dosage form DIN Brand name Manufacturer code
25MG Capsule 02466236 RYDAPT NVR

MITOTANE

Table: MITOTANE
Drug strength and dosage form DIN Brand name Manufacturer code
500MG Tablet 00463221 LYSODREN HRA

NILOTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

Patients has newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase; or

Patient has chronic phase or accelerated phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia; and

  • patient has disease progression/resistance to imatinib; or
  • documented intolerance to a prior oral TKI (imatinib, dasatinib or bosutinib).

Criteria for renewal every 12 months:

Confirmation from the clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so and has not developed unacceptable toxicities.

Table: NILOTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Capsule 02368250 TASIGNA NVR
200MG Capsule 02315874 TASIGNA NVR

NILUTAMIDE

Table: NILUTAMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Tablet 02221861 ANANDRON CHE

OLAPARIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

  • maintenance treatment of adult patients with high grade serous epithelial ovarian fallopian tube cancer; or
  • primary peritoneal cancer;
  • and
  • platinum-sensitive disease; and
  • relapsed BRCA-mutated disease (germline or somatic as detected by approved testing)
  • have completed at least two previous lines of platinum-based chemotherapy; and
  • radiologic response (complete or partial response) to their most recent platinum-based chemotherapy regimen as per the SOLO-2 trial; and
  • patient has an ECOG performance status of 0 to 2;
  • and
  • olaparib is used as monotherapy

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: OLAPARIB
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Capsule 02454408 LYNPARZA AZC
100MG Tablet 02475200 LYNPARZA AZC
150MG Tablet 02475219 LYNPARZA AZC

OSIMERTINIB

Limited use benefit (prior approval required).

1. First-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)

Criteria for initial 12-month coverage:

Patient with locally advanced (not amenable to curative intent therapy) or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions [exon 19 del] or exon 21 [L858R]); and

  • patient is previously untreated in the locally advanced or metastatic setting; and
  • patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no clinically meaningful disease progression or unacceptable toxicity.

2. Subsequent treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)

Criteria for initial 12-month coverage:

Patient with locally advanced or metastatic NSCLC who has progressed on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor therapy; and

  • patient is EGFR T790M mutation- positive; and
  • patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: OSIMERTINIB
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Tablet 02456214 TAGRISSO AZC
80MG Tablet 02456222 TAGRISSO AZC

PALBOCICLIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of post-menopausal clients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer; and

  • the patient has not received any prior treatment for metastatic disease (first-line treatment); and
  • palbociclib will be used in combination with an aromatase inhibitor; and
  • patient has an ECOG performance status of 0 to 2; and
  • patient is not resistant to prior (neo)adjuvant aromatase inhibitor therapy; and
  • patient does not have active or uncontrolled metastases to the central nervous system.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

or

Criteria for initial 12-month coverage:

For in combination with fulvestrant, for the treatment of patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer (mBC) whose disease has progressed after prior endocrine therapy.

  • patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: PALBOCICLIB
Drug strength and dosage form DIN Brand name Manufacturer code
75MG Capsule 02453150 IBRANCE PFI
100MG Capsule 02453169 IBRANCE PFI
125MG Capsule 02453177 IBRANCE PFI

PAZOPANIB

Limited use benefit (prior approval required).

Initial coverage criteria (12 months)

For the first-line treatment of patients with advanced or metastatic clear cell renal carcinoma; and

  • patient has an ECOG performance status of 0 to 2.

Renewal coverage criteria (12 months)

There is no objective evidence of disease progression.

Table: PAZOPANIB
Drug strength and dosage form DIN Brand name Manufacturer code
200MG Tablet 02352303 VOTRIENT NVR

POMALIDOMIDE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of relapsed or refractory multiple myeloma who meet all of the following criteria:

  • used in combination with dexamethasone; and
  • patient has relapsed or is refractory to at least two treatment regimens, including both bortezomib and lenalidomide; and
  • patient has demonstrated disease progression on the last regimen.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or development of unacceptable toxicity to pomalidomide requiring discontinuation of therapy.

Table: POMALIDOMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
1MG Capsule 02419580 POMALYST UNK
2MG Capsule 02419599 POMALYST UNK
3MG Capsule 02419602 POMALYST UNK
4MG Capsule 02419610 POMALYST UNK

PONATINIB HYDROCHLORIDE

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the treatment of patients who have confirmed T315i mutation positive disease, independent of previous TKI therapy; or

Treatment of last resort for patients with intolerances or contraindications to imatinib and all other second generation TKI's (dasatinib, nilotinib, bosutinib); or

For the treatment of patients with chronic phase chronic myeloid leukemia (CML) who have resistance/disease progression after at least two prior lines of TKI therapy where Iclusig would be available as third-line TKI option; or

For the treatment of patients with accelerated phase or blast phase CML or Ph+ ALL who have resistance or disease progression after at least one second generation TKI therapy;

and

  • an ECOG performance status of 0 to 2.

Note: Second generation TKI's (dasatinib, nilotinib, bosutinib) are not covered as options after ponatinib.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: PONATINIB HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
15MG Tablet 02437333 ICLUSIG ARI
45MG Tablet 02437341 ICLUSIG ARI

PROCARBAZINE HYDROCHLORIDE

Table: PROCARBAZINE HYDROCHLORIDE
Drug strength and dosage form DIN Brand name Manufacturer code
50MG Capsule 00012750 MATULANE UNK

REGORAFENIB

Limited use benefit (prior approval required).

1. For the treatment of Gastrointestinal Stromal Tumors (GIST)

Criteria for initial six-month coverage:

For patients with Gastrointestinal Stromal Tumors (GIST) who have failed or are unable to tolerate imatinib and sunitinib therapy; and

  • patient has an ECOG performance status of 0 or 1;

Note: Regorafenib will not be funded concomitantly with imatinib or sunitinib.

Criteria for assessment every 12 months:

There is no objective evidence of disease progression.

2. For the treatment of Hepatocellular Carcinoma (HCC)

Criteria for initial six-month coverage:

Patient diagnosed with unresectable HCC; and

  • patient has been previously treated with sorafenib or lenvatinib; and
  • patient was able to tolerate sorafenib as defined in the RESorCE trial criteria (≥400mg/day for ≥20 days of the last 28 days of treatment); and
  • patient has a Child-Pugh class status of A; and
  • patient has an ECOG performance status of 0 to 1

Criteria for assessment every 12 months:

There is no objective evidence of disease progression.

Table: REGORAFENIB
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Tablet 02403390 STIVARGA BAY

RIBOCICLIB (RIBOCICLIB SUCCINATE)

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of post-menopausal clients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer:

  • the patient has not received any prior treatment for metastatic disease (first-line treatment); and
  • ribociclib will be used in combination with letrozole; and
  • patient has an ECOG performance status of 0 to 2; and
  • patient is not resistant* to prior (neo)adjuvant nonsteroidal aromatase inhibitor therapy (NSAI); and
  • patient does not have active or uncontrolled metastases to the central nervous system.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

*Resistance is defined as disease progression occurring during or within 12 months following aromatase inhibitor therapy.

Table: RIBOCICLIB (RIBOCICLIB SUCCINATE)
Drug strength and dosage form DIN Brand name Manufacturer code
200MG Tablet 02473569 KISQALI NVR

RITUXIMAB

Limited use benefit (prior approval required).

For the treatment of:

  • rheumatoid arthritis according to established criteria.
  • granulomatosis polyangiitis according to established criteria.
  • microscopic polyangiitis according to established criteria.

(Please refer to Appendix A).

Table: RITUXIMAB
Drug strength and dosage form DIN Brand name Manufacturer code
10MG/ML Solution 02241927 RITUXAN HLR

RUXOLITINIB

Limited use benefit (prior approval required).

1. For the treatment of myelofibrosis:

Criteria for initial 6-month coverage:

  • intermediate to high risk symptomatic myelofibrosis as assessed using the Dynamic International Prognostic Scoring System (DIPSS) Plus; or
  • patient has symptomatic splenomegaly;
  • and
  • patient has an ECOG performance status of 0 to 3; and
  • patient previously untreated or refractory to other treatment.

Criteria for renewal every 12 months:

  • reduction in spleen size; or
  • improvement in disease symptoms.

2. For the treatment of patients with polycythemia vera:

Criteria for initial 6-month coverage:

Disease is resistant to hydroxyurea (HU) according to the modified European LeukemiaNet Criteria defined as below:

After 3 months of at least 2g/day of HU or at the maximally tolerated HU dose, patient showed:

  • need for phlebotomy to keep hematocrit < 45%; or
  • uncontrolled myeloproliferation (platelet > 400x109/L and WBC > 10x109/L); or
  • failure to reduce massive splenomegaly > 50% as measured by palpation.
  • or
  • Patient is intolerant to HU according to the modified European LeukemiaNet Criteria defined below:

After any dose of HU, patient showed:

  • absolute neutrophil count < 1.0 x 109/L , or platelet < 100x109/L or hemoglobin < 100 g/L at the lowest dose of HU required to achieve a response (response defined as hematocrit < 45% without phlebotomy, and/or all of the following: platelet ≤ 400x109/L , WBC ≤ 10 x 109/L , and non-palpable spleen); or
  • presence of leg ulcers or other unacceptable HU-related non-hematological toxicities (such as mucocutaneous manifestations, gastrointestinal symptoms, pneumonitis or fever, defined as Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade 3 or 4, or more than one week of CTCAE version 3.0 grade 2, or permanent discontinuation of HU, or interruption of HU until toxicity resolved, or hospitalization due to HU toxicity).
  • and
  • patient has an ECOG performance status of 0 to 3.

Criteria for renewal every 12 months:

  • reduction in spleen size; or
  • improvement in disease symptoms.
Table: RUXOLITINIB
Drug strength and dosage form DIN Brand name Manufacturer code
5MG Tablet 02388006 JAKAVI NVR
10MG Tablet 02434814 JAKAVI NVR
15MG Tablet 02388014 JAKAVI NVR
20MG Tablet 02388022 JAKAVI NVR

SUNITINIB MALATE

Limited use benefit (Prior approval required).

Criteria for initial 6-month coverage:

  • For patients with histologically proven unresectable or recurrent/metastatic GIST who have failed or are unable to tolerate imatinib therapy. sunitinib will not be funded concomitantly with imatinib;

or

Criteria for initial 12-month coverage:

  • Documented, progressive, unresectable, well or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors; and
  • patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: SUNITINIB MALATE
Drug strength and dosage form DIN Brand name Manufacturer code
12.5MG Capsule 02280795 SUTENT PFI
25MG Capsule 02280809 SUTENT PFI
50MG Capsule 02280817 SUTENT PFI

TAMOXIFEN CITRATE

Table: TAMOXIFEN CITRATE
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Tablet 00812404 APO-TAMOX APX
10MG Tablet 00851965 TEVA-TAMOXIFEN TEV
20MG Tablet 00812390 APO-TAMOX APX
20MG Tablet 02048485 NOLVADEX-D AZC
20MG Tablet 00851973 TEVA-TAMOXIFEN TEV

TEMOZOLOMIDE

Table: TEMOZOLOMIDE
Drug strength and dosage form DIN Brand name Manufacturer code
5MG Capsule 02441160 ACT TEMOZOLOMIDE ACG
5MG Capsule 02443473 TARO-TEMOZOLOMIDE TAR
5MG Capsule 02241093 TEMODAL FRS
20MG Capsule 02395274 ACT TEMOZOLOMIDE ACG
20MG Capsule 02443481 TARO-TEMOZOLOMIDE TAR
20MG Capsule 02241094 TEMODAL FRS
100MG Capsule 02395282 ACT TEMOZOLOMIDE ACG
100MG Capsule 02443511 TARO-TEMOZOLOMIDE TAR
100MG Capsule 02241095 TEMODAL FRS
140MG Capsule 02395290 ACT TEMOZOLOMIDE ACG
140MG Capsule 02413116 APO-TEMOZOLOMIDE APX
140MG Capsule 02443538 TARO-TEMOZOLOMIDE TAR
140MG Capsule 02312794 TEMODAL FRS
250MG Capsule 02395312 ACT TEMOZOLOMIDE ACG
250MG Capsule 02443554 TARO-TEMOZOLOMIDE TAR
250MG Capsule 02241096 TEMODAL FRS

THIOGUANINE

Table: THIOGUANINE
Drug strength and dosage form DIN Brand name Manufacturer code
40MG Tablet 00282081 LANVIS ASP

TRAMETINIB

Limited use benefit (prior approval required).

1. First-line treatment of patients with metastatic or unresectable melanoma.

Criteria for initial 6-month coverage:

For the first-line treatment of patients with metastatic or unresectable melanoma as monotherapy; or

For the first-line treatment of patients with metastatic or unresectable melanoma in combination with dabrafenib (Tafinlar)

And for patients who meet the following criteria:

  • patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; and
  • patient does not have brain metastases or brain metastases are asymptomatic or stable; and
  • patient has an ECOG performance status of 0 to 1; and
  • patient is previously untreated.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

2. Adjuvant treatment of patients with cutaneous melanoma.

Criteria for maximum 12-month coverage:

  • in combination with trametinib for the adjuvant treatment of patients with stage IIIA (limited to lymph node metastases of >1 mm) to stage IIID (8th edition of the American Joint Committee on Cancer Staging System) cutaneous melanoma; and
  • patient has documented BRAF V600 mutation cutaneous melanoma; and
  • disease must be completely resected including in-transit metastases*; and
  • patient has an ECOG performance status of 0 to 1.

Maximum duration of therapy is 12 months.

* Presence of regional lymph nodes with micrometastases after sentinel lymph node biopsy alone is allowed.

Table: TRAMETINIB
Drug strength and dosage form DIN Brand name Manufacturer code
0.5MG Tablet 02409623 MEKINIST NVR
2MG Tablet 02409658 MEKINIST NVR

TRETINOIN

Table: TRETINOIN
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Capsule 02145839 VESANOID CHE

TRIPTORELIN PAMOATE

Table: TRIPTORELIN PAMOATE
Drug strength and dosage form DIN Brand name Manufacturer code
3.75MG/VIAL Powder For Suspension 02240000 TRELSTAR UNK
11.25MG/VIAL Powder For Suspension 02243856 TRELSTAR UNK
22.5MG Powder For Suspension 02412322 TRELSTAR UNK

VANDETANIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For patients with symptomatic and/or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease; and

  • an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

Table: VANDETANIB
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Tablet 02378582 CAPRELSA SAC
300MG Tablet 02378590 CAPRELSA SAC

VEMURAFENIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the first-line treatment of patients with metastatic or unresectable melanoma as monotherapy; or

For the first-line treatment of patients with metastatic or unresectable melanoma in combination with cobimetinib (Cotellic).

And for patients who meet the following criteria:

  • patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; and
  • patient does not have brain metastases or brain metastases are asymptomatic or stable; and
  • patient has an ECOG performance status of 0 to 1.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Table: VEMURAFENIB
Drug strength and dosage form DIN Brand name Manufacturer code
ST240MG Tablet 02380242 ZELBORAF HLR

VENETOCLAX

Limited use benefit (prior approval required).

1. Monotherapy treatment in adult patients with chronic lymphocytic leukemia (CLL)

Criteria for initial 12-month coverage:

For the treatment of CLL who meet all of the following criteria:

Venclexta will be used as monotherapy; and

  • patient has received at least one prior therapy; and
  • patient has failed a B-cell receptor inhibitor (BCRi) or is intolerant to prior ibrutinib therapy; and
  • patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

2. In combination with rituximab for the treatment of chronic lymphocytic leukemia (CLL)

Criteria for 12-month coverage of venetoclax:

For the treatment of CLL; and

  • in combination with rituximab; and
  • patient has received at least one prior therapy; and
  • patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

Coverage is for a maximum duration of two years.

Table: VENETOCLAX
Drug strength and dosage form DIN Brand name Manufacturer code
10MG Tablet 02458039 VENCLEXTA ABV
50MG Tablet 02458047 VENCLEXTA ABV
100MG Tablet 02458055 VENCLEXTA ABV
100MG Tablet 02458063 VENCLEXTA ABV
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