10:00 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

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.

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.

ANASTROZOLE

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.

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.

BICALUTAMIDE

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.

BUSERELIN ACETATE

BUSULFAN

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.

CAPECITABINE

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.

CHLORAMBUCIL

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.

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.

CYCLOPHOSPHAMIDE

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.

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.

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.

ETOPOSIDE

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).

EXEMESTANE

FLUDARABINE PHOSPHATE

FLUTAMIDE

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.

HYDROXYUREA

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).

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.

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).

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).

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.

LETROZOLE

LEUPROLIDE ACETATE

LOMUSTINE

MEGESTROL ACETATE

MELPHALAN

MERCAPTOPURINE

METHOTREXATE SODIUM

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.

MITOTANE

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.

NILUTAMIDE

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.

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.

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.

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.

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.

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.

PROCARBAZINE HYDROCHLORIDE

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.

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.

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).

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.

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.

TAMOXIFEN CITRATE

TEMOZOLOMIDE

THIOGUANINE

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.

TRETINOIN

TRIPTORELIN PAMOATE

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.

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.

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.