Injectable and Health Care Administered Oncology Medical Drug Criteria Through Preferred (Optional)

Home , Abemaciclib, Belantamab mafodotin, Cetuximab, Copanlisib, Dacarbazine, Dinutuximab

Injectable and Health Care

Administered Oncology Medical Drug Program Summary

For patients with late stage metastatic disease (Stage IV), please refer to MP 2.373 Step Therapy Treatment in Cancer, Including Treatments for Stage Four, Advanced Metastatic Cancer and Severe Related Health Conditions for additional guidance

*No Preferred Strategy

The clinical rationale section is inf ormational, please refer to the medical drug criteria section for agents requiring medical drug review.

FDA APPROVED INDICATIONS AND DOSAGE1-65 Agent Indication Dosage Abraxane® [paclitaxel ● Metastatic breast cancer Metastatic breast cancer: (protein bound)] af ter failure of combination 260 mg/m2 intravenously chemotherapy or relapse over 30 minutes, every 3 Injectable suspension within 6 months of adjuvant weeks chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated

● Locally advanced or NSCLC: metastatic Non-Small Cell 100 mg/m2 intravenously Lung Cancer (NSCLC) as over 30 minutes on Days 1, f irst-line treatment in 8, and 15 of each 21-day combination with cycle. Administer carboplatin, in patients who carboplatin on Day 1 of each are not candidates for 21-day cycle immediately curative surgery or radiation af ter Abraxane therapy

● Metastatic adenocarcinoma Metastatic of the pancreas as first-line adenocarcinoma of the treatment in combination pancreas: with gemcitabine 125 mg/m2 intravenously over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle. Administer gemcitabine immediately af ter paclitaxel (protein bound) on days 1, 8, and 15 of each 28-day cycle Adcetris® (brentuximab Treatment of adult patients vedotin) with:

Injection for intravenous ● Previously untreated Stage Previously untreated use III or IV classical Hodgkin Stage III or IV cHL: 1.2 lymphoma (cHL) in mg/kg up to a maximum of combination with 120 mg every 2 weeks for a doxorubicin, vinblastine, and maximum of 12 doses dacarbazine

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage ● cHL consolidation in cHL consolidation: patients at high risk of Initiate within 4-6 weeks relapse or progression as post auto-HSCT or upon post autologous recovery from auto-HSCT. hematopoietic stem cell 1.8 mg/kg up to 180 mg transplantation (auto-HSCT) given intravenously over 30

consolidation minutes every 3 weeks for a maximum of 16 cycles or until disease progression or unacceptable toxicity

Relapsed cHL: ● cHL af ter f ailure of auto- 1.8 mg/kg up to 180 mg HSCT or af ter f ailure of at given intravenously over 30 least two prior multi-agent minutes every 3 weeks until chemotherapy regimens in disease progression or patients who are not unacceptable toxicity candidates for auto-HSCT Previously untreated ● Previously untreated sALCL or other CD30- systemic anaplastic large cell expressing PTCL: lymphoma (sALCL) or other 1.8 mg/kg up to a maximum CD30-expressing peripheral of 180 mg given T-cell lymphomas (PTCL), intravenously over 30 including minutes every 3 weeks for 6 angioimmunoblastic T-cell to 8 doses lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone Previously treated sALCL: ● Systemic anaplastic large 1.8 mg/kg up to 180 mg cell lymphoma (sALCL) after given intravenously over 30 f ailure of at least one prior minutes every 3 weeks until multi-agent chemotherapy disease progression or regimen unacceptable toxicity

pcALCL or CD30- ● Primary cutaneous expressing MF: anaplastic large cell 1.8 mg/kg up to 180 mg lymphoma (pcALCL) or given intravenously over 30 CD30-expressing mycosis minutes every 3 weeks for a fungoides (MF) in patients maximum of 16 cycles or who have received prior until disease progression or systemic therapy unacceptable toxicity

Alimta® (pemetrexed) ● In combination with Initial treatment in pembrolizumab and platinum combination with For intravenous use chemotherapy f or the initial pembrolizumab and treatment of patients with platinum chemotherapy: metastatic non-squamous 500 mg/m2 given non-small cell lung cancer intravenously over 10 (NSCLC), with no EGFR or minutes on Day 1 of each ALK genomic tumor 21-day cycle for 4 cycles. aberrations Following completion of platinum-based therapy, CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 2 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage treatment with Alimta with or without pembrolizumab is administered until disease progression or unacceptable toxicity

● In combination with Initial treatment of cisplatin f or the initial NSCLC in combination treatment of patients with with cisplatin: locally advanced or 500 mg/m2 IV over 10 metastatic non-squamous, minutes on Day 1 of each non-small cell lung cancer 21-day cycle f or up to six (NSCLC) cycles in the absence of disease progression or unacceptable toxicity

● As a single agent f or Maintenance treatment of maintenance treatment of NSCLC: patients with locally 500 mg/m2 IV over 10 advanced or metastatic minutes on Day 1 of each NSCLC whose disease has 21-day cycle until disease not progressed after 4 cycles progression or unacceptable of platinum-based first-line toxicity chemotherapy

● As a single agent f or Recurrent NSCLC: treatment of patients with 500 mg/m2 IV over 10 recurrent, metastatic non- minutes on Day 1 of each squamous NSCLC after prior 21-day cycle until disease chemotherapy progression or unacceptable toxicity

● Initial treatment, in Mesothelioma: combination with cisplatin, 500 mg/m2 IV over 10 f or patients with malignant minutes on Day 1 of each pleural mesothelioma whose 21-day cycle until disease disease is unresectable or progression or unacceptable who are otherwise not toxicity candidates for curative surgery There is no recommended dose for patients whose Limitations of use: creatinine clearance is less Alimta is not indicated f or than 45 mL/min the treatment of patients with squamous cell NSCLC Aliqopa™ (copanlisib) ● Treatment of adult FL: patients with relapsed 60 mg administered as a 1- Injection for intravenous f ollicular lymphoma (FL) who hour intravenous infusion on use have received at least two Days 1, 8, and 15 of a 28 prior systemic therapies day treatment cycle Arranon® (nelarabine) ● Treatment of patients with T-cell lymphoblastic T-cell acute lymphoblastic leukemia and T-cell Injection for intravenous leukemia and T-cell lymphoblastic lymphoma: use lymphoblastic lymphoma in Adult dose: 1,500 mg/m2 adult and pediatric patients administered intravenously age 1 year and older whose over 2 hours on days 1, 3, disease has not responded CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 3 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage to or has relapsed f ollowing and 5 repeated every 21 treatment with at least two days chemotherapy regimens. Pediatric dose: 650 mg/m2 administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days Arzerra® (ofatumumab) ● Untreated chronic ● Untreated CLL: lymphocytic leukemia (CLL) 300 mg on Day 1 f ollowed 1 Injection for intravenous in combination with week later by 1,000 mg on use chlorambucil (For patients Day 8 (Cycle 1) f ollowed by for whom fludarabine based 1,000 mg on Day 1 of therapy is considered subsequent 28-day cycles inappropriate) f or a minimum of 3 cycles until best response or a maximum of 12 cycles ● Relapsed CLL in ● Relapsed CLL in combination with combination with fludarabine fludarabine and and cyclophosphamide. cyclophosphamide: 300 mg on Day 1 followed by 1,000 mg on Day 8 (Cycle 1) followed by 1,000 mg on Day 1 of subsequent 28-day cycles for a maximum of 6 cycles

● Extended treatment for ● Extended treatment of CLL: recurrent or progressive CLL 300 mg on Day 1, followed f ollowing partial or by 1,000 mg 1 week later on incomplete response after at Day 8, followed by 1,000 mg least two lines of therapy 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years

● Refractory CLL: ● CLL ref ractory to 300 mg initial dose on Day fludarabine and 1, followed 1 week later by alemtuzumab 2,000 mg weekly for 7 doses (Infusions 2 through 8), followed 4 weeks later by 2,000 mg every 4 weeks for 4 doses (Infusions 9 through 12) Asparlas™ (calaspargase ● As a c om pone nt of a m ulti- 2,500 units/m2 given pegol-mknl) agent chemotherapeutic intravenously no more regimen for the treatment of frequently than every 21 Injection for intravenous acute lymphoblastic days use leukemia in pediatric and young adult patients age 1 month to 21 years Beleodaq® (belinostat) ● Treatment of adult PTCL: patients with relapsed or

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage Injection or intravenous refractory peripheral T-cell 1,000 mg/m2 administered use lymphoma (PTCL) over 30 minutes by intravenous infusion once daily on days 1-5 of a 21 day cycle until disease progression or unacceptable toxicity Belrapzo™ (bendamustine ● Treatment of patients with CLL: hydrochloride) chronic lymphocytic 100 mg/m2 administered leukemia (CLL) intravenously over 30 Injection for intravenous minutes on Days 1 and 2 of use a 28-day cycle up to 6 cycles

● Treatment of patients with NHL: indolent B-cell non-Hodgkin 120 mg/m2 administered lymphoma (NHL) that has intravenously over 60 progressed during or within minutes on Days 1 and 2 of six months of treatment with a 21-day cycle up to 8 rituximab or a rituximab- cycles containing regimen Besponsa™ (inotuzumab ● The treatment of adults ALL: ozogamicin) with relapsed or refractory First cycle: B-cell precursor acute 0.8 mg/m2 intravenously on Injection for intravenous lymphoblastic leukemia Day 1, 0.5 mg/m2 use (ALL) intravenously on Day 8, and Day 15

Subsequent cycles: Patients who have achieved a complete remission (CR) or a complete remission with incomplete hematologic recovery (Cri) and who will proceed to a hematopoietic stem cell transplant (HSCT): 0.5 mg/m2 intravenously on Days 1, 8, and 15 every 4 weeks for 2 -3 cycles

Patients who have achieved a complete CR or a Cri and who will NOT proceed to a hematopoietic stem cell transplant (HSCT): 0.5 mg/m2 intravenously on Days 1, 8, and 15 every 4 weeks for up to a maximum of 6 cycles

Patients who have NOT achieved a CR or a Cri: 0.8 mg/m2 intravenously on Day 1, 0.5 mg/m2 intravenously on Day 8 and Day 15 every 4 CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 5 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage weeks for 2 -3 cycles. Patients who do not achieve a CR or Cri within 3 cycles should discontinue treatment Blenrep (belantamab ● Treatment of adult Multiple myeloma: mafodotin-blmf) patients with relapsed or 2.5 mg/kg of actual body ref ractory multiple myeloma weight given as an Injection for intravenous who have received at least 4 intravenous infusion over use prior therapies including an approximately 30 minutes anti-CD38 monoclonal once every 3 weeks until antibody, a proteasome disease progression or inhibitor, and an unacceptable toxicity immunomodulatory agent Blincyto® (blinatumomab) ● Tr e a tm ent of B-cell MRD-positive B-cell precursor acute precursor ALL: Injection for intravenous lymphoblastic leukemia Patients weighing less than use (ALL) in first or second 45 kg: complete remission with Induction dosing: minimal residual disease 15 mcg/m2/day (not to (MRD) greater than or equal exceed 28 mcg/day) by to 0.1% intravenous infusion on days 1-28 of a 42 day cycle

Consolidation dosing: 15 mcg/m2/day (not to exceed 28 mcg/day) by intravenous infusion on days 1-28 of a 42 day cycle for up to 3 cycles

Patients weighing 45 kg or more: Induction dosing: 28 mcg/day by intravenous infusion on days 1-28 of a 42 day cycle

Consolidation dosing: 28 mcg/day by intravenous infusion on days 1-28 of a 42 day cycle for up to 3 cycles

Relapsed or refractory B- ● Tr e a tm ent of r e la pse d or cell precursor ALL: refractory B-cell precursor Patients weighing less than ALL 45 kg: Induction cycle 1: 5 mcg/m2/day (not to exceed 9 mcg/day) by intravenous infusion on days 1-7 and 15 mcg/m2/day (not to exceed 28 mcg/day) by CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 6 of 46

Induction cycle 2: 15 mcg/m2/day (not to exceed 28 mcg/day) by intravenous infusion on days 1-28 of a 42 day cycle

Consolidation cycles 3-5: 15 mcg/m2/day (not to exceed 28 mcg/day) by intravenous infusion on days 1-28 of each 42 day cycle

Continued therapy cycles 6- 9: 15 mcg/m2/day (not to exceed 28 mcg/day) by intravenous infusion on days 1-28 of each 84 day cycle

Patients weighing 45 kg or more: Induction cycle 1: 9 mcg/day by intravenous infusion on days 1-7 and 28 mcg/day by intravenous infusion on days 8-28 of a 42 day cycle

Induction cycle 2: 28 mcg/day by intravenous infusion on days 1-28 of a 42 day cycle

Consolidation cycles 3-5: 28 mcg/day by intravenous infusion on days 1-28 of each 42 day cycle

Continued therapy cycles 6- 9: 28 mcg/day by intravenous infusion on days 1-28 of each 84 day cycle Bortezomib (bortezomib) ● Treatment of patients with Previously untreated previously untreated multiple myeloma: multiple myeloma in CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 7 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage Injection for intravenous combination with oral Cycles 1-4: 1.3 mg/m2 use melphalan and oral intravenously as a 3-5 prednisone second bolus on days 1, 4, 8, 11, 22, 25, 29, and 32 of each 6 week cycle

Cycles 5-9: 1.3 mg/m2 intravenously as a 3-5 second bolus on days 1, 8, 22, and 29 of each 6 week cycle ● Treatment of relapsed multiple myeloma Relapsed multiple myeloma: 1.3 mg/m2 intravenously as a 3-5 second bolus on days 1, 4, 8, and 11 every 21 days for 8 cycles. For extended therapy of more than 8 cycles, Bortezomib may be administered on the standard schedule or, for relapsed multiple myeloma, on a maintenance schedule of once weekly for 4 weeks every 35 days ● Treatment of patients with previously untreated mantle Previously untreated cell lymphoma in mantle cell lymphoma: combination with 1.3 mg/m2 administered intravenous rituximab, intravenously on days 1, 4, cyclophosphamide, 8, and 11 every 21 days for doxorubicin, and oral 6 cycles prednisone (VcR-CAP)

● Treatment of relapsed mantle cell lymphoma Relapsed mantle cell lymphoma: 1.3 mg/m2 intravenously as a 3-5 second bolus on days 1, 4, 8, and 11 every 21 days for 8 cycles. For extended therapy of more than 8 cycles, Bortezomib may be administered on the standard schedule Cyramza® (ramucirumab) ● As a single agent or in GC: combination with paclitaxel, 8 mg/kg every 2 weeks. Injection for intravenous for advanced gastric or Continue therapy until use gastro-esophageal junction progression or unacceptable adenocarcinoma (GC), with toxicity occurs disease progression on or af ter prior f luoropyrimidine- or platinum-containing chemotherapy

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage ● In combination with NSCLC: 10 mg/kg on day of docetaxel, for treatment of a 21 day cycle prior to metastatic Non-Small Cell docetaxel inf usion. Continue Lung Cancer (NSCLC) with therapy until progression or disease progression on or unacceptable toxicity occurs af ter platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA- approved therapy for these aberrations prior to receiving Cyramza

● In combination with CC: FOLFIRI (leucovorin + 8 mg/kg every 2 weeks prior f luorouracil + irinotecan) to FOLFIRI administration. metastatic Colorectal Cancer Continue therapy until (CC) with disease progression or unacceptable progression on or after prior toxicity occurs therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine Hepatocellular ● As a single agent, for the carcinoma: treatment of hepatocellular 8 mg/kg every 2 weeks by carcinoma in patients who intravenous infusion over 30 have an alpha fetoprotein of - 60 minutes until disease ≥ 400 ng/mL and have been progression or unacceptable treated with sorafenib toxicity Danyelza® (naxitamab- ● In combination with High-risk neuroblastoma gqgk) granulocyte-macrophage in the bone or bone colony-stimulating f actor marrow: Injection for intravenous (GM-CSF), for the treatment 3 mg/kg/day (up to 150 use of pediatric patients 1 year mg/day) on Days 1, 3, and 5 of age and older and adult of each treatment cycle. patients with relapsed or Treatment cycles are refractory high-risk repeated every 4 weeks until neuroblastoma in the bone, complete response or partial or bone marrow who have response, followed by 5 demonstrated a partial additional cycles every 4 response, minor response, weeks. Subsequent cycles or stable disease to prior may be repeated every 8 therapy weeks. Discontinue Danyelza and GM-CSF for disease progression or unacceptable toxicity Darzalex® (daratumumab) Treatment of adult patient In combination with with multiple myeloma: bortezomib, melphalan, Injection for intravenous and prednisone: infusion ● In combination with 16 mg/kg actual body bortezomib, melphalan, and weight intravenously (IV) prednisone newly diagnosed weekly for weeks 1-6 (total patients who are ineligible of 6 doses), then 16 mg/kg f or autologous stem cell IV every 3 weeks for weeks transplant 7 to 54 (total of 16 doses), then 16 mg/kg IV every four CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 9 of 46

● In combination with In combination with lenalidomide and lenalidomide and dexamethasone, in newly dexamethasone: diagnosed patients who are 16 mg/kg actual body ineligible for autologous weight intravenously (IV) stem cell transplant and in once weekly for weeks 1 to patients with relapsed or 8 (total of 8 doses), then 16 ref ractory multiple myeloma mg/kg IV every two weeks who have received at least for weeks 9 to 24 (total of 8 one prior therapy doses), then 16 mg/kg IV every four weeks from week 25 onwards until disease progression

● In combination with In combination with bortezomib, thalidomide, bortezomib, thalidomide, and dexamethasone in newly and dexamethasone in diagnosed patients who are newly diagnosed eligible f or autologous stem patients: cell transplant 16 mg/kg actual body weight intravenously (IV) once weekly for weeks 1 to 8 (total of 8 doses), then 16 mg/kg IV every two weeks for weeks 9 to 16 (total of 4 doses), then stop for high dose chemotherapy and ASCT, then 16 mg/kg IV every two weeks from week 1-8 after ASCT (total of 4 doses)

● In combination with In combination with bortezomib and bortezomib and dexamethasone in patients dexamethasone: who have received at least 16 mg/kg actual body one prior therapy weight intravenously (IV) once weekly for weeks 1 to 9 (total of 9 doses), then 16 mg/kg IV every three weeks for weeks 10 to 24 (total of 5 doses), then 16 mg/kg IV every four weeks until disease progression

● In combination with In combination with pomalidomide and pomalidomide and dexamethasone in patients dexamethasone: who have had at least two 16 mg/kg actual body prior therapies including weight intravenously (IV) lenalidomide and a once weekly for weeks 1 to proteasome inhibitor 8 (total of 8 doses), then 16 mg/kg IV every two weeks CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 10 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage for weeks 9 to 24 (total of 8 doses), then 16 mg/kg (IV) every four weeks from week 25 onwards until disease progression

● As monotherapy, in As monotherapy patients who have received 16 mg/kg actual body at least three prior lines of weight intravenously (IV) therapy including a once weekly for weeks 1 to proteasome inhibitor (PI) 8 (total of 8 doses), then 16 and an immunomodulatory mg/kg IV every two weeks agent or who are double for weeks 9 to 24 (total of 8 refractory to a PI and an doses), then 16 mg/kg IV immunomodulatory agent every four weeks from week 25 onwards until disease progression Darzalex Faspro™ ● In combination with In combination with (daratumumab and bortezomib, melphalan, and bortezomib, melphalan, hyaluronidase-fihj) prednisone for the treatment and prednisone: of patients with newly 1,800mg/30,000 units Injection for subcutaneous diagnosed multiple myeloma (1,800 mg daratumumab use who are ineligible f or and 30,000 units autologous stem cell hyaluronidase) administered transplant subcutaneously over 3-5 minutes weekly for Weeks 1-6 (6 doses) then every 3 weeks for Weeks 7-54 (total of 16 doses) then every 4 weeks from Week 54 onwards until disease progression

● In combination with In combination with lenalidomide and lenalidomide and dexamethasone for the dexamethasone: treatment of patients with 1,800mg/30,000 units newly diagnosed multiple (1,800 mg daratumumab myeloma who are ineligible and 30,000 units f or autologous stem cell hyaluronidase) administered transplant and in patient subcutaneously over 3-5 with relapsed or refectory minutes weekly for Weeks multiple myeloma who have 1-8 (total of 8 doses) then received at least one prior every 2 weeks for Weeks 9- therapy 24 (total of 8 doses) then every 4 weeks from Week 25 onwards until disease progression

● In combination with In combination with bortezomib and bortezomib and dexamethasone in patients dexamethasone: who have received at least 1,800mg/30,000 units one prior therapy (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over 3-5 CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 11 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage minutes weekly for Weeks 1-9 (total of 9 doses) then every 3 weeks for weeks 10- 24 (total of 5 doses) then every 4 weeks from Week 25 onwards until disease progression

● As m onothe r a py, f or the As monotherapy: treatment of patients with 1,800mg/30,000 units multiple myeloma who have (1,800 mg daratumumab received at least three prior and 30,000 units lines of therapy including a hyaluronidase) administered proteasome inhibitor (PI) subcutaneously over 3-5 and an immunomodulatory minutes weekly for Weeks agent or who are double 1-8 (total of 8 doses) then refractory to a PI and an every 2 weeks for Weeks 9- immunomodulatory agent or 24 (total of 8 doses) then who are double-refractory to every 4 weeks from Week a PI and an 25 onwards until disease immunomodulatory agent progression Doxil® (doxorubicin ● Ovarian cancer after Ovarian cancer: hydrochloride liposome) f ailure of platinum-based 50 mg/m2 intravenously over chemotherapy 60 minutes every 28 days Injection for intravenous until disease progression or use unacceptable toxicity

● AIDS-related Kaposi’s AIDS-related Kaposi’s sarcoma after failure of prior sarcoma: systemic chemotherapy or 20 mg/m2 intravenously over intolerance to such therapy 60 minutes every 21 days until disease progression or unacceptable toxicity

● Multiple myeloma in Multiple myeloma: combination with bortezomib 30 mg/m2 intravenously in patients who have not over 60 minutes on day 4 of previously received each 21-day cycle f or eight bortezomib and have cycles or until disease received at least one prior progression or unacceptable therapy toxicity Elzonris™ (tagraxofusp- ● Treatment of blastic BPDCN: erzs) plasmacytoid dendritic cell 12 mcg/kg intravenously neoplasm (BPDCN) in adults over 15 minutes once daily Injection for intravenous and pediatric patients 2 on days 1 to 5 of a 21-day use years and older cycle until disease progression or unacceptable toxicity Empliciti™ (elotuzumab) ● In combination with In combination with lenalidomide and lenalidomide and Injection for intravenous dexamethasone for the dexamethasone for use treatment of adult patients multiple myeloma: with multiple myeloma who 10 mg/kg intravenously have received one to three every week for the first two prior therapies cycles and every 2 weeks thereafter until disease

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● In combination with In combination with pomalidomide and pomalidomide and dexamethasone for the dexamethasone for treatment of adult patients multiple myeloma: with multiple myeloma who 10 mg/kg administered have received at least two intravenously every week for prior therapies including the first two 28-day cycles. lenalidomide and a Starting at cycle 3 proteasome inhibitor administer at 20 mg/kg intravenously every 4 weeks Enhertu® (f am- ● Treatment of adult HER2-positive breast trastuzumab deruxtecan- patients with unresectable or cancer: nxkl) metastatic HER2-positive 5.4 mg/kg given as an breast cancer who have intravenous infusion once Injection for intravenous received two or more prior every 3 weeks (21-day use anti-HER2-based regimens cycle) until disease in the metastatic setting progression or unacceptable toxicity Erbitux® (cetuximab) ● Treatment of locally or Squamous cell carcinoma regionally advanced of the head and neck in Injection for intravenous squamous cell carcinoma of combination with use the head and neck in radiation therapy or combination with radiation platinum-based therapy therapy and fluorouracil: Initial dosing: ● Treatment of recurrent 400 mg/m2 administered locoregional disease or one week prior to metastatic squamous cell initiating a course of carcinoma of the head and radiation therapy or on neck in combination with the f irst day of platinum- platinum-based therapy with based therapy and fluorouracil f luorouracil as a 120- minute intravenous inf usion

Subsequent dosing: 250 mg/m2 weekly as a 60-minute infusion for the duration of radiation therapy (6-7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy and fluorouracil

● Treatment of recurrent or Squamous cell carcinoma metastatic squamous cell of the head and neck carcinoma of the head and monotherapy: neck progressing after Initial dosing: platinum-based therapy 400 mg/m2 administered as a 120-minute intravenous infusion CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 13 of 46

Subsequent dosing: 250 mg/m2 weekly as a 60-minute infusion until disease progression or unacceptable toxicity

● K-Ras wild-type, EGFR- Colorectal cancer as expressing, metastatic either monotherapy or in colorectal cancer as combination with determined by an FDA- irinotecan or FOLFIRI: approved test: Initial dosing: - In combination with 400 mg/m2 administered FOLFIRI f or f irst-line as a 120-minute treatment intravenous infusion

- In combination with Subsequent dosing: irinotecan in patients 250 mg/m2 weekly as a who are refractory to 60-minute infusion until irinotecan-based disease progression or chemotherapy unacceptable toxicity

- As a single agent in patients who have f ailed oxaliplatin and irinotecan-based chemotherapy or who are intolerant to irinotecan

Limitation of Use: Erbitux is not indicated f or treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown Evomela (melphalan) ● Use as a high-dose Conditioning treatment: conditioning treatment prior 100 mg/m2/day Injection for intravenous to hematopoietic progenitor administered over 30 use (stem) cell transplantation in minutes by intravenous patients with multiple infusion for 2 consecutive myeloma days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0). For patients who weigh more than 130% of their ideal body weight, body surface area should be calculated based on adjusted ideal body weight

● Palliative treatment of Palliative treatment: patients with multiple 16 mg/m2 administrated as myeloma for whom oral a single intravenous infusion therapy is not appropriate over 15-20 minutes at 2- week intervals for 4 doses, CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 14 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage then after adequate recovery from toxicity, at 4- week intervals Faslodex® (fulvestrant) ● Treatment of hormone Monotherapy: receptor (HR)-positive, 500 mg intramuscularly into Injection for intramuscular human epidermal growth the buttocks slowly (1-2 use f actor receptor2 (HER2)- minutes per injection) as negative advanced breast two 5 mL injections, one in cancer in postmenopausal each buttock on Days 1, 15, women not previously 29 and once monthly treated with endocrine thereafter therapy Combination therapy: ● Tr e a tm ent of HR-positive 500 mg intramuscularly into advanced breast cancer in the buttocks slowly (1-2 postmenopausal women with minutes per injection) as disease progression two 5 mL injections, one in f ollowing endocrine therapy each buttock on Days 1, 15, 29 and once monthly ● HR-positive, HER2- thereafter negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or f ollowing disease progression on endocrine therapy

● HR-positive, HER2- negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy Folotyn® (pralatrexate) ● Treatment of patients with PTCL: relapsed or refractory 30 mg/m2 administered as Injection for intravenous peripheral T-cell lymphoma an intravenous push over 3- use (PTCL) 5 minutes once weekly for 6 weeks in 7 week cycles until progressive disease or unacceptable toxicity Gazyva® (obinutuzumab) ● Untreated chronic Untreated CLL: lymphocytic leukemia (CLL) 100 mg on day 1 of cycle 1, Injection for intravenous in combination with 900 mg on day 2 of cycle 1, use chlorambucil 1000 mg on day 8 and 15 of cycle 1, 1000 mg on day 1 of cycles 2–6

Relapsed or refractory FL: ● Follicular lymphoma (FL) 1000 mg on day 1, 8, and that has relapsed after, or is 15 of cycle 1, and 1000 mg refractory to, a rituximab- on day 1 of cycles 2-6, and containing regimen. Gazyva then every 2 months for 2 is indicated f or use in years

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage combination with bendamustine for 6 cycles then used as monotherapy f or this diagnosis Previously untreated ● Previously untreated stage stage II bulky, III or IV II bulky, III or IV f ollicular follicular lymphoma: lymphoma (FL) adult 1000 mg on day 1, 8 and 15 patients. Gazyva is indicated of Cycle 1, 1000 mg on day for use in combination with 1 of Cycles 2-6 or Cycles 2- chemotherapy for 6 – 8 8, and then 1000 mg every cycles depending on regimen 2 months for up to 2 years used then used as monotherapy for this diagnosis Halaven® (eribulin ● Treatment of metastatic Breast cancer: mesylate) breast cancer who have 1.4 mg/m2 administered previously received at least intravenously over 2-5 Injection for intravenous two chemotherapeutic minutes on days 1 and 8 of use regimens for the treatment a 21 day cycle of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting

● Treatment of unresectable Liposarcoma: or metastatic liposarcoma in 1.4 mg/m2 administered patients who have received intravenously over 2-5 a prior anthracycline- minutes on days 1 and 8 of containing regimen a 21 day cycle Herceptin® (trastuzumab) ● Adjuvant treatment of Adjuvant treatment of HER2-overexpressing breast breast cancer: Injection for intravenous cancer: During and following use - As part of a treatment paclitaxel, docetaxel, or regimen consisting of docetaxel/carboplatin: doxorubicin, Initial dose of 4 mg/kg as an cyclophosphamide, and intravenous infusion over 90 either paclitaxel or minutes then 2 mg/kg as an docetaxel intravenous infusion over 30 minutes weekly during - As part of a treatment chemotherapy for the first regimen with docetaxel 12 weeks pf paclitaxel or and carboplatin docetaxel or the first 18 weeks of - As a single agent docetaxel/carboplatin f ollowing multi-modality therapy. One week following anthracycline based the last weekly dose of therapy Herceptin, administer Herceptin at 6 mg/kg as an intravenous infusion over 30-90 minutes every three weeks

As a single agent within three weeks following CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 16 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage completion of multi-modality anthracycline-based chemotherapy regimens: Initial dosing: 8 mg/kg as an intravenous infusion over 90 minutes

Subsequent dosing: 6 mg/kg as an intravenous infusion over 30-90 minutes every 3 weeks

● Metastatic breast cancer: Metastatic breast cancer - In combination with treatment: paclitaxel f or f irst-line Administer Herceptin, alone treatment of HER2- or in combination with overexpressing paclitaxel, at an initial dose metastatic breast cancer of 4 mg/kg as a 90-minute intravenous infusion - As a single agent f or followed by subsequent once treatment of HER-2 weekly doses of 2 mg/kg as overexpressing breast 30-minute intravenous cancer in patient who infusions until disease have received one or progression more chemotherapy regimens for metastatic disease

● The tr e a tm e nt of HER2- Metastatic gastric cancer: overexpressing metastatic Administer Herceptin at an gastric or gastroesophageal initial dose of 8 mg/kg as a junction adenocarcinoma in 90-minute intravenous combination with cisplatin inf usion f ollowed by and capecitabine or 5- subsequent doses of 6 f luorouracil in patients who mg/kg as an intravenous have not received prior infusion over 30-90 minutes treatment for metastatic every 3 weeks until disease disease progression Herceptin Hylecta™ ● The tr e a tm e nt of HER-2- Breast cancer: (trastuzumab and overexpressing breast 600mg/10,000 units hyaluronidase-oysk) cancer subcutaneously over approximately 2-5 minutes Injection for subcutaneous once every 3 weeks. use Patients with adjuvant breast cancer should be treated for 52 weeks or until disease recurrence, whichever occurs first; extending treatment in adjuvant breast cancer beyond one year is not recommended

Patients with metastatic breast cancer should be

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage treated until progression of disease Herzuma® (trastuzumab- ● Adjuvant treatment of Adjuvant treatment of pkrb) HER2-overexpressing breast breast cancer: cancer: During and following Injection for subcutaneous - As part of a treatment paclitaxel, docetaxel, or injection regimen consisting of docetaxel/carboplatin: doxorubicin, Initial dose of 4 mg/kg as an cyclophosphamide, and intravenous infusion over 90 either paclitaxel or minutes then 2 mg/kg as an docetaxel intravenous infusion over 30 minutes weekly during - As part of a treatment chemotherapy for the first regimen with docetaxel 12 weeks pf paclitaxel or and carboplatin docetaxel or the first 18 weeks of - As a single agent docetaxel/carboplatin f ollowing multi-modality therapy. One week following anthracycline based the last weekly dose of therapy Herceptin, administer Herceptin at 6 mg/kg as an intravenous infusion over 30-90 minutes every three weeks

As a single agent within three weeks following completion of multi-modality anthracycline-based chemotherapy regimens: Initial dosing: 8 mg/kg as an intravenous infusion over 90 minutes

Subsequent dosing: 6 mg/kg as an intravenous infusion over 30-90 minutes every 3 weeks

● Metastatic breast cancer: Metastatic breast cancer - In combination with treatment: paclitaxel f or f irst-line Administer Herceptin, alone treatment of HER2- or in combination with overexpressing paclitaxel, at an initial dose metastatic breast cancer of 4 mg/kg as a 90-minute intravenous infusion followed by subsequent once - As a single agent f or weekly doses of 2 mg/kg as treatment of HER-2 30-minute intravenous overexpressing breast infusions until disease cancer in patient who progression have received one or more chemotherapy regimens for metastatic disease

Metastatic gastric cancer: CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 18 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage ● The tr e a tm e nt of HER2- Administer Herceptin at an overexpressing metastatic initial dose of 8 mg/kg as a gastric or gastroesophageal 90-minute intravenous junction adenocarcinoma in inf usion f ollowed by combination with cisplatin subsequent doses of 6 and capecitabine or 5- mg/kg as an intravenous f luorouracil in patients who infusion over 30-90 minutes have not received prior every 3 weeks until disease treatment for metastatic progression disease Imlygic® (talimogene ● Local treatment of Melanoma: laherparepvec) unresectable cutaneous, Initial dose: subcutaneous, and nodal 106 (1 million) plaque- Suspension f or intralesional lesions in patients with forming units (PFU) per mL injection melanoma recurrent after initial surgery Subsequent doses: 108 (100 million) PFU per mL

The total injection volume for each treatment visit should not exceed 4 mL for Limitations of use: all injected lesions Imlygic has not been shown combined. It may not be to improve overall survival possible to inject all lesions or have an effect on visceral at each treatment visit or metastases over the full course of treatment Infugem (gemcitabine in ● In combination with Ovarian cancer: sodium chloride) carboplatin, f or the 1000 mg/m2 as an treatment of advanced intravenous infusion over 30 Injection for intravenous ovarian cancer that has minutes on Days 1 and 8 of use relapsed at least 6 months each 21-day cycle after completion of platinum-based therapy

● In combination with Breast cancer: paclitaxel, f or first-line 1250 mg/m2 intravenously treatment of metastatic over 30 minutes on Days 1 breast cancer after f ailure of and 8 of each 21-day cycle prior anthracycline- containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated

● In combination with Non-small cell lung cisplatin for the treatment of cancer: non-small cell lung cancer 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 each 28-day cycle OR 1250 mg/m2 intravenously over 30 minutes on days 1 and 8 each 21-day cycle

Pancreatic cancer:

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage ● As a single agent f or the 1000 mg/m2 intravenously treatment of pancreatic over 30 minutes weekly for cancer 7 weeks then 1 week rest then 1000 mg/m2 on Days 1, 8, and 15 of each 28-day cycle Istodax® (romidepsin) ● Treatment of cutaneous T- CTCL: cell lymphoma (CTCL) in 14mg/m2 administered Injection for intravenous patients who have received intravenously over a 4-hour use at least one prior systemic period on days 1,8, and 15 therapy of a 28-day cycle

● Treatment of peripheral T- PTCL: cell lymphoma (PTCL) in 14mg/m2 administered patients who have received intravenously over a 4-hour at least one prior therapy period on days 1,8, and 15 of a 28-day cycle Jelmyto™ (mitomycin) ● Adult patients with low- LG-UTUC: grade upper tract urothelial 4 mg/mL via ureteral Pyelocalyceal solution cancer (LG-UTUC) catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg) of mitomycin Jevtana® (cabazitaxel) ● In combination with Metastatic castrate prednisone for treatment of resistant prostate cancer: Injection for intravenous patients with metastatic 20 mg/m2 administered as a use castration-resistant prostate one-hour intravenous cancer previously treated infusion every three weeks with docetaxel-containing treatment regimen A dose of 25 mg/m2 can be used in select patients at the discretion of the treating healthcare provider Kadcyla® (ado- ● As a single agent f or the HER2-positive, metastatic trastuzumab) treatment of patients with breast cancer: HER2-positive, metastatic 3.6 mg/kg given as an Injection for intravenous breast cancer who previously intravenous infusion every 3 use received trastuzumab and a weeks (21-day cycle) until taxane, separately or in disease progression or combination. Patients should unacceptable toxicity have either: - Received prior therapy Do not administer Kadcyla at for metastatic disease or doses greater than 3.6 mg/kg - Developed disease recurrence during or within six months of completing adjuvant therapy

● As a single agent f or the HER2-positive early adjuvant treatment of breast cancer: patients with HER2-positive 3.6 mg/kg given as an early breast cancer who intravenous infusion every 3

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage have residual invasive weeks (21-day cycle) until disease after neoadjuvant disease progression or taxane and trastuzumab- unacceptable toxicity based treatment Do not administer Kadcyla at doses greater than 3.6 mg/kg Kanjinti™ (trastuzumab- ● Tr e a tm ent of HER2 During and following anns) overexpressing breast paclitaxel, docetaxel, or cancer docetaxel and carboplatin Injection for intravenous − As part of a total of 52 weeks of use treatment regimen therapy: consisting of Initial dose of 4 mg/kg as an doxorubicin, intravenous infusion over 90 cyclophosphamide, minutes then at 2 mg/kg as and either paclitaxel an intravenous infusion over or docetaxel 30 minutes weekly during − As part of a chemotherapy for the first treatment regimen 12 weeks of paclitaxel or with docetaxel and docetaxel or the first 18 carboplatin weeks of docetaxel and carboplatin

One week f ollowing the last weekly dose of Kanjinti, administer Kanjinti at 6 mg/kg as an intravenous infusion over 30-90 minutes every three weeks

− As a single agent As a single agent within f ollowing multi- three weeks following modality completion of multi- anthracycline based modality, anthracycline- therapy based chemotherapy regimens for 52 weeks total therapy: Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes

Subsequent doses at 6 mg/kg as an intravenous infusion over 30-90 minutes every 3 weeks

− In combination with Metastatic treatment, paclitaxel f or f irst-line breast cancer: treatment for Administer Kanjinti, alone or metastatic disease in combination with − As a single agent f or paclitaxel, at an initial dose treatment in patients of 4 mg/kg as a 90-minute who have received intravenous infusion one or more followed by subsequent once chemotherapy weekly doses of 2 mg/kg as regimens for a 30-minute intravenous metastatic disease CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 21 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage infusion until disease progression ● Tr e a tm ent of HER2 overexpressing metastatic Metastatic gastric or gastric or gastroesophageal gastroesophageal cancer: junction adenocarcinoma in Administer Kanjinti at an combination with cisplatin initial dose of 8 mg/kg as a and capecitabine or 5- 90-minute intravenous f luorouracil, in patients who inf usion f ollowed by have not received prior subsequent doses of 6 treatment for metastatic mg/kg as an intravenous disease infusion over 30-90 minutes every 3 weeks until disease progression Kyprolis® (carfilzomib) ● In combination with In Combination with dexamethasone or with Lenalidomide and Injection for intravenous lenalidomide plus Dexamethasone: use dexamethasone for the Administer intravenously as treatment of patients with a 10-minute infusion on two relapsed or refractory consecutive days, each week multiple myeloma who have for three weeks f ollowed by received one to three lines of a 12-day rest period. Each therapy 28-day period is considered one treatment cycle. The recommended starting dose is 20 mg/m2 in Cycle 1 on Days 1 and 2. If tolerated, escalate the dose to 27 mg/m2 on Days 8 of Cycle 1. From Cycle 13, omit the Day 8 and 9 doses of Kyprolis. Discontinue Kyprolis af ter Cycle 18.

In Combination with Dexamethasone: Administer intravenously as a 30-minute infusion, on two consecutive days, each week for three weeks followed by a 12-day rest period. Each 28-day period is considered one treatment cycle. Administer at a starting dose of 20 mg/m2 in Cycle 1 on Days 1 and 2. If tolerated, escalate the dose to 56 mg/m2 on Days 8 of Cycle 1. Continue until disease progression or unacceptable toxicity occurs.

● As a single agent f or the Monotherapy 20/27 treatment of patients with mg/m2 regimen: relapsed or refractory Administer intravenously as multiple myeloma who have a 10-minute infusion. In Cycles 1 through 12, CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 22 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage received one or more lines of administer on two therapy consecutive days, each week for three weeks followed by a 12-day rest period. Each 28-day period is considered one treatment cycle. From Cycle 13, omit the Day 8 and 9 doses of Kyprolis. The recommended starting dose is 20 mg/m2 in Cycle 1 on Days 1 and 2. If tolerated, escalate the dose to 27 mg/m2 on Day 8 of Cycle 1

Monotherapy 20/56 mg/m2 regimen: Administer intravenously as a 30-minute infusion. In Cycles 1 through 12, administer on two consecutive days, each week for three weeks followed by a 12-day rest period. Each 28-day period is considered one treatment cycle. From Cycle 13, omit the Day 8 and 9 doses of Kyprolis. The recommended starting dose is 20 mg/m2 in Cycle 1 on Days 1 and 2. If tolerated, escalate the dose to 56 mg/m2 on Day 8 of Cycle 1 Lartruvo™ (olaratumab) ● In combination with STS: doxorubicin, for the 15 mg/kg administered as Injection for intravenous treatment of adult patients an intravenous infusion over use with soft tissue sarcoma 60 minutes on Days 1 and 8 (STS) with a histologic of each 21-day cycle until subtype for which an disease progression or anthracycline-containing unacceptable toxicity regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery Lumoxiti™ ● Treatment of adult HCL: (moxetumomab pasudotox- patients with relapsed or 0.04 mg/kg administered as tdfk) ref ractory hairy cell leukemia a 30-minute intravenous (HCL) who received at least infusion on Days 1, 3, and 5 Injection for intravenous two prior systemic therapies, of each 28-day cycle. use including treatment with a Continue Lumoxiti treatment purine nucleoside analog for a maximum of 6 cycles, (PNA) disease progression, or unacceptable toxicity Margenza™ ● In combination with Breast cancer: (margetuximab-cmkb) chemotherapy, for treatment 15 mg/kg administered as of adult patients with an intravenous infusion metastatic HER2-positive every 3 weeks (21-day

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage Injection for intravenous breast cancer who have cycle) until disease use received two or more prior progression or unacceptable anti-HER2 regimens, at least toxicity. The initial dose one of which was for should be over 120 minutes, metastatic disease then over a minimum of 30 minutes for subsequent doses Monjuvi® (tafasitamab- ● In combination with DLBCL: cxix) lenalidomide f or the In combination with treatment of adult patients lenalidomide: Injection for intravenous with relapsed or refractory 12 mg/kg based on actual use dif f use large B-cell body weight administered as lymphoma (DLBCL) not an intravenous infusion on otherwise specified, days 1, 4, 8, 15, and 22 on including DLBCL arising f rom Cycle 1 (28 day cycle), then low grade lymphoma, and on days 1, 8, 15, and 22 on who are not eligible f or cycles 2 and 3 (each 28 day autologous stem cell cycle), then Days 1 and 15 transplant (ASCT) on cycles 4 and beyond. Maximum combination ● As m onothe r a py f or therapy is 12 cycles treatment of DLBCL after completion of combination As monotherapy after therapy with lenalidomide combination therapy: 12 mg/kg based on actual body weight administered as an intravenous infusion on Days 1 and 15 of each 28 day cycle until disease progression or unacceptable toxicity Mylotarg™ (gemtuzumab ● Tr e a tm ent of ne w ly- Newly-diagnosed CD33- ozogamicin) diagnosed CD33-positive positive AML: acute myeloid leukemia ● Combination regimen: Injection for intravenous (AML) in adults For the induction cycle, the use recommended dose is 3 mg/m2 (up to 4.5 mg) intravenously on Days 1, 4, and 7 in combination with daunorubicin and cytarabine. For patients requiring a second induction cycle, do NOT administer Mylotarg during the second induction cycle

For the consolidation cycles, the recommended dose is 3 mg/m2 (up to 4.5 mg) on day 1 in combination with daunorubicin and cytarabine for 2 cycles

● Single-agent regimen: For the induction cycle, the recommended dose is 6 mg/m2 intravenously as a CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 24 of 46

For continuation, the recommended dose is 2 mg/m2 intravenously on Day 1 every 4 weeks for up to 8 cycles

● Tr e a tm ent of r e la pse d or Relapsed or Refractory refractory CD33-positive CD33-positive AML: AML in adults and in The recommended dose is 3 pediatric patients 2 years mg/m2 intravenously on and older Days 1, 4, and 7 as a single agent as a single course of therapy Ogivri (trastuzumab-dkst) ● Adjuvant treatment of During and following HER2 overexpressing node paclitaxel, docetaxel, or Injection for intravenous positive or node negative docetaxel and carboplatin use (ER/PR negative or with one total of 52 weeks of high risk feature) breast therapy: cancer Initial dose of 4 mg/kg as an − As part of a intravenous infusion over 90 treatment regimen minutes then at 2 mg/kg as consisting of an intravenous infusion over doxorubicin, 30 minutes weekly during cyclophosphamide, chemotherapy for the first and either paclitaxel 12 weeks of paclitaxel or or docetaxel docetaxel or the first 18 − As part of a weeks of docetaxel and treatment regimen carboplatin with docetaxel and carboplatin One week f ollowing the last weekly dose of Ogivri, administer Ogivri at 6 mg/kg as an intravenous infusion over 30-90 minutes every three weeks

− As a single agent As a single agent within following multi- three weeks following modality completion of multi- anthracycline based modality, anthracycline- therapy based chemotherapy regimens for 52 weeks total therapy: Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes

Subsequent doses at 6 mg/kg as an intravenous CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 25 of 46

● Metastatic breast cancer Metastatic treatment, − In combination with breast cancer: paclitaxel f or f irst-line Administer Ogivri, alone or treatment for in combination with metastatic disease paclitaxel, at an initial dose − As a single agent f or of 4 mg/kg as a 90-minute treatment in patients intravenous infusion who have received followed by subsequent once one or more weekly doses of 2 mg/kg as chemotherapy a 30-minute intravenous regimens f or infusion until disease metastatic disease progression

● Tr e a tm ent of HER2 Metastatic gastric or overexpressing metastatic gastroesophageal cancer: gastric or gastroesophageal Administer Ogivri at an junction adenocarcinoma in initial dose of 8 mg/kg as a combination with cisplatin 90-minute intravenous and capecitabine or 5- inf usion f ollowed by f luorouracil, in patients who subsequent doses of 6 have not received prior mg/kg as an intravenous treatment for metastatic infusion over 30-90 minutes disease every 3 weeks until disease progression Onivyde™ (irinotecan ● In combination with Metastatic liposome) f luorouracil and leucovorin, adenocarcinoma of the for the treatment of patients pancreas: Injection for intravenous with metastatic 70 mg/m2 administered by use adenocarcinoma of the intravenous infusion over 90 pancreas after disease minutes every 2 weeks progression following gemcitabine-based therapy Ontruzant (trastuzumab- ● Adjuvant treatment of During and following dttb) Injection for HER2 overexpressing node paclitaxel, docetaxel, or intravenous use positive or node negative docetaxel and carbopla tin (ER/PR negative or with one total of 52 weeks of high risk feature) breast therapy: cancer Initial dose of 4 mg/kg as an − As part of a intravenous infusion over 90 treatment regimen minutes then at 2 mg/kg as consisting of an intravenous infusion over doxorubicin, 30 minutes weekly during cyclophosphamide, chemotherapy for the first and either paclitaxel 12 weeks of paclitaxel or or docetaxel docetaxel or the first 18 − As part of a weeks of docetaxel and treatment regimen carboplatin with docetaxel and carboplatin One week f ollowing the last weekly dose of Ogivri, administer Ogivri at 6 mg/kg as an intravenous infusion

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− As a single agent f ollowing multi- As a single agent within modality three weeks following anthracycline based completion of multi- therapy modality, anthracycline- based chemotherapy regimens for 52 weeks total therapy: Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes

Subsequent doses at 6 mg/kg as an intravenous infusion over 30-90 minutes every 3 weeks − In combination with paclitaxel f or f irst-line Metastatic treatment, treatment for breast cancer: metastatic disease Administer Ogivri, alone or − As a single agent f or in combination with treatment in patients paclitaxel, at an initial dose who have received of 4 mg/kg as a 90-minute one or more intravenous infusion chemotherapy followed by subsequent once regimens for weekly doses of 2 mg/kg as metastatic disease a 30-minute intravenous infusion until disease progression

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage locally advanced or disease progression or metastatic setting unacceptable toxicity Pepaxto® (melphalan ● In combination with Multiple myeloma: flufenamide) dexamethasone, for the 40 mg administered treatment of adult patients intravenously over 30 Injection for intravenous with relapsed or refractory minutes on Day 1 of each use multiple myeloma who have 28-day cycle until disease received at least four prior progression or until lines of therapy and whose unacceptable toxicity disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and on CD38-directed monoclonal antibody

Limitations of Use: Pepaxto is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical studies Perjeta® (pertuzumab) ● Metastatic HER2 positive Metastatic HER2 positive breast cancer in combination breast cancer: Injection for intravenous with trastuzumab and 840 mg administered as a use docetaxel in patients who 60 mg intravenous infusion have not received prior anti- followed by a 420 mg HER2 therapy or intravenous infusion over chemotherapy for metastatic 30–60 minutes every 3 disease weeks thereafter

● Neoadjuvant treatment, in Neoadjuvant treatment in combination with combination with trastuzumab and trastuzumab and chemotherapy, of patients chemotherapy: with HER2 positive, Locally 840 mg administered as a advanced, inflammatory, or 60 mg intravenous infusion early stage breast cancer followed by a 420 mg (either greater than 2 cm in intravenous infusion over diameter or node positive) 30–60 minutes every 3 weeks for 3 to 6 cycles. Following surgery, patients should continue to receive Perjeta and trastuzumab to complete 1 year of treatment (up to 18 cycles)

● Adjuvant treatment, in Adjuvant treatment in combination with combination with trastuzumab and trastuzumab and chemotherapy, of patients chemotherapy: with HER2 positive early 840 mg administered as a breast cancer at high risk of 60 mg intravenous infusion recurrence followed by a 420 mg intravenous infusion over 30–60 minutes every 3 CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 28 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage weeks for a total of 1 year (up to 18 cycles) Phesgo™ (pertuzumab, ● Use in combination with trastuzumab, and chemotherapy as: hyaluronidase-zzxf) o Neoadjuvant Neoadjuvant treatment: treatment of patients Initial dose of 1,200 mg Subcutaneous injection with HER2-positive, pertuzumab, 600 mg locally advanced, trastuzumab, and 30,000 inf lammatory, or units hyaluronidase in 15 mL early stage breast subcutaneously over cancer (either greater approximately 8 minutes than 2 cm in then maintenance dose of diameter or node 600 mg pertuzumab, 600 positive) as part of a mg trastuzumab, and complete treatment 20,000 units hyaluronidase regimen for early in 10 mL subcutaneously breast cancer over approximately 5 minutes every 3 weeks for 3 to 6 cycles. Following surgery, patients should continue to receive Phesgo to complete 1 year of treatment (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first

o Adjuvant treatment Adjuvant treatment: of patients with Her2- Initial dose (if not given positive early breast neoadjuvant) of 1,200 mg cancer at high risk of pertuzumab, 600 mg recurrence trastuzumab, and 30,000 units hyaluronidase in 15 mL subcutaneously over approximately 8 minutes then maintenance dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase in 10 mL subcutaneously over approximately 5 minutes every 3 weeks for a total of 1 year (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs f irst

● Use in combination with MBC: docetaxel for treatment of Initial dose of 1,200 mg patient with HER2-positive pertuzumab, 600 mg metastatic breast cancer trastuzumab, and 30,000 (MBC) who have not units hyaluronidase in 15 mL received prior anti-HER2 subcutaneously over therapy or chemotherapy for approximately 8 minutes metastatic disease then maintenance dose of 600 mg pertuzumab, 600 CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 29 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage mg trastuzumab, and 20,000 units hyaluronidase in 10 mL subcutaneously over approximately 5 minutes every 3 weeks until disease recurrence or unmanageable toxicity, whichever occurs first Polivy™ (polatuzumab ● In combination with Diffuse Large B-cell vedotin-piiq) bendamustine and a lymphoma: rituximab product for the 1.8 mg/kg administered as Injection for intravenous treatment of adult patients an intravenous infusion use with relapsed refractory every 21 days for 6 cycles diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies Portrazza™ ● In combination with Metastatic squamous (necitumumab) gemcitabine and cisplatin, non-small cell lung for first-line treatment of cancer: Injection for intravenous patients with metastatic 800 mg administered as an use squamous non-small cell intravenous infusion over 60 lung cancer minutes on days 1 and 8 of each 3-week cycle until Limitation of Use: disease progression of Portrazza is not indicated f or unacceptable toxicity treatment of non-squamous non-small cell lung cancer Romidepsin Injection for ● Treatment of cutaneous T- CTCL: intravenous use cell lymphoma (CTCL) in 14mg/m2 administered patients who have received intravenously over a 4-hour at least one prior systemic period on days 1,8, and 15 therapy of a 28-day cycle

● Tr e a tm ent of pe r ipher al T- PTCL: cell lymphoma (PTCL) in 14mg/m2 administered patients who have received intravenously over a 4-hour at least one prior therapy period on days 1,8, and 15 of a 28-day cycle Sarclisa ® (isatuximab- ● In combination with Multiple myeloma: irf c) pomalidomide and 10 mg/kg actual body dexamethasone, for the weight administered as an Injection for intravenous treatment of adult patients intravenous infusion in use with multiple myeloma who combination with have received at least two pomalidomide and prior therapies including dexamethasone on Days 1, lenalidomide and a 15, and 22 (weekly) Cycle 1 proteasome inhibitor then days 1, 15 (every 2 weeks) Cycle 2 and beyond until disease progression or unacceptable toxicity Synribo® (omacetaxine ● Treatment of adult CML: mepesuccinate) patients with chronic or Induction schedule: accelerated phase chronic 1.25 mg/m2 administered Injection for subcutaneous myeloid leukemia (CML) with subcutaneously twice daily use resistance and/or intolerance at approximately 12 hour

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage to two or more tyrosine intervals for 14 consecutive kinase inhibitors (TKI) days every 28 days until patients achieve a hematologic response

Maintenance dosing: 1.25 mg/m2 administered subcutaneously twice daily at approximately 12 hour intervals for 14 consecutive days every 28 days. Treatment should continue as long as patients are clinically benefiting from therapy Trazimera™ ● Adjuvant treatment of Adjuvant treatment of (trastuzumab-qyyp) HER2-overexpressing node breast cancer: positive or node negative Administer according to one Injection for intravenous (ER/PR negative or with one of the f ollowing doses and use high risk feature) breast schedules for a total of 522 cancer weeks of Trazimera therapy:

- As a part of a treatment During and following regimen consisting of paclitaxel, docetaxel, or doxorubicin, docetaxel and carboplatin: cyclophosphamide, and either paclitaxel or ● Initial dose of 4 mg/kg as docetaxel an intravenous infusion over 90 minutes then at 2 mg/k - As a part of a as an intravenous infusion treatment regimen over 30 minutes weekly with docetaxel and during chemotherapy for the carboplatin first 12 (paclitaxel or docetaxel) or 18 weeks - As a single agent (docetaxel and carboplatin) f ollowing multi- modality anthracycline ● One week f ollowing the based therapy last weekly dose of Trazimera, administer Trazimera at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks

As a single agent within three weeks f ollowing completion of multi- modality, anthracycline- based chemotherapy regimens: ● Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes

● Subs e que nt dos e s a t 6 mg/kg as an intravenous

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● Extending adjuvant treatment beyond one year is not recommended ● In combination with paclitaxel f or f irst-line Metastatic treatment of treatment he treatment of breast cancer: HER2-overexpressing Administer Trazimera, alone metastatic breast cancer or in combination with paclitaxel, at an initial dose ● As a single agent f or of 4 mg/kg as a 90-minute treatment of HER2- intravenous infusion overexpressing breast f ollowed by subsequent once cancer in patients who have weekly doses of 2 mg/kg as received one or more 30-minute intravenous chemotherapy regimens for infusions until disease metastatic disease progression

● In combination with cisplatin and capecitabine or Metastatic gastric cancer: 5-f luorouracil, f or the Administer Trazimera at an treatment of patients with initial dose of 8 mg/kg as a HER2-overexpressing 90-minute intravenous metastatic gastric or inf usion f ollowed by gastroesophageal junction subsequent doses of 6 adenocarcinoma who have mg/kg as an intravenous not received prior treatment infusion over 30 to 90 for metastatic disease minutes every three weeks until disease progression Trodelvy™ (sacituzumab ● Treatment of adult mTNBC: govitecan-hziy) patients with metastatic 10 mg/kg as an intravenous triple-negative breast cancer infusion once weekly on (mTNBC) who have received Days 1 and 8 of a 21 day at least two prior therapies cycle. Continue treatment for metastatic disease until disease progression or unacceptable toxicity Unituxin® (dinutuximab) ● In combination with Neuroblastoma: granulocyte-macrophage 17.5 mg/m2/day Injection for intravenous colony-stimulating f actor administered as an use (GM-CSF), interleukin-2 (IL- intravenous infusion over 10 2), and 13-cis-retinoic acid to 20 hours for 4 (RA), for the treatment of consecutive days for a pediatric patients with high maximum of 5 cycles risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy Vectibix® (panitumumab) ● Vectibix is indicated f or the mCRC: treatment of patients with 6 mg/kg every 14 days Injection for intravenous wild-type KRAS (exon 2 in administered as an use codons 12 or 13) metastatic intravenous infusion over 60 colorectal cancer (mCRC) as m inute s f or dos e s ≤ 1000

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage determined by an FDA- mg or over 90 minutes for approved test for this use: doses > 1000 mg - As first-line therapy in combination with FOLFOX - As monotherapy f ollowing disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown Velcade® (bortezomib) ● Treatment of adult Previously untreated patients with previously multiple myeloma: Injection for subcutaneous untreated multiple myeloma Cycles 1-4: 1.3 mg/m2 intravenous use in combination with oral intravenously as a 3-5 melphalan and oral second bolus or prednisone subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32 of each 6 week cycle

Cycles 5-9: 1.3 mg/m2 intravenously as a 3-5 second bolus or subcutaneously on days 1, 8, 22, and 29 of each 6 week cycle

● Treatment of adult Relapsed multiple patients with relapsed myeloma: multiple myeloma 1.3 mg/m2 intravenously as a 3-5 second bolus or subcutaneously on days 1, 4, 8, and 11 every 21 days for 8 cycles. For extended therapy of more than 8 cycles, Velcade may be administered on the standard schedule or, for relapsed multiple myeloma, on a maintenance schedule of once weekly for 4 weeks every 35 days

● Treatment of adult Previously untreated patients with previously mantle cell lymphoma: untreated mantle cell 1.3 mg/m2 administered lymphoma in combination intravenously on days 1, 4, with intravenous rituximab, 8, and 11 every 21 days for cyclophosphamide, 6 cycles

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage doxorubicin, and oral prednisone (VcR-CAP) Relapsed mantle cell ● Treatment of adult lymphoma: patients with relapsed 1.3 mg/m2 intravenously as mantle cell lymphoma a 3-5 second bolus or subcutaneously on days 1, 4, 8, and 11 every 21 days for 8 cycles. For extended therapy of more than 8 cycles, Velcade may be administered on the standard schedule Vyxeos™ (daunorubicin ● Treatment of adults with t-AML or AML-MRC: and cytarabine) newly-diagnosed therapy- First induction: related acute myeloid Daunorubicin 44 mg/m2 and Liposome injection f or leukemia (t-AML) or AML cytarabine 100 mg/m2 by intravenous use with myelodysplasia-related intravenous infusion over 90 changes (AML-MRC) minutes on days 1, 3, and 5

Second induction (only for those patients who failed to achieve a response with the f irst induction cycle): Starting 2-5 weeks after first induction: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 intravenously over 90 minutes on days 1 and 3

Consolidation: Starting 5-8 weeks after the start of the last induction: daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 intravenously over 90 minutes on days 1 and 3. Administer second consolidation cycle 5-8 weeks after the start of the f irst consolidation cycle in patients who do not show disease progression or unacceptable toxicity to Vyxeos Yondelis® (trabectedin) ● Treatment of unresectable Liposarcoma or or metastatic liposarcoma or leiomyosarcoma: Injection for intravenous leiomyosarcoma previously 1.5 mg/m2 administered as use treated with an an intravenous infusion over anthracycline-containing 24 hours every 21 days until regimen disease progression or unacceptable toxicity Zaltrap® (ziv-aflibercept) ● In combination with 5- mCRC: fluorouracil, leucovorin, 4 mg/kg as an intravenous Injection for intravenous irinotecan (FOLFIRI) f or infusion over 1 hour every inf usion patients with metastatic two weeks until disease

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Indication Dosage colorectal cancer (mCRC) progression or unacceptable that is resistant to or has toxicity progressed following an oxaliplatin-containing regimen Zepzelca™ (lurbinectedin) ● Treatment of adult SCLC: patients with metastatic 3.2 mg/m2 by intravenous Injection for intravenous small cell lung cancer (SCLC) infusion over 60 minutes use with disease progression on every 21 days until disease or af ter platinum-based progression or unacceptable chemotherapy toxicity Zevalin® (ibritumomab ● Tr e a tm ent of r e la pse d or NHL: tiuxetan) refractory, low-grade or If platelets ≥ 150,000/mm3 f ollicular B-cell non-Hodgkin af ter rituximab Injection for intravenous lymphoma (NHL) administration: 0.4 mCi/kg use intravenously ● Treatment of previously untreated f ollicular NHL in If platelets ≥ 100,000 but ≤ patients who achieve partial 149,000/mm3 af ter or complete response to rituximab administration: f irst-line chemotherapy 0.3 mCi/kg intravenously

CLINICAL RATIONALE For the purposes of the Injectable Oncology Agents criteria, indications deemed appropriate are those approved in FDA labeling and/or supported by NCCN Drugs & Biologics compendia with a category 1 or 2A recommendation.

Safety1-65 Agent Contraindication(s) ● Neutrophil counts of < 1,500 cells/m3 ● Severe hypersensitivity reaction to Abraxane Abraxane [paclitaxel (protein bound)]

● Concomitant use with bleomycin due to pulmonary toxicity Adcetris (brentuximab vedotin)

● History of severe hypersensitivity reaction Alimta (pemetrexed) to pemetrexed Aliqopa (copanlisib) ● None Arranon (nelarabine) ● None Arzerra (of atumumab) ● None ● History of serious hypersensitivity reactions to pegylated L-asparaginase ● History of serious thrombosis during L- asparaginase therapy Asparlas (calaspargase pegol-mknl) ● History of serious pancreatitis related to previous L-asparaginase treatment ● History of serious hemorrhagic events during previous L-asparaginase therapy Beleodaq (belinostat) ● None Besponsa (inotuzumab ozogamicin) ● None Blenrep (belantamab mafodotin-blmf ● None CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 35 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Contraindication(s) ● Known hypersensitivity to blinatumomab or Blincyto (blinatumomab) to any component of the product formulation ● Patients with a history of a hypersensitivity reaction to bendamustine, polyethylene Belrapzo (bendamustine hydrochloride) glycol 400, propylene glycol, or monothioglycerol ● Patients with hypersensitivity (not including local reactions) to bortezomib, boron, boric Bortezomib (bortezomib) acid, or glycine, including anaphylactic reactions ● Intrathecal administration Cyramza (ramucirumab) ● None ● History of severe hypersensitivity reaction Danyelza (naxitamab-gqgk) to naxitamab-gqgk ● Patients with a history of severe Darzalex (daratumumab) hypersensitivity to daratumumab or any of the components of the formulation ● Patients with a history of severe Darzalex Faspro (daratumumab and hypersensitivity to daratumumab or any of hyaluronidase-fihj) the components of the formulation Doxil (doxorubicin hydrochloride ● Hypersensitivity reactions to doxorubicin liposome) HCL or the components of Doxil Elzonris (tagraxofusp-erzs) ● None Empliciti (elotuzumab) ● None Enhertu (f am-trastuzumab deruxtecan- ● None nxkl) Erbitux (cetuximab) ● None ● History of serious allergic reaction to Evomela (melphalan) melphalan Faslodex (fulvestrant) ● Hypersensitivity Folotyn (pralatrexate) ● None ● Patients with known hypersensitivity reactions (e.g., anaphylaxis) to Gazyva (obinutuzumab) obinutuzumab or any of the excipients, including serum sickness with prior obinutuzumab use Halaven (eribulin mesylate) ● None Herceptin (trastuzumab) ● None Herceptin Hylecta (trastuzumab and ● None hyaluronidase) Herzuma® (trastuzumab-pkrb) ● None ● Immunocompromised patients Imlygic (talimogene laherparepvec) ● Pregnant patients Infugem (gemcitabine in sodium ● Patients with a known hypersensitivity to chloride) gemcitabine Istodax (romidepsin) ● None ● Perforation of the bladder or upper urinary Jelmyto (mitomycin) tract ● N e utr ophil c ounts of ≤ 1, 500/m m3 ● History of severe hypersensitivity to Jevtana (cabazitaxel) Jevtana or polysorbate 80 ● Pregnancy Kadcyla (ado-trastuzumab) ● None

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Agent Contraindication(s) Kanjinti (trastuzumab-anns) ● None Kyprolis (carfilzomib) ● None Lartruvo (olaratumab) ● None Lumoxiti (moxetumomab pasudotox- ● None tdfk) Margenza (margetuximab-cmkb) ● None Monjuvi (tafasitamab-cxix) ● None ● Hypersensitivity to Mylotarg or any of its Mylotarg (gemtuzumab ozogamicin) components ● None Ogivri (trastuzumab-dkst)

● Severe hypersensitivity reaction to Onivyde Onivyde (irinotecan liposome) or irinotecan HCL ● None Ontruzant (trastuzumab-dttb)

Padcev (enfortumab vedotin-ejfv) ● None ● History of serious hypersensitivity reaction Pepaxto (melphalan flufenamide) to melphalan f luf enamide or melphalan ● Known hypersensitivity to pertuzumab or to Perjeta (pertuzumab) any of its excipients ● Patients with known hypersensitivity to Phesgo (pertuzumab, trastuzumab, pertuzumab, or trastuzumab, or and hyaluronidase zzxf) hyaluronidase, or to any of its excipients ● None Polivy (polatuzumab vedotin-piiq) Portrazza (necitumumab) ● None Romidepsin ● None ● Patients with severe hypersensitivity to Sarclisa (isatuximab-irfc) isatuximab-irfc or any of its excipients Synribo (omacetaxine mepesuccinate) ● None Trazimera (trastuzumab-qyyp) ● None Trodelvy™ (sacituzumab govitecan- ● Severe hypersensitivity reaction to Trodelvy hziy) Unituxin (dinutuximab) ● History of anaphylaxis to dinutuximab Vectibix (panitumumab) ● None ● Patients with hypersensitivity (not including local reactions) to bortezomib, boron, or Velcade (bortezomib) mannitol, including anaphylactic reactions ● Contraindicated for intrathecal administration ● History of serious hypersensitivity to Vyxeos (daunorubicin and cytarabine) daunorubicin, cytarabine or any component of the formulation Yondelis (trabectedin) ● Known hypersensitivity to trabectedin Zaltrap (ziv-aflibercept) ● None Zepzelca (lurbinectedin) ● None Zevalin (ibritumomab tiuxetan) ● None

Injectable and Health Care Administered Oncology Medical Drug Criteria Through Preferred (optional)

TARGET AGENTS CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 37 of 46

© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective Date: 07/01/2021 Abraxane® [paclitaxel (protein bound)] Istodax® (romidepsin) Adcetris® (brentuximab vedotin) Jelmyto™ (mitomycin) Alimta® (pemetrexed) Jevtana® (cabazitaxel) Aliqopa™ (copanlisib) Kadcyla® (ado-trastuzumab) Arranon® (nelarabine) Kanjinti™ (trastuzumab-anns) Arzerra® (ofatumumab) Kyprolis® (carfilzomib) Asparlas™ (calaspargase pegol-mknl) Lartruvo™ (olaratumab) Beleodaq® (belinostat) Lumoxiti™ (moxetumomab pasudotox- Besponsa™ (inotuzumab ozogamicin) tdfk) Belrapzo™ (bendamustine hydrochloride) Margenza™ (margetuximab-cmkb) Blenrep (belantamab mafodotin-blmf) Monjuvi® (tafasitamab-cxix) Blincyto® (blinatumomab) Mylotarg™ (gemtuzumab ozogamicin) Bortezomib (bortezomib) Ogivri (trastuzumab-dkst) Cyramza® (ramucirumab) Onivyde™ (irinotecan liposome) Danyelza® (naxitamab-gqgk) Ontruzant (trastuzumab-dttb) Darzalex® (daratumumab) Padcev™ (enfortumab vendotin-ejfv) Darzalex Faspro™ (daratumumab and Pepaxto® (melphalan flufenamide) hyaluronidase-fihj) Perjeta® (pertuzumab) Doxil® (doxorubicin hydrochloride Phesgo™ (pertuzumab, trastuzumab, and liposome)a hyaluronidase-zzxf) Elzonris™ (tagraxofusp-erzs) Polivy™ (polatuzumab vedotin-piiq) Empliciti™ (elotuzumab) Portrazza™ (necitumumab) Enhertu® (f am-trastuzumab deruxtecan- Romidepsin nxkl) Sarclisa® (isatuximab-irfc) Erbitux® (cetuximab) Synribo® (omacetaxine mepesuccinate) Evomela (melphalan) Trazimera™ (trastuzumab-qyyp) Faslodex® (fulvestrant)a Trodelvy™ (sacituzumab govitecan-hziy) Folotyn® (pralatrexate) Unituxin® (dinutuximab) Gazyva® (obinutuzumab) Vectibix® (panitumumab) Halaven® (eribulin mesylate) Velcade® (bortezomib) Herceptin® (trastuzumab) Vyxeos™ (daunorubicin and cytarabine) Herceptin Hylecta™ (trastuzumab and Yondelis® (trabectedin) hyaluronidase-oysk) Zaltrap® (ziv-aflibercept) Herzuma® (trastuzumab-pkrb) Zepzelca™ (lurbinectedin) Imlygic® (talimogene laherparepvec) Zevalin® (ibritumomab tiuxetan) Infugem (gemcitabine in sodium chloride) a generic available

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Brand (generic) GPI Multisource HCPCS/J Code Code Abraxane [paclitaxel (protein bound)] 100 mg single use vial 21500012201920 M, N, O, or Y J9264 Adcetris (brentuximab vedotin) 50 mg powder for reconstitution 21353220202120 M, N, O, or Y J9042 single use vial Alimta (pemetrexed) 100 mg powder for reconstitution 21300053102110 M, N, O, or Y J9305 single use vial 500 mg powder for reconstitution 21300053102120 M, N, O, or Y J9305 single use vial Aliqopa (copanlisib) 60 mg solid f or reconstitution 21538020102120 M, N, O, or Y J9057 single use vial Arranon (nelarabine) 5 mg/mL single use vial 21300052002020 M, N, O, or Y J9261 Arzerra (of atumumab) 100 mg/5 mL single use vial 21351845001320 M, N, O, or Y J9302 1,000 mg/50 mL single use vial 21351845001360 M, N, O, or Y J9302 Asparlas (calaspargase pegol-mknl) 3750 units/5 mL single use vial 21250030502020 M, N, O, or Y J9118 Beleodaq (belinostat) 500 mg powder for reconstitution 21531520002120 M, N, O, or Y J9032 single use vial Belrapzo (bendamustine hydrochloride) 100 mg/4 mL multidose vial 21100009102005 M, N, O, or Y J9036 Besponsa (inotuzumab ozogamicin) 0.9 mg powder for reconstitution 21352640202130 M, N, O, or Y J9229 single use vial Blenrep (belantamab mafodotin-blmf) 100 mg powder for reconstitution 21350515202120 M, N, O, or Y J9037 single-dose vial Blincyto (blinatumomab)

35 mcg powder for reconstitution 21352020002120 M, N, O, or Y J9039 single use vial Bortezomib (bortezomib) 3.5 mg powder for injection) 21536015002122 M, N, O, or Y J9041, J9044 Cyramza (ramucirumab) 100 mg/10 mL single use vial 21335070002020 M, N, O or Y J9308 500 mg/50 mL single use vial 21335070002040 M, N, O or Y J9308 Danyelza (naxitamab-gqgk) 40 mg/10 mL single dose vial 21356050302020 M, N, O, or Y TBD Darzalex (daratumumab) 100mg/5 mL single use vial 21354027002020 M, N, O, or Y J9145 400 mg/20 mL single use vial 21354027002030 M, N, O, or Y J9145 Darzalex Faspro (daratumumab and hyaluronidase-fihj) 1800 mg -30,000 unit/15 mL 21990002152020 M, N, O, or Y C9062, J9144 single dose vial

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective 07/01/2021 Brand (generic) GPI Multisource HCPCS/J Code Code Doxil (doxorubicin hydrochloride liposome)a 2 mg/mL single use vial 21200040402210 M, N, O, or Y Q2050 Elzonris (tagraxofusp-erzs) 1000 mcg/mL single dose vial 21703080302020 M, N, O, or Y J9269 Empliciti (elotuzumab) 300 mg powder for reconstitution 21359030002120 M, N, O, or Y J9176 single use vial 400 mg powder for reconstitution 21359030002130 M, N, O, or Y J9176 single use vial Enhertu (f am-trastuzumab 21355070552120 M, N, O. or Y J9358 deruxtecan-nxkl)

Erbitux (cetuximab) 100 mg/50 mL single use vial 21360015002020 M, N, O, or Y J9055 200 mg/100 mL single use vial 21360015002025 M, N, O, or Y J9055 Evomela (melphalan) 50 mg single use vial 21101040102115 M, N, O, or Y J9245, J9246 Folotyn (pralatrexate) 20 mg/mL single use vial 21300054002020 M, N, O, or Y J9307 40 mg/2 mL single use vial 21300054002025 M, N, O, or Y J9307 Faslodex (fulvestrant)a 250 mg/5 mL pref illed syringe 21403530002024 M, N, O, or Y J9395 Gazyva (obinutuzumab) 2mg/mL single use vial 21351843002025 M, N, O, or Y J9301 Halaven (eribulin mesylate) 1 mg/2 mL single use vial 21500009202020 M, N, O, or Y J9179 Herceptin (trastuzumab) 150 mg single use vial 21170070002110 M, N, O, or Y J9355 440 mg multiple-dose vial 21170070002120 M, N, O, or Y J9355 Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) 600-10000 mg-unit/5 mL 21990002722020 M, N, O, or Y J9356 Herzuma (trastuzumab-pkrb) 150 mg single-dose vial 21170070602110 M, N, O, or Y Q5113 420 mg multiple-dose vial 21170070602120 M, N, O, or Y Q5113 Imlygic (talimogene laherparepvec) 1,000,000 plaque-f orming 21574070401820 M, N, O, or Y J9325 units/mL single use vial 100,000,000 plaque-f orming 21574070401840 M, N, O, or Y J9325 units/mL single use vial Infugem (gemcitabine in sodium chloride) 1200 mg/120 mL single dose bag 21300034112020 M, N, O, or Y J9199, J9198 1300 mg/130 mL single dose bag 21300034112024 M, N, O, or Y J9199, J9198 1400 mg/140 mL single dose bag 21300034112028 M, N, O, or Y J9199, J9198 1500 mg/150 mL single dose bag 21300034112032 M, N, O, or Y J9199, J9198 1600 mg/160 mL single dose bag 21300034112036 M, N, O, or Y J9199, J9198 1700 mg/170 mL single dose bag 21300034112040 M, N, O, or Y J9199, J9198 1800 mg/180 mL single dose bag 21300034112044 M, N, O, or Y J9199, J9198 1900 mg/190 mL single dose bag 21300034112048 M, N, O, or Y J9199, J9198 2000 mg/200 mL single dose bag 21300034112052 M, N, O, or Y J9199, J9198

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective 07/01/2021 Brand (generic) GPI Multisource HCPCS/J Code Code 2200 mg/220 mL single dose bag 21300034112056 M, N, O, or Y J9199, J9198 Istodax (romidepsin) 10 mg powder for reconstitution 21531560002120 M, N, O, or Y J9315 single use vial Jelmyto (mitomycin) 40 mg single-dose-carton 21200050002160 M, N, O, or Y C9064, J9281 Jevtana (cabazitaxel) 60 mg/1.5 mL single use vial 21500003002020 M, N, O, or Y J9043 Kadcyla (ado-trastuzumab) 100 mg single use vial 21355070302120 M, N, O, or Y J9354 160 mg single use vial 21355070302130 M, N, O, or Y J9354 Kanjinti (trastuzumab-anns) 150 mg single use vial 21170070142110 M, N, O, or Y Q5117 420 mg single use vial 21170070142121 M, N, O, or Y Q5117 Kyprolis (carfilzomib) 10 mg powder for reconstitution 21536025002105 M, N, O, or Y J9047 single use vial 30 mg powder for reconstitution 21536025002110 M, N, O, or Y J9047 single use vial 60 mg powder for reconstitution 21536025002120 M, N, O, or Y J9047 single use vial Lartruvo (olaratumab) 190 mg/19 mL single use vial 21490047002010 M, N, O, or Y J9285 500 mg/50 mL single use vial 21490047002020 M, N, O, or Y J9285 Lumoxiti (moxetumomab pasudotox-tdfk) 1 mg single use vial 21352236502120 M, N, O, or Y C9045 Margenza (margetuximab-cmkb) 250 mg/10 mL single dose vial 21353034202020 M, N, O, or Y TBD Monjuvi (tafasitamab-cxix) 200 mg powder for reconstitution 21351467202120 M, N, O. or Y J9349 single-dose vial Mylotarg (gemtuzumab ozogamicin) 4.5 mg powder for reconstitution 21353630202117 M, N, O, or Y J9203 single use vial Ogivri (trastuzumab-dkst) 150 mg single use vial 21170070302108 M, N, O, or Y Q5114 420 mg single use vial 21170070302120 M, N, O, or Y Q5114 Onivyde (irinotecan liposome) 43 mg/10 mL single use vial 21550040202220 M, N, O, or Y J9205 Ontruzant (trastuzumab-dttb) 150 mg single use vial 21170070342120 M, N, O, or Y Q5112 420 mg multiple-dose vial 21170070342140 M, N, O, or Y Q5112 Pepaxto (melphalan flufenamide) 20 mg single dose vial 21101040052120 M, N, O, or Y TBD Perjeta (pertuzumab) 420mg/14 mL single use vial 21170054002020 M, N, O, or Y J9306 Phesgo (pertuzumab. Trastuzumab, and hyaluronidase-zzxf) Pertuzumab 60 mg, trastuzumab 21990003552020 M, N, O, or Y J9316 60 mg, and hyaluronidase-zzxf

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective 07/01/2021 Brand (generic) GPI Multisource HCPCS/J Code Code 2000 unit per mL (pertuzumab 600 mg, trastuzumab 600 mg and hyaluronidase-zzxf 20,000 units per 10 mL) single dose vial Pertuzumab 80 mg, trastuzumab 40 mg, and hyaluronidase-zzxf 2000 unit per mL (pertuzumab 21990003552030 M, N, O. or Y J9316 1200 mg, trastuzumab 600 mg and hyaluronidase-zzxf 20,000 units per 15 mL) single dose vial Polivy (polatuzumab vedotin-piiq) 30 mg single dose vial 21354860302110 M, N, O or Y J9309 140 mg single dose vial 21354860302120 M, N, O, or Y J9309 Portrazza (necitumumab) 800 mg/50 mL single use vial 21360054002020 M, N, O, or Y J9295 Padcev (enfortumab vedotin-ejfv) 20 mg single use vial 21357026202120 M, N, O, or Y J9177 30 mg single use vial 21357026202130 M, N, O, or Y J9177 Romidepsin 27.5 mg/5.5 mL single-dose vial 21531560002030 M, N, O, or Y C9065, J9315 Sarclisa (isatuximab-irfc) 100 mg/5 mL single-dose vial 21354033202020 M, N, O, or Y J9227 500 mg/5 mL single-dose vial 21354033202030 M, N, O, or Y J9227 Synribo (omacetaxine mepesuccinate) 3.5 mg single use vial 21700040102120 M, N, O, or Y J9262 Trazimera (trastuzumab-qyyp) 150 mg single dose vial 21170070652110 M, N, O, or Y Q5116 420 mg single dose vial 21170070652120 M, N, O, or Y Q5116 Trodelvy (sacituzumab govitecan-hziy) 180 mg single dose vial 21551065402120 M, N, O, or Y C9066, J9317 Unituxin (dinutuximab) 17.5 mg/5 mL single use vial 21356028002020 M, N, O, or Y TBD Vectibix (panitumumab) 100 mg/5 mL single use vial 21360070002025 M, N, O, or Y J9303 400 mg/20 mL single use vial 21360070002035 M, N, O, or Y J9303 Velcade (bortezomib) 3.5 mg powder for injection single 21536015002120 M, N, O, or Y J9041, J9044 use vial Vyxeos (daunorubicin and cytarabine) 44-100 mg cake for reconstitution 21990002201930 M, N, O, or Y J9153 single use vial Yondelis (trabectedin) 1 mg vial 21107075002140 M, N, O, or Y J9352 Zaltrap (ziv-aflibercept) 100 mg/4 mL single use vial 21335010102020 M, N, O, or Y J9400 200 mg/8 mL single use vial 21335010102030 M, N, O, or Y J9400 Zepzelca (lurbinectedin) 4 mg single-dose vial 21100024002120 M, N, O, or Y J9223 Zevalin (ibritumomab tiuxetan)

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective 07/01/2021 Brand (generic) GPI Multisource HCPCS/J Code Code 3.2 mg/2 mL single use vial 21358035406420 M, N, O, or Y J9543 a Generic available

CRITERIA FOR APPROVAL The Target Agent will be approved when ALL of the f ollowing are met: 1. ONE of the f ollowing: A. Information has been provided that indicates the patient has been treated with the requested agent within the past 180 days OR B. The prescriber states the patient has been treated with the requested agent within the past 180 days AND is at risk if therapy is changed OR C. The patient has an FDA labeled indication for the requested agent AND ONE of the f ollowing: i. ALL of the f ollowing 1. ONE of the f ollowing: a. The requested indication does NOT require genetic/specific diagnostic testing (e.g., ALK, EGFR, HER2, KRAS) in FDA labeling OR b. The requested indication requires genetic/specific diagnostic testing in FDA labeling AND BOTH of the f ollowing: i. Genetic/specific diagnostic testing has been perf ormed AND ii. The results of the genetic/specific diagnostic testing indicate therapy with the requested agent is appropriate in FDA labeling AND 2. ONE of the f ollowing: a. The requested agent is FDA labeled as a first-line agent for the requested indication OR b. The patient has Stage four, advanced metastatic cancer or a severe adverse health condition experienced as a result of stage four, advanced metastatic cancer OR c. The patient has used the appropriate number and type(s) of prerequisite agent(s) listed in the FDA labeling f or the requested indication OR d. The patient has an intolerance or hypersensitivity to ALL of the required prerequisite agent(s) listed in the FDA labeling f or the requested indication OR e. The patient has an FDA labeled contraindication to ALL of the required prerequisite agent(s) listed in the FDA labeling f or the requested indication

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective 07/01/2021 AND 3. ONE of the f ollowing: a. The requested agent is approved for use as monotherapy in the FDA labeling f or the requested indication OR b. The requested agent will be used with all agent(s) and/or treatments (e.g., radiation) listed for concomitant use in the FDA labeling f or the requested indication AND 4. ONE of the f ollowing: a. The FDA label does NOT include a performance status requirement OR b. The patient meets the performance status requirement in the FDA labeling AND 5. If the client has preferred agents* (*preferred agents determined by client) ONE of the f ollowing: a. The requested agent is a preferred agent OR b. The patient has Stage four, advanced metastatic cancer or a severe adverse health condition experienced as a result of stage four, advanced metastatic cancer OR c. The requested agent is a non-preferred agent (as determined by client) AND ONE of the f ollowing: i. The patient’s medication history indicates use of a preferred agent for the requested indication OR ii. The patient has an intolerance or hypersensitivity to ALL preferred agent(s) for the requested indication OR iii. The patient has an FDA labeled contraindication to ALL preferred agent(s) for the requested indication OR iv. BOTH of the f ollowing: 1. NCCN does NOT specify the plan pref erred agent(s) as a preferred regimen for the requested indication AND 2. NCCN specifies the requested agent as a preferred regimen for the requested indication OR v. The prescriber has provided information in support of the non-preferred agent over the preferred agent(s) for the requested indication

Indication Non-preferred Preferred Agents Agents

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective 07/01/2021 OR ii. BOTH of the f ollowing: 1. The requested indication is supported by ALL requirements in either FDA labeling or NCCN 1 or 2A recommended use for the requested agent [i.e., this indication must be supported by ALL requirements in the FDA label or NCCN “Recommended Use” box (e.g., performance status, disease severity, previous failures, monotherapy vs combination therapy, etc.)] AND 2. If the client has preferred agents* (*preferred agents determined by client) ONE of the f ollowing: a. The requested agent is a preferred agent OR b. The requested agent is a non-preferred agent (as determined by client) AND ONE of the f ollowing: i. The patient’s medication history indicates use of a preferred agent for the requested indication OR c. The patient has Stage four, advanced metastatic cancer or a severe adverse health condition experienced as a result of stage four, advanced metastatic cancer ii. an intolerance or hypersensitivity to ALL preferred agent(s) for the requested indication OR iii. The patient has an FDA labeled contraindication to ALL preferred agent(s) for the requested indication OR iv. BOTH of the f ollowing: 1. NCCN does NOT specify the plan preferred agent(s) as a preferred regimen for the requested indication AND 2. NCCN specifies the requested agent as a preferred regimen for the requested indication OR v. The prescriber has provided information in support of the non-preferred agent over the preferred agent(s) for the requested indication

Indication Preferred Agents Non-Preferred Agents

OR D. The patient has an NCCN 1 or 2A recommended indication [i.e., this indication must be supported by ALL requirements in the NCCN “Recommended Use” box (e.g., performance status, disease severity, previous failures, monotherapy vs combination therapy, etc.)] AND if the client has preferred agents* (*preferred agents determined by client), ONE of the following: i. The requested agent is a preferred agent OR

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© Copyright Prime Therapeutics LLC. 03/2021 All Rights Reserved Effective 07/01/2021 ii. The patient has Stage four, advanced metastatic cancer or a severe adverse health condition experienced as a result of stage four, advanced metastatic cancer OR iii. The requested agent is a non-preferred agent (as determined by client) AND ONE of the f ollowing: 1. The patient’s medication history indicates use of a pref erred agent for the requested indication OR 2. The patient has an intolerance or hypersensitivity to ALL preferred agent(s) for the requested indication OR 3. The patient has an FDA labeled contraindication to ALL preferred agent(s) for the requested indication OR 4. BOTH of the f ollowing: a. NCCN does NOT specify the plan preferred agent(s) as a preferred regimen for the requested indication AND b. NCCN specifies the requested agent as a preferred regimen for the requested indication OR 5. The prescriber has provided information in support of the non- preferred agent over the preferred agent(s) for the requested indication Preferred Non-Preferred Preferred Agents Agents Agents

AND 2. The patient does NOT have any FDA labeled contraindications to the requested agent AND 3. The requested quantity (dose) and duration is within FDA labeled dosing for the requested indication or NCCN 1 or 2A compendia supported dosing for the requested indication

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