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

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Injectable and Health Care Administered Oncology Medical Drug Criteria Through Preferred (Optional) 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 CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 1 of 46 © 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 CBC_CS_Reg_MDC_Injectable_and_Health_Care_Administered_Oncology_P rogSum_AR0620_r0321 Page 4 of 46 © 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
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