Injectable and Healthcare Administered Oncology Drugs Notification

Commercial Drug Policy

Version Date: July 2023

Restricted Product(s):

For administration by a healthcare professional:

Abraxane® [paclitaxel (protein bound)]
Adcetris® (brentuximab vedotin)
Alimta® (pemetrexed)
Aliqopa™ (copanlisib)
Arzerra® (ofatumumab)
Bavencio® (avelumab)
Besponsa™ (inotuzumab ozogamicin)
Blincyto® (blinatumomab)
Danyelza® (naxitamab-gqgk)
Darzalex® (daratumumab)
Darzalex Faspro™ (daratumumab and hyaluronidase-fihj)
Elahere™ (mirvetuximab soravtansine-gynx)
Elzonris™ (tagraxofusp-erzs)
Empliciti™ (elotuzumab)
Enhertu® (fam-trastuzumab deruxtecan-nxki)
Erbitux® (cetuximab)
Erwinaze™ (asparaginase Erwinia chrysanthemi)
Fyarro™ (sirolimus albumin-bound nanoparticles)
Gazyva® (obinutuzumab)
Halaven® (eribulin mesylate)
Hycamtin® (topotecan)
Imfinzi® (durvalumab)
Imjudo® (tremelimumab-actl)
Imlygic® (talimogene laherparepvec)
Jemperli® (dostarlimab-gxly)
Jevtana® (cabazitaxel)
Kadcyla® (ado-trastuzumab emtansine)
Keytruda® (pembrolizumab)
Kimmtrak® (tebentafusp-tebn)
Kyprolis® (carfilzomib)
Libtayo® (cemiplimab-rwlc)
Lumoxiti™ (moxetumomab pasudotox-tdfk)
Lunsumio™ (mosunetuzumab-axgb)
Margenza® (margetuximab-cmkb)
Monjuvi® (tafasitamab-cxix)
Mylotarg™ (gemtuzumab ozogamicin)
Opdivo® (nivolumab)
OpdualagTM (nivolumab and relatlimab-rmbw)
Padcev™ (enfortumab vedotin-ejfv)
Pemfexy® (pemetrexed)
Perjeta® (pertuzumab)
Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf)
Polivy™ (polatuzumab vedotin-piiq)
Portrazza™ (necitumumab)
Poteligeo® (mogamulizumab-kpkc)
Provenge® (sipuleucel-T)
Rybrevant® (amivantamab-vmjw)
Rylaze [asparaginase Erwinia chrysanthemi (recombinant)- rywn]
Sarclisa® (isatuximab-irfc)
Sylvant® (siltuximab)
Tecentriq® (atezolizumab)
Tecvayli™ (teclistamab-cqyv)
Tivdak® (tisotumab vedotin-tftv)
Trodelvy™ (sacituzumab govitecan-hziy)
Vectibix® (panitumumab)
Vyxeos™ (daunorubicin and cytarabine)
Yervoy™ (ipilimumab)
Zepzelca™ (lurbinectedin)
Zynlonta® (loncastuximab tesirine-lpyl)
Zynyz™ (retifanlimab-dlwr)

FDA Approved Use:

Abraxane® [paclitaxel (protein bound)]
- Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy (prior therapy should have included an anthracycline unless clinically contraindicated)
- Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy
- Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine
Adcetris® (brentuximab vedotin)
- For treatment of adults with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine
- For treatment of pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide
- For treatment of adults with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation
- For treatment of adults with classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
- For treatment of adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone
- For treatment of adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multiagent chemotherapy regimen
- For treatment of adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy
Alimta® (pemetrexed)
- For initial treatment, in combination with pembrolizumab and platinum chemotherapy, of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations
- For initial treatment, in combination with cisplatin, of patients with locally advanced or metastatic, non-squamous NSCLC
- For maintenance treatment, as a single agent, of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
- For treatment, as a single agent, of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy
- Limitations of use: Not indicated for treatment of patients with squamous cell NSCLC
- For initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery
Aliqopa™ (copanlisib)
- For treatment of adults with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies
Arzerra® (ofatumumab)
- For treatment of chronic lymphocytic leukemia (CLL) in the following situations:
  - In combination with chlorambucil, for treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate
  - In combination with fludarabine and cyclophosphamide for treatment of patients with relapsed CLL
  - For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL
  - For treatment of patients with CLL refractory to fludarabine and alemtuzumab
Bavencio® (avelumab)
- Merkel cell carcinoma (MCC): For treatment of metastatic MCC in adults and pediatric patients 12 years and older
- Urothelial carcinoma (UC):
  - For maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy
  - For treatment of patients with locally advanced or metastatic UC who:
    - Have disease progression during or following platinum-containing chemotherapy
    - Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- Renal cell carcinoma (RCC): For first-line treatment, in combination with axitinib, of patients with advanced RCC
Besponsa™ (inotuzumab ozogamicin)
- For treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Blincyto® (blinatumomab)
- For treatment of adults and children with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
- For treatment of adults and children with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL)
Danyelza® (naxitamab-gqgk)
- For treatment, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), of pediatric patients 1 year of age and older and adults with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy
Darzalex® (daratumumab)
- For treatment of adults with multiple myeloma in the following situations:
  - in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory disease who have received at least one prior therapy
  - in combination with bortezomib, melphalan and prednisone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant
  - in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant
  - in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
  - in combination with carfilzomib and dexamethasone in patients with relapsed or refractory disease who have received one to three prior lines of therapy
  - in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
  - as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent
Darzalex Faspro™ (daratumumab and hyaluronidase-fihj)
- For treatment of adults with multiple myeloma in the following situations:
  - in combination with bortezomib, melphalan and prednisone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant
  - in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory disease who have received at least one prior therapy
  - in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant
  - in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
  - in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor
  - in combination with carfilzomib and dexamethasone in patients with relapsed or refractory disease who have received one to three prior lines of therapy
  - as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent
- For treatment of light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients
  - Limitations of use: Not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials
Elahere™ (mirvetuximab soravtansine-gynx)
- For treatment of adults with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.
Elzonris™ (tagraxofusp-erzs)
- For treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older
Empliciti™ (elotuzumab)
- For treatment, in combination with lenalidomide and dexamethasone, for adults with multiple myeloma who have received one to three prior therapies
- For treatment, in combination with pomalidomide and dexamethasone, for adults with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
Enhertu® (fam-trastuzumab deruxtecan-nxki)
- For treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either:
  - in the metastatic setting, or
  - in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy
- For treatment of adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
- For treatment of adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy
- For treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen
Erbitux® (cetuximab)
- For treatment of locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy
- For treatment of recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil
- For treatment of recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy
- For treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test:
  - in combination with FOLFIRI for first-line treatment
  - in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy
  - as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan
  - Limitations of use: Not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.
- For treatment of BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy
Erwinaze™ (asparaginase Erwinia chrysanthemi)
- For treatment of acute lymphoblastic leukemia (ALL), as a component of a multi-agent chemotherapeutic regimen, in patients who have developed hypersensitivity to E. coli-derived asparaginase
Fyarro™ (sirolimus albumin-bound nanoparticles)
- For treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa)
Gazyva® (obinutuzumab)
- For treatment, in combination with chlorambucil, for patients with previously untreated chronic lymphocytic leukemia
- For treatment, in combination with bendamustine followed by Gazyva monotherapy, for patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen
- For treatment, in combination with chemotherapy followed by Gazyva monotherapy in patients achieving at least a partial remission, for adults with previously untreated stage II bulky, III or IV follicular lymphoma
Halaven® (eribulin mesylate)
- For treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
- For treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen
Hycamtin® (topotecan)
- For treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent
- For treatment of patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent
- For treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin
Imfinzi® (durvalumab)
- For treatment of adults with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy
- For treatment, in combination with tremelimumab-actl and platinum-based chemotherapy, for adults with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations
- For first-line treatment, in combination with etoposide and either carboplatin or cisplatin, of adults with extensive-stage small cell lung cancer (ES-SCLC)
- For treatment, in combination with gemcitabine and cisplatin, of adults with locally advanced or metastatic biliary tract cancer (BTC)
- For treatment, in combination with tremelimumab-actl, of adults with unresectable hepatocellular carcinoma (uHCC)
Imjudo® (tremelimumab-actl)
- For treatment, in combination with durvalumab, of adults with unresectable hepatocellular carcinoma (uHCC)
- For treatment, in combination with durvalumab and platinum-based chemotherapy, of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations
Imlygic® (talimogene laherparepvec)
- For local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery
- Limitations of use: Not shown to improve overall survival or have an effect on visceral metastases
Jemperli® (dostarlimab-gxly)
- For treatment of adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation
- For treatment of adults with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options
Jevtana® (cabazitaxel)
- For treatment, in combination with prednisone, of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen
Kadcyla® (ado-trastuzumab emtansine)
- For treatment, as a single agent, of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:
- received prior therapy for metastatic disease, or
- developed disease recurrence during or within six months of completing adjuvant therapy
- For adjuvant treatment, as a single agent, of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment
- Patient selection for therapy is based on an FDA-approved companion diagnostic for Kadcyla. Assessment of HER2 protein overexpression and/or HER2 gene amplification should be performed using FDA-approved tests specific for breast cancers by laboratories with demonstrated proficiency.
Keytruda® (pembrolizumab)
- Melanoma
  - For treatment of patients with unresectable or metastatic melanoma
  - For adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection
- Non-small cell lung cancer (NSCLC)
  - For first-line treatment, in combination with pemetrexed and platinum chemotherapy, of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations
  - As first-line treatment, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, of patients with metastatic squamous NSCLC
  - As a single agent for first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:
    - stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
    - metastatic
  - As a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda.
  - As a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adults with stage IB (T2a ≥4 cm), II, or IIIA NSCLC
- Head and neck squamous cell cancer (HNSCC)
  - For first-line treatment, in combination with platinum and FU, of patients with metastatic or with unresectable, recurrent HNSCC
  - As a single agent for first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
  - As a single agent for treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
- Classical Hodgkin lymphoma (cHL)
  - For treatment of adults with relapsed or refractory cHL
  - For treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy
- Primary mediastinal large B-cell lymphoma (PMBCL)
  - For treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy
  - Limitations of use: Not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy
- Urothelial carcinoma
  - For treatment of patients with locally advanced or metastatic urothelial carcinoma who:
    - are not eligible for any platinum-containing chemotherapy, or
    - who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  - For treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy
- Microsatellite instability-high or mismatch repair deficient cancer
  - For treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options
  - Limitations of use: Safety and effectiveness in pediatric patients with MSI-H central nervous system cancers have not been established
- Microsatellite instability-high or mismatch repair deficient colorectal cancer (CRC)
  - For treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test
- Gastric cancer
  - For first-line treatment, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Esophageal cancer
  - For treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
    - in combination with platinum- and fluoropyrimidine-based chemotherapy, or
    - as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test
- Cervical cancer
  - For treatment as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
  - For treatment, in combination with chemotherapy, with or without bevacizumab, of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
- Hepatocellular carcinoma (HCC)
  - For treatment of patients with HCC who have been previously treated with sorafenib
- Merkel cell carcinoma (MCC)
  - For treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma
- Renal cell carcinoma (RCC)
  - For first-line treatment, in combination with axitinib, of adults with advanced RCC
  - For first-line treatment, in combination with lenvatinib, of adults with advanced RCC
  - For adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
- Endometrial carcinoma
  - For treatment, in combination with lenvatinib, of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
  - For treatment, as a single agent, of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
- Tumor mutational burden-high (TMB-H) cancer
  - For treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options
  - Limitations of use: Safety and effectiveness in pediatric patients with TMB-H central nervous system cancers have not been established
- Cutaneous squamous cell carcinoma (cSCC)
  - For treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation
- Triple-negative breast cancer (TNBC)
  - For treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
  - For treatment, in combination with chemotherapy, of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test
- Keytruda is indicated for use at an additional dosing regimen of 400 mg every 6 weeks for adult classical Hodgkin lymphoma and adult primary mediastinal large B-cell lymphoma indications
Kimmtrak ® (tebentafusp-tebn)
- For treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma
Kyprolis® (carfilzomib)
- For treatment of adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with:
  - Lenalidomide and dexamethasone; or
  - Dexamethasone; or
  - Daratumumab and dexamethasone; or
  - Daratumumab and hyaluronidase-fihj and dexamethasone; or
  - Isatuximab and dexamethasone
- For treatment, as a single agent, of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
Libtayo® (cemiplimab-rwlc)
- For treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation
- For treatment of basal cell carcinoma (BCC) in the following situations:
  - in patients with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
  - in patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
- For first-line treatment, in combination with platinum-based chemotherapy, of adults with non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations, and is:
  - locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or
  - metastatic
- For first-line treatment as a single agent, of adults with non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is:
  - locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or
  - metastatic
Lumoxiti™ (moxetumomab pasudotox-tdfk)
- For treatment of adults with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA)
- Limitations of use: Not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min)
Lunsumio™ (mosunetuzumab-axgb)
- For treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Margenza® (margetuximab-cmkb)
- For treatment, in combination with chemotherapy, of adults with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease
Monjuvi® (tafasitamab-cxix)
- For treatment, in combination with lenalidomide, for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT)
Mylotarg™ (gemtuzumab ozogamicin)
- For treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older
- For treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older
Opdivo® (nivolumab)
- Melanoma
  - For adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab
  - For adult and pediatric (12 years and older) patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting
- Non-small cell lung cancer (NSCLC)
  - For adults with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab
  - For adults with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy
  - For adults with metastatic non-small cell lung cancer and progression on or after 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 Opdivo.
  - For use in combination with platinum-doublet chemotherapy for neoadjuvant treatment of adults with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer
- Malignant pleural mesothelioma
  - For adults with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab
- Renal cell carcinoma (RCC)
  - For adults with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab
  - For adults with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib
  - For adults with advanced renal cell carcinoma who have received prior anti-angiogenic therapy
- Classical Hodgkin lymphoma (cHL)
  - For adults with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin; or after 3 or more lines of systemic therapy that includes autologous HSCT
- Squamous cell carcinoma of the head and neck (SCCHN)
  - For adults with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
- Urothelial carcinoma
  - For adjuvant treatment of adults with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC
  - For adults with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy; or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinumcontaining chemotherapy
- Colorectal cancer
  - For adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab
- Hepatocellular carcinoma (HCC)
  - For adults with hepatocellular carcinoma who have been previously treated with sorafenib in combination with ipilimumab
- Esophageal cancer
  - For adults with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT)
  - For adults with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy
  - For adults with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab
  - For adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy
- Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
  - For adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy
Opdualag™ (nivolumab and relatlimab-rmbw)
- For the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma
Padcev™ (enfortumab vedotin-ejfv)
- For treatment of adults with locally advanced or metastatic urothelial cancer who:
  - have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or
  - are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy
Pemfexy® (pemetrexed)
- For initial treatment, in combination with pembrolizumab and platinum chemotherapy, of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations
- For initial treatment, in combination with cisplatin, of patients with locally advanced or metastatic, non-squamous NSCLC
- For maintenance treatment, as a single agent, of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
- For treatment, as a single agent, of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy
  - Limitations of use: Not indicated for treatment of patients with squamous cell NSCLC
- For initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery
Perjeta® (pertuzumab)
- For treatment, in combination with trastuzumab and docetaxel, of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
- For neoadjuvant treatment, in combination with trastuzumab and chemotherapy, of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer o For adjuvant treatment, in combination with trastuzumab and chemotherapy, of patients with HER2-positive early breast cancer at high risk of recurrence
- Assessment of HER2 protein overexpression and/or HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency
Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf)
- For neoadjuvant treatment, in combination with chemotherapy, of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer
- For adjuvant treatment, in combination with chemotherapy, of patients with HER2-positive early breast cancer at high risk of recurrence
- For treatment, in combination with docetaxel, of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
- Assessment of HER2 protein overexpression and/or HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency
Polivy™ (polatuzumab vedotin-piiq)
- For treatment of adults, in combination with bendamustine and a rituximab product, for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies
Portrazza™ (necitumumab)
- For treatment, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous nonsmall cell lung cancer
  - Limitations of use: Not for treatment of non-squamous non-small cell lung cancer
Poteligeo® (mogamulizumab-kpkc)
- For treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy
Provenge® (sipuleucel-T)
- For treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer
Rybrevant® (amivantamab-vmjw)
- For treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy
Rylaze [asparaginase Erwinia chrysanthemi (recombinant)-rywn]
- For treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL), as a component of a multi-agent chemotherapeutic regimen, in adults and pediatric patients 1 month or older who have developed hypersensitivity to E. coliderived asparaginase
Sarclisa® (isatuximab-irfc)
- For treatment, in combination with pomalidomide and dexamethasone, of adults with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
- For treatment, in combination with carfilzomib and dexamethasone, of adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
Sylvant® (siltuximab)
- For treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative
- Limitation of use: Not studied in patients with MCD who are HIV positive or HHV-8 positive because Sylvant did not bind to virally produced IL-6 in a nonclinical study
Tecentriq® (atezolizumab)
- Non-small cell lung cancer (NSCLC)
  - As adjuvant treatment following resection and platinum-based chemotherapy for adults with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test
  - For first-line treatment of adults with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
  - For first-line treatment, in combination with bevacizumab, paclitaxel, and carboplatin, of adults with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations
  - For first-line treatment, in combination with paclitaxel protein-bound and carboplatin, of adults with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations
  - For treatment of adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDAapproved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq.
- Small cell lung cancer (SCLC)
  - For first-line treatment, in combination with carboplatin and etoposide, of adults with extensive-stage small cell lung cancer (ES-SCLC)
- Hepatocellular carcinoma (HCC)
  - For treatment, in combination with bevacizumab, for adults with unresectable or metastatic HCC who have not received prior systemic therapy
- Melanoma
  - For treatment, in combination with cobimetinib and vemurafenib, for adults with BRAF V600 mutation-positive unresectable or metastatic melanoma
- Alveolar soft part sarcoma (ASPS)
  - For treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS
Tecvayli™ (teclistamab-cqyv)
- For treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody
Tivdak® (tisotumab vedotin-tftv)
- For treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
Trodelvy™ (sacituzumab govitecan-hziy)
- For treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease
- For treatment of adults with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting
- For treatment of adults with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinumcontaining chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PDL1) inhibitor
Vectibix® (panitumumab)
- For treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC):
  - In combination with FOLFOX for first-line treatment
  - As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecancontaining chemotherapy
- Limitation of use: Not for treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown
Vyxeos™ (daunorubicin and cytarabine)
- For treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older
Yervoy™ (ipilimumab)
- For treatment of melanoma in the following situations:
  - Unresectable or metastatic melanoma in adults and pediatric patients 12 years and older, as a single agent
  - Unresectable or metastatic melanoma in adults and pediatric patients 12 years and older, in combination with nivolumab
  - Adjuvant treatment of adults with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy
- For treatment of adults with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab
- For treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab
- For treatment of adults with hepatocellular carcinoma who have been previously treated with sorafenib, in combination with nivolumab
- For treatment of non-small cell lung cancer (NSCLC) in the following situations:
  - Adults with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab
  - Adults with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as firstline treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy
- For treatment of adults with unresectable malignant pleural mesothelioma, as first-line treatment in combination with nivolumab
- For treatment of adults with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first-line treatment in combination with nivolumab
Zepzelca™ (lurbinectedin)
- For treatment of adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy
Zynlonta® (loncastuximab tesirine-lpyl)
- For treatment of relapsed or refractory large B-cell lymphoma in adults after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma
Zynyz™ (retifanlimab-dlwr)
- For treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma

NOTE: This policy only addresses FDA labeled and compendia supported off-label oncologic indications for the above restricted agents. Any nononcologic FDA labeled or compendia supported uses for the above restricted products are not addressed in this policy and may be addressed elsewhere.

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

ALL of the following:
1. ONE of the following:
  1. The patient has been treated with the requested agent within the past 180 days; OR
  2. The prescriber indicates the patient has been treated with the requested agent within the past 180 days AND is at risk if therapy is changed; OR
The patient has an FDA labeled indication for the requested agent and route of administration; AND
1. ONE of the following:
  1. The requested indication does NOT require genetic/specific diagnostic testing (e.g., ALK, EGFR, HER2, KRAS) in FDA labeling; OR
  2. The requested indication requires genetic/specific diagnostic testing in FDA labeling AND both of the following:
    1. Genetic/specific diagnostic testing has been performed; AND
    2. The results of the genetic/specific diagnostic testing indicate therapy with the requested agent is appropriate in FDA labeling; AND
2. ONE of the following:
  1. The requested agent will be used as a first-line agent AND is FDA labeled as a first-line agent for the requested indication, including any genomic aberrations (e.g., EGFR, ALK) and/or tumor expression factors [e.g., PD-L1 Tumor Proportion Score (TPS) values]; OR
  2. The patient has used the appropriate number and type(s) of prerequisite agent(s) listed in the FDA labeling for the requested indication, including any genomic aberrations (e.g., EGFR, ALK) and/or tumor expression factors [e.g., PD-L1 Tumor Proportion Score (TPS) values]; OR
  3. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the required prerequisite agent(s) listed in the FDA labeling for the requested indication, indication including any genomic aberrations (e.g., EGFR, ALK) and/or tumor expression factors [e.g., PD-L1 Tumor Proportion Score (TPS) values]; AND
3. ONE of the following:
  1. The requested agent is being used as monotherapy AND is approved for use as monotherapy in the FDA labeling for the requested indication, including any genomic aberrations (e.g., EGFR, ALK) and/or tumor expression factors [e.g., PD-L1 Tumor Proportion Score (TPS) values]; OR
  2. The requested agent will be used in combination as combination therapy with all agent (s) and/or treatments (e.g., radiation) listed for concomitant use in the FDA labeling for the requested indication; AND
4. ONE of the following:
  1. The FDA label does NOT include a performance status requirement; OR
  2. The patient meets the performance status requirement in the FDA labeling; OR
The patient has an indication that is supported by ALL requirements in NCCN 1 or 2A recommended use for the requested agent [i.e., the 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)]; AND
The patient has not experienced disease progression or unacceptable toxicity on the same treatment as the requested agent or during treatment with another agent from the same drug class in a prior line of therapy (e.g., PD-L1/PD-1 inhibitors) unless there is acceptable supporting literature for use beyond progression in a different combination regimen; AND
ONE of the following:
1. The patient’s age is within FDA labeling for the requested indication or NCCN 1 or 2A compendia supported recommendation for the requested agent; OR
2. The prescriber has provided information in support of using the requested agent for the patient’s age; AND
The patient does NOT have any FDA labeled contraindications to the requested agent; AND
The requested quantity (dose) and treatment duration (and maximum units) is within FDA labeled dosing for the requested indication or NCCN 1 or 2A compendia supported dosing for the requested indication.

Duration of Approval: 365 days (1 year) or for duration of treatment as supported in FDA labeling or in NCCN 1 or 2A recommendations for the requested indication, whichever is shorter

Continuation Criteria for Approval:

The patient was approved through Blue Cross NC initial criteria for approval; OR
The patient would have met initial criteria for approval at the time they started therapy; AND
The patient has continued clinical benefit while receiving the requested agent as demonstrated by tumor response or lack of disease progression, and an acceptable toxicity profile; AND
The requested quantity (dose) and treatment duration (and maximum units) is within FDA labeled dosing for the requested indication or NCCN 1 or 2A compendia supported dosing for the requested indication.

Duration of Approval: 365 days (1 year) or for duration of treatment as supported in FDA labeling or in NCCN 1 or 2A recommendations for the requested indication, whichever is shorter

NOTE:

Use of injectable and healthcare administered oncology agents may be considered medically necessary for clinical indications not listed above when the drug is prescribed for the treatment of cancer either:

In accordance with FDA label when clinical benefit has been established, and it is not determined to be investigational as defined in the Blue Cross NC Corporate Medical Policy (CMP), “Investigational (Experimental) Services.” [please refer to CMP “Investigational (Experimental) Services” for a summary of evidence standards from nationally recognized compendia]; OR
In accordance with specific strong endorsement or support by nationally recognized compendia (e.g., National Comprehensive Cancer Network, NCCN), when such recommendation is based on the highest level of evidence (Level 1, 2A), and/or uniform consensus of clinical appropriateness has been reached.

FDA Label Reference:

Medication	Indication	Dosing	HCPCS
Abraxane® [paclitaxel (protein bound)] intravenous (IV) infusion	Metastatic breast cancer (MBC) Locally advanced or metastatic NSCLC Metastatic adenocarcinoma of the pancreas	IV: 260 mg/m² every 3 weeks IV: 100 mg/m² on days 1, 8, and 15 of each 21- day cycle (administer carboplatin on day 1 of each 21-day cycle immediately after Abraxane) IV: 125 mg/m² on days 1, 8, and 15 of each 28- day cycle (administer gemcitabine immediately after Abraxane on days 1, 8, and 15 of each 28- day cycle) Do not substitute Abraxane for other paclitaxel products	J9264
Adcetris® (brentuximab vedotin) intravenous (IV) infusion	Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in adults, in combination with doxorubicin, vinblastine, and dacarbazine Previously untreated high risk cHL in pediatric patients cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation cHL after failure of auto-HSCT or after failure of ≥2 prior multiagent chemotherapy regimens in patients who are not auto-HSCT candidates Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30- expressing peripheral T-cell lymphomas (PTCL) in combination with cyclophosphamide, doxorubicin, and prednisone sALCL after failure of at least one prior multiagent chemotherapy regimen Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy	IV: Monotherapy for adults: 1.8 mg/kg up to a maximum of 180 mg every 3 weeks In combination with chemotherapy for adults with previously untreated Stage III or IV cHL: 1.2 mg/kg up to a maximum of 120 mg every 2 weeks for a maximum of 12 doses In combination with chemotherapy for pediatric patients ≥ 2 years old with previously untreated high risk cHL: 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for a maximum of 5 doses In combination with chemotherapy for adults with previously untreated PTCL: 1.8 mg/kg upto a maximum of 180 mg every 3 weeks for 6 to 8 doses	J9042
Alimta® (pemetrexed) or generic pemetrexed intravenous (IV) infusion	Non-squamous NSCLC Mesothelioma	IV: Non-squamous NSCLC: Initial treatment of metastatic disease: 500 mg/m² , administered after pembrolizumab and prior to carboplatin or cisplatin in patients with a CrCl of 45 mL/min or greater, on day 1 of each 21-day cycle for four cycles, until disease progression or unacceptable toxicity Initial treatment of locally advanced or metastatic disease: 500 mg/m² , administered prior to cisplatin in patients with a CrCl of 45 mL/min or greater, on day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity Maintenance treatment: 500 mg/m² on day 1 of each 21-day cycle, in patients with a CrCl of 45 mL/min or greater, until disease progression or unacceptable toxicity after 4 cycles of platinum-based first-line chemotherapy Recurrent disease: 500 mg/m² on day 1 of each 21-day cycle, in patients with a CrCl of 45 mL/min or greater, until disease progression or unacceptable toxicity Mesothelioma: 500 mg/m² on day 1 of each 21- day cycle, administered with cisplatin, in patients with a creatinine clearance of 45 mL/min or greater, until disease progression or unacceptable toxicity	J9305 J9294 J9296 J9297 J9314
Aliqopa™ (copanlisib) intravenous (IV) infusion	Relapsed follicular lymphoma in adults after at least two prior systemic therapies	IV: 60 mg on days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (3 weeks on, 1 week off); continue until disease progression or unacceptable toxicity	J9057
Arzerra® (ofatumumab) intravenous (IV) infusion	Untreated CLL in combination with chlorambucil Relapsed CLL in combination with fludarabine and cyclophosphamide Extended treatment of recurrent or progressive CLL following partial or incomplete response after at least two lines of therapy CLL refractory to fludarabine and alemtuzumab	IV: 300 mg on day 1 followed by 1,000 mg on day 8, then 1,000 mg on day 1 of every subsequent 28- day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles 300 mg on day 1 followed by 1,000 mg on day 8, then 1,000 mg on day 1 of every subsequent 28- day cycle for a maximum of 6 cycles 300 mg on day 1 followed by 1,000 mg on day 8, then 1,000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years 300 mg on day 1 followed 1 week later by 2,000 mg weekly for 7 doses (infusions 2-8), followed 4 weeks later by 2,000 mg every 4 weeks for 4 doses (infusions 9-12)	J9302
Bavencio® (avelumab) intravenous (IV) infusion	Metastatic merkel cell carcinoma (MCC) in patients ≥ 12 years old Locally advanced or metastatic urothelial carcinoma (UC): Maintenance treatment in patients who have not progressed with first-line platinum-containing chemotherapy In patients with disease progression during or following platinumcontaining chemotherapy In patients with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy Advanced renal cell carcinoma (RCC), first-line treatment in combination with axitinib	IV: Metastatic MCC: 800 mg every 2 weeks until disease progression or unacceptable toxicity Locally advanced or metastatic UC: 800 mg every 2 weeks until disease progression or unacceptable toxicity RCC: 800 mg every 2 weeks until disease progression or unacceptable toxicity	J9023
Besponsa™ (inotuzumab ozogamicin) intravenous (IV) infusion	Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults	IV: First cycle: 0.8 mg/m² on day 1, and 0.5 mg/m² on days 8 and 15 for a total dose of 1.8 mg/m² per 21- day cycle Subsequent cycles (response dependent): Complete response (CR) or complete remission with incomplete hematologic recovery (CRi) achieved: 0.5 mg/m² on days 1, 8, and 15 for a total dose of 1.5 mg/m² per 28-day cycle CR or CRi not achieved: 0.8 mg/m² on day 1, and 0.5 mg/m² on days 8 and 15 for a total dose of 1.8 mg/m² per 28-day cycle Discontinue treatment if CR or CRi not achieved within 3 cycles Duration: If proceeding to HSCT: 2 cycles, consider third cycle if CR or CRi and minimal residual disease negativity are not achieved after 2 cycles If not proceeding to HSCT: maximum of 6 cycles	J9229
Blincyto® (blinatumomab) intravenous (IV) infusion	CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) ≥ 0.1% in adults and children Relapsed or refractory CD19- positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children	MRD-positive B-cell precursor ALL: Weight-based dosing according to prescribing information A treatment course consists of 1 induction cycle followed by up to 3 additional consolidation cycles A single treatment cycle of induction or consolidation consists of 28 days of continuous infusion followed by a 14-day treatment-free interval (total 42 days) Relapsed or refractory B-cell precursor ALL Weight-based dosing according to prescribing information A treatment course consists of up to 2 induction cycles followed by 3 additional consolidation cycles, and up to 4 additional cycles of continued therapy A single treatment cycle of induction or consolidation consists of 28 days of continuous infusion followed by a 14-day treatment-free interval (total 42 days) A single treatment cycle of continued therapy consists of 28 days of continuous infusion followed by a 56-day treatment free interval (total 84 days)	J9039
Danyelza® (naxitamab-gqgk) intravenous (IV) infusion	Relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in pediatric patients 1 year of age and older and adults who have demonstrated a partial response, minor response, or stable disease to prior therapy	IV: 3 mg/kg/day (up to 150 mg/day) administered on days 1, 3, and 5 of each 28-day treatment cycle; repeat until complete or partial response, followed by 5 additional 28-day cycles. Subsequent cycles may be repeated every 8 weeks. Discontinue for disease progression or unacceptable toxicity	J9348
Darzalex® (daratumumab) intravenous (IV) infusion	Multiple myeloma	IV: 16 mg/kg actual body weight according to recommended schedule in prescribing information	J9145
Darzalex Faspro™ (daratumumab and hyaluronidase-fihj) subcutaneous (SC) injection	Multiple myeloma Light chain (AL) amyloidosis	SC: (1,800 mg daratumumab and 30,000 units hyaluronidase) administered into the abdomen over approximately 3 to 5 minutes according to recommended schedule in prescribing information	J9144
Elahere™ (mirvetuximab soravtansine-gynx) intravenous (IV) infusion	FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have received one to three prior systemic treatment regimens	IV: 6 mg/kg adjusted ideal body weight every 3 weeks until disease progression or unacceptable toxicity	C9146 J3490[D] J3590[D] J9999[D]
Elzonris™ (tagraxofusp-erzs) intravenous (IV) infusion	Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and olde	IV: 12 mcg/kg over 15 minutes once daily on days 1 to 5 of a 21-day cycle First cycle to be administered in the inpatient setting. Subsequent cycles may be administered in the inpatient or appropriate outpatient setting	J9269
Empliciti™ (elotuzumab) intravenous (IV) infusion	Multiple myeloma	IV: With lenalidomide and dexamethasone: 10 mg/kg every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity With pomalidomide and dexamethasone: 10 mg/kg every week for the first two cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity	J9176
Enhertu® (fam-trastuzumab deruxtecan-nxki) intravenous (IV) infusion	Unresectable or metastatic HER2-positive breast cancer in adults who have received a prior anti-HER2-based regimen Unresectable or metastatic HER2-low breast cancer in adults Unresectable or metastatic non-small cell lung cancer (NSCLC) in adults whosetumors have activating HER2 mutations Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adults who have received a prior trastuzumab-based regimen	IV: Breast cancer: 5.4 mg/kg once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity Lung cancer: 5.4 mg/kg once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity Gastric cancer: 6.4 mg/kg once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity Enhertu is not to be substituted for or with trastuzumab or ado-trastuzumab emtansine.	J9358
Erbitux® (cetuximab) intravenous (IV) infusion	Locally or regionally advanced squamous cell carcinoma of the head and neck Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer BRAF V600E MutationPositive Metastatic Colorectal Cancer (CRC)	IV: In combination with radiation therapy: Initial dose: 400 mg/m² one week prior to initiating a course of radiation therapy Subsequent doses: 250 mg/m² every week for the duration of radiation therapy (6–7 weeks) As single-agent or in combination with chemotherapy: Weekly: Initial dose of 400 mg/m² , and subsequent doses of 250 mg/m² once weekly Biweekly: 500 mg/m² every two weeks Continue treatment until disease progression or unacceptable toxicity	J9055
Erwinaze (asparaginase Erwinia chrysanthemi) intramuscular (IM) injection	Acute lymphoblastic leukemia (ALL), as a component of a multiagent chemotherapeutic regimen, in patients who have developed hypersensitivity to E. coli-derived asparaginase	IM: 25,000 IU/m² three times weekly (Monday/Wednesday/Friday) for 6 doses for each planned pegaspargase dose, when replacing a long-acting asparaginase product. To substitute for a dose of native E. coli asparaginase, give 25,000 IU/m² for each scheduled dose of native E. coli asparaginase	J9019
Fyarro™ (sirolimus albumin-bound nanoparticles) intravenous (IV) infusion	Locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa) in adults	IV: 100 mg/m² on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity	J9331
Gazyva® (obinutuzumab) intravenous (IV) infusion	Previously untreated chronic lymphocytic leukemia Follicular lymphoma in patients who relapsed after, or are refractory to, a rituximab-containing regimen Previously untreated stage II bulky, III or IV follicular lymphoma	IV: Chronic lymphocytic leukemia: 100 mg on day 1 and 900 mg on day 2 of Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2–6 Follicular lymphoma: 1000 mg on day 1, 8, and 15 of Cycle 1, 1000 mg on day 1 of Cycles 2-6 or Cycles 2-8, and then 1000 mg every 2 months for up to 2 years	J9301
Halaven® (eribulin mesylate) intravenous (IV) infusion	Metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease Metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease	IV: 1.4 mg/m² on Days 1 and 8 of a 21-day cycle	J9179
Hycamtin® (topotecan) intravenous (IV) infusion	Metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent Small cell lung cancer (SCLC) platinumsensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin	Ovarian Cancer and SCLC: 1.5 mg/m² IV daily for 5 consecutive days, starting on day 1 of a 21-day cycle Cervical Cancer: 0.75 mg/m² IV on days 1, 2, and 3, with cisplatin 50 mg/m² on day 1, of a 21-day cycle	J9351
Imfinzi® (durvalumab) intravenous (IV) infusion	Unresectable, Stage III non-small cell lung cancer (NSCLC) inadults whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy Metastatic NSCLC in adults with no sensitizing EGFR mutations or ALK genomic tumor aberrations, in combination with tremelimumab-actl and platinum-based chemotherapy For first-line treatment of extensive-stage small cell lung cancer (ESSCLC) in adults Locally advanced or metastatic biliary tract cancer (BTC) in adults, in combination with gemcitabine and cisplatin Unresectable hepatocellular carcinoma (uHCC) in adults, in combination with tremelimumab-act	IV: Stage III NSCLC: Wt ≥30 kg: 10 mg/kg every 2 weeks or 1500 mg every 4 weeks Wt <30 kg: 10 mg/kg every 2 weeks Metastatic NSCLC: Wt ≥30 kg: 1500 mg every 3 weeks in combination with chemotherapy for 4 cycles, and then 1500 mg every 4 weeks as a single agent Wt <30 kg: 20 mg/kg every 3 weeks in combination with chemotherapy, and then 20 mg/kg every 4 weeks as a single agent ES-SCLC: Wt ≥30 kg: 1500 mg every 3 weeks in combination with chemotherapy, and then 1500 mg every 4 weeks as a single agent Wt <30 kg: 20 mg/kg every 3 weeks in combination with chemotherapy, and then 10 mg/kg every 2 weeks as a single agent BTC: Wt ≥30 kg: 1500 mg every 3 weeks in combination with chemotherapy, and then 1500 mg every 4 weeks as a single agent Wt <30 kg: 20 mg/kg every 3 weeks in combination with chemotherapy, and then 20 mg/kg every 4 weeks as a single agent uHCC: Wt ≥30 kg: 1500 mg in combination with chemotherapy as a single dose atcycle 1/day 1, and then as a single agent every 4 weeks Wt <30 kg: 20 mg/kg in combination with chemotherapy as a single dose at cycle 1/day1, and then as a single agent every 4 weeks	J9173
Imjudo® (tremelimumab-actl) intravenous (IV) infusion	Unresectable hepatocellular carcinoma (uHCC) in adults, in combination with durvalumab Metastatic NSCLC in adults with no sensitizing EGFR mutations or ALK genomic tumor aberrations, in combination with durvalumab and platinumbased chemotherapy	IV: uHCC: Wt ≥30 kg: 300 mg as a single dose in combination with durvalumab 1500 mg at cycle 1/day 1, and then durvalumab as a single agent every 4 weeks Wt <30 kg: 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at cycle 1/day1, and then durvalumab as a single agent every 4 weeks Metastatic NSCLC: Wt ≥30 kg: 75 mg every 3 weeks in combination with durvalumab 1500 mg and platinum-based chemotherapy for 4 cycles, and then durvalumab 1500 mg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 75 mg in combination with durvalumab dose 6 at week 16 Wt <30 kg: 1 mg/kg every 3 weeks in combination with durvalumab 20 mg/kg and platinum-based chemotherapy for 4 cycles, and then durvalumab 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 1 mg/kg in combination with durvalumab dose 6 at week 16	C9147 J3490[D] J3590[D] J9999[D]
Imlygic® (talimogene laherparepvec) intralesional injection	Local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery	Initial dose is up to a maximum of 4 mL at a concentration of 106 (1 million) plaque-forming units (PFU) per mL. Subsequent doses should be administered up to 4 mL at a concentration of 108 (100 million) PFU per mL.	J9325
Jemperli® (dostarlimab-gxly) intravenous (IV) infusion	Mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinumcontaining regimen Mismatch repair deficient (dMMR) recurrent or advanced solid tumors that have progressed on or following prior treatment and in patients who have no satisfactory alternative treatment options	IV: Dose 1 through 4: 500 mg every 3 weeks; Subsequent dosing beginning 3 weeks after Dose 4 (Dose 5 onwards): 1,000 mg every 6 weeks	J9272
Jevtana® (cabazitaxel) intravenous (IV) infusion	Metastatic castration-resistant prostate cancer in patients previously treated with a docetaxelcontaining treatment regimen	IV: 20 mg/m² every three weeks in combination with oral prednisone 10 mg daily throughout treatment. A dose of 25 mg/m² can be used in select patients at the discretion of the treating healthcare provider.	J9043
Kadcyla® (ado-trastuzumab emtansine) intravenous (IV) infusion	HER2-positive, metastatic breast cancer, as a single agent, in patients who previously received trastuzumab and a taxane, separately or in combination HER2-positive early breast cancer (EBC), as single-agent adjuvant treatment, in patients who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment	IV: 3.6 mg/kg every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity, or a total of 14 cycles for patients with EBC Do not administer at doses greater than 3.6 mg/kg Do not substitute for or with trastuzumab	J9354
Keytruda® (pembrolizumab) intravenous (IV) infusion	Melanoma Non-small cell lung cancer (NSCLC) Head and neck squamous cell cancer (HNSCC) Classical Hodgkin lymphoma (cHL) Primary mediastinal large B-cell lymphoma (PMBCL) Urothelial carcinoma High-risk, BCG-unresponsive, nonmuscle invasive bladder cancer (NMIBC) Microsatellite instabilityhigh (MSI-H) or mismatch repair deficient (dMMR) cancer Microsatellite instabilityhigh (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) Microsatellite instabilityhigh (MSI-H) or mismatch repair deficient (dMMR) endometrial carcinoma Gastric cancer Esophageal cancer Cervical cancer Hepatocellular carcinoma (HCC) Merkel cell carcinoma (MCC) Renal cell carcinoma (RCC) Endometrial carcinoma Tumor mutational burden-high (TMB-H) cancer Cutaneous squamous cell carcinoma (cSCC) Triple-negative breast cancer (TNBC)	IV: Monotherapy Indication: Adults with unresectable or metastatic melanoma Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks Duration/Timing of Treatment: Until disease progression or unacceptable toxicity Indication: Adjuvant treatment of adults with melanoma, NSCLC, or RCC Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks Duration/Timing of Treatment: Until disease recurrence, unacceptable toxicity, or up to 12 months Indication: Adults with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic urothelial carcinoma, MSI-H or dMMR cancer, MSIH or dMMR CRC, MSI-H or dMMR endometrial carcinoma, esophageal cancer, cervical cancer, HCC, MCC, TMB-H cancer, or cSCC Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks Duration/Timing of Treatment: Until disease progression, unacceptable toxicity, or up to 24 months Indication: Adults with high-risk BCG-unresponsive NMIBC Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks Duration/Timing of Treatment: Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months Indication: Pediatric patients with cHL, PMBCL, MSI-H or dMMR cancer, MCC, or TMBH cancer Recommended Dosage: 2 mg/kg every 3 weeks (up to a maximum of 200 mg) Duration/Timing of Treatment: Until disease progression, unacceptable toxicity, or up to 24 months Indication: Pediatric patients (12 years and older) for adjuvant treatment of melanoma Recommended Dosage: 2 mg/kg every 3 weeks (up to a maximum of 200 mg) Duration/Timing of Treatment: Until disease recurrence, unacceptable toxicity, or up to 12 months Combination Therapy Indication: Adults with NSCLC, HNSCC, or esophageal cancer Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks (Administer Keytruda prior to chemotherapy when given on same day) Duration/Timing of Treatment: Until disease progression, unacceptable toxicity, or up to 24 months Indication: Adults with gastric cancer Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks (Administer Keytruda prior to trastuzumab and chemotherapy when given on same day) Duration/Timing of Treatment: Until disease progression, unacceptable toxicity, or up to 24 months Indication: Adults with cervical cancer Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks (Administer Keytruda prior to chemotherapy with or without bevacizumab when given on same day) Duration/Timing of Treatment: Until disease progression, unacceptable toxicity, or (for Keytruda) up to 24 months Indication: Adults with RCC Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks (Administer Keytruda in combination with axitinib 5 mg orally twice daily OR in combination with lenvatinib 20 mg orally once daily) Duration/Timing of Treatment: Until disease progression, unacceptable toxicity, or (for Keytruda) up to 24 months Indication: Adults with endometrial carcinoma Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks (Administer Keytruda in combination with lenvatinib 20 mg orally once daily) Duration/Timing of Treatment: Until disease progression, unacceptable toxicity, or (for Keytruda) up to 24 months Indication: Adults with high-risk early-stage TNBC Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks (Administer Keytruda prior to chemotherapy when given on same day) Duration/Timing of Treatment: Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with Keytruda as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicity Indication: Adults with locally recurrent unresectable or metastatic TNBC Recommended Dosage: 200 mg every 3 weeks, or 400 mg every 6 weeks (Administer Keytruda prior to chemotherapy when given on same day) Duration/Timing of Treatment: Until disease progression, unacceptable toxicity, or up to 24 months	J9271
Kimmtrak® (tebentafusp-tebn) intravenous (IV) infusion	HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma	IV: 20 mcg on day 1, 30 mcg on day 8, 68 mcg on day 15, and 68 mcg once every week thereafter. Administer until unacceptable toxicity or disease progression occur.	J9274
Kyprolis® (carfilzomib) intravenous (IV) infusion	Relapsed or refractory multiple myeloma in adults who have received one to three lines of therapy, in combination with other chemotherapy Single-agent treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy	In combination with dexamethasone, or daratumumab and dexamethasone, or daratumumab and hyaluronidase-fihj and dexamethasone: 20/70 mg/m² IV once weekly In combination with dexamethasone, or daratumumab and dexamethasone, or daratumumab and hyaluronidase-fihj and dexamethasone, or isatuximab and dexamethasone, or monotherapy: 20/56 mg/m² IV twice weekly In combination with lenalidomide and dexamethasone, or monotherapy: 20/27 mg/m² IV twice weekly	J9047
Libtayo® (cemiplimab-rwlc) intravenous (IV) infusion	Metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) in patients who are not candidates for curative surgery or curative radiation Locally advanced BCC (laBCC) or metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate First-line treatment, in combination with platinumbased chemotherapy, of adults with NSCLC with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic First-line treatment, as single agent, of adults with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%], with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic	IV: 350 mg every 3 weeks	J9119
Lumoxiti™ (moxetumomab pasudotox-tdfk) intravenous (IV) infusion	Relapsed or refractory hairy cell leukemia (HCL) in adults who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA)	IV: 0.04 mg/kg on days 1, 3, and 5 of each 28-day cycle	J9313
Lunsumio™ (mosunetuzumabaxgb) intravenous (IV) infusion	Relapsed or refractory follicular lymphoma in adults after two or more lines of systemic therapy	IV: Cycle 1 Day 1: 1 mg Cycle 1 Day 8: 2 mg Cycle 1 Day 15: 60 mg Cycle 2 Day 1: 60 mg Cycle 3+ Day 1: 30 mg Administer for 8 cycles unless patient experiences unacceptable toxicity or disease progression. For patients who achieve complete response, no further treatment beyond 8 cycles. For patients who achieve partial response or have stable disease in response to 8 treatment cycles, administer an additional 9 cycles of treatment (17 cycles total), unless a patient experiences unacceptable toxicity or disease progression	C9399[D] J3490[D] J3590[D] J9999[D]
Margenza® (margetuximab-cmkb) intravenous (IV) infusion	Metastatic HER2-positive breast cancer in adults who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease	IV: Initial dose of 15 mg/kg over 120 minutes, then over a minimum of 30 minutes every 3 weeks for all subsequent doses	J9353
Monjuvi® (tafasitamab-cxix) intravenous (IV) infusion	Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and in patients who are not eligible for autologous stem cell transplant (ASCT)	IV: 12 mg/kg according to the following dosing schedule: Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle Give in combination with lenalidomide for a maximum of 12 cycles and then continue Monjuvi as monotherapy until disease progression or unacceptable toxicity	J9349
Mylotarg™ (gemtuzumab ozogamicin) intravenous (IV) infusion	Newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients ≥ 1 month old Relapsed or refractory CD33- positive AML in adults and pediatric patients ≥ 2 years old	Newly-diagnosed de novo AML (combination regimen) Adults: Induction – 3 mg/ m² (up to one 4.5 mg vial) on days 1, 4, and 7 in combination with daunorubicin and cytarabine; Consolidation – 3 mg/m² on day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine Pediatric patients 1 month and older: 3 mg/m² for patients with body surface area (BSA) 0.6 m2 or greater; 0.1 mg/kg for patients with BSA less than 0.6 m² Newly-diagnosed AML (single-agent regimen) Adults: Induction – 6 mg/m² (not limited to one 4.5 mg vial) on day 1 and 3 mg/m² (not limited to one 4.5 mg vial) on day 8; Continuation – For patients without evidence of disease progression following induction, up to 8 continuation courses of Mylotarg 2 mg/m² (not limited to one 4.5 mg vial) on day 1 every 4 weeks Relapsed/refractory AML (single-agent regimen): 3 mg/m² (up to one 4.5 mg vial) on days 1, 4, and 7	J9203
Opdivo® (nivolumab) intravenous (IV) infusion	Melanoma Non-small cell lung cancer (NSCLC) Malignant pleural mesothelioma Renal cell carcinoma (RCC) Classical Hodgkin lymphoma (cHL) Squamous cell carcinoma of the head and neck (SCCHN) Urothelial carcinoma Colorectal cancer Hepatocellular carcinoma (HCC) Esophageal cancer Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma	IV: Unresectable or metastatic melanoma Adult and pediatric patients ≥ 40 kg: 240 mg every 2 weeks or 480 mg every 4 weeks Pediatric patients < 40 kg: 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks Adult and pediatric patients ≥ 40 kg: 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks Pediatric patients < 40 kg: 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks Adjuvant treatment of melanoma: Adult and pediatric patients ≥ 40 kg: 240 mg every 2 weeks or 480 mg every 4 weeks Pediatric patients < 40 kg: 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks Neoadjuvant treatment of resectable (tumors ≥4 cm or node positive) NSCLC 360 mg with platinum-doublet chemotherapy on the same day every 3 weeks for 3 cycles Metastatic NSCLC 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy 240 mg every 2 weeks or 480 mg every 4 weeks Malignant pleural mesothelioma: 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks Advanced RCC 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks 240 mg every 2 weeks or 480 mg every 4 weeks administered in combination with cabozantinib 40 mg once daily without food 240 mg every 2 weeks or 480 mg every 4 weeks cHL: 240 mg every 2 weeks or 480 mg every 4 weeks Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN): 240 mg every 2 weeks or 480 mg every 4 weeks Adjuvant treatment of urothelial carcinoma: 240 mg every 2 weeks or 480 mg every 4 weeks Locally advanced or metastatic urothelial carcinoma: 240 mg every 2 weeks or 480 mg every 4 weeks MSI-H or dMMR metastatic colorectal cancer: Adult and pediatric patients ≥ 40 kg: 240 mg every 2 weeks or 480 mg every 4 weeks Pediatric patients < 40 kg: 3 mg/kg every 2 weeks Adult and pediatric patients ≥ 40 kg: 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks HCC: 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks Adjuvant treatment of resected esophageal or gastroesophageal cancer: 240 mg every 2 weeks or 480 mg every 4 weeks for total treatment duration of 1 year Esophageal squamous cell carcinoma: 240 mg every 2 weeks or 480 mg every 4 weeks in combination with chemotherapy regimen of fluoropyrimidine- and platinumcontaining chemotherapy 3 mg/kg every 2 weeks or 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks 240 mg every 2 weeks or 480 mg every 4 weeks Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC, GEJC, or EAC): 360 mg every 3 weeks with fluoropyrimidine- and platinumcontaining chemotherapy every 3 weeks 240 mg every 2 weeks with fluoropyrimidine- and platinumcontaining chemotherapy every 2 weeks	J9299
Opdualag™ (nivolumab and relatlimab-rmbw) intravenous (IV) infusion	Unresectable or metastatic melanoma in adult and pediatric patients 12 years of age or older	IV: Adults and pediatric patients ≥ 12 years of age who weigh at least 40 kg: 480 mg nivolumab and 160 mg relatlimab every 4 weeks	J9298
Padcev™ (enfortumab vedotin-ejfv) intravenous (IV) infusion	Locally advanced or metastatic urothelial cancer in adults	IV: 1.25 mg/kg (up to a maximum dose of 125 mg) given on days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity	J9177
Pemfexy ® (pemetrexed) or generic pemetrexed intravenous (IV) infusion	Non-squamous NSCLC Mesothelioma	IV: Non-squamous NSCLC: Initial treatment of metastatic disease: 500 mg/m² , administered after pembrolizumab and prior to carboplatin or cisplatin in patients with a CrCl of 45 mL/min or greater, on day 1 of each 21-day cycle for four cycles, until disease progression or unacceptable toxicity Initial treatment of locally advanced or metastatic disease: 500 mg/m² , administered prior to cisplatin in patients with a CrCl of 45 mL/min or greater, on day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity Maintenance treatment: 500 mg/m² on day 1 of each 21-day cycle, in patients with a CrCl of 45 mL/min or greater, until disease progression or unacceptable toxicity after 4 cycles of platinum-based first-line chemotherapy Recurrent disease: 500 mg/m² on day 1 of each 21-day cycle, in patients with a CrCl of 45 mL/min or greater, until disease progression or unacceptable toxicity Mesothelioma: 500 mg/m² on day 1 of each 21- day cycle, administered with cisplatin, in patients with a creatinine clearance of 45 mL/min or greater, until disease progression or unacceptable toxicity	J9304 J9294 J9296 J9297 J9314
Perjeta® (pertuzumab) intravenous (IV) infusion	HER2-positive metastatic breast cancer (MBC) in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease Neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer Adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence	Initial dose is 840 mg IV, followed every 3 weeks thereafter by 420 mg MBC: Administer with trastuzumab or trastuzumab hyaluronidase-oysk, and docetaxel every 3 weeks Neoadjuvant: Administer with trastuzumab or trastuzumab hyaluronidase-oysk, and chemotherapy preoperatively every 3 weeks for 3 to 6 cycles Adjuvant: Administer with trastuzumab or trastuzumab hyaluronidase-oysk, and chemotherapy postoperatively every 3 weeks for a total of 1 year (up to 18 cycles)	J9306
Phesgo™ (pertuzumab, trastuzumab, and hyaluronidasezzxf) subcutaneous (SC) injection	For neoadjuvant treatment of HER2- positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer For adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence HER2-positive metastatic breast cancer (MBC) in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease	Initial dose is 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase SC over approximately 8 minutes, followed every 3 weeks by a dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC over approximately 5 minutes Neoadjuvant: Administer SC every 3 weeks and chemotherapy IV preoperatively for 3 to 6 cycles Adjuvant: Administer SC every 3 weeks and chemotherapy IV postoperatively for a total of 1 year (up to 18 cycles) MBC: Administer SC and docetaxel IV every 3 weeks For SC use in thigh only, do not administer intravenously Dosing and administration are different than IV pertuzumab and trastuzumab products	J9316
Polivy™ (polatuzumab vedotin-piiq) intravenous (IV) infusion	Relapsed or refractory diffuse large B-cell lymphoma in adults, in combination with bendamustine and a rituximab product, after at least two prior therapies	IV: 1.8 mg/kg every 21 days for 6 cycles	J9309
Portrazza™ (necitumumab) intravenous (IV) infusion	First-line treatment for metastatic squamous non-small cell lung cancer, in combination with gemcitabine and cisplatin	IV: 800 mg (absolute dose) on days 1 and 8 of each 3-week cycle. Continue until disease progression or unacceptable toxicity.	J9295
Poteligeo® (mogamulizumab-kpkc) intravenous (IV) infusion	Relapsed or refractory mycosis fungoides or Sézary syndrome in adults after at least one prior systemic therapy	IV: 1 mg/kg on days 1, 8, 15, and 22 of the first 28- day cycle and on days 1 and 15 of each subsequent cycle. Continue until disease progression or unacceptable toxicity.	J9204
Provenge® (sipuleucel-T) intravenous (IV) infusion	Asymptomatic or minimally symptomatic metastatic castrateresistant (hormone-refractory) prostate cancer	IV: 3 complete doses at approximately 2-week intervals (each dose contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF)	Q2043
Rybrevant® (amivantamab-vmjw) intravenous (IV) infusion	Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy	Given IV once weekly for 4 weeks, then every 2 weeks starting on week 5 onwards, at the following dosing: < 80 kg: 1050 mg ≥ 80 kg: 1400 mg	J9061
Rylaze [asparaginase Erwinia chrysanthemi (recombinant)-rywn] intramuscular (IM) injection	Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and pediatric patients ≥ 1 month old who have developed hypersensitivity to E. coli-derived asparaginase	IM: When given every 48 hours: 25 mg/m² every 48 hours, when replacing a long-acting asparaginase product When given Monday/Wednesday/Friday: 25 mg/m² on Monday morning and Wednesday morning, and 50 mg/m² on Friday afternoon, when replacing a long-acting asparaginase product	J9021
Sarclisa® (isatuximab-irfc) intravenous (IV) infusion	Multiple myeloma in adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor Relapsed or refractory multiple myeloma in adults who have received 1 to 3 prior lines of therapy	IV: 10 mg/kg every week for 4 weeks followed by every 2 weeks until disease progression or unacceptable toxicity	J9227
Sylvant® (siltuximab) intravenous (IV) infusion	Multicentric Castleman’s disease (MCD) in patients who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative	IV: 11 mg/kg every 3 weeks	J2860
Tecentriq® (atezolizumab) intravenous (IV) infusion	Non-small cell lung cancer (NSCLC) Small cell lung cancer (SCLC) Hepatocellular carcinoma (HCC) Melanoma Alveolar soft part sarcoma (ASPS)	IV: NSCLC: Adjuvant setting: Administer following resection and up to 4 cycles of platinum-based chemotherapy as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for up to 1 year Metastatic setting: 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks SCLC: 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks HCC: 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks Melanoma: Following completion of a 28-day cycle of cobimetinib and vemurafenib, give 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks with cobimetinib and vemurafenib ASPS: Adults: 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks Pediatric patients ≥ 2 years: 15 mg/kg (up to a maximum of 1200 mg) every 3 weeks	J9022
Tecvayli™ (teclistamab-cqyv) subcutaneous (SC) injection	Relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy	SC: Step-up doses of 0.06 mg/kg on day 1 and 0.3 mg/kg on day 4, followed by 1.5 mg/kg (on day 7) once weekly until disease progression or unacceptable toxicity	C9148 J3490[D] J3590[D] J9999[D]
Tivdak® (tisotumab vedotin-tftv) intravenous (IV) infusion	Recurrent or metastatic cervical cancer in adults with disease progression on or after chemotherapy	IV: 2 mg/kg (up to a maximum of 200 mg) every 3 weeks until disease progression or unacceptable toxicity	J9273
Trodelvy™ (sacituzumab govitecanhziy) intravenous (IV) infusion	Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults who have received two or more prior systemic therapies, at least one of them for metastatic disease Unresectable locally advanced or metastatic hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting Locally advanced or metastatic urothelial cancer (mUC) in adults who have previously received a platinum-containing chemotherapy and either programmed death receptor1 (PD-1) or programmed death-ligand 1 (PDL1) inhibitor	IV: 10 mg/kg once weekly on days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity	J9317
Vectibix® (panitumumab) intravenous (IV) infusion	Wild-type RAS metastatic colorectal cancer (mCRC)	IV: 6 mg/kg every 14 days over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg)	J9303
Vyxeos™ (daunorubicin and cytarabine) intravenous (IV) infusion	Newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older	IV: Induction: Vyxeos (daunorubicin 44 mg/m² and cytarabine 100 mg/m² ) liposome on days 1, 3, and 5 and on days 1 and 3 for subsequent cycles of induction, if needed. Consolidation: Vyxeos (daunorubicin 29 mg/m² and cytarabine 65 mg/m² ) liposome on days 1 and 3	J9153
Yervoy™ (ipilimumab) intravenous (IV) infusion	Unresectable or metastatic melanoma Adjuvant treatment of melanoma Advanced renal cell carcinoma MSI-H or dMMR metastatic colorectal cancer Hepatocellular carcinoma Metastatic non-small cell lung cancer Malignant pleural mesothelioma Esophageal squamous cell carcinoma	IV: 3 mg/kg every 3 weeks for a maximum of 4 doses 3 mg/kg immediately after nivolumab 1 mg/kg on the same day, every 3 weeks for 4 doses IV: 10 mg/kg every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years IV: 1 mg/kg immediately after nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses IV: 1 mg/kg immediately after nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses IV: 3 mg/kg immediately after nivolumab 1 mg/kg on the same day, every 3 weeks for 4 doses IV: 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks; or 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks and 2 cycles of platinum-doublet chemotherapy IV: 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks IV: 1 mg/kg every 6 weeks with nivolumab 3 mg/kg every 2 weeks or 360 mg every 3 weeks	J9228
Zepzelca™ (lurbinectedin) intravenous (IV) infusion	Metastatic small cell lung cancer (SCLC) in adults with disease progression on or after platinumbased chemotherapy	IV: 3.2 mg/m² every 21 days	J9223
Zynlonta® (loncastuximab tesirinelpyl) intravenous (IV) infusion	Relapsed or refractory large B-cell lymphoma in adults	IV: Administered on day 1 of each cycle (every 3 weeks) 0.15 mg/kg every 3 weeks for 2 cycles 0.075 mg/kg every 3 weeks for subsequent cycles	J9359
Zynyz™ (retifanlimab-dlwr) intravenous (IV) infusion	Metastatic or recurrent locally advanced Merkel cell carcinoma in adults	IV: 500 mg every 4 weeks	C9399[D] J3490[D] J3590[D] J9999[D]

Other applicable oncology-specific HCPCS codes: S0353, S0354

Other ICD-10 codes that may be applicable to this policy: C00.0-C49.9, C4A.0-C4A.9, C50.011-C79.9, C7A.00-C7A.8, C7B.00-C7B.8, C80.0- C86.6, C88.2-C96.Z, D00.00-D09.9, Z51.11, Z51.12

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

July 2023: Criteria change: Added Pemfexy (pemetrexed) for treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and for treatment of malignant pleural mesothelioma in patients whose disease is unresectable or who are otherwise not candidates for curative surgery, and added HCPCS code J9304 and associated dosing to FDA label reference table. Removed Blenrep (belantamab mafodotin-blmf) from policy due to FDA market withdrawal based on the confirmatory clinical trial not meeting requirements of FDA Accelerated Approval regulations; Blenrep is now only available for continued use through the manufacturer’s compassionate use program. Removed Zoladex (goserelin) from policy and added it to a separate individual policy (Gonadotropin Releasing Hormone Therapy). Policy notification given 4/3/2023 for effective date 7/1/2023.

May 2023: Criteria change: Added newly approved Zynyz to policy for treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma, added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table.

April 2023: Coding update: Added HCPCS codes C9146 for Elahere, C9147 for Imjudo, and C9148 for Tecvayli to dosing reference table effective 4/1/2023; deleted C9399 for all three drugs termed 3/31/2023. Added HCPCS codes J9294 (hospira), J9296 (accord), and J9297 (sandoz) for generic pemetrexed products to dosing reference table effective 4/1/2023.

April 2023: Criteria update: For Darzalex: Updated indication for multiple myeloma in combination with pomalidomide and dexamethasone to patients who have received at least two prior therapies instead of one prior line of therapy. For Enhertu: Added FDA-approved testing within the indication for unresectable or metastatic HER2-low breast cancer for clarity according to label. For Jemperli: Updated indication for dMMR recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen to add in any setting or not candidates for curative surgery or radiation. For Keytruda: Added indication for use as a single agent for adjuvant treatment following resection and platinum-based chemotherapy for adults with stage IB (T2a ≥4 cm), II, or IIIA NSCLC; adjusted use at an additional dosing regimen of 400 mg every 6 weeks from all indications to specifically for adult classical Hodgkin lymphoma and adult primary mediastinal large B-cell lymphoma indications; adjusted wording according to label throughout for an FDA approved test where appropriate; and updated dosing reference table according to FDA label for clarity. For Opdivo: Added specification of use within adult and/or pediatric patients by indication according to label; and adjusted dosing by age and weight per indication within dosing reference table according to label. For Rylaze: Added additional dosing regimen option within dosing reference table according to label. For Tecentriq: Removed accelerated approval indication for urothelial carcinoma according to label; added indication for alveolar soft part sarcoma in adult and pediatric patients 2 years of age and older with unresectable or metastatic disease; and updated dosing and reference table according to label. For Trodelvy: Added indication for unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting; and updated dosing reference table according to label. For Yervoy: Added specification of use within adult and/or pediatric patients by indication according to label.

March 2023: Criteria change: Added newly approved Lunsumio to policy for treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, and added associated dosing to FDA label reference table.

March 2023: Coding update: Added HCPCS code J9314 (teva) for generic pemetrexed to dosing reference table effective 1/1/2023.

December 2022: Criteria update: Added newly approved Elahere to policy for treatment of adults with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens; and associated dosing to FDA label reference table. Added newly approved Imjudo to policy for treatment of adults with unresectable hepatocellular carcinoma (uHCC) and for treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitizing EGFR mutation or ALK genomic tumor aberrations; and associated dosing to FDA label reference table. Added newly approved Tecvayli for treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, and associated dosing to FDA label reference table.

November 2022: Criteria update: For Adcetris: Added indication for previously untreated high risk cHL in pediatric patients, and associated dosing to FDA label reference table. For Enhertu: Added indications for unresectable or metastatic HER2-positive breast cancer in the neoadjuvant or adjuvant setting, unresectable or metastatic HER2-low breast cancer, unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 mutations, and associated dosing to FDA label reference table. For Imfinzi: Added indications for metastatic NSCLC, locally advanced or metastatic biliary tract cancer, and unresectable hepatocellular carcinoma, and associated dosing to FDA label reference table. For Keytruda: Removed previously treated gastric cancer indication, adjusted endometrial carcinoma indications and associated dosing within FDA label reference table. For Kyprolis: Added indication for use in combination with isatuximab and dexamethasone, and adjusted associated dosing within FDA label reference table. For Libtayo: Added additional NSCLC indication and associated dosing to FDA label reference table. For Opdivo: Added additional esophageal cancer indications and associated dosing to FDA label reference table. For Yervoy: Added indications for unresectable advanced or metastatic esophageal squamous cell carcinoma and associated dosing to FDA label reference table, and adjusted dosing for melanoma and NSCLC. Removed tables with listed preferred and non-preferred bevacizumab, rituximab, and trastuzumab products, as these products are applicable to a separate individual medical policy (Preferred Injectable Oncology Program).

October 2022: Coding update: Added HCPCS codes J9274 for Kimmtrak and J9298 for Opdualag to dosing reference table effective 10/1/2022; deleted C9095, J3490, J3590, and J9999 for Kimmtrak and C9399, J3490, J3590, and J9999 for Opdualag termed 9/30/2022.

October 2022: Criteria change: Removed Herceptin Hylecta and Rituxan Hycela from policy and added them to a separate individual policy (Preferred Injectable Oncology Program). Policy notification given 8/4/2022 for effective date 10/1/2022.

July 2022: Coding update: Added HCPCS codes C9095 for Kimmtrak and J9331 for Fyarro to dosing reference table effective 7/1/2022, deleted C9399 for Kimmtrak and C9091, C9399, J3490, J3590, and J9999 for Fyarro termed 6/30/2022.

June 2022: Criteria change: Removed the following products from the policy and created individual policy for these products (Preferred Injectable Oncology Program): Avastin, Herceptin, Herzuma, Ontruzant, Riabni, Rituxan, Trazimera. The following products were removed from the policy and no longer require prior authorization for ONCOLOGY indications: Mvasi, Zirabev, Ruxience, Truxima, Kanjinti, Ogiviri.

May 2022: Criteria change: Added newly approved Opdualag with associated criteria and dosing to FDA label reference table. Added new indication for Opdivo for use in combination with platinum-doublet chemotherapy for neoadjuvant treatment of adult patients with resectable (tumors at least 4 cm or node positive) non-small cell lung cancer.

April 2022: Criteria change: Added newly approved Kimmtrak to policy for treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, and associated dosing to FDA label reference table. Addition of Erwinaze, Rybrevant, Rylaze, and Tivdak to remain on notice for effective date 4/1/2022. Additional policy notification given 2/15/2022 for effective date 4/1/2022.

April 2022: Coding update: Added HCPCS code J9273 for Tivdak,J9359 for Zynlonta, and C9091 for Fyarro to dosing reference table effective 4/1/2022, deleted C9086, J3490, J3590, J9999 for Tivdak and Zynlonta termed 3/31/2022.

February 2022: Criteria change: Added newly approved Fyarro to policy for treatment of locally advanced unresectable or metastatic malignant PEComa, and associated dosing to FDA label reference table. Added other applicable HCPCS and diagnosis codes for clarity

February 2022: Original medical policy criteria issued. Policy notification given 12/17/2021 for effective date 2/15/2022.

Further historical criteria changes and updates for Corporate Medical Policies for each individual drug are available upon request from Medical Policy and/or Corporate Pharmacy.

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