Oncologic Therapies

Afinitor® (Everolimus) Approval Criteria (Breast Cancer Diagnosis):

• Diagnosis of advanced breast cancer; AND  
• Negative expression of Human Epidermal Receptor Type 2 (HER2); AND
• Hormone receptor-positive (ER positive); AND
• Used in combination with exemestane, fulvestrant, or tamoxifen; AND
• Member must have failed treatment with, have a contraindication to, or be intolerant to letrozole or anastrozole.

Afinitor® (Everolimus) Approval Criteria [Neuroendocrine Tumors of Pancreatic Origin (PNET) or Neuroendocirne Tumors (NET) of Gastrointestinal or Lung OriginDiagnosis]:

• Diagnosis of unresectable, locally advanced, or metastatic neuroendocrine tumors of pancreatic origin (PNET) gastrointestinal, or lung (NET) origin; AND
• Progressive disease from a previous treatment.
• Authorizations will be for the duration of three months. Reauthorization may be granted if the patient does not show evidence of progressive disease while on everolimus therapy.

Afinitor® (Everolimus) Approval Criteria (Renal Cell Carcinoma Diagnosis):

• Diagnosis of advanced renal cell carcinoma; AND  
• Failure of treatment with sunitinib or sorafenib.
• Everolimus may also be approved to be used in combination with lenvatinib for advanced renal cell carcinoma.
• Authorizations will be for the duration of three months. Reauthorization may be granted if the patient does not show evidence of progressive disease while on everolimus therapy

Afinitor® (Everolimus) Approval Criteria [Renal Angiomyolipoma and Tuberous Sclerosis Complex (TSC) Diagnosis]:

• Diagnosis of renal angiomyolipoma and tuberous sclerosis complex (TSC); and
• Not requiring immediate surgery; AND
• Used in pediatric and adult patients with age ≥ 1 year.

Afinitor® (Everolimus) Approval Criteria [Subependymal Giant Cell Astrocytoma (SEGA) with Tuberous Sclerosis Complex (TSC) Diagnosis]:

• Diagnosis of subependymal giant cell astrocytoma (SEGA) with tuberous sclerosis complex (TSC); AND
• Requires therapeutic intervention but cannot be curatively resected.

Afinitor® (Everolimus) Approval Criteria [Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures Diagnosis]:

• An FDA approved diagnosis of TSC-associated partial-onset seizures; AND
• Initial prescription must be written by a neurologist or neuro-oncologist; AND
• Member must have failed therapy with at least three other medications commonly used for seizures; AND
• Afinitor® must be used as adjunctive treatment; AND
• The member must not be taking any P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) concurrently with Afinitor®; AND
• The member must not be taking St. John’s wort concurrently with Afinitor®; AND
• The prescriber must verify that Afinitor® trough levels and adverse reactions (e.g., non-infectious pneumonitis, stomatitis, hyperglycemia, dyslipidemia, thrombocytopenia, neutropenia, febrile neutropenia) will be monitored, and dosing changes or discontinuations will correspond with recommendations in the drug labeling; AND
• Verification from the prescriber that female members will use contraception while receiving Afinitor® therapy and for eight weeks after the last dose of Afinitor® and that male members with female partners of reproductive potential will use contraception while receiving Afinitor® therapy and for four weeks after the last dose of Afinitor®; AND
• The member’s recent body surface area (BSA) must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling. 
• Initial approvals will be for the duration of three months. For continuation, the prescriber must include information regarding improved response/effectiveness of the medication. 

Alecensa® (Alectinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

• A diagnosis of recurrent or metastatic NSCLC; AND
• Anaplastic lymphoma kinase (ALK) positivity; AND
• Alectinib must be used as a single-agent only; AND
• Alectinib may be used in first-line or recurrent setting.

Aliqopa™ (Copanlisib) Approval Criteria [Follicular Lymphoma (FL) Diagnosis]:  

• A diagnosis of relapsed/refractory FL; AND
• Member must have failed at least 2 prior systemic therapies.  

• A diagnosis of metastatic NSCLC; AND
• Anaplastic lymphoma kinase (ALK) positivity; AND
• Progressed on or intolerant to crizotinib; AND
• Brigatinib must be used as a single-agent only.

Arzerra® (Ofatumumab) Approval Criteria [Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Diagnosis]:  

• As first-line treatment of CLL in combination with chlorambucil or bendamustine; OR
• For relapsed or refractory disease as a single-agent or in combination with fludarabine and cyclophosphamide; OR
• As maintenance therapy as second-line extended dosing following complete or partial response to relapsed or refractory therapy (maximum 2 years).  

Arzerra® (Ofatumumab) Approval Criteria [Waldenström’s Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma Diagnosis]:

• For previously treated disease that does not respond to primary therapy or for progressive or relapsed disease; AND
• As a single-agent or combination therapy; AND
• Member is rituximab-intolerant. 

• A patient-specific, clinically significant reason why the member cannot use pegaspargase must be provided; AND
• Member must be 1 month to 21 years of age.  

• A diagnosis of unresectable or metastatic GIST in adult members; AND
• Member has a PDGFRA exon 18 mutation (including PDGFRA D842V mutations).  

• Adult and pediatric members 12 years of age and older; AND
• Iobenguane scan positive; AND
• Unresectable, locally advanced or metastatic pheochromocytoma or PPGL requiring systemic anticancer therapy. 

Bavencio® (Avelumab) Approval Criteria [Merkel Cell Carcinoma (MCC) Diagnosis]:

• A diagnosis of metastatic MCC; AND
• Member must be 12 years of age or older. 

Bavencio® (Avelumab) Approval Criteria [Renal Cell Carcinoma (RCC) Diagnosis]:

• Diagnosis of advanced RCC; AND
• Must be used as first-line treatment; AND
• Must be used in combination with axitinib.

Bavencio® (Avelumab) Approval Criteria [Urothelial Carcinoma Diagnosis]:

• A diagnosis of locally advanced or metastatic urothelial carcinoma; AND
• Disease has progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. 

Besponsa® (Inotuzumab Ozogamicin) Approval Criteria:   

• Besponsa® must be used as a single-agent only; AND  
• Member must have one of the following:
  • Relapsed/refractory Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL); OR  
  • Relapsed/refractory Philadelphia chromosome positive (Ph+) ALL who are intolerant/refractory to two or more Tyrosine Kinase Inhibitors (TKIs).  

Balversa™ (Erdafitinib) Approval Criteria [Urothelial Carcinoma Diagnosis]:   

• A diagnosis of locally advanced or metastatic urothelial carcinoma; AND  
• Tumor positive for FGFR2 or FGFR3 genetic mutation; AND  
• Use in second-line or greater treatments including: 
  • Following at least 1 line of platinum-containing chemotherapy; AND
  • Within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy 

bosutinib (Bosulif®)

bosutinib (Bosulif®) Approval Criteria [Chronic Myeloid Leukemia (CML) Diagnosis]:  

• Patients with chronic, accelerated, or blast phase CML; AND
• Newly diagnosed or resistant/intolerant to other tyrosine kinase inhibitors (TKIs).

bosutinib (Bosulif®) Approval Criteria [Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Diagnosis]:

• Bosulif® may be authorized for relapsed/refractory ALL either as:
  • Single-agent; OR
  • In combination with an induction regimen not previously given; AND 
• Bosulif® must be only used in patients with E255K/V, F317L/VI/C, F359V/C/I, T315A, or Y253H mutations. 

Braftovi™ (Encorafenib) Approval Criteria [Melanoma Diagnosis]:

• Diagnosis of unresectable or metastatic melanoma; AND
• BRAF V600E or V600K mutation; AND
• Used in combination with binimetinib.

Brukinsa™ (Zanubrutinib) Approval Criteria [Mantle Cell Lymphoma (MCL) Diagnosis]: 

• Adult members with a diagnosis of MCL; AND
• Member must have received at least 1 prior therapy.   

Bynfezia Pen™ (Octreotide) Approval Criteria [Metastatic Carcinoid Tumor or Vasoactive Intestinal Peptide-Secreting Tumors (VIPoma) Diagnosis]: 

• A diagnosis of advanced metastatic carcinoid tumor or VIPoma; AND
• Presence of severe diarrhea or flushing; AND
• A patient-specific, clinically significant reason why the member cannot use other available short-acting injectable formulations of octreotide must be provided.  

Bynfezia Pen™ (Octreotide) Approval Criteria [Acromegaly Diagnosis]:

• A diagnosis of acromegaly; AND
• Documentation of inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate or cabergoline at maximally tolerated doses; AND
• A patient-specific, clinically significant reason why the member cannot use other available short-acting injectable formulations of octreotide must be provided.  

Calquence® (Acalabrutinib) Approval Criteria [Mantle Cell Lymphoma (MCL) Diagnosis]:  

• As a single-agent. 

Calquence® (Acalabrutinib) Approval Criteria [Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Diagnosis]:

• As a single-agent.

Copiktra™ (Duvelisib) Approval Criteria [Follicular Lymphoma (FL) Diagnosis]: 

• A diagnosis of relapsed or refractory FL; AND
• Progression of disease following 2 or more lines of systemic therapy; AND
• Must be used as a single-agent.

Copiktra™ (Duvelisib) Approval Criteria [Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Diagnosis]:

• A diagnosis of relapsed or refractory CLL or SLL; AND
• Progression of disease following 2 or more lines of systemic therapy; AND
• Must be used as a single-agent.   

Cotellic® (Cobimetinib) Approval Criteria [Melanoma Diagnosis]:

• All of the following criteria must be met for approval: 
  • Diagnosis of unresectable or metastatic melanoma; AND
  • BRAF V600E or V600K mutation detected by an FDA-approved test; AND
    • Cobimetinib is not indicated for wild-type BRAF melanoma 
  • One of the following is met: 
    • Used as first-line therapy in combination with vemurafenib; OR
    • Used as second-line therapy or subsequent therapy with vemurafenib  

Cyramza® (Ramucirumab) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]: A diagnosis of NSCLC; AND

• Subsequent therapy for metastatic disease after progression; AND
• Ramucirumab must be used in combination with docetaxel.

Cyramza® (Ramucirumab) Approval Criteria [Colorectal Cancer Diagnosis]:

• A diagnosis of colorectal cancer; AND
• Subsequent therapy for metastatic disease after progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine; AND
• Ramucirumab must be used in combination with an irinotecan based regimen.

Cyramza® (Ramucirumab) Approval Criteria [Esophageal Cancer Diagnosis]:

• A diagnosis of unresectable, locally advanced, recurrent or metastatic esophageal or esophagogastic junction adenocarcinoma; AND
• Member must have a Karnofsky performance score greater than or equal to 60%; AND
• Ramucirumab must be used as a single-agent or in combination with paclitaxel.

Cyramza® (Ramucirumab) Approval Criteria [Gastric Cancer Diagnosis]:

• A diagnosis of gastric cancer; AND
• Member is not a surgical candidate or has unresectable, locally advanced, recurrent or metastatic disease; AND
• Member has a Karnofsky performance score of greater than or equal to 60%; AND
• Ramucirumab must be used as a single-agent or in combination with paclitaxel.   

Cyramza® (Ramucirumab) Approval Criteria [Hepatocellular Carcinoma (HCC) Diagnosis]:  

• A diagnosis of HCC; AND
• Used as second-line or greater therapy; AND
• Previously failed sorafenib; AND
• Has an alpha-fetoprotein concentration ≥400ng/mL; AND
• Used as a single-agent.

Daurismo™ (Glasdegib) Approval Criteria [Acute Myeloid Leukemia (AML) Diagnosis]:  

• Newly diagnosed AML in members 75 years of age or older or in adult members who have significant comorbidities that preclude use of intensive chemotherapy [severe cardiac disease, ECOG performance status ≥2, or serum creatinine (SCr) >1.3]; AND
• In combination with low-dose cytarabine (LDAC).  

Elzonris® (Tagraxofusp-erzs) Approval Criteria [Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Diagnosis]:  

• Diagnosis of BPDCN; AND
• Member must be 2 years of age or older; AND
• Must be used as a single-agent.   

vismodegib (Erivedge®)

• Either of the following criteria must be met for approval: 
  • Diagnosis of locally advanced basal cell carcinoma (BCC) that has either: 
    • Recurred following surgery or radiation therapy; OR
    • Surgery or radiation is contraindicated; OR
  • Diagnosis of metastatic basal cell carcinoma. 

apalutamide (Erleada™) Interim Approval Criteria:  

• A diagnosis of nonmetastatic prostate cancer; AND
• Castration-resistant or disease progression while on androgen deprivation therapy; AND
• Prostate specific antigen doubling time of ≤ 10 months; AND
• Concomitant treatment with a gonadotropin-releasing hormone (GnRH) analog or prior history of bilateral orchiectomy.

Gazyva® (Obinutuzumab) Approval Criteria [Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Diagnosis]:  

• As a single-agent for relapsed or refractory disease; OR
• In combination with chlorambucil, bendamustine, ibrutinib, or venetoclax for first-line therapy; AND
• When obinutuzumab is used in combination with venetoclax, maximum approval duration will be 6 treatment cycles of obinutuzumab.

Gazyva® (Obinutuzumab) Approval Criteria [Follicular Lymphoma (FL) Diagnosis]:

• Grade 1 or 2 patients with Stage I (≥7cm), contiguous Stage II (≥7cm), noncontiguous Stage II, Stage III, or Stage IV patients (first, second, or subsequent therapy); AND
• In combination with CHOP (cyclophosphamide, doxorubicin, vincristine, AND prednisone), CVP (cyclophosphamide, vincristine, and prednisone), or bendamustine; AND
• When used for maintenance therapy a total of 12 doses will be approved.

Gazyva® (Obinutuzumab) Approval Criteria [Gastric or Nongastric Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma, Nodal or Splenic Marginal Zone Lymphoma (MZL) Diagnosis]:

• As second-line or subsequent therapy in combination with bendamustine; OR
• Maintenance therapy as second-line consolidation or extended dosing in rituximab-refractory patients treated with obinutuzumab and bendamustine for a total of 12 doses.

Gilotrif® (Afatinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

The following criteria must be met when used in the first-line setting: 

• A diagnosis of metastatic NSCLC; AND
• Epidermal growth factor receptor (EGFR) mutation detected; AND
• Afatinib when used in the first-line setting must be used as a single-agent only. 

The following criteria must be met when used in the second-line setting: 

• A diagnosis of metastatic NSCLC; AND
• Progressed following platinum-based chemotherapy; AND
• Afatinib when used in the second-line setting may be used as a single-agent or in combination with cetuximab in patients with a known sensitizing EGFR mutation who are T790M negative.

Gilotrif® (Afatinib) Approval Criteria [Head and Neck Cancer Diagnosis]:

• A diagnosis of head and neck cancer; AND
• Disease progression on or after platinum containing chemotherapy; AND
• Non-nasopharyngeal cancer must be one of the following:  
  • Newly diagnosed T4b, any N, M0 disease, unresectable nodal disease with no metastases, or for patients who are unfit for surgery and performance status (PS) 3; OR
  • Metastatic (M1) disease at initial presentation, recurrent/persistent disease with distant metastases, or unresectable locoregional recurrence or second primary with prior radiation therapy (RT) and PS 0 to 2; OR
  • Unresectable locoregional recurrence without prior RT and PS 3; AND
• Afatinib must be used as a single-agent. 

• Diagnosis of metastatic breast cancer; AND 
• 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.

Halaven® (Eribulin) Approval Criteria [Liposarcoma Diagnosis]:

• Diagnosis of unresectable or metastatic liposarcoma; AND         
• Previously received an anthracycline-containing chemotherapy regimen.
• Authorizations will be for the duration of three months. Reauthorization may be granted if the patient does not show evidence of progressive disease while on eribulin therapy. 

Herzuma (trastuzumab-pkrb) Approval Criteria [Breast Cancer Diagnosis]:  

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing breast cancer; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab) must be provided.  

Herzuma (trastuzumab-pkrb) Approval Criteria [Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Diagnosis]:

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab) must be provided. 

• A diagnosis of advanced metastatic, hormone receptor positive, Human Epidermal Receptor Type 2 (HER2)-negative breast cancer in combination with:
  • Letrozole as initial endocrine-based therapy in postmenopausal women; or 
  • Fulvestrant in women with disease progression following endocrine therapy. 
• Authorizations will be for the duration of three months. Reauthorization may be granted if the patient does not show evidence of progressive disease while on palbociclib therapy. 

Idhifa® (Enasidenib) Approval Criteria [Acute Myeloid Leukemia (AML) Diagnosis]:  

• Newly diagnosed AML in members 75 years of age or older or in adult members who have comorbidities that preclude use of intensive chemotherapy; AND
  • As a single-agent; AND
  • IDH2 mutation; OR 
• Relapsed/refractory AML; AND
  • As a single-agent; AND
  • IDH2 mutation. 

• A diagnosis of Grade 1 or 2 FL; AND
• As subsequent therapy (third-line or greater) for histologic transformation to non-germinal center diffuse large B-cell lymphoma.

Imbruvica® (Ibrutinib) Approval Criteria [Gastric or Nongastric Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma, Nodal or Splenic Marginal Zone Lymphoma (MZL) Diagnosis]:

• As second-line or subsequent therapy for refractory or progressive disease.

Imbruvica® (Ibrutinib) Approval Criteria [Chronic Graft-Versus-Host Disease (cGVHD) Diagnosis]:

• A diagnosis of cGVHD after failure of one or more lines of therapy.

Imbruvica® (Ibrutinib) Approval Criteria [Histologic Transformation of Marginal Zone Lymphoma (MZL) to Diffuse Large B-Cell Lymphoma Diagnosis]:

• As third-line or greater therapy for patients who have transformed to non-germinal center diffuse large B-cell lymphoma.

Imbruvica® (Ibrutinib) Approval Criteria [Mantle Cell Lymphoma (MCL) Diagnosis]:

• As second-line or subsequent therapy; AND
• Used as a single-agent or in combination with rituximab or lenalidomide/rituximab.

Imbruvica® (Ibrutinib) Approval Criteria [Diffuse Large B-Cell Lymphoma Diagnosis or Acquired Immunodeficiency Syndrome (AIDS)-Related B-Cell Lymphoma Diagnosis]:

• A diagnosis of non-germinal center diffuse large B-cell lymphoma; AND      
• As second-line or subsequent therapy; AND
• Member is not a candidate for high-dose therapy.

Imbruvica® (Ibrutinib) Approval Criteria [Post-Transplant Lymphoproliferative Disorders Diagnosis]:

• As second-line and subsequent therapy in patients with partial response, persistent, or progressive disease; AND
• Non-germinal center B-cell type.

Imbruvica® (Ibrutinib) Approval Criteria [Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Diagnosis]:

• As first or subsequent therapy for CLL/SLL; AND
• As a single-agent or in combination with bendamustine/rituximab, rituximab, or obinutuzumab.

Imbruvica® (Ibrutinib) Approval Criteria [Hairy Cell Leukemia Diagnosis]:

• As a single-agent in patients with indication for treatment for progression.

Imbruvica® (Ibrutinib) Approval Criteria [Waldenström’s Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma Diagnosis]:

• As first or subsequent therapy; AND
• As a single-agent or in combination with rituximab.

Imfinzi® (Durvalumab) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

• A diagnosis of stage III NSCLC; AND
• Disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Imfinzi® (Durvalumab) Approval Criteria [Small Cell Lung Cancer (SCLC) Diagnosis]:

• Diagnosis of extensive-stage SCLC; AND
  
• In combination with etoposide and either cisplatin or carboplatin followed by single- agent maintenance. 

Imfinzi® (Durvalumab) Approval Criteria [Urothelial Carcinoma Diagnosis]:

• A diagnosis of locally advanced or metastatic urothelial carcinoma; AND
• Progressed on or following platinum-containing chemotherapy.

Imlygic® (Talimogene Laherparepvec) Approval Criteria [Melanoma Diagnosis]:  

All of the following criteria must be met for approval:

• Patient has unresectable cutaneous, subcutaneous, or nodal lesions that are recurrent after initial surgery; AND
• Talimogene laherparepvec is not indicated with visceral metastases.
• The patient is not immunocompromised or pregnant.

Inrebic® (fedratinib) Approval Criteria [Myelofibrosis Diagnosis]:  

• Diagnosis of myelofibrosis in adult members;AND
• Intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia).

Ixempra® (Ixabepilone) Approval Criteria (Medical Billing Only):   

• Diagnosis of metastatic or locally advanced breast cancer; AND 
• Usage as either:
  • In combination with capecitabine after failure of an anthracycline and a taxane; OR
    • May be used in combination in taxane only resistance if anthracyclines not indicated; OR  
  • Monotherapy after failure of an anthracycline, a taxane, and capecitabine. 

• A diagnosis of metastatic, castration-resistant prostate cancer; AND
• Member must have been previously treated with a docetaxel-containing regimen; AND
• Cabazitaxel should be used in combination with prednisone; AND
• Approvals will be for the duration of three months at which time additional authorization may be granted if the prescriber documents that the member has not shown evidence of progressive disease while on cabazitaxel therapy.

• Positive expression of Human Epidermal Receptor Type 2 (HER2); AND
• Diagnosis of metastatic breast cancer; AND
• Member has previously received trastuzumab and a taxane, separately or in combination; AND
• Members should also have either:
  • Received prior therapy for metastatic disease; OR
  • Developed disease recurrence during or within six months of completing adjuvant therapy. 

Kanjinti™ (Trastuzumab-anns) Approval Criteria [Breast Cancer Diagnosis]:  

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing breast cancer; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab) must be provided.  

Kanjinti™ (Trastuzumab-anns) Approval Criteria [Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Diagnosis]:

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab) must be provided.  

Keytruda® (Pembrolizumab) Approval Criteria [Cervical Cancer Diagnosis]:   

• A diagnosis of recurrent or metastatic cervical cancer; AND
• Patient has had disease progression on or after chemotherapy; AND
• Tumors must express PD-L1 [Combined Positive Score (CPS) ≥1]; AND  
• The patient has not previously failed other PD-1 inhibitors [e.g., Opdivo® (nivolumab)]. 

Keytruda® (Pembrolizumab) Approval Criteria [Endometrial Cancer Diagnosis]:  

• Diagnosis of advanced endometrial cancer that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); AND  
• Progressive disease following prior systemic therapy; AND
• Member is not a candidate for curative surgery or radiation; AND
• Must be used in combination with lenvatinib; AND
• Member has not previously failed other PD-1 inhibitors [e.g., Opdivo® (nivolumab)]. 

Keytruda® (Pembrolizumab) Approval Criteria [Esophageal Cancer Diagnosis]:

• Diagnosis of locally advanced or metastatic esophageal carcinoma; AND
• Must be used following disease progression after 1 or more prior lines of systemic therapy; AND
• Tumor must be squamous cell histology; AND
• Tumor must have positive PD-L1 expression [Combined Positive Score (CPS) ≥10]; AND  
• Pembrolizumab must be used as monotherapy; AND
• Member has not previously failed other PD-1 inhibitors [e.g., Opdivo® (nivolumab)]. 

Keytruda® (Pembrolizumab) Approval Criteria [Hodgkin Lymphoma Diagnosis]:

• All of the following criteria must be met for approval:
  • Diagnosis of relapsed or refractory classical Hodgkin lymphoma; AND
    • Exception: lymphocyte-predominant Hodgkin lymphoma   
  • Pembrolizumab must be used as a single-agent; AND
  • The patient has not previously failed other PD-1 inhibitors [i.e. Opdivo® (nivolumab)]. 

Keytruda® (Pembrolizumab) Approval Criteria [Metastatic Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

• All of the following criteria must be met for approval:
• Diagnosis of metastatic NSCLC; AND
• The patient has not previously failed other PD-1 inhibitors [i.e. Opdivo® (nivolumab)]; AND
• Tumor proportion scores for PD-L1 expression as follows:
  • Single-agent, first-line: ≥1% 
  • First-line in combination with carboplatin and pemetrexed: no expression required 
  • Second-line: ≥1%; AND  
• Patient meets one of the following:
  • Previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC) in combination with pemetrexed and carboplatin; OR
  • New diagnosis as first-line therapy (patient has not received chemotherapy to treat disease) if:
    • Tumor does not express sensitizing EGFR mutations or ALK translocations; OR
  • Single-agent for disease progression on or after platinum-containing chemotherapy (cisplatin or carboplatin): 
    • Patients with EGFR-mutation-positive should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab. This does not apply if tumors do not have these mutations; AND
      • Examples of drugs for EGFR-mutation-positive tumors: osimertinib, eroltinib, afatinib, or gefitinib  
    • Patients with ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.  This does not apply if tumors do not have these mutations; AND
      • Examples of drugs for ALK-mutation-positive tumors: crizotinib, ceritinib, or alectinib  

Keytruda® (Pembrolizumab) Approval Criteria [Head and Neck Cancer Diagnosis]: 

• All of the following criteria must be met for approval:
  • Squamous cell histology; AND
  • If used in the recurrent setting, member has not previously failed other PD-1 inhibitors [[e.g., Opdivo® (nivolumab)]; AND
  • Dose does not exceed 200mg every three weeks. 

Keytruda® (Pembrolizumab) Approval Criteria [Melanoma Diagnosis]:

• All of the following criteria must be met for approval:
  • Diagnosis of unresectable or metastatic melanoma; AND   
  • Pembrolizumab must be used as a single-agent; AND
  • Patient meets one of the following:
    • Pembrolizumab is being used as first-line therapy; OR
    • Pembrolizumab is being used as second-line therapy or subsequent therapy for disease progression if not previously used; AND
  • The patient has not previously failed other PD-1 inhibitors [i.e. Opdivo® (nivolumab)].  

Keytruda® (Pembrolizumab) Approval Criteria [Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumor (Tissue/Site-Agnostic) or Metastatic Colorectal Cancer Diagnosis]:

• MSI-H or dMMR solid tumors that have progressed following prior treatment with no satisfactory alternative treatment options; OR
• MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Keytruda® (Pembrolizumab) Approval Criteria [Non-Muscle Invasive Bladder Cancer (NMIBC) Diagnosis]:

• A diagnosis of high-risk, NMIBC; AND
• Member must have failed therapy with Bacillus Calmette-Guerin (BCG)-therapy; AND
• Member must be ineligible for or has elected not to undergo cystectomy. 

Keytruda® (Pembrolizumab) Approval Criteria [Primary Mediastinal Large B-cell Lymphoma (PMBCL) Diagnosis]:

• A diagnosis of PMBCL in adult or pediatric patients; AND
• Patient must have refractory disease or pembrolizumab must be used in patients who have relapsed after 2 or more prior lines of therapy; AND
• Authorizations will not be granted for patients who require urgent cytoreduction; AND
• The patient has not previously failed other PD-1 inhibitors [e.g., Opdivo® (nivolumab)].
  
  

Keytruda® (Pembrolizumab) Approval Criteria [Urothelial Carcinoma Diagnosis]:

• Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy; OR  
• Within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; OR  
• Frontline pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
  • Cisplatin ineligibility is defined as:
    • Baseline creatinine clearance of <60mL/min, or Class III heart failure, or grade 2 or greater peripheral neuropathy, or grade 2 or greater hearing loss.  

Keytruda® (Pembrolizumab) Approval Criteria [Gastric or Gastroesophageal Junction Tumor Diagnosis]:

• Recurrent, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma; AND
• Tumors must express PD-L1; AND
• Disease progression on or after 2 or more prior systemic therapies (including fluoropyrimidine- and platinum-containing chemotherapy, and if appropriate, HER2/neu-targeted therapy).

Keytruda® (Pembrolizumab) Approval Criteria [Nonmetastatic Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:  

• A diagnosis of stage 3 NSCLC; AND  
• Ineligible for surgery or definitive chemoradiation; AND
• Tumor proportion scores for PD-L1 expression ≥1%; AND
• The member has not previously failed other PD-1 inhibitors [e.g., Opdivo® (nivolumab)]. 

Keytruda® (Pembrolizumab) Approval Criteria [Non-Muscle Invasive Bladder Cancer (NMIBC) Diagnosis]:

• A diagnosis of high-risk, NMIBC; AND
• Member must have failed therapy with Bacillus Calmette-Guerin (BCG)-therapy; AND
• Member must be ineligible for or has elected not to undergo cystectomy. 

Keytruda® (Pembrolizumab) Approval Criteria [Renal Cell Carcinoma (RCC) Diagnosis]:  

• Member must have newly diagnosed or recurrent stage 4 clear-cell RCC; AND
• Have received no previous systemic therapy for advanced disease; AND
• Must be used in combination with Inlyta® (axitinib); AND
• The member has not previously failed other PD-1 inhibitors [e.g., Opdivo® (nivolumab)].  

Keytruda® (Pembrolizumab) Approval Criteria [Small Cell Lung Cancer (SCLC) Diagnosis]:

• Diagnosis of metastatic SCLC; AND
• Progressed on or following a platinum-based regimen and at least 1 other regimen; AND
• Member has not previously failed other PD-1 inhibitors [e.g., Opdivo® (nivolumab)].
•  

ribociclib (Kisqali®)

Kisqali® (Ribociclib) Approval Criteria [Breast Cancer Diagnosis]: 

• Member must be Hormone Receptor (HR)-positive; AND
• Member must be Human Epidermal Receptor Type 2 (HER2)-negative; AND
• If used in combination with an aromatase inhibitor: 
  • Diagnosis of advanced or metastatic breast cancer, initial therapy; OR 
• If used in combination with fulvestrant: 
  • Diagnosis of advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy; AND
  • Must be used in postmenopausal women only.  

Kisqali® Femara® Co-Pack (Ribociclib/Letrozole) Approval Criteria:

• A diagnosis of advanced or metastatic breast cancer, initial therapy; AND
• Member must be Hormone Receptor (HR)-positive; AND
• Member must be Human Epidermal Receptor Type 2 (HER2)-negative.

tisagenlecleucel (Kymriah™) Approval Criteria [Lymphoma Diagnosis]:  

• Large B-cell lymphoma [including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (FL)]; AND
• Relapsed or refractory disease; AND
• Member must be 18 years of age or older;  AND
• Member must not have primary central nervous system lymphoma; AND
• Member must have had two or more lines of therapy; AND
• Health care facilities must be on the certified list to administer chimeric antigen receptor (CAR) T-cells and must be trained in the management of cytokine release syndrome (CRS), neurologic toxicities, and comply with the REMS requirements.  

 tisagenlecleucel (Kymriah™) Approval Criteria [Acute Lymphoblastic Leukemia (ALL) Diagnosis]:

• All of the following must be met for approval:
  • B-Cell precursor acute lymphoblastic leukemia (ALL); AND
  • Member must be 25 years of age or younger; AND
  • Refractory or in second or later relapse:
    • Philadelphia chromosome negative (Ph-) ALL: must be refractory or with ≥2 relapses; OR
    • Philadelphia chromosome positive (Ph+) ALL: must have failed ≥2 Tyrosine Kinase Inhibitors (TKIs); AND
  • Therapies to consider prior to tisagenlecleucel if appropriate: clinical trial, multi-agent chemotherapy with or without hematopoietic cell transplantation (HCT), blinatumomab (category 1 recommendation), and inotuzumab (category 1 recommendation).  
• Healthcare facilities must be on the certified list to administer CAR T cells and must be trained in the management of cytokine release syndrome (CRS), neurologic toxicities, and comply with the REMS requirements.   

Libtayo® (Cemiplimab-rwlc) Approval Criteria [Cutaneous Squamous Cell Carcinoma (CSCC) Diagnosis]:   

• Diagnosis of metastatic or locally advanced CSCC; AND
• Member is not eligible for curative surgery or radiation; AND
• Member has not received prior immunotherapy agent(s) [e.g., Keytruda® (pembrolizumab), Opdivo® (nivolumab), Yervoy® (ipilimumab)].  

Lorbrena® (Lorlatinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:   

• A diagnosis of metastatic NSCLC; AND  
• Tumor expresses anaplastic lymphoma kinase (ALK) translocation; AND
• Used as a single-agent as second-line therapy following disease progression on either alectinib or ceritinib; OR  
• Used as a single-agent as third-line or greater therapy following disease progression on crizotinib and 1 other ALK inhibitor (i.e., ceritinib, alectinib). 

• Treatment of relapsed or refractory HCL in adults; AND
• Member has received at least 2 prior systemic therapies, including treatment with a purine nucleoside analog (PNA); AND
• Creatinine clearance (CrCl) ≥30mL/minute/1.73m²; AND
• As a single-agent. 

Lynparza® (Olaparib) Approval Criteria [Ovarian Cancer Diagnosis]:   

• Diagnosis of deleterious or suspected deleterious germline BRCA mutated (gBRCAm), advanced ovarian cancer; AND
• The member must have been treated with three or more prior lines of chemotherapy. Prior chemotherapy regimens should be documented on the prior authorization request; AND
• A quantity limit based on FDA approved dosing will apply.  

Lynparza® (Olaparib) Approval Criteria [Breast Cancer Diagnosis]:

• Diagnosis of metastatic breast cancer; AND
• Member must have shown progression on previous chemotherapy in any setting; AND
• Human epidermal receptor 2 (HER2)-negative; AND
• Positive test for a germline BRCA-mutation (gBRCAm); AND
• Members with hormone receptor positive disease must have failed prior endocrine therapy or are considered to not be a candidate for endocrine therapy.

Lynparza® (Olaparib) Approval Criteria [Maintenance Treatment Diagnosis]:

• Used for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy; AND
• The member must have been completed therapy with the platinum agent in the prior 8 weeks; AND
• A quantity limit based on FDA approved dosing will apply.

 Lutathera® (Lutetium Lu 177 Dotatate) Approval Criteria [Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Diagnosis]:  

• Diagnosis of progressive locoregional advanced disease or metastatic disease; AND
• Positive imaging of somatostatin receptor; AND  
• Must be used as second-line or subsequent therapy following progression on octreotide or lanreotide; OR  
• May be used first-line for treatment of pheochromocytoma/paraganglioma.  

Mekinist® (Trametinib) Approval Criteria [Anaplastic Thyroid Cancer (ATC) Diagnosis]:

• Diagnosis of ATC; AND
• Locally advanced or metastatic disease; AND
• BRAF V600E mutation; AND
• No satisfactory locoregional treatment options.

Mekinist® (Trametinib) Approval Criteria [Melanoma Diagnosis]:  

• All of the following criteria must be met for approval:
  • Diagnosis of unresectable or metastatic melanoma; AND
  • BRAF V600E or V600K mutation detected by an FDA-approved test; AND
    • Trametinib is not indicated for wild-type BRAF melanoma. 
  • One of the following is met:
    • Used as first-line therapy in combination with dabrafenib; OR
    • Used as second-line therapy or subsequent therapy with dabrafenib and patient has an ECOG performance status of 0 to 2; OR
    • Used as second-line therapy or subsequent therapy as a single-agent if:
      • Patient was intolerant to prior BRAF inhibitor therapy (dabrafenib, vemurafenib); AND
      • No evidence of disease progression on prior BRAF inhibitor therapy (dabrafenib, vemurafenib) 

Mekinist® (Trametinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

• All of the following criteria must be met for approval:
  • BRAF V600E or V600K mutation detected by an FDA-approved test; AND
    • Trametinib is not indicated for wild-type BRAF NSCLC 
  • Trametinib must be used in combination with dabrafenib. 
  • Diagnosis of refractory or metastatic disease. 

Mektovi® (Binimetinib) Approval Criteria [Melanoma Diagnosis]:

• Diagnosis of unresectable or metastatic melanoma; AND
• BRAF V600E or V600K mutation; AND
• Used in combination with encorafenib.

• For adjuvant treatment in early stage breast cancer; AND
• Member must have Human Epidermal Receptor Type 2 (HER2)-overexpressed breast cancer; AND
• Neratinib must be used to follow adjuvant trastuzumab-based therapy. 
• Authorizations will be for the duration of three months. Reauthorization may be granted if the patient does not show evidence of progressive disease while on neratinib therapy. 

Ogivri™ (Trastuzumab-dkst) Approval Criteria [Breast Cancer Diagnosis]:

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing breast cancer; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab).

Ogivri™ (Trastuzumab-dkst) Approval Criteria [Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Diagnosis]:

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab).

Ontruzant® (trastuzumab-dttb) Approval Criteria [Breast Cancer Diagnosis]:  

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing breast cancer; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab) must be provided.  

Ontruzant® (trastuzumab-dttb) Approval Criteria [Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Diagnosis]:

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab) must be provided.  

Opdivo® (Nivolumab) Approval Criteria [Adjuvant Treatment of Melanoma]:   

• All of the following criteria must be met for approval:
  • Patient has complete resection of melanoma; AND 
  • Diagnosis of stage IIIB/C melanoma following complete resection; AND
  • Nivolumab must be used as a single-agent; AND
  • Dose as follows:
    • Single-agent: 240mg every two weeks 
    • Maximum duration of 1 year.  

Opdivo® (Nivolumab) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

• All of the following criteria must be met for approval: 
  • Diagnosis of metastatic NSCLC; AND
  • Tumor histology is one of the following:
    • Adenocarcinoma; OR
    • Squamous cell; OR
    • Large Cell; AND
  • Nivolumab must be used as a single-agent; AND
  • Disease progression on or after platinum-containing chemotherapy (cisplatin or carboplatin); AND
  • The patient has not previously failed other PD-1 inhibitors [i.e. Keytruda® (pembrolizumab)]; AND
  • Dose as follows:
    • Single-agent: 240mg every two weeks or 480mg every four weeks. 

Opdivo® (Nivolumab) Approval Criteria [Small Cell Lung Cancer Diagnosis]: 

• All of the following criteria must be met for approval: 
  • One of the following criteria is met:
    • Disease relapsed within six months of initial chemotherapy; OR
    • Disease is progressive on initial chemotherapy; AND  
  • Nivolumab must be used as a single-agent or in combination with ipilimumab; AND
  • The patient has not previously failed other PD-1 inhibitors (i.e. Keytruda® (pembrolizumab)]. 

Opdivo® (Nivolumab) Approval Criteria [Hodgkin Lymphoma Diagnosis]:

• All of the following criteria must be met for approval: 
  • Diagnosis of relapsed or refractory classical Hodgkin lymphoma; AND
    • Exception: lymphocyte-predominant Hodgkin lymphoma   
  • Nivolumab must be used as a single-agent; AND
  • The patient has not previously failed other PD-1 inhibitors [i.e. Keytruda® (pembrolizumab)]. 

Opdivo® (Nivolumab) Approval Criteria [Head and Neck Cancer]:  

• A diagnosis of recurrent or metastatic head and neck cancer; AND
• Squamous cell histology; AND
• Patient has received prior platinum containing regimen (cisplatin or carboplatin); AND
• The patient has not previously failed other PD-1 inhibitors [e.g., Keytruda® (pembrolizumab)]; AND
• Dose as follows: 240mg every two weeks or 480mg every four weeks.

 Opdivo® (Nivolumab) Approval Criteria [Hepatocellular Carcinoma (HCC) Diagnosis]:

• Relapsed or progressive disease; AND
• Member must have been previously treated with sorafenib. 

Opdivo® (Nivolumab) Approval Criteria [Metastatic Colorectal Cancer Diagnosis]:

• Diagnosis of metastatic colorectal cancer; AND
• Disease has progressed on treatment with 5-FU, oxaliplatin, and irinotecan; AND
• Tumor possesses high microsatellite-instability or mismatch repair deficiency; AND
• Used as a single-agent or in combination with ipilimumab. 

Opdivo® (Nivolumab) Approval Criteria [Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer Diagnosis]:

• Diagnosis of MSI-H or dMMR metastatic colorectal cancer; AND
• Progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Opdivo® (Nivolumab) Approval Criteria [Renal Cell Carcinoma(RCC) Diagnosis]:

• For nivolumab monotherapy:
  • Diagnosis of relapsed or surgically unresectable stage IV disease; AND
    • Failed prior therapy with one of the following medications:
      • Sunitinib; OR
      • Sorafenib; OR
      • Pazopanib; OR
      • Axitinib; AND
• For nivolumab use in combination with ipilimumab: 
  • A diagnosis of relapsed or surgically unresectable stage IV disease in the initial treatment of patients with intermediate or poor risk, previously untreated, advanced RCC; AND 
• The patient has not previously failed other PD-1 inhibitors [i.e. Keytruda® (pembrolizumab)]; AND
• Dose as follows:
  • Single-agent: 240mg every two weeks or 480mg every four weeks; OR
  • In combination with ipilimumab: nivolumab 3mg/kg followed by ipilimumab 1mg/kg on the same day, every three weeks for a maximum of four doses, then nivolumab 240mg every two weeks or 480mg every four weeks. 

Opdivo® (Nivolumab) Approval Criteria [Unresectable of Metastatic Melanoma Diagnosis]:

• All of the following criteria must be met for approval:
  • Diagnosis of unresectable or metastatic melanoma; AND
  • Nivolumab must be used as a single-agent, or in combination with ipilimumab:
    • As first-line therapy for untreated melanoma; OR
    • As second-line or subsequent therapy for documented disease progression while receiving or since completing most recent therapy:
      • If the patient has not previously failed other PD-1 inhibitors [i.e. Keytruda® (pembrolizumab)]; AND
      • Dose as follows:
    • Single-agent: 240mg every two weeks or 480mg every four weeks; OR
    • In combination with ipilimumab: 1mg/kg, followed by ipilimumab on the same day, every three weeks for four doses, then 240mg every two weeks or 480mg every four weeks.

Opdivo® (Nivolumab) Approval Criteria [Urothelial Bladder Cancer Diagnosis]:

• A diagnosis of metastatic or unresectable locally advanced cancer; and
• Used as second-line or greater therapy; AND
• Patient has failed a platinum containing regimen

Pemfexy™ (Pemetrexed) Approval Criteria:

• An FDA approved diagnosis; AND
• A patient-specific, clinically significant reason the member cannot use Alimta® (pemetrexed) must be provided.

• Positive expression of Human Epidermal Receptor Type 2 (HER2); AND
• Usage for either:
  • Metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease:
    • Used in combination with trastuzumab and docetaxel; OR
  • Neoadjuvant treatment of patients with locally advanced, inflammatory, or early stage breast cancer (either greater than 2cm in diameter or node positive): 
    • Used in combination with trastuzumab and docetaxel of paclitaxel; OR  
  • Adjuvant systemic therapy for patients with node positive, HER2-positive tumors or high-risk node negative members [tumor >1cm; tumor 0.5 to 1cm with histologic or nuclear grade 3; estrogen receptor (ER)/progesterone receptor (PR) negative; or age <35]: 
    • Used in combination with trastuzumab and paclitaxel following AC (doxorubicin/cyclophosphamide); OR
    • Used in combination with trastuzumab and docetaxel following AC; OR
    • Used in combination with TCH (docetaxel/carboplatin/trastuzumab). 

• Relapsed/refractory DLBCL or high grade B-cell lymphoma after at least 2 prior therapies; AND
• Used in combination with bendamustine and rituximab; AND
• Member is not a candidate for transplant.  

• A diagnosis of metastatic, castration-resistant prostate cancer; AND
• Member must be asymptomatic or minimally symptomatic; AND
• Member must not have hepatic metastases; AND
• Member must have a life expectancy of greater than six months; AND
• Approvals will be for the duration of three months at which time additional authorization may be granted if the prescriber documents that the member has not shown evidence of progressive disease while on sipuleucel-T therapy.

Rozlytrek® (Entrectinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:  

• Diagnosis of metastatic NSCLC; AND
• ROS1-positive.

Rozlytrek® (Entrectinib) Approval Criteria [Solid Tumor Diagnosis]:

• Diagnosis of solid tumors; AND
• Member must be 12 years of age or older; AND
• Neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; AND
• Metastatic or not a surgical candidate; AND
• Progressed following treatment or have no satisfactory alternative therapy. 

• An FDA approved diagnosis; AND
• A patient-specific, clinically significant reason why the member cannot use Rituxan® (rituximab) must be provided. 

Sarclisa® (Isatuximab-irfc) Approval Criteria [Multiple Myeloma Diagnosis]:  

• Relapsed/refractory multiple myeloma after at least 2 prior therapies (must have included lenalidomide and a proteasome inhibitor); AND
• In combination with pomalidomide and dexamethasone. 

Sprycel® (Dasatinib) Approval Criteria [Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Diagnosis]:

• Member must have 1 of the following:  
  • Upfront therapy (including induction and consolidation) in combination with multi-agent chemotherapy or as a single-agent; OR  
  • Maintenance therapy including:
    •  In combination with vincristine and prednisone, with or without methotrexate and mercaptopurine; OR
    • Post-hematopoietic stem cell transplant; OR   
  • Relapsed/refractory as a single-agent or in combination with multi-agent chemotherapy.  

Sprycel® (Dasatinib) Approval Criteria [Chronic Myeloid Leukemia (CML) Diagnosis]:

• Member must have 1 of the following:
  • Chronic, accelerated, or blast phase CML; OR
  • Post-hematopoietic stem cell transplant.  

Sprycel® (Dasatinib) Approval Criteria [Soft Tissue Sarcoma – Gastrointestinal Stromal Tumors (GIST) Diagnosis]:

• Member must have all of the following:
  • Progressive disease and failed imatinib, sunitinib, or regorafenib; AND  
  • PDGFRA D842V mutation.  

Tafinlar® (Dabrafenib) Approval Criteria [Anaplastic Thyroid Cancer (ATC) Diagnosis]:  

• Diagnosis of ATC; AND
• Locally advanced or metastatic disease; AND
• BRAF V600E mutation; AND
• No satisfactory locoregional treatment options.  

Tafinlar® (Dabrafenib) Approval Criteria [Melanoma Diagnosis]:

• All of the following criteria must be met for approval:
  • Diagnosis of unresectable or metastatic melanoma; AND
  • BRAF V600E or V600K mutation detected by an FDA-approved test; AND
    • Not indicated for wild-type BRAF melanoma    
  • Dabrafenib must be used as a single-agent or in combination with trametinib (Mekinist®); AND
  • One of the following is met:
    • Used as first-line therapy; OR
    • Used as second-line therapy or subsequent therapy and patient has an ECOG performance status of 0 to 2.  

Tafinlar® (Dabrafenib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

• All of the following criteria must be met for approval:
  • BRAF V600E or V600K mutation detected by an FDA-approved test; AND
    • Not indicated for wild-type BRAF NSCLC 
  • Dabrafenib must be used as a single-agent or in combination with trametinib (Mekinist®) 
  • Diagnosis of refractory or metastatic disease 

Tagrisso™ (Osimertinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

• A diagnosis of metastatic NSCLC; AND
  • Epidermal growth factor receptor (EGFR) T790M mutation-positive disease and following progression on erlotinib, afatinib, or gefitinib for asymptomatic disease, symptomatic brain lesions, or multiple symptomatic systemic lesions; OR  
  • First-line treatment of patients of EGFR exon 19 deletions of exon 21 L858R mutations.

Tarceva® (Erlotinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:  

• A diagnosis of NSCLC; AND
• Recurrence or metastatic disease; AND
• Epidermal growth factor receptor (EGFR) mutation detected; AND
• Erlotinib must be used as a single-agent only. 

Tarceva® (Erlotinib) Approval Criteria [Pancreatic Cancer Diagnosis]:

• A diagnosis of pancreatic cancer; AND
• Locally advanced unresectable or metastatic disease; AND
• Erlotinib must be used as a first-line agent only; AND
• Erlotinib must be used in combination with gemcitabine.

Tarceva® (Erlotinib) Approval Criteria [Kidney Cancer Diagnosis]:

• A diagnosis of kidney cancer; AND
• Non-clear cell type; AND
• Relapsed disease or for surgically unresectable stage IV disease; AND
• Erlotinib must be used as a single-agent only.

Tarceva® (Erlotinib) Approval Criteria [Bone Cancer – Chordoma Diagnosis]:

• A diagnosis of bone cancer – chordoma; AND
• Recurrent disease; AND
• Erlotinib must be used as a single-agent only.

Tarceva® (Erlotinib) Approval Criteria [Pancreatic Adenocarcinoma Diagnosis]:

• A diagnosis of pancreatic adenocarcinoma; AND
• Locally advanced unresectable disease or metastatic disease; AND
• Erlotinib must be used in combination with gemcitabine. 

Tasigna® (Nilotinib) Approval Criteria [Chronic Myeloid Leukemia (CML) Diagnosis]:  

• Member must have 1 of the following:  
  • Newly diagnosed chronic, accelerated, or blast phase CML; OR
  • Philadelphia Chromosome Positive (Ph+) CML chronic phase (CP) resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy; OR
  • Post-hematopoietic stem cell transplantation.  

Tazverik™ (Tazemetostat) Approval Criteria [Epithelioid Sarcoma Diagnosis]:  

• A diagnosis of metastatic or locally advanced epithelioid sarcoma; AND
• Member is not eligible for complete resection; AND
• Member must be 16 years of age or older.  

Tecentriq® (Atezolizumab) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:  

• A diagnosis of non-squamous NSCLC; AND 
  • First-line therapy for metastatic disease; AND
  • The member does not have epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations; AND 
  • Atezolizumab must be used in combination with bevacizumab, paclitaxel, AND carboplatin (maximum of 6 cycles) or in combination with paclitaxel (protein bound) and carboplatin; AND 
  • Atezolizumab and bevacizumab may be continued after the above combination in members without disease progression (applies to the bevacizumab/paclitaxel/carboplatin regimen); OR
• A diagnosis of NSCLC; AND
  • Subsequent therapy for metastatic disease; AND
  • Atezolizumab must be used as a single-agent only. 

Tecentriq® (Atezolizumab) Approval Criteria [Urothelial Carcinoma]:

• A diagnosis of locally advanced or metastatic urothelial carcinoma; AND
• Progressed on or following platinum containing chemotherapy or in cisplatin ineligible patients.

Tecentriq® (Atezolizumab) Approval Criteria [Small Cell Lung Cancer (SCLC) Diagnosis]:  

• A diagnosis of SCLC; AND
• First-line therapy; AND
• Extensive-stage disease; AND
• Atezolizumab must be used in combination with carboplatin and etoposide.

Tecentriq® (Atezolizumab) Approval Criteria [Breast Cancer Diagnosis]:  

• Unresectable locally advanced or metastatic triple-negative breast cancer; AND
• In combination with nab-paclitaxel (Abraxane®); AND
• Member must have positive expression of programmed death ligand-1 (PD-L1); AND
• Member has not failed other immunotherapy(ies).

Tibsovo® (Ivosidenib) Approval Criteria [Acute Myeloid Leukemia (AML) Diagnosis]:  

• Newly diagnosed AML in members 75 years of age or older or in adult members who have comorbidities that preclude use of intensive chemotherapy; AND
  • As a single-agent; AND
  • IDH1 mutation; OR  
• Relapsed/refractory AML; AND
  • As a single-agent; AND
  • IDH1 mutation.  

Trazimera™ (Trastuzumab-qyyp) Approval Criteria [Breast Cancer Diagnosis]:

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing breast cancer; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab).

Trazimera™ (Trastuzumab-qyyp) Approval Criteria [Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Diagnosis]:

• Diagnosis of human epidermal receptor 2 (HER2)-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma; AND
• A patient-specific, clinically significant reason why the member cannot use Herceptin® (trastuzumab).

Truxima® (Rituximab-abbs) Approval Criteria:

• An FDA approved diagnosis; AND
• A patient-specific, clinically significant reason why the member cannot use Rituxan® (rituximab) must be provided.  

Turalio™ (Pexidartinib) Approval Criteria [Soft Tissue Sarcoma – Pigmented Villonodular Synovitis (PVNS)/Tenosynovial Giant Cell Tumor (TGCT) Diagnosis]:   

• Member must not be a candidate for surgery; AND
• Pexidartinib must be used as a single-agent only. 

Tykerb® (Lapatinib) Approval Criteria (Pharmacy Billing Only):  

• An FDA approved diagnosis of metastatic or recurrent breast cancer; AND
• Positive expression of Human Epidermal Receptor Type 2 (HER2); AND
• Tykerb® must be used in combination with one of the following:
  • Herceptin (trastuzumab); OR
  • Xeloda (capecitabine); OR
  • An aromatase inhibitor [e.g. Aromasin® (exemestane), Femara® (letrozole) or Arimidex® (anastrozole)] if also estrogen receptor positive (ER positive).   

Venclexta® (Venetoclax) Approval Criteria [Acute Myeloid Leukemia (AML) Diagnosis]:   

• Member meets 1 of the following:
  • Member must be 75 years of age or older; OR  
  • If the member is younger than 75 years of age, they must be unable to tolerate intensive induction chemotherapy; AND  
• As first-line therapyor relapsed/refractory disease; AND  
• Must be used in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC). 

Venclexta™ (Venetoclax) Approval Criteria [Mantle Cell Lymphoma (MCL) Diagnosis]:  

• As second-line or subsequent therapy; AND 
• As a single-agent only.  

Venclexta™ (Venetoclax) Approval Criteria [Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Diagnosis]:

• Untreated disease in combination with obinutuzumab for a maximum duration of 12 months; OR
• Relapsed/refractory disease in combination with rituximab or as a single-agent.  

Verzenio™ (Abemaciclib) Approval Criteria [Breast Cancer Diagnosis]:   

• Used in one of the following settings:  
  • In combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women; OR
  • In combination with fulvestrant with disease progression following endocrine therapy in advanced or metastatic breast cancer; OR  
  • As monotherapy for disease progression following endocrine therapy and prior chemotherapy in metastatic breast cancer; AND  
• All the following criteria must be present:
  • Advanced or metastatic breast cancer; AND
  • Progressed after endocrine therapy when used with fulvestrant or as initial therapy in combination with an aromatase inhibitor; AND
  • Hormone receptor positive; AND
  • Human epidermal receptor 2 (HER2)-negative.

Vitrakvi® (Larotrectinib) Approval Criteria [Solid Tumors With Neurotrophic Receptor Tyrosine Kinase (NTRK) Gene Fusion Diagnosis]:   

• Diagnosis of a solid tumor with a NTRK gene fusion without a known acquired resistance mutation; AND
• Disease is metastatic or surgical resection (or radioactive iodine refractory if thyroid carcinoma) is contraindicated; AND
• Documentation of no satisfactory alternative treatments or progression following acceptable alternative treatments. 

Vizimpro® (Dacomitinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:   

• A diagnosis of metastatic NSCLC; AND
• Member has not received prior epidermal growth factor receptor (EGFR) therapy for metastatic disease; AND
• Member must meet 1 of the following:
  • EGFR exon 19 deletion; OR  
  • Exon 21 L858R substitution mutation. 

Xalkori® (Crizotinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:  

• A diagnosis of metastatic NSCLC (first-line or subsequent therapy); AND
• Anaplastic lymphoma kinase (ALK) or ROS1 positivity; OR  
• MET amplification; AND
• Crizotinib must be used as a single-agent only. 

Xalkori® (Crizotinib) Approval Criteria [Soft Tissue Sarcoma – Inflammatory Myofibroblastic Tumor (IMT) with Anaplastic Lymphoma Kinase (ALK) Translocation Diagnosis]:

• A diagnosis of soft tissue sarcoma – IMT; AND
• Anaplastic lymphoma kinase (ALK) positivity; AND
• Crizotinib must be used as a single-agent only. 

Xofigo® (Radium-223 Dichloride) Approval Criteria (Pharmacy Billing Only):

• A diagnosis of metastatic, castration-resistant prostate cancer; AND
• Member must have symptomatic bone metastases; AND
• Member must not have known visceral metastatic disease; AND
• Prescriber must verify radium-223 is not to be used in combination with chemotherapy; AND
• Member must have an absolute neutrophil count ≥ 1.5 x 10⁹/L, platelet count ≥ 100 x 10⁹/L, and hemoglobin ≥10 g/dL; AND
• Approvals will be for the duration of three months at which time additional authorization may be granted if the prescriber documents the following:  
  • The member has not shown evidence of progressive disease while on radium-223 dichloride therapy; AND
  • Member must have an absolute neutrophil count ≥ 1 x 10⁹/L, platelet count ≥ 100 x 10⁹/L (radium-223 dichloride should be delayed 6 to 8 weeks otherwise). 

Xospata® (Gilteritinib) Approval Criteria [Acute Myeloid Leukemia (AML) Diagnosis]:

• Relapsed/refractory AML; AND
• FLT3 mutation; AND
• As a single-agent. 

Xtandi® (Enzalutamide) Approval Criteria (Pharmacy Billing Only):

• A diagnosis of castration-resistant prostate cancer; AND
• Approvals will be for the duration of three months at which time additional authorization may be granted if the prescriber documents that the member has not shown evidence of progressive disease while on enzalutamide therapy.

• A diagnosis of metastatic, castration-resistant prostate cancer (CRPC); AND
• Concomitant treatment with a gonadotropin-releasing hormone (GnRH) analog or prior history of bilateral orchiectomy.  
• Abiraterone must be used in combination with a corticosteroid.   

Yervoy® (Ipilimumab) Approval Criteria [Adjuvant Treatment of Melanoma]: 

• All of the following criteria must be met for approval:
  • Patient has complete resection of melanoma with lymphadenectomy; AND
  • Patient has Stage III disease with regional nodes of greater than 1 mm and no in-transit metastasis; AND
  • Ipilimumab must be used as a single-agent;  AND
  • Maximum doses of 10mg/kg will apply. 

Yervoy® (Ipilimumab) Approval Criteria [Metastatic Colorectal Cancer Diagnosis]:

• Diagnosis of metastatic colorectal cancer; AND
• Disease has progressed on treatment with 5-FU, oxaliplatin, and irinotecan; AND
• Tumor possesses high microsatellite-instability or mismatch repair deficiency; AND  
• Used in combination with nivolumab.

Yervoy® (Ipilimumab) Approval Criteria [Renal Cell Carcinoma (RCC) Diagnosis]:

• A diagnosis of relapsed or surgically unresectable stage IV disease in the initial treatment of patients with intermediate or poor risk, previously untreated, advanced RCC; AND
• Ipilimumab must be used in combination with nivolumab; AND
• The patient has not failed previous PD-1 inhibitors [e.g., Keytruda® (pembrolizumab)]; AND
• Dose as follows: nivolumab 3mg/kg followed by ipilimumab 1mg/kg on the same day, every three weeks for a maximum of four doses, then nivolumab 240mg every two weeks or 480mg every four weeks.

Yervoy® (Ipilimumab) Approval Criteria [Small Cell Lung Cancer Diagnosis]: 

• All of the following criteria must be met for approval: 
  • One of the following criteria is met: 
    • Disease relapsed within six months of initial chemotherapy; OR
    • Disease is progressive on initial chemotherapy; AND
  • Used in combination with nivolumab. 

Yervoy® (Ipilimumab) Approval Criteria [Unresectable or Metastatic Melanoma Diagnosis]:

• All of the following criteria must be met for approval:
  • Ipilimumab is used in combination with nivolumab as:  
    • First-line therapy; OR 
    • Second-line or subsequent therapy for disease progression if nivolumab was not previously used; AND
  • Ipilimumab is used as a single-agent for one of the following:  
    • First-line therapy as a single course of four treatments; OR
    • Second-line or subsequent lines of therapy as a single course of four treatments; OR
    • Retreatment, consisting of a 4-dose limit, for an individual who had no significant systemic toxicity during prior ipilimumab therapy, and whose disease progressed after being stable for greater than six months following completion of a prior course of ipilimumab, and for whom no intervening therapy has been administered; AND
  • Maximum dose of 3mg/kg will apply.  

Yescarta® (Axicabtagene) Approval Criteria [Lymphoma Diagnosis]:   

• Large B-cell lymphoma [including diffuse large B cell lymphoma (DLBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (FL)]; AND
• Member must be 18 years of age or older; AND
• Relapsed or refractory disease; AND
• Member must not have primary central nervous system lymphoma; AND
• Member must have had two or more lines of therapy; AND
• Health care facilities must be on the certified list to administer chimeric antigen receptor (CAR) T-cells and must be trained in the management of cytokine release syndrome (CRS), neurologic toxicities, and comply with the REMS requirements.  

Yonsa® (Abiraterone) Approval Criteria:  

• A diagnosis of metastatic, castration-resistant prostate cancer (CRPC); AND
• Concomitant treatment with a gonadotropin-releasing hormone (GnRH) analog or prior history of bilateral orchiectomy.
• Abiraterone must be used in combination with a corticosteroid. 

Zelboraf® (Vemurafenib) Approval Criteria [Melanoma Diagnosis]:

• All of the following criteria must be met for approval: 
  • Diagnosis of unresectable or metastatic melanoma; AND
  • BRAF V600E or V600K mutation detected by an FDA-approved test; AND
    • Not indicated for wild-type BRAF melanoma 
  • Vemurafenib must be used as a single-agent or in combination with cobimetinib; AND
  • One of the following is met:
    • Used as first-line therapy; OR
    • Used as second-line therapy or subsequent therapy.  

Zelboraf® (Vemurafenib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

• All of the following criteria must be met for approval:
  • BRAF V600E or V600K mutation detected by an FDA-approved test; AND
    • Vemurafenib is not indicated for wild-type BRAF NSCLC 
  • Vemurafenib must be used as a single-agent
  • Diagnosis of refractory or metastatic disease. 

Zelboraf® (Vemurafenib) Approval Criteria [Hairy-Cell Leukemia Diagnosis]:

• All of the following criteria must be met for approval: 
  • Vemurafenib must be used as a single-agent; AND
  • Vemurafenib is being used to treat disease progression following failure of purine analog therapy (i.e. pentostatin, cladribine). 

Zelboraf® (Vemurafenib) Approval Criteria [Erdheim-Chester Disease]:

• All of the following criteria must be met for approval:
  • BRAF V600E or V600K mutation detected by an FDA-approved test; AND  
  • Vemurafenib must be used as a single-agent.  

• A patient-specific, clinically significant reason why the member cannot use Avastin® (bevacizumab) must be provided. 

Zydelig® (Idelalisib) Approval Criteria [Follicular Lymphoma (FL) Diagnosis]:  

• A diagnosis of Grade 1 to 2 FL; AND
• As second-line or subsequent therapy for refractory or progressive disease; AND
• Refractory to both alkylator and rituximab therapy.   

Zydelig® (Idelalisib) Approval Criteria [Gastric or Nongastric Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma, Nodal or Splenic Marginal Zone Lymphoma (MZL) Diagnosis]:

• As second-line or subsequent therapy for refractory or progressive disease; AND
• Refractory to both alkylator and rituximab therapy.

Zydelig® (Idelalisib) Approval Criteria [Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Diagnosis]:

• For relapsed or refractory disease; AND
• In combination with rituximab or rituximab/bendamustine; OR
• As a single-agent.  

Zykadia® (Ceritinib) Approval Criteria [Non-Small Cell Lung Cancer (NSCLC) Diagnosis]:

• A diagnosis of metastatic NSCLC; AND
• Anaplastic lymphoma kinase (ALK) positivity; AND
• Ceritinib must be used as a single-agent only.

Zykadia® (Ceritinib) Approval Criteria [Soft Tissue Sarcoma – Inflammatory Myofibroblastic Tumor (IMT) with Anaplastic Lymphoma Kinase (ALK) Translocation Diagnosis]:

• A diagnosis of soft tissue sarcoma – IMT; AND
• Anaplastic lymphoma kinase (ALK) positivity; AND
• Ceritinib must be used as a single-agent only.  

Zytiga® (abiraterone) Approval Criteria [Castration-Sensitive Prostate Cancer (CSPC) Diagnosis]:

• A diagnosis of metastatic, high-risk, CSPC; AND
• Abiraterone must be used in combination with a corticosteroid.