Oncologic Therapies 2017 Archives

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; 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.

Prior Authorization Form - Afinitor

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
• Progressed on or intolerant to crizotinib; OR
• Member has asymptomatic disease with rapid radiologic progression on crizotinib; AND
• Alectinib must be used as a single-agent only. 

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

• All of the following criteria must be met for approval:
  
  • 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.

Prior Authorization Form - Alecensa

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

• 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.

 Prior Authorization Form - Alunbrig

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 [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. 

Prior Authorization Form - Bravencio

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 and patient has an ECOG performance status of 0 to 2. 

Prior Authorization Form - Cotellic 

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

• A diagnosis of NSCLC; AND
• Subsequent therapy for metastatic disease after progression; AND
• Member must have an ECOG performance status of 0 to 2; 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% or an ECOG performance score of 0 to 2; 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% or an ECOG performance score of 0 to 2; AND
• Ramucirumab must be used as a single-agent or in combination with paclitaxel.   

 Prior Authorization Form - Cyramza

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. 

Prior Authorization Form - Erivedge  

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. 

Prior Authorization Form - Gilotrif

• 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. 

Prior Authorization Form - Halaven

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.

Prior Authorization Form - Imlygic 

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. 

Prior Authorization Form - Ixempra   

• 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.

Prior Authorization Form - Jevtana  

• 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. 

Prior Authorization Form - Kadcyla

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 [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: ≥50% 
• 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; AND
• ECOG performance status 0 to 1; 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  
• ECOG performance status 0 to 2. 

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

• All of the following criteria must be met for approval:
• Diagnosis of recurrent or metastatic disease; AND
• Squamous cell histology; AND
• Patient has received prior platinum containing regimen (cisplatin or carboplatin); AND
• ECOG performance status 0 to 1; 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 patient has ECOG performance status 0 to 2; 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 [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 an ECOG performance status of 2, 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). 

Prior Authorization Form - Keytruda

tisagenlecleucel (Kymriah™) Approval Criteria:

• 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.   

Prior Authorization Form - Kymriah  

ribociclib (Kisqali®)

Kisqali® (Ribociclib) Approval Criteria: 

• A patient-specific, clinically significant reason why the member cannot use the co-packaged formulation with letrozole; AND
• 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; AND
• Ribociclib must be given in combination with an aromatase inhibitor; AND 
• Ribociclib must be used in postmenopausal women only. 
• 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 ribociclib therapy.

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; AND
• Ribociclib must be used in postmenopausal women only. 
• 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 ribociclib/letrozole therapy. 

Prior Authorization Form - Kisqali

• 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); AND
  • ECOG performance status is 0 to 2. 

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. 

Prior Authorization Form - Mekinist

• 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. 

Prior Authorization Form - Nerlynx

• 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
• Patient has ECOG performance status 0 to 2 
• Dose as follows:
• Single-agent: 240mg every two weeks 
• In combination with ipilimumab: 1mg/kg, followed by ipilimumab on the same day, every three weeks for four doses, then 240mg every two weeks.

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
  • ECOG performance status 0 to 2; 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. 

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
  • ECOG performance status 0 to 2 
  • 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 [Renal Cell Cancer Diagnosis]:

• All of the following criteria must be met for approval:
• 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
• Nivolumab must be used as a single-agent; AND
• ECOG performance status 0 to 2; AND
• The patient has not previously failed other PD-1 inhibitors [i.e. Keytruda® (pembrolizumab)] 
• Dose as follows:
• Single-agent: 240mg every two 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 [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
• Member has an ECOG performance status of 0 to 1; AND
• Dose as follows:
  
  • 3mg/kg every two 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; AND
• Member has an ECOG performance status of 0 to 1.

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.

Prior Authorization Form - Opdivo

• 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; OR
• Neoadjuvant treatment of patients with locally advanced, inflammatory, or early stage breast cancer (either greater than 2cm in diameter or node positive); AND  
• Used in combination with trastuzumab and docetaxel (neoadjuvant treatment may also contain other agents as well in addition to trastuzumab and docetaxel).

Prior Authorization Form - Perjeta

Provenge® (Sipuleucel-T) Approval Criteria (Medical Billing Only):

• 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
• Good performance status (ECOG 0 to 1); 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.

Prior Authorization Form - Provenge  

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. 

Prior Authorization Form - Tafinlar  

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

• A diagnosis of 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; AND
• Osimertinib must be used for subsequent therapy only. 

Prior Authorization Form - Tagrisso

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
• Member must have good performance status (ECOG 0 to 2); 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
• Member must have good performance status (ECOG 0 to 2); AND
• Erlotinib must be used in combination with gemcitabine. 

Prior Authorization Form - Tarceva

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

• A diagnosis of NSCLC; AND
• Subsequent therapy for metastatic disease; AND
• Member must have an ECOG performance score of 0 to 2; 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.

Prior Authorization Form - Tecentriq

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).   

Prior Authorization Form - Tykerb

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). 

Prior Authorization Form - Xofigo

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. 

Prior Authorization Form - Xalkori

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

• A diagnosis of metastatic, 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.

Prior Authorization Form - Xtandi

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

• All of the following criteria must be met for approval:
  
  • ECOG performance status 0 to 2; AND
  • 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.

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 [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; AND   
• ECOG performance status 0 to 2. 

Prior Authorization Form - Yervoy

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 and patient has an ECOG performance status of 0 to 2.
    

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. 

Prior Authorization Form - Zelboraf  

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.  

Prior Authorization Form - Zykadia

Zytiga® (Abiraterone) Approval Criteria (Pharmacy Billing Only):

• A diagnosis of metastatic, castration-resistant prostate cancer; AND
• Abiraterone must be used in combination with a corticosteroid; 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 abiraterone therapy.

Prior Authorization Form - Zytiga