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; 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

Halaven® (Eribulin) Approval Criteria (Medical Billing Only:

• 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

Ibrance® (Palbociclib)* Approval Criteria (Pharmacy Billing Only):

• 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.

Prior Authorization - Ibrance

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

Kadcyla® (Ado-Trastuzumab) Approval Criteria (Medical Billing Only):

• 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

Perjeta® (Pertuzumab) Approval Criteria (Medical Billing Only):

• 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

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

Jevtana® (Cabazitaxel) Approval Criteria (Medical Billing Only):

• 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

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

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

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

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