Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Pertuzumab (Perjeta) may be considered medically necessary for ANY of the following:
Food and Drug Administration (FDA) Indications:
Breast Cancer
- In combination with trastuzumab and docetaxel for the treatment of individuals with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease; or
- In combination with trastuzumab and chemotherapy as neoadjuvant treatment of individuals with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; or
- In combination with trastuzumab and chemotherapy as adjuvant treatment of individuals with HER2-positive early breast cancer at high risk of reoccurrence; or
National Comprehensive Cancer Network (NCCN) Recommendations:
Breast Cancer
- Preoperative systemic therapy for individuals with HER2-positive tumors and locally advanced clinical stage T2 or greater and M0, or N1 or greater and M0 disease in ANY of the following:
- In combination with trastuzumab and paclitaxel following AC (doxorubicin and cyclophosphamide) regimen; or
- As a component of TCHP (docetaxel, carboplatin, trastuzumab, and pertuzumab) regimen; or
- In combination with trastuzumab and docetaxel following AC regimen; or
- Adjuvant systemic therapy for clinical stage T1-3, N1, M0 individuals with node positive HER2-positive tumors:
- In combination with trastuzumab and paclitaxel following AC regimen; or
- As a component of TCHP regimen; or
- In combination with trastuzumab and docetaxel following AC regimen; or
- As adjuvant systemic therapy for individuals with HER2-positive tumors and locally advanced clinical stage T2 or greater and M0, or N1 or greater and M0 disease following completion of planned chemotherapy and following mastectomy or lumpectomy with surgical axillary staging, with trastuzumab in ANY of the following:
- ypT0N0 or pCR (pathological complete response); or
- ypT1-4N0 or residual disease (if ado-trastuzumab discontinued for toxicity); or
- ypN1 or greater, or node positive (if ado-trastuzumab discontinued for toxicity); or
- Used for recurrent or metastatic stage IV HER2-positive disease that is either hormone receptor-negative or hormone receptor-positive in ANY of the following:
- As first-line therapy in combination with trastuzumab with docetaxel or paclitaxel; or
- In combination with trastuzumab with or without cytotoxic therapy (e.g., vinorelbine or taxane) for one line of therapy beyond first-line therapy in individuals previously treated with chemotherapy and trastuzumab in the absence of pertuzumab (Perjeta); or
Colon Cancer
- As therapy in combination with trastuzumab in HER2-amplified and RAS wild-type individuals who are not appropriate for intensive therapy, if no previous treatment with a HER2 inhibitor in ANY of the following:
- Primary treatment for locally unresectable or medically inoperable disease; or
- Unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy; or
- Primary treatment for synchronous abdominal/peritoneal metastases that are non-obstructing, or following local therapy for those with existing or imminent obstruction; or
- Synchronous unresectable metastases of other sites; or
- Primary treatment for unresectable metachronous metastases in individuals in ANY of the following:
- Who have not received previous adjuvant leucovorin, fluorouracil, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) within the past 12 months; or
- Who have received fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy; or
- Who have not received any previous chemotherapy; or
- Unresectable metachronous metastases that remain unresectable after primary treatment; or
- As adjuvant therapy in combination with trastuzumab in HER2-amplied and RAS wild-type individuals who are not appropriate for intensive therapy in ANY of the following:
- Following synchronized or staged resection for synchronous liver and/or lung metastases that converted from unresectable to resectable disease after primary treatment; or
- Following resection and/or local therapy for resectable metachronous metastases in those who have received previous chemotherapy; or
- For unresectable metachronous metastases that converted to resectable disease after primary treatment; or
- As subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease in HER2-amplified and RAS wild-type individuals not previously treated with a HER2 inhibitor, previously treated with ANY of the following:
- Oxaliplatin-based therapy without irinotecan; or
- Irinotecan-based therapy without oxaliplatin; or
- Oxaliplatin or irinotecan; or
- A fluoropyrimidine without irinotecan or oxaliplatin; or
Rectal Cancer
- As therapy in combination with trastuzumab in HER2-amplified and RAS wild-type individuals who are not appropriate for intensive therapy, if no previous treatment with a HER2 inhibitor in ANY of the following:
- Synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable with no progression of primary tumor after primary systemic therapy; or
- Following palliative radiation therapy (RT) or chemo/RT for synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable with progression of primary tumor after primary systemic therapy; or
- As primary treatment for synchronous abdominal/peritoneal metastases that are non-obstructing, or following local therapy for those with existing or imminent obstruction; or
- As primary treatment for synchronous unresectable metastases of other sites; or
- As primary treatment for unresectable metachronous metastases in individuals in ANY of the following:
- Who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months; or
- Who have received previous 5-FU/LV or capecitabine therapy; or
- Who have not received any previous chemotherapy; or
- As adjuvant therapy in combination with trastuzumab in HER2-amplified and RAS wild-type who are not appropriate for intensive therapy in ANY of the following:
- As treatment following resection and/or local therapy for resectable metachronous metastases in those who have received previous chemotherapy; or
- As treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment; or
- As subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease in HER2-amplified and RAS wild-type individuals not previously treated with a HER2 inhibitor, previously treated with ANY of the following:
- Oxaliplatin-based therapy without irinotecan; or
- Irinotecan-based therapy without oxaliplatin; or
- Oxaliplatin or irinotecan; or
- A fluoropyrimidine without irinotecan or oxaliplatin; or
Head and Neck Cancers - Salivary Gland Tumors
- As systemic therapy in combination with trastuzumab for recurrent human epidermal growth factor receptor 2 (HER2) in certain circumstances which include ANY of the following:
- Distant metastases in individuals with a performance status (PS) of 0-3; or
- Unresectable locoregional recurrence or second primary with prior radiation therapy.
The use of pertuzumab (Perjeta) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
