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Bevacizumab

The use of bevacizumab is medically necessary when all of the following are true:
Patient is at least 18 years of age, and
Patient must have no recent history of hemorrhage or hemoptysis (the presence of blood in sputum); and
Patient must not have had a surgical procedure within the preceding 28 days or have a surgical wound that has not fully healed

The use of bevacizumab is considered medically necessary for the following conditions:

I. FDA-approved indications:

Cervical cancer – in combination with paclitaxel and cisplatin or topotecan in persistent, recurrent, or metastatic disease
CNS – Brain cancer (glioblastoma) – as a single agent or in combination with carmustine, temozolomide, or lomustine in patients with recurrent disease
Colon cancer – in combination with fluoropyrimidine-, irinotecan-, or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab-containing regimen
Colon cancer – in combination with intravenous 5-FU-based chemotherapy for first- or second-line treatment of metastatic disease
Hepatocellular carcinoma – in combination with atezolizumab in patients with unresectable or metastatic disease who have not received prior systemic therapy
Non-small cell lung cancer – in combination with carboplatin and paclitaxel for first-line treatment of non-squamous, unresectable, locally advanced, recurrent, or metastatic disease
Ovarian cancer – for the treatment of recurrent epithelial disease in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant disease or in combination with carboplatin and paclitaxel or carboplatin and gemcitabine followed by single agent bevacizumab for platinum-sensitive disease
Ovarian cancer – in combination with carboplatin and paclitaxel followed by single agent bevacizumab for stage III-IV disease following initial surgical resection
Rectal cancer – in combination with fluoropyrimidine-, irinotecan-, or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab-containing regimen
Rectal cancer – in combination with intravenous 5-FU-based chemotherapy for first- or second-line treatment of metastatic disease

II. Bevacizumab is recommended by the NCCN Drugs and Biologics Compendium® for off-label use for the following indications and considered medically necessary :

Breast cancer – in combination with paclitaxel for patients with HER2-negative, stage IV or recurrent disease
Cervical cancer – in combination with paclitaxel and carboplatin as first- or second-line therapy for local/regional recurrence or stage IVB or distant metastases
Cervical cancer – as single agent, second-line therapy of local/regional recurrence or stage IVB or distant metastases
CNS – Brain cancer (anaplastic glioma) – as a single agent or in combination with carmustine, temozolomide, or lomustine for recurrent disease if bevacizumab monotherapy fails and it is desirable to continue the steroid sparing effects of bevacizumab and as short course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Brain cancer (glioblastoma) – as short course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Brain cancer (meningioma) – as short course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect or as a single agent or in combination with everolimus for patients with surgically inaccessible recurrent or progressive disease when radiation therapy is not possible
CNS – Brain cancer (low-grade glioma/pilocytic and infiltrative supratentorial astrocytoma/oligodendroglioma, medulloblastoma, and metastatic spine tumors) – as short course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Brain metastases (limited or extensive) – as short-course single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Intracranial and spinal ependymoma (excluding subependymoma) – as a single agent for progression or recurrent disease in patients who are refractory to surgery or radiation therapy, if received prior radiation therapy and had gross total or subtotal resection with negative cerebrospinal fluid (CSF) cytology, subtotal resection and evidence of metastases (brain, spine, or CSF), or unresectable disease
CNS – Intracranial and spinal ependymoma (excluding subependymoma) – as short-course, single agent therapy for the management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
CNS – Primary CNS lymphoma – as short-course, single agent therapy for management of symptoms driven by radiation therapy necrosis, poorly controlled vasogenic edema, or mass effect
Colon cancer – in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin); FOLFIRI (fluorouracil, leucovorin and irinotecan); CapeOX (capecitabine and oxaliplatin); or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) in candidates for intensive therapy, or in combination with 5-FU/LV (fluorouracil and leucovorin); or capecitabine in non-candidates for intensive therapy as primary treatment for locally unresectable or medically inoperable disease
Colon cancer – adjuvant treatment in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin); FOLFIRI (fluorouracil, leucovorin, and irinotecan); CapeOX (capecitabine and oxaliplatin); FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) in candidates for intensive therapy, or in combination with 5-FU/LV (fluorouracil and leucovorin); or capecitabine in non-candidates for intensive therapy following synchronized or staged resection for synchronous liver and/or lung metastases that converted from unresectable to resectable disease after primary treatment, following resection and/or local therapy for resectable metachronous metastases in patients who have received previous chemotherapy, or for unresectable metachronous metastases that converted to resectable disease after primary treatment
Colon cancer – adjuvant treatment in combination with irinotecan for unresectable metachronous metastases that converted to resectable disease after primary treatment
Colon cancer – primary or initial therapy in combination with CapeOX (capecitabine and oxaliplatin) or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as primary treatment for unresectable synchronous liver and/or lung metastases; in combination with CapeOX (capecitabine and oxaliplatin) or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) in candidates for intensive therapy, or in combination with capecitabine in non-candidates for intensive therapy as primary treatment for synchronous abdominal/peritoneal metastases, for unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy, or for unresectable synchronous metastases of other sites
Colon cancer – primary or initial therapy in combination with irinotecan for unresectable metachronous metastases in patients who have had adjuvant FOLFOX or CapeOX therapy within the past 12 months or in combination with CapeOX (capecitabine and oxaliplatin), FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan), or capecitabine in patients who have had previous 5F/LV or capecitabine or who have not had previous chemotherapy
Colon cancer – primary or initial therapy in combination with CapeOX (capecitabine and oxaliplatin), FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan), or capecitabine in patients with unresectable metachronous metastases that remain unresectable after primary treatment
Colon cancer – subsequent therapy for disease progression in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin); FOLFIRI (fluorouracil, leucovorin, and irinotecan); FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan); CapeOX (capecitabine and oxaliplatin); irinotecan; Irinotecan and oxaliplatin, or trifluridine and tipiracil
Endometrial cancer – as a single agent for endometrioid adenocarcinoma, serous carcinoma, clear cell carcinoma, undifferentiated/dedifferentiated carcinoma, or carcinosarcoma disease that has progressed following cytotoxic chemotherapy
Endometrial cancer – in combination with carboplatin and paclitaxel for endometrioid adenocarcinoma, serous carcinoma, clear cell carcinoma, undifferentiated/dedifferentiated carcinoma, or carcinosarcoma with advanced and recurrent disease
Hepatocellular carcinoma – first-line therapy in combination with atezoluzumab for liver-confined disease, disease that is inoperable by perforance status, comorbidity, or with minimal or uncertain extrahepatic disease, or disease with extensive liver tumor burden
Malignant pleural mesothelioma -in combination with pemetrexed and cisplatin followed by single agent maintenance bevacizumab or pemetrexed and carboplatin followed by single agent maintenance bevacizumab for unresectable, clinical stage I-IIIA disease and epithelioid or biphasic histology or clinical stage IIIB or IV disease, sarcomatoid, or medically inoperable tumors
Non-small cell lung cancer (NSCLC) – as first-line therapy for the treatment of stage IV or recurrent disease in combination with carboplatin and pemetrexed; cisplatin and pemetrexed; or atezolizumab, carboplatin, and paclitaxel
Non-small cell lung cancer (NSCLC) – as a single agent or in combination with pemetrexed or atezolizumab as continuation maintenance therapy for non-squamous, stage IV metastatic or recurrent disease
Non-small cell lung cancer (NSCLC) – as subsequent therapy for the treatment of stage IV or recurrent disease in combination with carboplatin and paclitaxel; carboplatin and pemetrexed; cisplatin and pemetrexed; or atezolizumab, carboplatin, and paclitaxel
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer) – as neoadjuvant chemotherapy in combination with paclitaxel and carboplatin in patients who are poor surgical candidates or who have a low likelihood of optimal cytoreduction
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer) – as primary adjuvant therapy in combination with carboplatin and paclitaxel for pathologic stage II-IV disease or following interval debulking surgery in patients with response or stable disease to neoadjuvant therapy
Ovarian cancer (mucinous carcinoma) – as primary adjuvant therapy for pathologic state II-IV disease in combination with carboplatin and paclitaxel; fluorouracil, leucovorin, and oxaliplatin; or capecitabine and oxaliplatin
Ovarian cancer (grade 1 endometrioid carcinoma; low-grade serous carcinoma/ovarian borderline epithelial tumors with invasive implants; carcinosarcoma; and clear cell carcinoma) – as primary adjuvant therapy for pathologic stage II-IV disease in combination with carboplatin and paclitaxel
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer; carcinosarcoma; and clear cell carcinoma) – for persistent or recurrent disease in combination with carboplatin and liposomal doxorubicin for immediate treatment for serially rising CA-125 in patients who previously received chemotherapy or for complete remission and relapse 6 or more months after completing prior chemotherapy
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer; carcinosarcoma; and clear cell carcinoma) – for persistent or recurrent disease in combination with niraparib for immediate treatment for serially rising CA-125 in patients who previously received chemotherapy or for radiographic and/or clinical relapse in patients with previous complete remission and relapse after 6 or more months after completing prior chemotherapy
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer; carcinosarcoma; clear cell carcinoma; mucinous carcinoma) – for persistent or recurrent disease in combination with liposomal doxorubicin, topotecan, or weekly paclitaxel in patients who have had no more than 2 prior chemotherapy regimens
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer; carcinosarcoma; and clear cell carcinoma) – for persistent or recurrent disease in combination with oral cyclophosphamide for immediate treatment for serially rising CA-125 and previously received chemotherapy; progression on primary, maintenance, or recurrence therapy; stable or persistent disease (if not on maintenance therapy); and complete remission and relapse 6 or more months after completing chemotherapy
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer; carcinosarcoma; clear cell carcinoma; and mucinous carcinoma) – for persistent or recurrent disease as a single agent for immediate treatment for serially rising CA-125 levels and previously received chemotherapy; progression on primary, maintenance, or recurrence therapy; stable or persistent disease (if not on maintenance therapy); complete remission and relapse less than 6 months after completing chemotherapy; and radiographic and/or clinical relapse and previous complete remission and relapse 6 or more months after completing prior chemotherapy
Ovarian cancer (mucinous carcinoma) – for persistent or recurrent disease in combination with fluorouracil, leucovorin, and oxaliplatin; capecitabine and oxaliplatin; carboplatin and gemcitabine; or carboplatin and liposomal doxorubicin for immediate treatment for serially rising CA-125 in patients who previously received chemotherapy or complete remission and relapse 6 or more months after completing prior chemotherapy
Ovarian cancer (mucinous carcinoma) – for persistent or recurrent disease in combination with carboplatin and paclitaxel for clinical relapse in patients who have not received prior chemotherapy; rising CA-125 levels in patients who have not received prior chemotherapy; immediate treatment for serially rising CA-125 in patients who previously received chemotherapy; or complete remission and relapse 6 or more months after completing prior chemotherapy
Ovarian cancer (mucinous carcinoma) – for persistent or recurrent disease in combination with liposomal doxorubicin; oral cyclophosphamide; topotecan; or weekly paclitaxel for immediate treatment for serially rising CA-125 in patients who previously received chemotherapy; progression on primary, maintenance, or recurrence therapy; stable or persistent disease (if not on maintenance therapy); or complete remission and relapse less than 6 months after completing chemotherapy
Ovarian cancer (mucinous carcinoma) – for persistent or recurrent disease as a single agent for clinical relapse of stage II-IV disease
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer) – maintenance therapy for partial or complete remission following primary therapy with bevacizumab for stage II-IV disease as a single agent for BRCA1 and BRCA2 wild-type tumors or in combination with olaparib for BRCA1 and BRCA2 wild-type tumors or tumors with BRCA1 or BRCA2 germline or somatic mutations
Ovarian cancer (epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer; mucinous carcinoma; carcinosarcoma; and clear cell carcinoma) – as single agent, maintenance therapy for partial or complete response following recurrence therapy with chemotherapy plus bevacizumab for platinum-sensitive disease
Rectal cancer – as primary treatment in combination with capecitabine or 5FU-LV (fluorouracil and leucovorin) (in non-candidates for intensive therapy) and FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), or CapeOX (capecitabine and oxaliplatin) in candidates for intensive therapy) in patients with T3, N Any; T1-2, N1-2; T4, N Any disease; locally unresectable disease; or medically inoperable disease when resection is contraindicated following neoadjuvant therapy or total neoadjuvant therapy
Rectal cancer –  as adjuvant therapy for stage IV disease following resection and/or local therapy for resectable metachronous metastases in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), CapeOX (capecitabine and oxaliplatin), or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) in candidates for intensive therapy or with 5-FU/LV (fluorouracil and leucovorin) or capecitabine in patients who are not candidates for intensive therapy
Rectal cancer – as adjuvant therapy for stage IV, unresectable metachronous metastases that converted to resectable disease after primary treatment in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), CapeOX (capecitabine and oxaliplatin), or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) in candidates for intensive therapy or with 5-FU/LV (fluorouracil and leucovorin) or capecitabine in patients who are not candidates for intensive therapy
Rectal cancer – in combination with CapeOX (capecitabine and oxaliplatin) or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) in candidates for intensive therapy or with capecitabine in non-candidates for intensive therapy for 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; 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; primary treatment for synchronous abdominal/peritoneal metastases or primary treatment for synchronous unresectable metastases of other sites
Rectal cancer – in combination with CapeOX (capecitabine and oxaliplatin) or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) in candidates for intensive therapy 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
Rectal cancer – in combination with CapeOX (capecitabine and oxaliplatin) or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) in candidates for intensive therapy or in combination with capecitabine for non-candidates for intensive therapy for unresectable isolated pelvic/anastomotic recurrence
Rectal cancer – as subsequent therapy for disease progression in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan), CapeOX (capecitabine and oxaliplatin), irinotecan, irinotecan and oxaliplatin, or trifluridine and tipiracil
Renal cell cancer (clear cell histology) – as subsequent, single agent therapy for relapse or stage IV disease
Renal cell cancer (non-clear cell histology) – in combination with erlotinib for relapsed or stage IV advanced papillary carcinoma, including hereditary leiomyomatosis and renal cell cancer
Renal cell cancer (non-clear cell histology) – as single agent or in combination with everolimus for relapse or stage IV disease
Soft tissue sarcoma – as a single agent for the treatment of angiosarcoma
Soft tissue sarcoma – in combination with temozolomide for the treatment of solitary fibrous tumor and hemangiopericytoma
Vulvar cancer – in combination with cisplatin and paclitaxel or carboplatin and paclitaxel as additional treatment for larger T2, T3, locally advanced disease
Vulvar cancer – in combination with cisplatin and paclitaxel or carboplatin and paclitaxel as primary treatment for metastatic disease
Vulvar cancer – in combination with cisplatin and paclitaxel or carboplatin and paclitaxel for isolated inguinofemoral/pelvic lymph node recurrence if prior external beam radiation therapy
Vulvar cancer – in combination with cisplatin and paclitaxel or carboplatin and paclitaxel for clinical nodal or distant recurrence with multiple pelvic nodes, distant metastasis, or prior pelvic external beam radiation therapy

If the drug use is not on the FDA label, does not appear  NCCN Drugs and Biologics Compendium or Triple-S has not published a  Medical Policy covering the off-label use, then the drug use is not approved and the use of the drug is considered investigational.

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