Coverage for vascular diseases of the eye have been moved to Medical Policy: Intravitreal Injection of Vascular Endothelial Growth Factor (VEGF) Antagonists and Related Biosimilars 08.00.74m.
On February 20, 2020, the following language was added to the Company-Designated Preferred Products section of the Policy section: Coverage of a biosimilar product as an alternate to a reference product is not considered a form of step therapy by the Company.
Primary treatment for T3, N Any; T1-2, N1-2; T4, N Any; or locally unresectable or medically inoperable disease if resection is contraindicated following total neoadjuvant therapy (proficient mismatch repair/microsatellite-stable [pMMR/MSS] or ineligible for or progressed on checkpoint inhibitor immunotherapy for deficient mismatch repair/microsatellite instability-high [dMMR/MSI-H] or polymerase epsilon/delta [POLE/POLD1] mutation) or neoadjuvant/definitive immunotherapy (dMMR/MSI-H) if intensive therapy not recommended
Therapy in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin), FOLFIRI (fluorouracil, leucovorin, and irinotecan), CapeOX (capecitabine and oxaliplatin), or FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) regimen (strongly consider FOLFIRINOX for individuals with excellent performance status) if intensive therapy recommended (proficient mismatch repair/microsatellite-stable [pMMR/MSS] or ineligible for or progressed on checkpoint inhibitor immunotherapy for deficient mismatch repair/microsatellite instability-high [dMMR/MSI-H] or polymerase epsilon/delta [POLE/POLD1] mutation)
Therapy in combination with capecitabine or 5-FU/leucovorin (fluorouracil and leucovorin) regimen if intensive therapy not recommended (proficient mismatch repair/microsatellite-stable [pMMR/MSS] or ineligible for or progressed on checkpoint inhibitor immunotherapy for deficient mismatch repair/microsatellite instability-high [dMMR/MSI-H] or polymerase epsilon/delta [POLE/POLD1] mutation)
Primary treatment for synchronous liver only and/or lung only metastases (proficient mismatch repair/microsatellite-stable [pMMR/MSS]; deficient mismatch repair/microsatellite instability-high [dMMR/MSI-H] or polymerase epsilon/delta [POLE/POLD1] mutation and not a candidate for immunotherapy) that are unresectable or medically inoperable in combination with
Preferred anti-angiogenic therapy as initial treatment for individuals with unresectable metachronous metastases (proficient mismatch repair/microsatellite-stable [pMMR/MSS]) and previous FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months
Second-line and subsequent therapy for progression of advanced or metastatic disease (proficient mismatch repair/microsatellite-stable [pMMR/MSS] or ineligible for or progressed on checkpoint inhibitor immunotherapy for deficient mismatch repair/microsatellite instability-high [dMMR/MSI-H] or polymerase epsilon/delta [POLE/POLD1] mutation)
COLON CANCER
Appendiceal Adenocarcinoma
NCCN note: *May also be used for pericardial mesothelioma and tunica vaginalis testis mesothelioma
NCCN note: *May also be used for pericardial mesothelioma and tunica vaginalis testis mesothelioma
NCCN notes: *May also be used for pericardial mesothelioma and tunica vaginalis testis mesothelioma**High-risk features include Ki-67 >9%, nodal metastasis, high tumor burden (Peritoneal Cancer Index [PCI] >17), completeness of cytoreduction (CC) score >1, biphasic disease, or bicavitary disease
In combination with erlotinib for EGFR mutation-positive (e.g., exon 19 deletion or L858R) nonsquamous cell histology, recurrent, advanced, or metastatic disease with no history of hemoptysis as (except for locoregional recurrence or symptomatic local disease (excluding mediastinal lymph node recurrence with prior radiation therapy) with no evidence of disseminated disease) either first-line therapy or continuation of therapy following disease progression on combination of erlotinib with bevacizumab for asymptomatic disease, symptomatic brain lesions, or symptomatic systemic limited progression (if T790M negative)
The above regimens are used as:
Treatment for recurrent, advanced, or metastatic disease in individuals with performance status 0-1, tumors of nonsquamous cell histology, and no history of recent hemoptysis in combination with atezolizumab, carboplatin and paclitaxel (if no contraindications** to PD-1 or PD-L1 inhibitors) for any of the following indications:
NCCN notes:* Complete genotyping for EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET and RET, repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these individuals are treated as though they do not have driver oncogenes**Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents, or presence of an oncogene (e.g., EGFR [exon 19 deletions, p.L858R point mutation in exon 21], ALK rearrangements, RET rearrangements), which would predict lack of benefit.
Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer
as immediate treatment for serially rising CA-125 in individuals who previously received chemotherapy (platinum-sensitive or platinum-resistant)
for progression on primary, maintenance, or recurrence therapy (platinum-resistant)
in individuals with complete remission and relapse ≥6 months after completing prior chemotherapy (platinum-resistant) in combination with:
Maintenance therapy as a single agent (useful in certain circumstances) if used previously as part of a combination therapy for individuals with partial or CR following recurrence therapy with chemotherapy plus bevacizumab for platinum-sensitive disease
Carcinosarcoma (Malignant Mixed Müllerian Tumors)
Malignant Sex Cord-Stromal Tumors
Clear Cell Carcinoma of the Ovary
Grade 1 Endometrioid Carcinoma
Low-Grade Serous Carcinoma
Maintenance therapy as a single agent if used previously as part of a combination therapy for individuals with PR or CR following recurrence therapy with chemotherapy plus bevacizumab for platinum-sensitive disease
Therapy for platinum-resistant persistent disease or recurrence (except for immediate treatment of biochemical relapse)
in combination with any of the following:
Second-line or subsequent therapy as a single agent for recurrent disease that has progressed on prior cytotoxic chemotherapy for any of the following indications:
The World Health Organization (WHO) grading system is contained in the volume Histological Typing of Tumours of the Central Nervous System. The WHO grade has four categories of tumors:
From the histological point of view the WHO system is based on the same criteria as the St Anne-Mayo system.
See Attachment A.
C9257 Injection, bevacizumab, 0.25 mg
J9035 Injection, bevacizumab, 10 mg
Q5107 Injection, bevacizumab-awwb, biosimilar, (Mvasi), 10 mg
Q5118 Injection, bevacizumab-bvzr, biosimilar, (Zirabev), 10 mg
Q5126 Injection, bevacizumab-maly, biosimilar, (Alymsys), 10 mg
Q5129 Injection, bevacizumab-adcd (Vegzelma), biosimilar, 10mg