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.
Food and Drug Administration (FDA) Indication
Siltuximab (Sylvant) may be considered medically necessary for individuals 18 years of age or older for any of the following indications:
- Treatment of individual with multicentric Castleman’s disease (CD) who is human immunodeficiency virus-negative and human herpesvirus-8 (HHV-8)-negative; and
- Individual does not have organ failure; and
- No concurrent clinically significant infection (for example, Hepatitis B or C); and
- No concurrent lymphoma; and
- Individualsmust have hematology laboratory tests prior to first siltuximab (Sylvant) dose showing the following absolute neutrophil count: greater than or equal to 1.0 x109/L; and
- Individuals platelet count is greater than or equal to 75 x109/L; and
- Individuals hemoglobin is less than or equal to 17g/dL; or
National Comprehensive Cancer Network (NCCN) Recommendations
B-Cell Lymphomas – Castleman’s Disease (CD)
- Second-line therapy as a single agent for relapsed or refractory unicentric CD for individuals with plasmacytic/mixed histology who are human immunodeficiency virus-negative and human herpesvirus-8-negative; or
- Single-agent therapy for active idiopathic multicentric CD with no organ failure for individuals with plasmacytic/mixed histology who are human immunodeficiency virus-negative and human herpes-virus-8-negative, when used as any of the following:
- As primary treatment; or
- As alternate treatment for relapsed disease; or
- If no response to primary treatment.
Siltuximab (Sylvant) is considered experimental/investigational for any other indication and therefore non-covered. Scientific evidence does not support its use for any other indications.