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.
Polatuzumab vedotin-piiq (Polivy) may be considered medically necessary in individuals 18 years of age and older for the following:
Food and Drug Administration (FDA) Indications:
Diffuse Large B-Cell Lymphoma
- For the treatment of relapsed or refractory diffuse large B cell lymphoma (DLBCL) when ALL of the following criteria are met:
- Given in combination with bendamustine and a rituximab product; and
- Documentation of diagnosis of DLBCL;and
- Documentation of at least two (2) prior therapies;and
- Administration of prophylaxis forPneumocystis jirovecipneumonia and herpes virus throughout treatment with polatuzumab vedotin (Polivy).; or
National Comprehensive Cancer Network (NCCN) Recommendations
AIDS-Related B-Cell Lymphoma
- As subsequent therapy, after at least 2 prior therapies, as a single agent or in combination with bendamustine with or without a rituximab product for relapse of ANY of the following:
- AIDS-related DLBCL; or
- Primary effusion pneumonia; or
- HHV8-positive DLBCL, not otherwise specified; or
- Without rituximab for relapse of AIDS-related plasmablastic lymphoma in non-candidates for transplant; or
Diffuse Large B-Cell Lymphoma
- As a single agent or in combination with bendamustine and/or a rituximab product as subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease after at least 2 prior therapies in non-candidates for transplant; or
Follicular Lymphoma (Grade 1-2)
- As a single agent or in combination with bendamustine and/or a rituximab product for treatment of histologic transformation to DLBCL without translocations of MYC and BCL2 and/or BCL6 in individuals who have received EITHER:
- Minimal or no chemoimmunotherapy prior to histologic transformation to DLBCL and have no response or progressive disease after chemoimmunotherapy (anthracycline or anthracenedione-based regimens, unless contraindicated); or
- Multiple prior therapies including at least 2 lines of chemoimmunotherapy for indolent or transformed disease; or
- As a single agent or in combination with bendamustine and/or a rituximab product as subsequent therapy after at least 2 prior therapies for refractory or progressive disease in individuals with indications for treatment; or
High-Grade B- Cell Lymphomas
- As a single agent or in combination with bendamustine and/or a rituximab product as second-line and subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease after at least 2 prior therapies in non-candidates for transplant; or
Histologic Transformation of Nodal Marginal Zone to Diffuse Large B-Cell Lymphoma
- As a single agent or in combination with bendamustine and/or a rituximab product for individuals who have received multiple prior therapies including at least 2 lines of chemoimmunotherapy for indolent or transformed disease; or
Mantle Cell Lymphoma
- As subsequent therapy after at least 2 prior therapies as a single agent or in combination with bendamustine and/or a rituximab product for stage I-II, aggressive stage II bulky, III, or IV, or symptomatic indolent stage II bulky, III, or IV disease in individuals who have stable disease or partial response with substantial disease after induction therapy, or who have relapsed or progressive disease; or
Post-Transplant Lymphoproliferative Disorder
- As subsequent therapy as a single agent or with bendamustine and/or a rituximab product for individuals with a partial response, persistent or progressive disease after receiving at least 2 lines of chemoimmunotherapy for monomorphic post-transplant lymphoproliferative disorder.
The use of polatuzumab vedotin-piiq (Polivy) for any other indication is considered experimental/investigational as the published peer reviewed literature does not support its efficacy or safety for any other indications.
Procedure Codes
