Asset Publisher
Polivy™ (polatuzumab vedotin-piiq) (Intravenous)
Policy Number: VP-0482
(Intravenous)
Last Review Date: 07/02/2024
Date of Origin: 07/01/2019
Dates Reviewed: 07/2019, 09/2019, 07/2020, 12/2020, 07/2021, 07/2022, 05/2023, 07/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization 1,6
Coverage will be provided for 6 months (up to 6 cycles of therapy) and may NOT be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- Polivy 30 mg single-dose vial: 2 vials per 21 days
- Polivy 140 mg single-dose vial: 1 vial per 21 days
- Max Units (per dose and over time) [HCPCS Unit]:
- 200 billable units every 21 days
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- Patient is at least 18 years of age; AND
- Patient will receive prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus; AND
- Patient does not currently have Grade ≥ 2 peripheral neuropathy; AND
- Patient does not have CNS lymphoma; AND
B-Cell Lymphomas † ‡ 1-5
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- Diffuse Large B-Cell Lymphoma (DLBCL) Ф, High-Grade B-Cell Lymphomas (HGBL), HIV-Related B-Cell Lymphomas (includes all of the following: diffuse large B-cell lymphoma, primary effusion lymphoma, HHV8-positive diffuse large B-cell lymphoma [not otherwise specified], and plasmablastic lymphoma)
- Used in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP); AND
- Used as first line therapy (Only applies to DLBCL and High-Grade B-Cell Lymphoma) †; AND
- Patient has an International Prognostic Index (IPI) score of ≥2; OR
- Used as a single agent or in combination with bendamustine and/or rituximab (Note: Use for relapsed plasmablastic lymphoma excludes use with rituximab); AND
- Used as subsequent therapy in patients with no intention to proceed to transplant; AND
- Used for relapsed disease >12 months after completion of first-line therapy; OR
- Used for primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy in non-candidates for CAR T-cell therapy; OR
- Used as alternative systemic therapy (if not previously used) for relapsed/refractory disease in non-candidates for CAR T-cell therapy; OR
- Used as bridging option until CAR T-cell product is available for primary refractory disease or relapsed disease <12 months after completion of first-line therapy
- Used as subsequent therapy in patients with no intention to proceed to transplant; AND
- Used in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP); AND
- Diffuse Large B-Cell Lymphoma (DLBCL) Ф, High-Grade B-Cell Lymphomas (HGBL), HIV-Related B-Cell Lymphomas (includes all of the following: diffuse large B-cell lymphoma, primary effusion lymphoma, HHV8-positive diffuse large B-cell lymphoma [not otherwise specified], and plasmablastic lymphoma)
-
- Histologic Transformation of Indolent Lymphomas ‡
- Used as a single-agent or in combination with bendamustine and/or rituximab in patients with no intention to proceed to transplant; AND
- Patient has previously been treated with an anthracycline-based regimen; AND
- Patient had histologic transformation to DLBCL after minimal or no prior treatment; AND
- Used as additional therapy for partial response, no response, progressive, or relapsed disease following chemoimmunotherapy; OR
- Patient had histologic transformation to DLBCL after multiple lines of prior therapies including ≥2 chemoimmunotherapy regimens for indolent or transformed disease; OR
- Patient had histologic transformation to DLBCL after minimal or no prior treatment; AND
- Patient has previously been treated with an anthracycline-based regimen; AND
- Used as a single-agent or in combination with bendamustine and/or rituximab in patients with no intention to proceed to transplant; AND
- Histologic Transformation of Indolent Lymphomas ‡
- Used in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP); AND
- Patient had histologic transformation to DLBCL or high-grade B-cell lymphoma with MYC and BCL6 rearrangement (without BCL2 rearrangements); AND
-
- Used after minimal or no prior therapy; AND
- Patient has an IPI score of ≥2
-
- Patient had histologic transformation to DLBCL or high-grade B-cell lymphoma with MYC and BCL6 rearrangement (without BCL2 rearrangements); AND
-
- Post-Transplant Lymphoproliferative Disorders ‡
- Patient has monomorphic B-cell type disease; AND
- Used as a single-agent or in combination with bendamustine and/or rituximab; AND
- Used as subsequent therapy in patients with no intention to proceed to transplant; AND
- Post-Transplant Lymphoproliferative Disorders ‡
-
-
-
- Used for relapsed disease >12 months after completion of initial treatment with chemoimmunotherapy; OR
- Used for primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of initial treatment with chemoimmunotherapy in non-candidates for CAR T-cell therapy; OR
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-
-
-
-
- Used as alternative systemic therapy (if not previously used) for relapsed/refractory disease in non-candidates for CAR T-cell therapy; OR
- Used as a bridging option until CAR T-cell product is available for primary refractory disease or relapsed disease <12 months after completion of initial treatment with chemoimmunotherapy
-
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† FDA Approved Indication(s), ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1,3,4
Coverage cannot be renewed.
- Dosage/Administration 1,6
Indication |
Dose |
Previously untreated DLBCL or HGBL |
Administer 1.8 mg/kg intravenously every 21 days for 6 cycles in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone.
|
Relapsed/refractory DLBCL |
Administer 1.8 mg/kg intravenously every 21 days for 6 cycles in combination with bendamustine and rituximab product.
|
All Other Indications |
Administer 1.8 mg/kg intravenously every 21 days for 6 cycles. |
- Billing Code/Availability Information
HCPCS code:
- J9309 – Injection, polatuzumab vedotin-piiq 1 mg; 1 mg = 1 billable unit
NDC:
- Polivy 30 mg lyophilized powder for injection, single-dose vial: 50242-0103-xx
- Polivy 140 mg lyophilized powder for injection, single-dose vial: 50242-0105-xx
- References
- Polivy [package insert]. South San Francisco, CA; Genentech, Inc; April 2023. Accessed May 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for polatuzumab vedotin. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed May 2024.
- Sehn LH, Kamdar M, Herrera AF, et al. Randomized phase 2 trial of polatuzumab vedotin (pola) with bendamustine and rituximab (BR) in relapsed/refractory (r/r) FL and DLBCL. J Clin Oncol 2018; 36:15_suppl, 7507-7507 doi:10.1200/JCO.2018.36.15_suppl.7507
- Sehn LH, Herrera AF, Matasar MJ, et al. Polatuzumab vedotin (Pola) plus bendamustine (B) with rituximab (R) or obinutuzumab (G) in relapsed/refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Updated results of a phase (Ph) Ib/II study (abstract). Blood 2018;132:Abstract 1683.
- Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Jan 27;386(4):351-363. doi: 10.1056/NEJMoa2115304.
- Sehn LH, Herrera AF, Flowers CR, et al. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020 Jan 10;38(2):155-165. doi: 10.1200/JCO.19.00172.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C83.30 |
Diffuse large B-cell lymphoma unspecified site |
C83.31 |
Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck |
C83.32 |
Diffuse large B-cell lymphoma intrathoracic lymph nodes |
C83.33 |
Diffuse large B-cell lymphoma intra-abdominal lymph nodes |
C83.34 |
Diffuse large B-cell lymphoma lymph nodes of axilla and upper limb |
C83.35 |
Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb |
C83.36 |
Diffuse large B-cell lymphoma intrapelvic lymph nodes |
C83.37 |
Diffuse large B-cell lymphoma, spleen |
C83.38 |
Diffuse large B-cell lymphoma lymph nodes of multiple sites |
C83.39 |
Diffuse large B-cell lymphoma extranodal and solid organ sites |
C83.80 |
Other non-follicular lymphoma, unspecified site |
C83.81 |
Other non-follicular lymphoma, lymph nodes of head, face and neck |
C83.82 |
Other non-follicular lymphoma, intrathoracic lymph nodes |
C83.83 |
Other non-follicular lymphoma, intra-abdominal lymph nodes |
C83.84 |
Other non-follicular lymphoma, lymph nodes of axilla and upper limb |
C83.85 |
Other non-follicular lymphoma, lymph nodes of inguinal region and lower limb |
C83.86 |
Other non-follicular lymphoma, intrapelvic lymph nodes |
C83.87 |
Other non-follicular lymphoma, spleen |
C83.88 |
Other non-follicular lymphoma, lymph nodes of multiple sites |
C83.89 |
Other non-follicular lymphoma, extranodal and solid organ sites |
C83.90 |
Non-follicular (diffuse) lymphoma, unspecified site |
C83.91 |
Non-follicular (diffuse) lymphoma, unspecified lymph nodes of head, face, and neck |
C83.92 |
Non-follicular (diffuse) lymphoma, unspecified intrathoracic lymph nodes |
C83.93 |
Non-follicular (diffuse) lymphoma, unspecified intra-abdominal lymph nodes |
C83.94 |
Non-follicular (diffuse) lymphoma, unspecified lymph nodes of axilla and upper limb |
C83.95 |
Non-follicular (diffuse) lymphoma, unspecified lymph nodes of inguinal region and lower limb |
C83.96 |
Non-follicular (diffuse) lymphoma, unspecified intrapelvic lymph nodes |
C83.97 |
Non-follicular (diffuse) lymphoma, unspecified spleen |
C83.98 |
Non-follicular (diffuse) lymphoma, unspecified lymph nodes of multiple sites |
C83.99 |
Non-follicular (diffuse) lymphoma, unspecified extranodal and solid organ sites |
C85.10 |
Unspecified B-cell lymphoma, unspecified site |
C85.11 |
Unspecified B-cell lymphoma, lymph nodes of head, face, and neck |
C85.12 |
Unspecified B-cell lymphoma, intrathoracic lymph nodes |
C85.13 |
Unspecified B-cell lymphoma, intra-abdominal lymph nodes |
C85.14 |
Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb |
C85.15 |
Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb |
C85.16 |
Unspecified B-cell lymphoma, intrapelvic lymph nodes |
C85.17 |
Unspecified B-cell lymphoma, spleen |
C85.18 |
Unspecified B-cell lymphoma, lymph nodes of multiple sites |
C85.19 |
Unspecified B-cell lymphoma, extranodal and solid organ sites |
C85.20 |
Mediastinal (thymic) large B-cell lymphoma, unspecified site |
C85.21 |
Mediastinal (thymic) large B-cell lymphoma, lymph nodes of head, face and neck |
C85.22 |
Mediastinal (thymic) large B-cell lymphoma, intrathoracic lymph nodes |
C85.23 |
Mediastinal (thymic) large B-cell lymphoma, intra-abdominal lymph nodes |
C85.24 |
Mediastinal (thymic) large B-cell lymphoma, lymph nodes of axilla and upper limb |
C85.25 |
Mediastinal (thymic) large B-cell lymphoma, lymph nodes of inguinal region and lower limb |
C85.26 |
Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes |
C85.27 |
Mediastinal (thymic) large B-cell lymphoma, spleen |
C85.28 |
Mediastinal (thymic) large B-cell lymphoma, lymph nodes of multiple sites |
C85.29 |
Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites |
C85.80 |
Other specified types of non-Hodgkin lymphoma, unspecified site |
C85.81 |
Other specified types of non-Hodgkin lymphoma, lymph nodes of head, face and neck |
C85.82 |
Other specified types of non-Hodgkin lymphoma, intrathoracic lymph nodes |
C85.83 |
Other specified types of non-Hodgkin lymphoma, intra-abdominal lymph nodes |
C85.84 |
Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb |
C85.85 |
Other specified types of non-Hodgkin lymphoma, lymph nodes of inguinal region of lower limb |
C85.86 |
Other specified types of non-Hodgkin lymphoma, intrapelvic lymph nodes |
C85.87 |
Other specified types of non-Hodgkin lymphoma, spleen |
C85.88 |
Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites |
C85.89 |
Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites |
D47.Z1 |
Post-transplant lymphoproliferative disorder (PTLD) |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |