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

1. Length of Authorization ^1,6

Coverage will be provided for 6 months (up to 6 cycles of therapy) and may NOT be renewed.

2. Dosing Limits

1. 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

2. Max Units (per dose and over time) [HCPCS Unit]:

• 200 billable units every 21 days

3. 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

• • 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

• • 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
• 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

• • 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

• • • • 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

• • • • 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

† FDA Approved Indication(s), ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,3,4

Coverage cannot be renewed.

5. Dosage/Administration ^1,6

6. 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

7. References

1. Polivy [package insert]. South San Francisco, CA; Genentech, Inc; April 2023. Accessed May 2024.
2. 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.
3. 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 
4. 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.
5. 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.
6. 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

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