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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.

  1. Length of Authorization 1,6

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

  1. 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
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 200 billable units every 21 days
  1. 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

  1. Renewal Criteria 1,3,4

Coverage cannot be renewed.

  1. 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.

  • Administer Polivy, cyclophosphamide, doxorubicin, and a rituximab product in any order on Day 1 after the administration of prednisone. Prednisone is administered on Days 1–5 of each cycle.

Relapsed/refractory DLBCL

Administer 1.8 mg/kg intravenously every 21 days for 6 cycles in combination with bendamustine and rituximab product.

  • Administer Polivy, bendamustine, and rituximab product in any order on Day 1 of each cycle.

All Other Indications

Administer 1.8 mg/kg intravenously every 21 days for 6 cycles.

  1. 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
  1. 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

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