Asset Publisher
Polivy™ (polatuzumab vedotin-piiq) (Intravenous)
Policy Number: VP-0482
Last Review Date: 05/04/2023
Date of Origin: 07/01/2019
Dates Reviewed: 07/2019, 09/2019, 07/2020, 12/2020, 07/2021, 07/2022, 05/2023
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. |
I. Length of Authorization 1,6
Coverage will be provided for 6 months (up to 6 cycles of therapy) and may NOT be renewed.
II. 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
III. 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 as first line therapy (Only applies to DLBCL and High-Grade B-Cell Lymphoma) †; AND
- Used in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP); AND
- Patient has an International Prognostic Index (IPI) score of ≥2; OR
- Used as subsequent therapy in patients with no intention to proceed to transplant; AND
- 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 for relapsed or refractory 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 if no intention to proceed to CAR T-cell therapy; OR
- Used as alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy
- 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 first line therapy (Only applies to DLBCL and High-Grade B-Cell Lymphoma) †; 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)
-
- Follicular Lymphoma (grade 1-2)
- Used as subsequent therapy (if not previously given); AND
- Used as a single-agent or in combination with bendamustine and/or rituximab; AND
- Patient has no response, relapsed, or progressive disease
- Histologic Transformation of Indolent Lymphomas to Diffuse Large B-cell Lymphoma (DLBCL)
- 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 additional therapy for partial response, no response, or progressive disease following chemoimmunotherapy; OR
- Used after multiple prior therapies for indolent or transformed disease
- Post-Transplant Lymphoproliferative Disorders
- Patient has monomorphic B-cell type disease; AND
- Used as subsequent therapy in patients with no intention to proceed to transplant; AND
- Used as a single-agent or in combination with bendamustine and/or rituximab; AND
- Follicular Lymphoma (grade 1-2)
-
-
- Used for relapsed or refractory 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 if no intention to proceed to CAR T-cell therapy; OR
-
-
-
- Used as alternative systemic therapy (if not previously used) for relapsed/refractory disease if no intention to proceed to CAR T-cell therapy
-
† FDA Approved Indication(s), ‡ Compendia Recommended Indication(s); Ф Orphan Drug
IV. Renewal Criteria 1,3,4
Coverage cannot be renewed.
V. 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. |
VI. 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
VII. References
- Polivy [package insert]. South San Francisco, CA; Genentech, Inc; April 2023. Accessed April 2023.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for polatuzumab vedotin. National Comprehensive Cancer Network, 2023. 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 April 2023.
- 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
- 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 |
C82.00 |
Follicular lymphoma grade I, unspecified site |
C82.01 |
Follicular lymphoma grade I, lymph nodes of head, face and neck |
C82.02 |
Follicular lymphoma, grade I, intrathoracic lymph nodes |
C82.03 |
Follicular lymphoma grade I, intra-abdominal lymph nodes |
C82.04 |
Follicular lymphoma grade I, lymph nodes of axilla and upper limb |
C82.05 |
Follicular lymphoma grade I, lymph nodes of inguinal regional and lower limb |
C82.06 |
Follicular lymphoma grade I, intrapelvic lymph nodes |
C82.07 |
Follicular lymphoma grade I, spleen |
C82.08 |
Follicular lymphoma grade I, lymph nodes of multiple sites |
C82.09 |
Follicular lymphoma grade I, extranodal and solid organ sites |
C82.10 |
Follicular lymphoma grade II, unspecified site |
C82.11 |
Follicular lymphoma grade II, lymph nodes of head, face and neck |
C82.12 |
Follicular lymphoma, grade II, intrathoracic lymph nodes |
C82.13 |
Follicular lymphoma grade II, intra-abdominal lymph nodes |
C82.14 |
Follicular lymphoma grade II, lymph nodes of axilla and upper limb |
C82.15 |
Follicular lymphoma grade II, lymph nodes of inguinal region and lower limb |
C82.16 |
Follicular lymphoma grade II, intrapelvic lymph nodes |
C82.17 |
Follicular lymphoma grade II, spleen |
C82.18 |
Follicular lymphoma grade II, lymph nodes of multiple sites |
C82.19 |
Follicular lymphoma grade II, extranodal and solid organ sites |
C82.20 |
Follicular lymphoma grade III, unspecified, unspecified site |
C82.21 |
Follicular lymphoma grade III, unspecified, lymph nodes of head, face and neck |
C82.22 |
Follicular lymphoma, grade III, unspecified, intrathoracic lymph nodes |
C82.23 |
Follicular lymphoma grade III, unspecified, intra-abdominal lymph nodes |
C82.24 |
Follicular lymphoma grade III, unspecified, lymph nodes of axilla and upper limb |
C82.25 |
Follicular lymphoma grade III, unspecified, lymph nodes of inguinal region and lower limb |
C82.26 |
Follicular lymphoma grade III, unspecified, intrapelvic lymph nodes |
C82.27 |
Follicular lymphoma grade III, unspecified, spleen |
C82.28 |
Follicular lymphoma grade III, unspecified, lymph nodes of multiple sites |
C82.29 |
Follicular lymphoma grade III, unspecified, extranodal and solid organ sites |
C82.30 |
Follicular lymphoma grade IIIa, unspecified site |
C82.31 |
Follicular lymphoma grade IIIa, lymph nodes of head, face and neck |
C82.32 |
Follicular lymphoma, grade IIIa, intrathoracic lymph nodes |
C82.33 |
Follicular lymphoma grade IIIa, intra-abdominal lymph nodes |
C82.34 |
Follicular lymphoma grade IIIa, lymph nodes of axilla and upper limb |
C82.35 |
Follicular lymphoma grade IIIa, lymph nodes of inguinal region and lower limb |
C82.36 |
Follicular lymphoma grade IIIa, intrapelvic lymph nodes |
C82.37 |
Follicular lymphoma grade IIIa, spleen |
C82.38 |
Follicular lymphoma grade IIIa, lymph nodes of multiple sites |
C82.39 |
Follicular lymphoma grade IIIa, extranodal and solid organ sites |
C82.40 |
Follicular lymphoma grade IIIb, unspecified site |
C82.41 |
Follicular lymphoma grade IIIb, lymph nodes of head, face and neck |
C82.42 |
Follicular lymphoma, grade IIIb, intrathoracic lymph nodes |
C82.43 |
Follicular lymphoma grade IIIb, intra-abdominal lymph nodes |
C82.44 |
Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb |
C82.45 |
Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb |
C82.46 |
Follicular lymphoma grade IIIb, intrapelvic lymph nodes |
C82.47 |
Follicular lymphoma grade IIIb, spleen |
C82.48 |
Follicular lymphoma grade IIIb, lymph nodes of multiple sites |
C82.49 |
Follicular lymphoma grade IIIb, extranodal and solid organ sites |
C82.50 |
Diffuse follicle center lymphoma, unspecified site |
C82.51 |
Diffuse follicle center lymphoma, lymph nodes of head, face and neck |
C82.52 |
Diffuse follicle center lymphoma, intrathoracic lymph nodes |
C82.53 |
Diffuse follicle center lymphoma, intra-abdominal lymph nodes |
C82.54 |
Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb |
C82.55 |
Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb |
C82.56 |
Diffuse follicle center lymphoma, intrapelvic lymph nodes |
C82.57 |
Diffuse follicle center lymphoma, spleen |
C82.58 |
Diffuse follicle center lymphoma, lymph nodes of multiple sites |
C82.59 |
Diffuse follicle center lymphoma, extranodal and solid organ sites |
C82.60 |
Cutaneous follicle center lymphoma, unspecified site |
C82.61 |
Cutaneous follicle center lymphoma, lymph nodes of head, face and neck |
C82.62 |
Cutaneous follicle center lymphoma, intrathoracic lymph nodes |
C82.63 |
Cutaneous follicle center lymphoma, intra-abdominal lymph nodes |
C82.64 |
Cutaneous follicle center lymphoma, lymph nodes of axilla and upper limb |
C82.65 |
Cutaneous follicle center lymphoma, lymph nodes of inguinal region and lower limb |
C82.66 |
Cutaneous follicle center lymphoma, intrapelvic lymph nodes |
C82.67 |
Cutaneous follicle center lymphoma, spleen |
C82.68 |
Cutaneous follicle center lymphoma, lymph nodes of multiple sites |
C82.69 |
Cutaneous follicle center lymphoma, extranodal and solid organ sites |
C82.80 |
Other types of follicular lymphoma, unspecified site |
C82.81 |
Other types of follicular lymphoma, lymph nodes of head, face and neck |
C82.82 |
Other types of follicular lymphoma, intrathoracic lymph nodes |
C82.83 |
Other types of follicular lymphoma, intra-abdominal lymph nodes |
C82.84 |
Other types of follicular lymphoma, lymph nodes of axilla and upper limb |
C82.85 |
Other types of follicular lymphoma, lymph nodes of inguinal region and lower limb |
C82.86 |
Other types of follicular lymphoma, intrapelvic lymph nodes |
C82.87 |
Other types of follicular lymphoma, spleen |
C82.88 |
Other types of follicular lymphoma, lymph nodes of multiple sites |
C82.89 |
Other types of follicular lymphoma, extranodal and solid organ sites |
C82.90 |
Follicular lymphoma, unspecified, unspecified site |
C82.91 |
Follicular lymphoma, unspecified, lymph nodes of head, face and neck |
C82.92 |
Follicular lymphoma, unspecified, intrathoracic lymph nodes |
C82.93 |
Follicular lymphoma, unspecified, intra-abdominal lymph nodes |
C82.94 |
Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb |
C82.95 |
Follicular lymphoma, unspecified lymph nodes of inguinal region and lower limb |
C82.96 |
Follicular lymphoma, unspecified, intrapelvic lymph nodes |
C82.97 |
Follicular lymphoma, unspecified, spleen |
C82.98 |
Follicular lymphoma, unspecified, lymph nodes of multiple sites |
C82.99 |
Follicular lymphoma, unspecified, extranodal and solid organ sites |
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)
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 Determination (NCD), Local Coverage Articles (LCAs) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered 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, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
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 |