Polatuzumab vedotin-piiq (Polivy) (ARCHIVED)

Policy ID: I-217-007

Section: Injections

Effective Date: October 01, 2019

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-217-007

Section: Injections

Effective Date: October 01, 2019

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Polatuzumab vedotin-piiq (Polivy ^® ) is a novel CD79b-directed antibody-drug conjugate with activity against dividing B cells, consisting of humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b, the small molecule anti-mitotic agent monomethyl auristatin E (MMAE), and a protease-cleavable linker that covalently attaches MMAE to the antibody. Polatuzumab vedotin-piiq (Polivy) binds to CD78b of the B-cell receptor; upon binding polatuzumab vedotin-piiq (Polivy) is internalized and the linker is cleaved by lysosomal proteases enabling intracellular delivery of MMAE. MMAE binds to microtubules, inhibits cell division, and induces apoptosis, thus killing dividing cells.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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:

Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse Large B-Cell Lymphoma (DLBCL)
- 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 at least two (2) prior therapies; or
- For the treatment of previously untreated DLBCL, not otherwise specified or high-grade B-cell lymphoma (HGBL) when ALL the following criteria are met:
  - Individual has International Prognostic Index score of two (2) or greater; and
  - Given in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP); or

Compendia Sources

Polatuzumab vedotin (Polivy) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations

The use of polatuzumab vedotin (Polivy) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Code

J9309

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Note: Premedications are recommended during the course of therapy with polatuzumab vedotin-piiq (Polivy), including antihistamine and antipyretic.

Diagnosis Codes

Covered Diagnosis Codes for J9309

C82.00

C82.01

C82.02

C82.03

C82.04

C82.05

C82.06

C82.07

C82.08

C82.09

C82.10

C82.11

C82.12

C82.13

C82.14

C82.15

C82.16

C82.17

C82.18

C82.19

C82.20

C82.21

C82.22

C82.23

C82.24

C82.25

C82.26

C82.27

C82.28

C82.29

C82.30

C82.31

C82.32

C82.33

C82.34

C82.35

C82.36

C82.37

C82.38

C82.39

C82.40

C82.41

C82.42

C82.43

C82.44

C82.45

C82.46

C82.47

C82.48

C82.49

C82.50

C82.51

C82.52

C82.53

C82.54

C82.55

C82.56

C82.57

C82.58

C82.59

C82.60

C82.61

C82.62

C82.63

C82.64

C82.65

C82.66

C82.67

C82.68

C82.69

C82.80

C82.81

C82.82

C82.83

C82.84

C82.85

C82.86

C82.87

C82.88

C82.89

C82.90

C82.91

C82.92

C82.93

C82.94

C82.95

C82.96

C82.97

C82.98

C82.99

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

C85.10

C85.11

C85.12

C85.13

C85.14

C85.15

C85.16

C85.17

C85.18

C85.19

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

D47.Z1

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Coding update

Internal Medical Policy Committee 9-21-2020

Added Additional NCCN recommendations and
Added Diagnosis codes

Internal Medical Policy Committee 9-21-2021 Annual Review

Internal Medical Policy Committee 9-28-2022 - Effective November 01, 2022

Removed NCCN recommendations and added this statement 'Polatuzumab vedotin (Polivy) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.' and
Updated experimental/investigational statement

Internal Medical Policy Committee 9-12-2023 - Effective November 01, 2023

Added additional DLBCL criteria for untreated individuals
Updated diagnosis codes

Internal Medical Policy Committee 9-17-2024 Effective November 01, 2024

Removed Administration of prophylaxis for Pneumocystis jiroveci pneumonia and herpes virus throughout treatment with polatuzumab vedotin (Polivy) criteria

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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