CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Evolent Clinical Guideline 3120 for Polivy (polatuzumab vedotin)

Defines accepted indications, continuation and exclusion criteria, dosing limits, and coding for polatuzumab vedotin (Polivy) for members across Commercial, Exchange/Marketplace, and Medicaid lines of business; describes evidence sources required to support use and prior authorization processing by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEvolent Clinical Guideline 3120 for Polivy (polatuzumab vedotin)

Policy CodePolicy N/A

Change TypeRevised (template conversion, updated indications/references)

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization from Evolent and support clinical justification with FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per Medicare Benefit Policy Manual Chapter 15.

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1362 Polivy policy; updated indication section and references (June 2025).

Updated NCH verbiage to Evolent (June 2024).

3Covered Indication Categories

3Exclusion Criteria Count

1Drug Code Listed

Coverage Summary

Coverage stance: covered_with_criteria for Polivy (polatuzumab vedotin). Accepted uses include first-line therapy for Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma (HGBL) in combination with R-CHP for patients with an International Prognostic Index (IPI) >= 2, and second-line or subsequent therapy for DLBCL as single agent or with bendamustine (with or without rituximab). Continuation of prior therapy may be allowed when all continuation exemption conditions are met: no disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request. Scope: Commercial, Exchange/Marketplace, Medicaid. Effective: 2025-06-01. Last review: 2025-06.

Initial Therapy Criteria

Diffuse Large B-Cell Lymphoma (DLBCL) - First-line

Polivy may be used when ALL of the following are met for first-line therapy:

ALL of the following

Diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBL)
Use in combination with R-CHP (rituximab + cyclophosphamide + doxorubicin + prednisone) as first line/initial treatment
International Prognostic Index (IPI) score of 2 or greaterIPI >= 2

First-line use is specifically in combination with R-CHP and is supported by a key randomized controlled trial (Tilly H et al., N Engl J Med 2022) and product labeling/guidance per the guideline.

Continuation Therapy Criteria

General Continuation Request Exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization<= 30 days
Additional medication(s) are not being added to the continuation request

DLBCL - Second-line or Subsequent Therapy

Polivy may be used when ALL of the following are met for second-line or later therapy:

ALL of the following

Diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL)
Use as a single agent or in combination with bendamustine, with or without rituximab or rituximab biosimilars

Exclusion Criteria / Not Approvable Uses

Polivy is not approvable when ANY of the following exclusion criteria are met:

ANY of the following

Use of Polivy after disease progression with the same regimen or prior Polivy or bendamustine unless prior therapy was completed more than a year ago
Dosing exceeds single dose limit of Polivy 1.8 mg/kgsingle dose > 1.8 mg/kg
Treatment exceeds the maximum duration limit of 6 cyclestreatment cycles > 6
Investigational use for an off-label indication that lacks sufficient evidence or is not generally accepted by the medical community
Sufficient evidence includes support from FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature; inadequate evidence includes case reports, abstracts without full articles, or indications not represented in the literature

Use of Polivy after disease progression on the same regimen or after prior Polivy or bendamustine is excluded unless the prior therapy was completed more than one year ago.

Provider Actions

Prior Authorization

Prior authorization required by Evolent

Evolent processes all medication requests for Polivy and prior authorization is required per this policy. Requests must be authorized by Evolent or they may be deemed not approvable and not reimbursable.

J9309
Evidence must meet standards listed in policy (e.g., FDA labeling, CMS-recognized compendia, NCCN/ASCO, acceptable peer-reviewed literature per Medicare Benefit Policy Manual Chapter 15)

Documentation Required

Supportive evidence required

Clinical justification must reference FDA product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS criteria. Case reports and abstracts without full published articles are insufficient as supportive evidence.

Denial Risk

Denial risk for investigational/off-label without adequate evidence

Requests for investigational or off-label uses that lack sufficient evidence or are not generally accepted by the medical community may be excluded and denied under this policy.

Documentation Required

Continuation request exemption documentation

To qualify for a continuation exemption for a previously non-approvable medication, documentation must show all of the following: no disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medications are being added to the continuation request.

Background

Evolent Clinical Guideline defines accepted uses of Polivy for DLBCL and HGBL based on FDA labeling and major oncology compendia/guidelines (NCCN/ASCO). Evolent manages prior authorizations and requires that use be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature. Continuation of prior therapy may be allowed under the specified continuation exemption conditions when documentation demonstrates no progression, prior use within the last year without >30-day lapse in authorization, and no added medications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEvolent Clinical Guideline 3120 for Polivy (polatuzumab vedotin)

Policy CodePolicy N/A

Change TypeRevised (template conversion, updated indications/references)

Effective DateJun 1, 2025

Next Review Date

On This Page

OpenPayer

Evolent Clinical Guideline 3120 for Polivy (polatuzumab vedotin)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Exclusion Criteria / Not Approvable Uses

Applicable Codes

Provider Actions

Clinical Evidence

Background

Revision History