CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Polivy (polatuzumab vedotin) coverage criteria for B-cell lymphomas

Defines coverage and authorization criteria for Polivy (polatuzumab vedotin) for FDA‑approved and compendial B-cell lymphoma indications for members of the plan, including initial and continuation authorization rules.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPolivy (polatuzumab vedotin) coverage criteria for B-cell lymphomas

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, IPI score when relevant, prior lines of therapy, and transplant/CAR T candidacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 cyclesmaximum authorization duration for continuation

2+ prior therapiesrelapsed/refractory DLBCL requirement

IPI ≥ 2first-line combination requirement

FDA + compendialcoverage stance

Coverage and Medical Necessity Criteria

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FDA‑Approved Indications

Covered when ALL of the following are met for FDA‑approved indications:

First-line DLBCL/HGBL combination: Polivy in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL)IPI >= 2

FDA indication requires International Prognostic Index (IPI) score of 2 or greater

Relapsed/refractory DLBCL: Polivy in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory DLBCL after at least two prior therapies>= 2 prior therapies

FDA indication for relapsed/refractory DLBCL

Compendial Indications

Covered compendial uses when ALL listed criteria (where specified) are met:

Compendial B‑cell lymphoma indications: High-grade B-cell lymphomas (HGBL); monomorphic post-transplant lymphoproliferative disorders (B-cell type); histologic transformation of indolent lymphomas to DLBCL; HIV-related B-cell lymphomas; follicular lymphoma; DLBCL; other compendial B-cell lymphoma indications

Condition-specific additional criteria (see items below) per compendia and policy text

Use as subsequent treatment or bridging: When used as subsequent treatment as a single agent or in combination with bendamustine with or without rituximab, the member is not a candidate for transplant or the medication will be used as a bridging option until CAR T-cell product is available

Applies across multiple compendial indications

Monomorphic post‑transplant and HIV‑related lymphoma criteria: For monomorphic post-transplant lymphoproliferative disorders (B-cell) and HIV-related B-cell lymphomas, member is not a candidate for transplant or drug is used as bridging until CAR T-cell product is available

Explicit requirement in policy for these compendial indications

Continuation Therapy

Continuation of therapy covered when ALL of the following are met:

Continuation authorization: No evidence of unacceptable toxicity or disease progression while on the current regimenmember has not received 6 or more cycles

Authorization may be granted up to 6 months (6 cycles total)

Regimens and Indication-Specific Regimens

Regimen	Indication	Coverage status
Polivy (polatuzumab vedotin) + rituximab product + cyclophosphamide + doxorubicin + prednisone (R‑CHP)
Previously untreated diffuse large B‑cell lymphoma (DLBCL) or high‑grade B‑cell lymphoma (HGBL) with International Prognostic Index (IPI) score of 2 or greater
FDA‑approved first‑line combination regimen; coverage requires IPI ≥ 2

Regimen	Indication	Coverage status
Polivy (polatuzumab vedotin) + bendamustine + rituximab product
Relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) after at least two prior therapies
FDA‑approved relapsed/refractory regimen (requires ≥2 prior therapies); alternative: Polivy as single agent or Polivy + bendamustine ± rituximab for subsequent‑line use when member is not transplant candidate or as bridging to CAR‑T

First-line and Subsequent-line Considerations

Line of Therapy

First-line: Polivy in combination with R-CHP for untreated DLBCL or HGBL when International Prognostic Index (IPI) score is 2 or greaterIPI >= 2

FDA‑approved first-line use for stage II-IV disease with IPI >=2

Second-line or subsequent: Polivy as subsequent treatment in relapsed/refractory disease as: (a) in combination with bendamustine with or without rituximab, or (b) as single agent — when member is not a candidate for transplant or as bridging to CAR T-cell therapy>= 2 prior therapies for the specific FDA relapsed/refractory indication

Described for relapsed/refractory DLBCL and applicable compendial uses

Key Coding and Thresholds

International Prognostic Index (IPI)

IPI score requirementInternational Prognostic Index (IPI) score of 2 or greater

ContextRequired for first-line use of Polivy in combination with R-CHP for previously untreated DLBCL or HGBL

Source wordingPolicy: first‑line therapy ... in members who have International Prognostic Index score of 2 or greater

Maximum authorized cycles for continuation

Maximum authorized cyclesAuthorization up to 6 months (6 cycles total)

Continuation conditionGranted when there is no evidence of unacceptable toxicity or disease progression while on current regimen

LimitNot eligible if member has received 6 or more cycles

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Polivy (polatuzumab vedotin-piiq) for FDA‑approved indications and compendial uses. Approval is contingent on verification of the applicable clinical criteria (e.g., diagnosis of DLBCL or HGBL, International Prognostic Index score when relevant, prior lines of therapy, transplant candidacy, and intended combination regimen).

Affected indications include: FDA‑approved first‑line use in combination with R‑CHP for previously untreated DLBCL or HGBL with an IPI ≥2; FDA‑approved use in combination with bendamustine plus a rituximab product for relapsed/refractory DLBCL after ≥2 prior therapies; and listed compendial uses such as subsequent‑line single‑agent therapy or in combination with bendamustine ± rituximab for various B‑cell lymphoma subtypes.

Step Therapy

Step/Sequence Considerations

For relapsed or refractory B‑cell lymphomas, Polivy may be used as a single agent or in combination with bendamustine with or without a rituximab product when clinically appropriate (for example, when the member is not a candidate for transplant or when the drug is being used as a bridge to CAR T‑cell therapy). For first‑line therapy of previously untreated DLBCL or HGBL, Polivy is used in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R‑CHP) for members with an International Prognostic Index (IPI) score of 2 or greater.

Relapsed/refractory setting: single‑agent Polivy or Polivy + bendamustine ± rituximab; member not a transplant candidate or using as bridge to CAR T.
First‑line setting: Polivy + R‑CHP for stage II–IV DLBCL/HGBL with IPI ≥2.

Documentation Required

Required Clinical Documentation

Documentation supporting the diagnosis and treatment history must be submitted with the PA request. This includes pathology reports confirming DLBCL or other relevant B‑cell lymphoma subtype, prior treatment regimens and number of prior lines of therapy, transplant candidacy status, International Prognostic Index (IPI) score when applicable, and rationale for chosen combination or single‑agent use.

Pathology report or diagnostic documentation.
Detailed prior therapy history (agents, number of lines, response).
Transplant candidacy and intent (e.g., bridging to CAR T).
IPI score for first‑line DLBCL/HGBL requests when applicable.

Denial Risk

Denial Risk for Unmet Criteria

Requests that do not meet the approval criteria for FDA‑approved indications or accepted compendial uses may be denied. Denial risk is increased when documentation of diagnosis, prior therapies, IPI score, or transplant candidacy is incomplete or absent.

Incomplete or missing supporting documentation.
Use inconsistent with FDA‑approved indications or listed compendial uses.

Note

Authorization Duration and Reauthorization

Authorization for continuation of therapy may be granted for up to 6 months (6 cycles total) provided there is no evidence of unacceptable toxicity or disease progression on the current regimen and the member has not already received 6 or more cycles of Polivy.

Continuation approvals: up to 6 months (6 cycles total).
Reauthorization requires documentation of clinical benefit (no progression) and acceptable toxicity profile.

Definitions and Clinical Terms

High-grade B-cell lymphoma (HGBL)

DefinitionHigh-grade B-cell lymphoma (HGBL) includes double‑hit or triple‑hit lymphomas

Policy relevancePolicy references HGBL as an indicated population for Polivy when criteria are met

Use scenariosMay be treated with Polivy as first‑line in combination with R‑CHP when IPI >= 2, or as subsequent therapy (single agent or with bendamustine +/- rituximab)

International Prognostic Index (IPI) score requirement

Required IPI thresholdIPI score of 2 or greater is required for first‑line combination use (R‑CHP) in untreated DLBCL/HGBL

Applies toPolivy in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R‑CHP)

Policy referenceDocument states first‑line therapy for stage II‑IV disease when member has International Prognostic Index score of 2 or greater

Background

Polivy (polatuzumab vedotin) is indicated for treatment of diffuse large B‑cell lymphoma (DLBCL) and is also listed in compendia for several B‑cell lymphoma subtypes including high‑grade B‑cell lymphomas (HGBLs), monomorphic post‑transplant lymphoproliferative disorders (B‑cell type), histologic transformation of indolent lymphomas to DLBCL, HIV‑related B‑cell lymphomas, follicular lymphoma, and DLBCL. All other indications not specified in the FDA‑approved or compendial lists are considered experimental/investigational and not medically necessary.