CurrentNeighborhood Health Plan of Rhode IslandPolicy 3095-A

Polivy 3095 A Sgm P2023 1

Defines covered FDA-approved and compendia-based indications, initial authorization (up to 6 cycles/6 months), continuation/reauthorization criteria, and exclusions (experimental/investigational) for Polivy when approval criteria are met and no member-specific exclusions exist.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPolivy 3095 A Sgm P2023 1

Policy CodePolicy 3095-A

Change TypeClarified indications and authorization length

Effective Date

Next Review Date

Key ActionObtain prior authorization showing the member meets the specified FDA-approved or compendial criteria (including IPI where applicable) and that the member is not a transplant candidate when required; authorization is for up to 6 cycles/6 months.

SourceLink

POLICY UPDATE CHANGES

Indications include FDA-approved combinations and a list of compendial B-cell lymphoma uses with up to 6-cycle authorization.

2FDA-approved regimen categories

6Maximum cycles authorized per member

6Covered compendial B-cell lymphoma subtypes listed

Coverage Summary

policy_number: 3095-A; subject: Polivy (polatuzumab vedotin-piiq) coverage for B-cell lymphomas; status: CURRENT. Purpose: Defines coverage for FDA-approved and compendia-based indications for Polivy when approval criteria are met and no member-specific exclusions exist. Scope summary: Includes covered FDA-approved combinations and specified compendial B-cell lymphoma uses, authorization of up to 6 cycles (6 months) when criteria are met, continuation/reauthorization requirements, and exclusion of other indications as experimental/investigational. Coverage stance: covered_with_criteria.

Background: Polivy is indicated by the FDA in combination regimens for certain DLBCL settings and has additional compendial uses for various B-cell lymphomas. The policy authorizes up to 6 cycles when the member meets criteria and is not a transplant candidate where specified. Providers must obtain prior authorization documenting the specific FDA-approved or compendial indication (including IPI score where applicable) and transplant candidacy when required; authorization is for up to 6 cycles/6 months.

Quick Facts / Authorization Thresholds

Maximum authorized durationUp to 6 cycles (6 months)

International Prognostic Index (IPI) score requirementIPI >= 2 required for first-line R-CHP use in stage II-IV DLBCL or HGBL

Coverage stancecovered_with_criteria

Authorized cycles6

Initial Therapy Criteria (Covered Indications and Authorization)

Covered Indications and Authorization Criteria

The indications below (FDA-approved and compendial uses) are covered provided all approval criteria are met and the member has no exclusions to the prescribed therapy. Authorization of up to 6 months (up to 6 cycles) may be granted.

FDA-Approved Indications

Polivy in combination with bendamustine and a rituximab product for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.
Polivy in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater.IPI >= 2

Compendial Uses - B-Cell Lymphomas (Covered when stated subtype criteria are met)

B-Cell lymphoma subtypes (any of the following)
- High-grade B-cell lymphomas (HGBLs)
- Monomorphic post-transplant lymphoproliferative disorders (B-cell type)
- HIV-related B-cell lymphomas (includes HIV-related DLBCL, primary effusion lymphoma, HIV-related plasmablastic lymphoma, HHV8-positive DLBCL)
- Histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma
- Follicular lymphoma
- Diffuse large B-cell lymphoma (DLBCL)
Exclusion Note: All other indications are considered experimental/investigational and not medically necessary.

Sub-type Specific Criteria (Authorization up to 6 cycles)

Authorization of 6 months (up to 6 cycles) may be granted for treatment of B-cell lymphomas with any of the following subtypes when the listed criteria are met:

A. Diffuse Large B-cell Lymphoma (DLBCL)

Requested drug used as subsequent treatment as a single agent, or in combination with bendamustine with or without rituximab for relapsed or refractory disease when the member is not a candidate for transplant, or the requested medication will be used as a bridging option until CAR T-cell product is available.
Requested drug used as first-line therapy for stage II-IV disease in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) in members who have an IPI score of 2 or greater.IPI >= 2

B. High-grade B-cell lymphomas (HGBLs)

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

Continuation / Reauthorization Criteria

Authorization up to 6 months (6 cycles total) may be granted for continued treatment when reauthorization is requested for a covered indication.

Indication is listed in Section II (FDA-approved or compendial).
No evidence of unacceptable toxicity while on the current regimen.
No evidence of disease progression while on the current regimen.
Member has not received 6 or more cycles of the requested drug.< 6 cycles prior to reauthorization

Unproven / Exclusions

Exclusions

Exclusion - Experimental/Investigational: All other indications are considered experimental/investigational and not medically necessary.

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization required with indication and criteria

Providers must obtain prior authorization demonstrating the member meets the specific FDA-approved or compendial criteria (including IPI score where applicable) and that the member is not a transplant candidate when required. Authorization may be granted for up to 6 cycles (6 months).

Documentation Required

Document lack of unacceptable toxicity and absence of disease progression for reauthorization

For continuation/reauthorization, the provider must document there is no evidence of unacceptable toxicity while on the current regimen, no evidence of disease progression while on the current regimen, and that the member has not already received 6 or more cycles of the requested drug. Authorization for continued treatment may be granted for up to 6 months (6 cycles total).

Applicable Codes

N/A - No procedure/drug codes provided in documentmixed

No codes listed

Clinical Evidence

Key references: Polivy package insert (April 2023); NCCN Drugs & Biologics Compendium (2023); NEJM 2022 trial (Tilly et al.).

Evidence summary: This policy restates the FDA-approved indications and compendial uses and the authorization length of up to 6 cycles as reflected in the cited references and internal criteria; no material changes to indications or authorization length are made.

Background and Definitions

Polivy is FDA-indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two prior therapies, and in combination with a rituximab product plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for previously untreated DLBCL or high-grade B-cell lymphoma (HGBL) in patients with an International Prognostic Index (IPI) score of >= 2 (stage II–IV where specified). Compendial uses include multiple B-cell lymphoma subtypes (HGBL, monomorphic post-transplant B-cell PTLD, HIV-related B-cell lymphomas, histologic transformation to DLBCL, follicular lymphoma, and DLBCL).

Authorization: Treatment and continuation may be authorized for up to 6 months (up to 6 cycles) when specified criteria are met. Where noted, use is limited to members who are not candidates for transplant or when the drug is used as a bridging therapy while awaiting availability of a CAR T-cell product.

Definition: Bridging therapy — Use of the medication to manage disease while awaiting availability of a CAR T-cell product.

Revision History

clarified

Indications include FDA-approved combinations and a list of compendial B-cell lymphoma uses with up to 6-cycle authorization. Document restates FDA and compendia indications and authorization length. is_material: false

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPolivy 3095 A Sgm P2023 1

Policy CodePolicy 3095-A

Change TypeClarified indications and authorization length

Effective Date

Next Review Date

SourceLink

On This Page

Requested drug used as first-line therapy in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) and member has an International Prognostic Index score of 2 or greater.IPI >= 2

C. Monomorphic post-transplant lymphoproliferative disorders (B-cell type)

Requested drug used as subsequent treatment as a single agent, or in combination with bendamustine with or without rituximab.
Member is not a candidate for transplant or the requested medication will be used as a bridging option until CAR T-cell product is available.

D. HIV-related B-cell lymphomas

Requested drug used as subsequent treatment as a single agent, or in combination with bendamustine with or without rituximab.
Member is not a candidate for transplant or the requested medication will be used as a bridging option until CAR T-cell product is available.

E. Histologic transformation of indolent lymphomas to DLBCL

Requested drug used as subsequent treatment as a single agent, or in combination with bendamustine with or without rituximab.
Member is not a candidate for transplant.

F. Follicular lymphoma

Requested drug used as subsequent treatment as a single agent, or in combination with bendamustine with or without rituximab.