ModifiedmhnPolicy CP.PHAR.433

Polatuzumab Vedotin-piiq (Polivy) — Medical Necessity Criteria for B‑Cell Lymphomas

Governs medical necessity criteria, dosing, and coverage conditions for polatuzumab vedotin (Polivy) for specified B-cell lymphomas across payer lines of business.

Policy Summary

Payermhn

PolicyPolatuzumab Vedotin-piiq (Polivy) — Medical Necessity Criteria for B‑Cell Lymphomas

Policy CodePolicy CP.PHAR.433

Change TypeCriteria additions and revisions (first-line addedprior-therapy requirements reducedPTLD pathways updated)

Effective DateSep 1, 2019

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that the patient meets the updated criteria (diagnosis, age ≥18, dosing limits, and therapy-line requirements).

SourceLink

POLICY UPDATE CHANGES

Added criteria for use as first-line treatment in combination with R-CHP for previously untreated DLBCL or HGBL with IPI ≥ 2.

Allowed use in relapsed/refractory DLBCL after at least one prior therapy as single agent or in combination when transplant/CAR T is not an option or as bridging to CAR T.

Updated HCPCS code to J9309 and updated coding implications language.

3Q 2024 annual review consolidated FDA and NCCN recommended uses into one criteria set under the umbrella diagnosis of B-cell lymphoma and adjusted first-line use criteria.

3Q 2025 annual review updated PTLD criteria to remove monomorphic requirement and added combination use options and CAR T-cell therapy bridging language.

3Q 2022 annual review: for DLBCL per NCCN modified to require only one prior therapy and allow single-agent use; added DLBCL subtypes in Appendix D.

1.8 mg/kgDose per administration

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Coverage Criteria for Polatuzumab vedotin (Polivy)

Initial Therapy Criteria

Covered when ALL of the following are met for Initial Approval — B‑Cell Lymphoma

Initial Approval A: B-Cell Lymphoma: 1. Diagnosis of one of the specified B-cell lymphomas: DLBCL (see Appendix D for DLBCL subtypes), HGBL, post-transplant lymphoproliferative disorder (PTLD) B‑cell type (off-label), specified HIV-related B‑cell lymphoma subtypes (off-label), or histologic transformation of indolent lymphoma to DLBCL (off-label).

See Appendix D for DLBCL subtypes.

Provider and Age: 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 18 years.

Treatment setting options: 4. One of the following (a or b): a) For DLBCL (including histologic transformation), HGBL, or PTLD only: ALL of: i) if DLBCL or HGBL, member has not previously received treatment; ii) Polivy is prescribed in combination with R-CHP; iii) member has an IPI or stage-modified IPI score ≥ 2. OR b) For any B-cell lymphoma: ALL of: i) member is not a candidate for allogeneic or autologous stem cell transplant or CAR T-cell therapy (or Polivy is prescribed as bridging therapy while awaiting CAR T); ii) member has received ≥ 1 prior therapy; iii) Polivy is prescribed as either 1) single agent, 2) (non-transplant/CAR T candidates only) in combination with Lunsumio, or 3) in combination with bendamustine and/or a rituximab product.

Prior authorization may be required for accompanying agents.

Dose limits: 5. Request meets one of: a) Dose does not exceed 1.8 mg/kg on Day 1 of a 21-day cycle for a maximum of 6 cycles; OR b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).1.8 mg/kg; max 6 cycles

Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy Criteria

Covered when ALL of the following are met for Continued Therapy — B‑Cell Lymphoma

Continued Therapy A: B-Cell Lymphoma: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Polivy for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. Member meets one of: a) has received < 6 cycles of Polivy; OR b) has received less than the number of cycles recommended by NCCN for the covered indication; 4. If request is for a dose increase, new dose must either a) not exceed 1.8 mg/kg on Day 1 of a 21-day cycle for a maximum of 6 cycles; OR b) be supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

Approval duration: 12 months (medical justification supports requests beyond 6).

First-line — Line-of-Therapy Node

Top-level first-line use criteria for previously untreated disease

First-line (previously untreated DLBCL/HGBL): Polivy in combination with R-CHP for adult patients with previously untreated DLBCL or HGBL with an IPI score ≥ 2.IPI ≥ 2

FDA-approved indication; see Appendix B for rituximab products and Appendix D for DLBCL subtypes.

Second-line — Line-of-Therapy Node

Top-level second-line / relapsed or refractory use criteria

Relapsed/Refractory (second-line or later): Polivy in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory DLBCL after prior therapies; per updated criteria, use after ≥ 1 prior therapy is allowed in certain NCCN-recommended contexts including single-agent Polivy or Polivy as bridging to CAR T when transplant/CAR T is not an option.>=1 prior therapy (pathway-dependent)

Policy reflects both FDA (≥2 prior therapies for the bendamustine+rituximab pathway) and NCCN-aligned uses (≥1 prior therapy for certain pathways).

Consolidated clinical criteria (summary)

Consolidated clinical criteria summary — updates aligned to FDA and NCCN across annual reviews

B-cell lymphoma umbrella: FDA-approved and NCCN-recommended uses are consolidated under a single B-cell lymphoma diagnosis with specific pathways for first-line and later-line therapy.

3Q2024 consolidation.

First-line use summary: First-line use added for DLBCL and HGBL per NCCN; stage-modified IPI score may be used as an alternate pathway and histologic transformation of indolent lymphoma to DLBCL is included.

3Q2024.

DLBCL later-line changes: For DLBCL, prior-therapy requirement was reduced to at least one prior therapy for many requests and single-agent use was allowed per 3Q2022 update; subsequent reviews refined indications and operational details.>=1 prior therapy

3Q2022–3Q2025.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety consistent with the off‑label use policies listed. Refer to the payer off‑label use guidance (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) when requesting authorization for an off‑label indication.

Per the 3Q 2024 policy update aligning FDA and NCCN recommendations, follicular lymphoma was removed as a coverable off‑label use because it is no longer supported by NCCN. Requests for follicular lymphoma will not be authorized under the off‑label pathways in this policy unless future guideline evidence or policy updates reinstate coverage.

The inclusion of HCPCS or other billing codes in this policy is for informational purposes only. Inclusion of a code does not guarantee coverage; lack of alignment between the submitted request and the medical necessity criteria in this policy may result in denial. Providers should verify current professional coding guidance prior to claim submission.

Regimens and Combinations Covered

Regimen	Indication	Coverage
Polivy 1.8 mg/kg IV every 21 days x6 in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP)	Previously untreated diffuse large B‑cell lymphoma (DLBCL) or high‑grade B‑cell lymphoma (HGBL) — includes histologic transformation of indolent lymphoma to DLBCL; IPI or stage‑modified IPI score ≥ 2 required	Covered
Dose: 1.8 mg/kg on Day 1 of a 21‑day cycle; maximum 6 cycles per regimen	Approval duration: initial 6 months; continued therapy per criteria

Regimen	Indication	Coverage/Notes
Polivy 1.8 mg/kg IV every 21 days x6 in combination with bendamustine and a rituximab product	Relapsed or refractory DLBCL	covered_with_criteria
Polivy as single agent OR Polivy in combination with Lunsumio for non‑transplant/CAR T candidates or as bridging to CAR T	Relapsed or refractory DLBCL when member has received ≥ 1 prior therapy (policy reflects FDA and NCCN pathways)	Use allowed per policy criteria; prior authorization may be required for accompanying agents

Regimen	Indication	Coverage/Requirement
Polivy in combination with R‑CHP	Post‑transplant lymphoproliferative disorder (PTLD) with IPI score ≥ 2	Covered
IPI ≥ 2 required for R‑CHP combination pathway	Policy removed monomorphic requirement for PTLD and added this combination option (3Q2025 update)	Prior authorization required per policy

Regimen	Indication	Coverage/Notes
Polivy in combination with Lunsumio	Second‑line PTLD for patients who are not candidates for transplant/CAR T or when used as bridging to CAR T	Covered
Applicable when member has received ≥ 1 prior therapy (per second‑line pathway) and is non‑transplant/CAR T candidate or bridging to CAR T	Policy added option for combination with Lunsumio for non‑transplant/CAR T candidates (3Q2025 update); prior authorization may be required

Billing and Coding Information

HCPCS CodesHCPCS

J9309

Injection, polatuzumab vedotin-piiq (Polivy)

Referenced HCPCS CodesHCPCS

J9309

Injection, polatuzumab vedotin-piiq (Polivy)

inv-09: Dose per administration — 1.8 mg/kg on Day 1 of a 21-day cycle

Dose per administration1.8 mg/kg IV on Day 1 of a 21‑day cycle

Dose ceiling per policyDose must not exceed 1.8 mg/kg per administration unless supported by practice guidelines or peer‑reviewed literature with submitted evidence

Administration timingGiven on Day 1 of each 21‑day cycle

inv-10: Maximum cycles — 6 cycles (approval durations described as 6 months initial; continued therapy approvals up to 12 months with justification)

Maximum number of cycles (typical)6 cycles

Initial approval duration6 months (covers up to 6 cycles)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Polivy (polatuzumab vedotin-piiq) per the clinical criteria in this policy. Providers must obtain prior authorization for requests that meet the policy's indications, dosing limits, and documentation requirements before administration. Authorization decisions are based on the policy criteria and the most recent clinical updates (NCCN/FDA-aligned criteria through 3Q2025).

Prior authorization required for Polivy when used for covered indications per CP.PHAR.433 effective 2019-09-01 and subsequent annual updates through 3Q2025
Clinical criteria updated through 3Q2025 — ensure submitted request matches current policy criteria (e.g., first-line DLBCL pathways, prior-therapy and sequencing rules, PTLD updates)
Prior authorization may also be required for concomitant agents (e.g., rituximab products, bendamustine, Lunsumio, chemotherapy) per formulary rules

Denial Risk

Documentation and Risk of Denial

Definitions and Abbreviations

inv-20: DLBCL — diffuse large B-cell lymphoma, includes multiple NCCN-defined subtypes listed in Appendix D

DefinitionDLBCL = diffuse large B‑cell lymphoma (DLBCL)

ScopeIncludes multiple NCCN‑defined DLBCL subtypes listed in Appendix D (eg, DLBCL, NOS; primary mediastinal LBCL; double expressor DLBCL; HGBL with translocations; primary cutaneous DLBCL; etc.)

ReferenceSee Appendix D for the full list of NCCN DLBCL subtypes included under this policy

inv-21: HGBL — high-grade B-cell lymphoma

TermHGBL = high‑grade B‑cell lymphoma

ContextHGBL is included among covered B‑cell lymphoma diagnoses in the policy (see dosing/regimen guidance for previously untreated HGBL)

Line of Therapy Specific Criteria

First-line — Alternate First-line Node

Alternate first-line pathway and annual-review consolidation notes

Alternate First-line Pathway: Per NCCN and FDA consolidation, first-line use is permitted for previously untreated DLBCL or HGBL when Polivy is given with R-CHP and the member has an IPI or stage-modified IPI ≥ 2; histologic transformation to DLBCL is included as an acceptable indication for this pathway.IPI or stage-modified IPI ≥ 2

3Q2024 consolidation added stage-modified IPI as alternate pathway.

Second-line — Alternate Second-line Node

Alternate second-line pathways reflecting recent updates for PTLD and relapsed/refractory use

Second-line — Alternate Pathways: For relapsed or refractory disease, options include Polivy with bendamustine plus a rituximab product per FDA pathway (historically after ≥2 prior therapies) and NCCN-aligned pathways allowing use after ≥1 prior therapy as single agent or in combinations when transplant/CAR T is not feasible or when used as bridging to CAR T. For PTLD, second-line use may be for patients not candidates for CAR T-cell therapy or as bridging until CAR T is available; Lunsumio combination is an option for non-transplant/CAR T candidates.

Background

Polatuzumab vedotin (Polivy) is a CD79b‑directed antibody‑drug conjugate that delivers a cytotoxic payload to dividing B cells. It is approved by the FDA for use in specified B‑cell lymphomas, including first‑line use in combination with R‑CHP for previously untreated diffuse large B‑cell lymphoma (DLBCL) or high‑grade B‑cell lymphoma (HGBL) with an IPI ≥ 2, and for relapsed or refractory DLBCL in combination with bendamustine plus a rituximab product. The typical dosing regimen referenced in this policy is 1.8 mg/kg IV on Day 1 of a 21‑day cycle for up to 6 cycles, with continuation approvals considered when documentation supports clinical benefit.

Policy Revision History

2022-05-02annual_review

3Q 2022 annual review: modified DLBCL requirements per NCCN to require only one prior therapy and allow single-agent use; updated Appendix D with DLBCL subtypes.

2024-05-20annual_review

3Q 2024 annual review: consolidated FDA and NCCN recommended uses into a single B‑cell lymphoma criteria set, added stage-modified IPI as an alternate first-line pathway, allowed first-line use for histologic transformation to DLBCL, and removed follicular lymphoma as a coverable off-label use.

2025-05-13annual_review

Policy Summary

Payermhn

PolicyPolatuzumab Vedotin-piiq (Polivy) — Medical Necessity Criteria for B‑Cell Lymphomas

Policy CodePolicy CP.PHAR.433

Change TypeCriteria additions and revisions (first-line addedprior-therapy requirements reducedPTLD pathways updated)

Effective DateSep 1, 2019

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that the patient meets the updated criteria (diagnosis, age ≥18, dosing limits, and therapy-line requirements).

SourceLink

On This Page

Billing Rule

Billing Code and Coding Guidance

Coding guidance is provided for informational purposes only. Inclusion of a code does not guarantee coverage. Providers should verify current coding guidance prior to claim submission.

HCPCS J9309 — Injection, polatuzumab vedotin-piiq (Polivy)
Inclusion or exclusion of codes in this policy does not guarantee coverage; verify payer-specific and up-to-date professional coding resources before billing
Coding references were updated in policy reviews through 3Q2025 — check the latest policy version for any code changes

inv-23: Post-transplant lymphoproliferative disorder (PTLD) — policy removed monomorphic requirement and added combination therapy options and CAR T-related bridging language

PTLD policy changePolicy removed the requirement that PTLD be monomorphic per 3Q2025 NCCN updates

Combination therapy optionsAdded option to use Polivy in combination with R‑CHP for PTLD with IPI ≥ 2 and option to combine with Lunsumio for non‑transplant/CAR T candidates

CAR T bridging languageClarified that Polivy may be prescribed as bridging therapy while awaiting CAR T‑cell therapy or for patients who are not candidates for CAR T