MHN Polatuzumab Vedotin (Polivy) Prior Auth

Coverage Criteria for Polatuzumab vedotin (Polivy)

Initial Therapy — Covered when ALL criteria are met (B-Cell Lymphoma)

Covered when ALL of the following are met for Initial Approval (B-Cell Lymphoma):

Initial Approval - B-Cell Lymphoma

Eligible diagnoses (1)
- a: DLBCL: DLBCL (including subtypes per Appendix D)
- b: HGBL: High-grade B-cell lymphoma (HGBL)
- c: PTLD: Post-transplant lymphoproliferative disorder (PTLD) (B-cell type) (off-label)
- d: HIV-related subtypes: One of: HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL NOS, HIV-related plasmablastic lymphoma (off-label)
- e: Histologic transformation: Histologic transformation of indolent lymphoma to DLBCL (off-label)
Prescriber: Prescribed by or in consultation with an oncologist or hematologist
Age ≥ 18 years
Treatment setting
- a: Frontline for DLBCL/HGBL/PTLD: All of: (i) if DLBCL or HGBL, member is treatment-naïve; (ii) Polivy prescribed with R-CHP; (iii) IPI or stage-modified IPI ≥ 2
- b: Relapsed/refractory or other B-cell lymphoma: All of: (i) member is not a candidate for autologous/allogeneic SCT or CAR T-cell therapy OR prescribed as bridging to CAR T; (ii) member has received ≥ 1 prior therapy; (iii) Polivy prescribed as single agent OR in combination with Lunsumio (non-transplant/CAR T candidates only) OR in combination with bendamustine and/or a rituximab product
Dose constraints: Request meets dosing limits: either dose ≤ 1.8 mg/kg Day 1 q21 days for max 6 cycles, or dose supported by practice guidelines/peer-reviewed literature with prescriber evidence; prescribed regimen must be FDA-approved or recommended by NCCN

Continuation Therapy — Covered when ALL criteria are met (B-Cell Lymphoma)

Covered when ALL of the following are met for Continued Therapy (B-Cell Lymphoma):

Continued Therapy - B-Cell Lymphoma

Current therapy: Member is currently receiving Polivy via Centene benefit, or documentation supports current receipt and at least 30 days of therapy
Response: Member is responding positively to therapy
Cycle count: One of: member has received < 6 cycles of Polivy OR member has received less than the number of cycles recommended by NCCN for the indication
Dose increase: If request is for dose increase, new dose either ≤ 1.8 mg/kg Day 1 q21 days for max 6 cycles OR supported by practice guidelines/peer-reviewed literature with prescriber evidence

Coverage criteria — summary of revisions and scope

Document history notes changes to coverage criteria for B-cell lymphomas including first-line and subsequent-line use per NCCN and FDA updates.

Documented policy updates: Annual reviews (2021-2025) updated HCPCS coding, consolidated FDA and NCCN recommended uses into one criteria set under B-cell lymphoma, modified line-of-therapy requirements (e.g., requiring only one prior therapy for DLBCL), allowed certain first-line uses per NCCN (including stage-modified IPI alternatives and histologic transformation), added PTLD combination options and CAR T-cell bridging language, and removed follicular lymphoma as a coverable off-label use.

See full policy sections for concrete criteria logic and effective dates.

Requests for polatuzumab vedotin (Polivy) for indications that are not FDA‑approved and are not specifically addressed by this policy will not be authorized unless the provider submits sufficient documentation demonstrating efficacy and safety consistent with the applicable off‑label use policy. See the referenced off‑label use policies for required evidence: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid).

Per recent guideline and policy updates, follicular lymphoma has been removed as a coverable off‑label indication for polatuzumab vedotin because it is no longer supported by the NCCN. Requests for treatment of follicular lymphoma with Polivy will therefore not be approved under the off‑label allowances in this policy.

Coding information in this policy is provided for reference only. Inclusion or exclusion of any codes does not guarantee coverage, and the absence of a code in this document should not be interpreted as denial of coverage. Prior to claim submission, providers should confirm coding and billing guidance using current professional resources.

Coding and Dose Limits

HCPCS CodesHCPCS

J9309

Injection, polatuzumab vedotin-piiq (Polivy)

inv-08: Maximum Dose

Maximum dose1.8 mg/kg per dose

Dose schedule constraintAdminister Day 1 of a 21-day cycle

Maximum cycles tied to dose limitWhen dose ≤1.8 mg/kg: maximum of 6 cycles

inv-09: Maximum Cycles (initial)

Initial therapy cycle limit6 cycles

Cycle frequencyEvery 21 days (q21 days)

Continuation criteria related noteRequests for additional cycles beyond 6 must be supported by guideline/literature evidence

Provider Requirements and Actionable Guidance

Prior Authorization

Provider Requirements and Actionable Guidance

Prior authorization is required for Polivy (polatuzumab vedotin‑piiq). Providers must request authorization and include clinical documentation supporting the request. Requests lacking required documentation or for non‑covered indications will be denied.

Prior authorization required for Polivy; verify payer-specific PA process prior to treatment.
Dose limits: 1.8 mg/kg IV on Day 1 of a 21‑day cycle, maximum 6 cycles unless supported by practice guidelines or peer‑reviewed literature with prescriber justification.
Coverage is limited to the indications and clinical criteria in this policy; non‑FDA approved indications not addressed in this policy will be denied unless sufficient off‑label evidence is provided per off‑label use policies (see policy references).
Therapy sequencing: Polivy may be used as first‑line in DLBCL/HGBL in combination with R‑CHP when criteria met (including IPI or stage‑modified IPI ≥2). For relapsed/refractory disease, Polivy can be used in patients not candidates for transplant or CAR T‑cell therapy, or as bridging therapy while awaiting CAR T; it may be used as a single agent or in combination with bendamustine ± rituximab or with Lunsumio for eligible non‑transplant/CAR T candidates.
Prior authorization may also be required for concomitant agents (chemotherapy, Lunsumio, bendamustine, rituximab products).
Providers must submit supporting documentation: office chart notes, relevant labs, prior therapy history, staging/IP I scores, transplant/CAR T candidacy evidence, and any guideline or literature supporting off‑label dosing or duration.

Background

Polatuzumab vedotin‑piiq (Polivy) is a CD79b‑directed antibody‑drug conjugate that delivers a cytotoxic agent to dividing B cells. The agent is FDA‑approved 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 in combination with bendamustine plus a rituximab product for relapsed or refractory DLBCL after prior therapies. Dosing for DLBCL regimens is typically 1.8 mg/kg IV on Day 1 of a 21‑day cycle for up to 6 cycles, when used in the approved combination regimens.

Definitions and Key Terms

inv-19: Polatuzumab vedotin (Polivy) — key drug descriptor

Generic namePolatuzumab vedotin-piiq

Brand namePolivy

Mechanism of actionCD79b-directed antibody-drug conjugate

Therapeutic classAntibody-drug conjugate for B‑cell lymphomas

inv-20: DLBCL dosing regimen

Dose and schedule1.8 mg/kg IV on Day 1 every 21 days

DurationTypically administered for 6 cycles in combination regimens

Line of Therapy Specific Criteria

first-line

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

salvage

Salvage (relapsed/refractory) DLBCL: Polivy in combination with bendamustine and a rituximab product for relapsed or refractory DLBCL after at least two prior therapies

second-line

Second-line / non-transplant or bridging use: Polivy may be used for patients who are not candidates for autologous/allogeneic transplant or CAR T-cell therapy, or as bridging to CAR T; member must have received ≥ 1 prior therapy; Polivy may be given as single agent, in combination with Lunsumio for non-transplant/CAR T candidates, or with bendamustine and/or a rituximab product

Covered Regimens and Indications

Regimen	Indication	Dose / Schedule	Coverage Status
Polivy in combination with R-CHP (rituximab product, cyclophosphamide, doxorubicin, and prednisone)
Previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) with IPI or stage‑modified IPI ≥ 2
Polivy 1.8 mg/kg IV on Day 1 of a 21‑day cycle for up to 6 cycles (Polivy, rituximab product, cyclophosphamide, and doxorubicin on Day 1; prednisone Days 1–5)
Covered

Regimen	Indication	Dose / Schedule	Coverage Status
Polivy in combination with bendamustine and a rituximab product
Relapsed or refractory DLBCL after ≥ 2 prior therapies
Polivy 1.8 mg/kg IV on Day 1 of a 21‑day cycle for up to 6 cycles (Polivy, bendamustine, and rituximab product administered on Day 1)
Covered

Regimen	Indication / Patient population	Dose / Schedule	Coverage Status
Polivy as single agent
Patients with B‑cell lymphoma who are not candidates for autologous/allogeneic stem cell transplant or CAR T‑cell therapy, or when prescribed as bridging to CAR T therapy
Polivy 1.8 mg/kg IV on Day 1 of a 21‑day cycle for up to 6 cycles (or dosing supported by guidelines/literature with prescriber evidence)
Covered

Regimen	Indication	Notes	Coverage Status
Polivy in combination with R-CHP
Post‑transplant lymphoproliferative disorder (PTLD) — B‑cell type with IPI score ≥ 2
NCCN update allows R‑CHP combination for PTLD with IPI ≥ 2; regimen follows DLBCL dosing and scheduling
Covered

Regimen	Indication / Line	Policy modification	Coverage Status
Polivy single‑agent use
Certain DLBCL indications (per NCCN) — various lines
Policy modified to allow single‑agent use in some DLBCL scenarios and to require only one prior therapy for DLBCL per NCCN alignment
Covered

OpenPayer

Polatuzumab Vedotin-piiq (Polivy)

Coverage Criteria for Polatuzumab vedotin (Polivy)

Coding and Dose Limits

Provider Requirements and Actionable Guidance

Background

Definitions and Key Terms

Line of Therapy Specific Criteria

Covered Regimens and Indications