CurrentViva HealthPolicy IC-0482

Polivy (polatuzumab vedotin-piiq) for B‑cell lymphomas — Coverage Criteria

Medical policy governing coverage and authorization criteria for intravenous polatuzumab vedotin (Polivy) for specified B‑cell lymphomas; applies to outpatient administration and prior authorization for adults.

Policy Summary

PayerViva Health

PolicyPolivy (polatuzumab vedotin-piiq) for B‑cell lymphomas — Coverage Criteria

Policy CodePolicy IC-0482

Change TypeNo material changes

Effective DateJul 1, 2019

Next Review DateJan 6, 2025

Key ActionObtain prior authorization; limit coverage to adults meeting clinical criteria for specified B‑cell lymphomas for up to 6 months (up to 6 cycles).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsLength of authorization

1.8 mg/kg q21dStandard dose

J9309HCPCS code

≥18Min age

200/21dMax billable units

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Initial Therapy

Initial Therapy — Covered when ALL of the following baseline requirements are met and one of the lymphoma-specific pathways below applies:

ALL of the following

Patient is at least 18 years of age.
Patient will receive prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus.
Patient does not currently have Grade ≥ 2 peripheral neuropathy.
Patient does not have CNS lymphoma.

B-Cell Lymphomas — First-line (DLBCL/HGBL)

DLBCL / High-Grade B-Cell Lymphoma (first-line) — Use as first-line therapy only when ALL of the following are met:

ALL of the following

Diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBL).
Used in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP).
Used as first-line therapy (Only applies to DLBCL and High-Grade B-Cell Lymphoma).
AND one of the following
- Patient has an International Prognostic Index (IPI) score of ≥2.
- Patient had histologic transformation to DLBCL or high-grade B-cell lymphoma with MYC and BCL6 rearrangement (without BCL2 rearrangements); AND used after minimal or no prior therapy; AND patient has an IPI score of ≥2.

B-Cell Lymphomas — Relapsed/Refractory (Second-line)

Relapsed / Refractory B-Cell Lymphomas — Covered when ONE of the following applies:

ANY of the following

Used as a single agent or in combination with bendamustine and/or rituximab for subsequent therapy in patients with no intention to proceed to transplant; AND used for relapsed disease >12 months after completion of first-line therapy.
Used as a single agent or in combination with bendamustine and/or rituximab for primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy in noncandidates for CAR T-cell therapy.
Used as an alternative systemic therapy (if not previously used) for relapsed/refractory disease in non-candidates for CAR T-cell therapy.
Used as a bridging option until CAR T-cell product is available for primary refractory disease or relapsed disease <12 months after completion of first-line therapy.

Exclusions / Limitations

Coverage Exclusions / Limitations:

ALL of the following

Use in patients with CNS lymphoma is excluded from coverage.
Treatment for patients with Grade ≥2 peripheral neuropathy at the time of request is not eligible for approval under the initial criteria.

Continuation / Renewal

Continuation / Renewal — Criteria and dosing considerations for ongoing therapy:

ALL of the following

Clinical response (partial response, complete response, or stable disease) documented by treating clinician and supported by radiographic or clinical assessment prior to renewal approval.
No development of Grade ≥2 peripheral neuropathy while on therapy; if Grade ≥2 peripheral neuropathy develops, continuation is not eligible under these criteria.
No evidence of CNS lymphoma involvement during therapy.
Dose and schedule consistent with labeled regimen: 1.8 mg/kg intravenously every 21 days for up to 6 cycles for B-cell lymphomas unless clinically justified to continue beyond 6 cycles with documented benefit and review.

Regimens and Indications Covered

Regimen	Indication	Coverage
Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP)	First-line therapy for Diffuse Large B‑Cell Lymphoma (DLBCL) or High‑Grade B‑Cell Lymphoma (HGBL) when patient has an International Prognostic Index (IPI) score ≥2	Covered with criteria

Regimen	Indication / patient context	Coverage
Polatuzumab vedotin as a single agent	Subsequent therapy for relapsed or refractory B‑cell lymphomas in patients with no intention to proceed to transplant (including relapsed disease >12 months after first‑line therapy, primary refractory disease, or relapsed <12 months in noncandidates for CAR T; also as bridging to CAR T)	Covered with criteria
Polatuzumab vedotin in combination with bendamustine and/or rituximab	Subsequent therapy for relapsed or refractory B‑cell lymphomas or histologic transformation or monomorphic B‑cell PTLD in patients with no intention to proceed to transplant; includes use in noncandidates for CAR T and specified transformation pathways	Covered with criteria

Billing Codes and Diagnosis Mapping

Covered HCPCS CodesHCPCSCovered

J9309

Injection, polatuzumab vedotin-piiq 1 mg; 1 mg = 1 billable unit

NDCsNDC

50242-0103-xx	Polivy 30 mg lyophilized powder for injection, single-dose vial
50242-0105-xx	Polivy 140 mg lyophilized powder for injection, single-dose vial

Covered ICD-10 Diagnosis CodesICD-10Covered

C83.30	Diffuse large B-cell lymphoma unspecified site
C83.31	Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck
C83.32	Diffuse large B-cell lymphoma intrathoracic lymph nodes
C83.33	Diffuse large B-cell lymphoma intra-abdominal lymph nodes
C83.34	Diffuse large B-cell lymphoma lymph nodes of axilla and upper limb
C83.35	Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb
C83.36	Diffuse large B-cell lymphoma intrapelvic lymph nodes
C83.37	Diffuse large B-cell lymphoma, spleen
C83.38	Diffuse large B-cell lymphoma lymph nodes of multiple sites
C83.39	Diffuse large B-cell lymphoma extranodal and solid organ sites

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International Prognostic Index (IPI)

International Prognostic Index (IPI) requirementIPI score >= 2 is required for first-line use of polatuzumab vedotin in combination with R-CHP for DLBCL and HGBL

Applies to first-line DLBCL/HGBLRequirement applies when polatuzumab is used as part of R-CHP as first-line therapy

Also required for certain transformed disease pathwaysAn IPI >= 2 is required when R-CHP is used after histologic transformation to DLBCL or HGBL with MYC and BCL6 rearrangement (without BCL2 rearrangement)

Max HCPCS units per 21 days

Maximum HCPCS billing units per dosing interval200 billable units every 21 days

HCPCS unit definitionHCPCS J9309 is billed as 1 mg = 1 billable unit (see coding table)

Dosing interval contextStandard dosing for B-cell lymphomas is 1.8 mg/kg administered every 21 days; total billed units should not exceed the 200-unit cap per 21-day period

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage is limited to adults meeting the clinical criteria for specified B‑cell lymphomas and is authorized for a limited duration (6 months / up to 6 cycles).

Prior authorization required
Authorization duration: 6 months (up to 6 cycles); no renewal

Denial Risk

Eligibility-related Denial Risks

Requests for patients who are under 18 years of age, who currently have Grade ≥ 2 peripheral neuropathy, or who have CNS lymphoma do NOT meet initial approval criteria and are at risk for denial. Ensure documentation demonstrates the patient meets all listed eligibility criteria (including prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus where applicable).

Denial risk: age <18 years
Denial risk: Grade ≥ 2 peripheral neuropathy
Denial risk: CNS lymphoma

Billing Rule

Billing Documentation

Include HCPCS and, when available, NDC information on claims. Use J9309 with units billed per mg (1 mg = 1 billable unit). NDCs for Polivy single‑dose vials may be provided when billing supports NDC-level detail.

HCPCS: J9309 - Injection, polatuzumab vedotin-piiq 1 mg (1 mg = 1 billable unit)
NDCs (when applicable): 50242-0103-xx (30 mg vial); 50242-0105-xx (140 mg vial)

Note

Sequencing and Therapy Context

Policy specifies where polatuzumab is used in the treatment sequence: as part of R-CHP (with rituximab, cyclophosphamide, doxorubicin, prednisone) for first‑line DLBCL/HGBL with an IPI ≥2; and as single‑agent or combined with bendamustine and/or rituximab in various subsequent‑line settings (including relapsed, refractory, post‑transplant, and histologic transformation scenarios) with restrictions such as no intent to proceed to transplant or timing relative to prior therapy. For first‑line use, the IPI ≥2 requirement applies to DLBCL and HGBL.

First-line: R-CHP for DLBCL/HGBL only, IPI ≥2 required
Subsequent-line: single-agent or with bendamustine and/or rituximab per documented scenario (no intent to proceed to transplant, timing relative to prior therapy, CAR T-cell candidacy considerations)
Relapsed plasmablastic lymphoma: excludes use with rituximab

OpenPayer

Polivy (polatuzumab vedotin-piiq) for B‑cell lymphomas — Coverage Criteria

Coverage and Medical Necessity Criteria

Regimens and Indications Covered

Billing Codes and Diagnosis Mapping

Prior Authorization, Documentation, and Billing Guidance

Definitions and Regimen Notes

Clinical Background

Policy Revision History