CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Polivy 3095 A Sgm P2023

Defines covered indications, compendial uses, authorization duration, and continuation criteria for Polivy (polatuzumab vedotin-piiq) for adult patients with various B-cell lymphomas, including FDA-approved and NCCN compendial uses. Specifies authorization up to 6 months (up to 6 cycles) and continuation requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPolivy 3095 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionRequest authorization and document that the member meets the FDA-approved or compendial indication criteria (including transplant candidacy or bridging need when required) to receive coverage; authorization may be granted up to 6 months (up to 6 cycles).

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

6Covered Indications Listed

6Max Authorization (cycles)

2IPI Score Threshold

Coverage Summary

Coverage status: covered_with_criteria. Policy aligns covered uses to FDA-approved indications and NCCN compendial indications and limits authorization to up to 6 months (up to 6 cycles). For first-line use of Polivy with R-CHP in DLBCL or HGBL the policy requires an International Prognostic Index (IPI) score ≥ 2. Covered uses include FDA-specified relapsed/refractory DLBCL after ≥2 prior therapies (Polivy + bendamustine + rituximab) and first-line Polivy + R-CHP for previously untreated DLBCL or HGBL with IPI ≥ 2; compendial B-cell lymphoma indications are also covered when criteria are met.

Thresholds and Authorization Limits

International Prognostic Index (IPI) score>= 2 (for first-line R-CHP combination use in DLBCL and HGBL)

Authorization durationUp to 6 months (up to 6 cycles)

Covered Indications Listed6

Maximum Authorization Cycles6

Initial Therapy Criteria (FDA-Approved & Compendial Uses)

FDA-Approved Indications

Covered when ALL of the following are met:

Polivy in combination with bendamustine and a rituximab product is 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) is for treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL) NOS or high-grade B-cell lymphoma (HGBL) who have an International Prognostic Index (IPI) score of 2 or greater.>= 2 (IPI)

Compendial Uses (B-Cell Lymphomas)

Covered when the listed compendial indication is met and additional specific criteria (below) are satisfied; all other indications are considered experimental/investigational and not medically necessary.

Compendial Indications (any of the following)

High-grade B-cell lymphomas (HGBLs)
Monomorphic post-transplant lymphoproliferative disorders (B-cell type)
Human Immunodeficiency Virus (HIV)-related B-cell lymphomas (including HIV-related DLBCL, primary effusion lymphoma, HIV-related plasmablastic lymphoma, and HHV8-positive DLBCL)
Histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma
Follicular lymphoma
Diffuse large B-cell lymphoma (DLBCL)

Authorization general rule: Authorization of 6 months (up to 6 cycles) may be granted for treatment of B-cell lymphomas with any of the above subtypes.Up to 6 months (up to 6 cycles)

DLBCL specific criteria (A)

DLBCL use cases (any of the following)
- 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 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.>= 2 (IPI)

HGBL criteria (B)

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.
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.>= 2 (IPI)

Monomorphic post-transplant lymphoproliferative disorders (C): 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 medication will be used as a bridging option until CAR T-cell product is available.

HIV-related B-cell lymphomas (D): 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 medication will be used as a bridging option until CAR T-cell product is available.

Histologic transformation to DLBCL (E): 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.

Follicular lymphoma (F): Requested drug used as subsequent treatment as a single agent, or in combination with bendamustine with or without rituximab.

Continuation Therapy Criteria

Continuation of Therapy

Authorization for continued treatment may be granted when ALL of the following are met:

Member requests reauthorization for an indication listed in Section II.

There is no evidence of unacceptable toxicity while on the current regimen.

There is no evidence of disease progression while on the current regimen.

Member has not received 6 or more cycles of the requested drug.< 6 cycles

Provider Actions

Prior Authorization

Authorization required

Authorization may be granted for up to 6 months (up to 6 cycles) for covered indications. Providers must request prior authorization and meet the specific indication criteria (FDA-approved or compendial uses) to receive coverage.

Documentation Required

Document transplant candidacy or bridging need

For many compendial uses, document that the member is not a candidate for transplant or that the medication will be used as a bridging option until a CAR T‑cell product is available.

Denial Risk

Experimental/Investigational exclusions

Requests for indications not listed as FDA‑approved or compendial uses are considered experimental/investigational and are not medically necessary and likely to be denied.

Documentation Required

Continuation documentation

For reauthorization, document absence of unacceptable toxicity while on the current regimen, absence of disease progression, and that the member has received fewer than 6 cycles (authorization up to 6 months/6 cycles total).

Applicable Codes

No codes provided in documentmixed

No codes listed

Clinical Evidence & References

Evidence sources: Package insert (April 2023); NCCN Drugs & Biologics Compendium (2023); Micromedex; NEJM 2022 trial (Tilly et al.); CVS Caremark clinical consults.

Background

Background and context: Polivy (polatuzumab vedotin-piiq) is FDA-indicated and recognized in compendia for multiple B-cell lymphomas. The policy limits covered uses to those that match FDA approvals and NCCN compendial indications, provides authorization up to 6 months (up to 6 cycles), and specifies reauthorization criteria requiring absence of unacceptable toxicity, absence of disease progression, and that the member has received fewer than 6 cycles. It also documents transplant candidacy or use as a bridging therapy to CAR T-cell therapy when applicable for many compendial uses.