CurrentNeighborhood Health Plan of Rhode IslandPolicy 2374-A

Venclexta (venetoclax) — Coverage Criteria

Defines prior authorization, coverage criteria, and authorization durations for Venclexta (venetoclax) for Neighborhood Health Plan of Rhode Island members when used for FDA-approved and compendial oncology indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVenclexta (venetoclax) — Coverage Criteria

Policy CodePolicy 2374-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation (including t(11;14) and TP53 mutation where applicable) to request up to 12 months of coverage when indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration for covered indications

1-2 linesCLL/SLL uses

t(11;14)biomarker required for some indications

CLL/SLL, AMLPrimary FDA-approved indications

Coverage Criteria for Venclexta (venetoclax)

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Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Covered when criteria below are met (authorization of 12 months may be granted):

CLL/SLL: Venclexta for CLL/SLL when used as monotherapy, in combination with rituximab (Rituxan) or obinutuzumab (Gazyva), or used as first-line therapy in combination with ibrutinib (Imbruvica).

Authorization of 12 months; combination-specific duration limits apply under Continuation of Therapy.

Newly-Diagnosed Acute Myeloid Leukemia (AML)

Covered when used in combination and patient meets one of the listed risk/age/comorbidity conditions:

Newly-diagnosed AML combination use: Venclexta in combination with decitabine, azacitidine, or low‑dose cytarabine for newly‑diagnosed AML when one of the following is met: the member is 75 years of age or older; the member has poor/adverse risk disease and is a candidate for intensive induction therapy; the member has comorbidities that preclude treatment with intensive induction chemotherapy or is not a candidate for intensive induction therapy; or the member will use Venclexta in a post‑induction therapy regimen following response to a venetoclax‑based regimen.

Authorization of 12 months.

Relapsed or Refractory Acute Myeloid Leukemia (AML)

Covered when used in combination with hypomethylating agents or low-dose cytarabine:

Relapsed/Refractory AML: Venclexta in combination with azacitidine, decitabine, or low‑dose cytarabine for relapsed or refractory acute myeloid leukemia.

Authorization of 12 months.

Mantle Cell Lymphoma (MCL)

Covered when used as specified for mantle cell lymphoma:

MCL subsequent therapy: Venclexta as subsequent treatment for mantle cell lymphoma as a single agent or in combination with rituximab or ibrutinib.

Authorization of 12 months.

MCL TP53 mutated induction: Venclexta used as induction therapy for TP53‑mutated mantle cell lymphoma in combination with obinutuzumab (Gazyva) and zanubrutinib (Brukinsa).

Authorization of 12 months; documentation of TP53 mutation where applicable.

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

BPDCN: Venclexta in combination with azacitidine, decitabine, or low‑dose cytarabine for blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Authorization of 12 months.

Multiple Myeloma (MM) and Systemic Light Chain Amyloidosis (SLCA)

Multiple Myeloma: Venclexta for relapsed or progressive multiple myeloma in combination with dexamethasone and with or without daratumumab (including daratumumab with hyaluronidase‑fihj) or with a proteasome inhibitor.

Authorization of 12 months; documentation of t(11;14) is required where applicable.

Systemic Light Chain Amyloidosis: Venclexta for relapsed or refractory systemic light chain amyloidosis with translocation t(11;14), used as a single agent or in combination with dexamethasone.

Authorization of 12 months; documentation of t(11;14) required.

Waldenstrom Macroglobulinemia / Lymphoplasmacytic Lymphoma (WM/LPL)

Waldenstrom Macroglobulinemia/ LPL: Venclexta for subsequent treatment of Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL) as a single agent.

Authorization of 12 months.

Myelodysplastic Syndrome (MDS)

Myelodysplastic Syndrome: Venclexta in combination with azacitidine or decitabine for myelodysplastic syndrome (MDS).

Authorization of 12 months.

Hairy Cell Leukemia

Covered when both conditions below are met:

Hairy Cell Leukemia: Member has relapsed or refractory hairy cell leukemia and has progressed on previous therapy AND the member's disease is resistant to BRAF inhibitor therapy.

Authorization of 12 months; may be used as single agent or in combination with rituximab.

Myeloproliferative Neoplasms

Myeloproliferative Neoplasms: Venclexta for accelerated/blast phase myeloproliferative neoplasms to manage disease progression when used in combination with azacitidine or decitabine.

Authorization of 12 months.

B-Cell / T-Cell Acute Lymphoblastic Leukemia (B-ALL/T-ALL)

B-ALL/T-ALL: Venclexta for relapsed or refractory B‑cell or T‑cell acute lymphoblastic leukemia (B‑ALL/T‑ALL) when used in combination with vincristine, pegaspargase or calaspargase, and prednisone or dexamethasone.

Authorization of 12 months.

Continuation of Therapy

Continuation of therapy reauthorization conditions:

Continuation of Therapy: Reauthorization may be granted for listed indications when there is no evidence of unacceptable toxicity or disease progression on the current regimen.

Specific duration caps for CLL/SLL combinations: with Rituxan, Venclexta will not be used longer than 24 months from cycle 1 day 1 of Rituxan initiation; with Gazyva, Venclexta will not be used longer than 12 cycles; with Imbruvica, Venclexta will not be used longer than 13 cycles.

All indications for Venclexta (venetoclax) that are not listed as FDA-approved or as compendial uses in this policy are considered experimental/investigational and not medically necessary. Requests for coverage for unlisted indications may be denied.

Covered Drug Regimens and Combinations

Regimen	Indication	Coverage status
Venclexta in combination with azacitidine
Newly-diagnosed or relapsed/refractory acute myeloid leukemia (AML); see age/comorbidity and risk criteria for newly-diagnosed use
Authorization of up to 12 months may be granted when criteria are met

Regimen	Indication	Coverage status
Venclexta in combination with ibrutinib (Imbruvica) as first-line therapy
Chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) — first-line use
Authorization of up to 12 months may be granted when used as first-line with ibrutinib

Regimen	Indication	Coverage status
Venclexta with a proteasome inhibitor (in combination with dexamethasone)
Relapsed or progressive multiple myeloma
Authorization of up to 12 months may be granted when used with dexamethasone ± daratumumab (with hyaluronidase-fihj) or with a proteasome inhibitor

Regimen	Indication	Coverage status
Venclexta with vincristine, pegaspargase or calaspargase, and prednisone or dexamethasone
Relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) or T-cell acute lymphoblastic leukemia (T-ALL)
Authorization of up to 12 months may be granted when used in combination per criteria

Provider Action Items and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of up to 12 months may be granted when the request meets the specific indication criteria described in this policy.

Authorization duration: up to 12 months when criteria are met

Prior Authorization

Hairy Cell Leukemia — Prerequisites for Authorization

For hairy cell leukemia, authorization of up to 12 months may be granted for treatment of relapsed or refractory disease, as a single agent or in combination with rituximab, when ALL of the following are met: member has progressed on previous therapy for relapsed or refractory disease; and member has disease resistant to BRAF inhibitor therapy.

Indication: Relapsed or refractory hairy cell leukemia
Required prior treatments: Progression on previous therapy for relapsed/refractory disease
Additional requirement: Disease resistant to BRAF inhibitor therapy
Authorization duration: up to 12 months

Biomarker and Genetic Testing Requirements

inv-22: t(11;14) — biomarker requirement referenced for certain indications

BiomarkerChromosomal translocation t(11;14)

Required forMultiple myeloma (relapsed or progressive) — documentation of t(11;14) required where applicable

Also required forSystemic light chain amyloidosis (SLCA) — translocation t(11;14) required for coverage

Documentation noteSubmit test results demonstrating the presence of t(11;14) to initiate prior authorization review

inv-23: TP53 mutation — biomarker referenced where applicable for specific indications

BiomarkerTP53 mutation

Context of useRequired documentation where applicable; specifically noted for mantle cell lymphoma induction when TP53-mutated disease is treated with venetoclax plus obinutuzumab and zanubrutinib

Documentation noteSubmit documentation of TP53 mutation status to initiate prior authorization review when relevant to the indication

Line of Therapy Specifications

first-line | subsequent

first-line | subsequent: May be used as first‑line in combination with ibrutinib or as subsequent therapy in the listed combinations for the applicable indications (e.g., CLL/SLL).

Refer to indication‑specific criteria for eligibility and authorization duration.

first-line | salvage

first-line | salvage: Used as first‑line in select patients with newly‑diagnosed AML who meet age/comorbidity/risk criteria, and as salvage therapy in relapsed/refractory AML when used in combination regimens.

Authorization of 12 months.

Definitions and Key Terms

inv-19: t(11;14) — Chromosomal translocation t(11;14) referenced as a required documentation biomarker for certain indications

BiomarkerChromosomal translocation t(11;14)

Indications referencing requirementMultiple myeloma (relapsed/progressive) and systemic light chain amyloidosis — t(11;14) cited as required documentation where applicable

Provider actionInclude test reports confirming t(11;14) with prior authorization submission

Source guidanceCompendial uses list and Documentation section specify t(11;14) requirement

Background

Venclexta (venetoclax) is an oral BCL-2 inhibitor used to treat multiple hematologic malignancies. It is FDA‑approved for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and is used in combination regimens for acute myeloid leukemia (AML). Policy coverage and authorization depend on the specific indication, the combination regimen, relevant biomarkers (for some indications), and whether the patient meets the clinical criteria outlined for each disease state. Authorization of up to 12 months may be granted when the request meets the applicable indication-specific criteria.

Revision History

2024policy_publicationLatest

Policy reference 2374-A published/issued (document footer indicates 2024).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVenclexta (venetoclax) — Coverage Criteria

Policy CodePolicy 2374-A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

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