CurrentNeighborhood Health Plan of Rhode IslandPolicy 2374-A

Venclexta (venetoclax) coverage and prior authorization criteria

Policy governs coverage and prior authorization criteria for venetoclax (Venclexta), including FDA-approved indications and specified compendial uses across hematologic malignancies, duration limits, and required documentation for authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVenclexta (venetoclax) coverage and prior authorization criteria

Policy CodePolicy 2374-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit documentation of the presence of translocation t(11;14) and TP53-mutation where applicable to initiate prior authorization review.

POLICY UPDATE CHANGES

No material clinical/coverage changes in this brief (has_material_change=false).

12 monthsTypical authorization length

t(11;14)Genetic requirement cited for MM and SLCA

Multiple indicationsCovered FDA and compendial indications listed

Coverage Summary & Indications

Policy provides mixed coverage: Venclexta (venetoclax) is covered for FDA-approved indications (CLL/SLL; newly‑diagnosed AML in adults ≥75 years or who are unfit for intensive induction when used with azacitidine, decitabine, or low‑dose cytarabine) and for multiple compendial hematologic malignancy uses, provided all indication‑specific approval criteria and required documentation are met.

General Coverage Statement

Venclexta (venetoclax) is considered a covered benefit for the indications below provided all approval criteria are met and the member has no exclusions to prescribed therapy.

ALL of the following

Requested indication is one of the FDA-approved indications or listed compendial uses.
Submission includes required documentation (see Documentation section).

FDA-Approved Indications

Covered when ALL of the following are met:

ANY of the FDA-approved indications

Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients.
Newly-diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, when used in combination with azacitidine, decitabine, or low-dose cytarabine.

Compendial Uses

Authorization of 12 months may be granted when the specific condition-specific criteria below are met:

ANY of the following

Mantle cell lymphoma (MCL)
See MCL-specific nodes for required combinations and sequence.
Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Acute myeloid leukemia (AML) – compendial uses beyond FDA label per AML nodes
Multiple myeloma (MM) with translocation t(11;14)
Systemic light chain amyloidosis (SLCA) with translocation t(11;14)
Waldenstrom Macroglobulinemia / Lymphoplasmacytic Lymphoma (WM/LPL)
Hairy cell leukemia
Myelodysplastic syndrome (MDS)
Accelerated/blast phase myeloproliferative neoplasms
B-cell acute lymphoblastic leukemia / T-cell acute lymphoblastic leukemia (B-ALL / T-ALL)
Chronic myelomonocytic leukemia (CMML)

Initial Authorization Criteria by Indication

CLL/SLL initial-regimen options and combinations

Authorization of 12 months may be granted when ONE of the following is met:

ANY of the following

Requested medication will be used as monotherapy.
Requested medication will be used in combination with rituximab.
Requested medication will be used as first-line therapy in combination with either acalabrutinib (Calquence) with or without obinutuzumab, or ibrutinib (Imbruvica).

Newly-Diagnosed AML: age/comorbidity + regimen requirements

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Venclexta is used in combination with decitabine, azacitidine, or low-dose cytarabine.
AND member meets ONE of
- Member is 75 years of age or older.
- Member has poor/adverse risk disease and is a candidate for intensive induction therapy.
- Member has comorbidities that preclude treatment with intensive induction chemotherapy or is not a candidate for or declines intensive induction therapy.
- Member will use Venclexta in a post-induction therapy regimen following response to a Venclexta-based regimen.

Relapsed/Refractory AML regimen-based combinations

Authorization of 12 months may be granted when ONE of the following regimen-based combinations is met:

ANY of the following

Venclexta used in combination with azacitidine, decitabine, or low-dose cytarabine.
Venclexta used in combination with cladribine, idarubicin, and cytarabine.
Venclexta used in combination with fludarabine, cytarabine, a granulocyte colony-stimulating factor (G-CSF), with or without idarubicin.

Mantle Cell Lymphoma initial/subsequent use criteria

Authorization of 12 months may be granted when ONE of the following is met:

ANY of the following

Requested medication will be used as subsequent treatment as a single agent or in combination with rituximab or ibrutinib.
Requested medication will be used as induction therapy for TP53-mutated disease in combination with obinutuzumab (Gazyva) and zanubrutinib (Brukinsa).

BPDCN combination with hypomethylating agents

Authorization of 12 months may be granted when used in combination with hypomethylating agents:

Venclexta used in combination with azacitidine, decitabine, or low-dose cytarabine.

Multiple Myeloma with t(11;14) criteria

Authorization of 12 months may be granted for relapsed or progressive disease when ALL of the following are met:

ALL of the following

Member has translocation t(11;14).
Venclexta used in combination with dexamethasone and with or without daratumumab or daratumumab and hyaluronidase-fihj or a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib).

Systemic Light Chain Amyloidosis with t(11;14)

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Member has translocation t(11;14).
Venclexta used as single agent or in combination with dexamethasone for relapsed or refractory disease.

Waldenstrom Macroglobulinemia / LPL subsequent single-agent use

Authorization of 12 months may be granted when the following is met:

Venclexta used as subsequent treatment as a single agent.

Hairy Cell Leukemia progression + BRAF-resistance criteria

Authorization of 12 months may be granted when BOTH of the following are met:

ALL of the following

Member has progressed on previous therapy for relapsed or refractory disease.
Member has disease resistant to BRAF inhibitor therapy.

Myelodysplastic Syndrome high-risk + combination requirement

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Member has higher risk MDS (e.g., IPSS-R intermediate, high and very high risk disease).
Venclexta used in combination with azacitidine or decitabine.

Myeloproliferative Neoplasms accelerated/blast phase combination use

Authorization of 12 months may be granted when the following is met:

Venclexta used in combination with azacitidine or decitabine for management of disease progression.

B-ALL / T-ALL relapsed/refractory regimen combination

Authorization of 12 months may be granted when the following combination is used:

Venclexta used in combination with vincristine, pegaspargase or calaspargase, and prednisone or dexamethasone.

Chronic Myelomonocytic Leukemia CMML-2 combination with hypomethylating agent

Authorization of 12 months may be granted when the following is met:

Venclexta used in combination with a hypomethylating agent (e.g., azacitidine, decitabine).

Continuation / Reauthorization Criteria

Continuation of Therapy / Reauthorization

Authorization of 12 months may be granted for continued treatment when all continuation criteria are met:

ALL of the following

Indication is listed in the Coverage Criteria section.
There is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Duration limits specific to combinations are adhered to (see duration limits under CLL/SLL continuation notes).

Authorizations are generally granted for 12 months when condition‑specific criteria are met; note that CLL/SLL combinations have additional combination‑specific duration limits (see continuation notes for CLL/SLL).

Prior Authorization & Documentation Requirements

Documentation Required

Required documentation for prior authorization

Submit documentation showing presence of translocation t(11;14) and TP53 mutation results when applicable as part of the prior authorization request.

Prior Authorization

Prior authorization duration and reauthorization

Authorizations are generally granted for 12 months. Reauthorization requires documentation that there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Documentation Required

CLL/SLL combination-specific duration limits

For CLL/SLL continuation and reauthorization, adhere to the following combination-specific duration limits: Venclexta with rituximab — Venclexta not to be used longer than 24 months from cycle 1 day of Rituxan initiation; Venclexta with Gazyva (obinutuzumab) — Venclexta not to be used longer than 12 cycles; Venclexta with ibrutinib (Imbruvica) or acalabrutinib (Calquence) — Venclexta not to be used longer than 13 cycles.

Providers should include regimen details and supporting genetic/diagnostic test reports (for example, documentation of translocation t(11;14) and TP53‑mutation where applicable) with the prior authorization submission to facilitate review.

Applicable Codes & Policy Reference

Policy Reference Numbermixed

2374-A

Reference number for this policy document

Evidence & References

Primary references: Venclexta package insert (AbbVie July 2024); NCCN Drugs & Biologics Compendium 2025; NCCN AML and MM guidelines 2025; IBM Micromedex DRUGDEX.

Background and Definitions

Background: Venclexta (venetoclax) is FDA‑approved for CLL/SLL and for newly‑diagnosed AML in older or unfit adults when given with azacitidine, decitabine, or low‑dose cytarabine. The policy also lists multiple compendial hematologic malignancy uses (for example, MCL, BPDCN, relapsed/refractory AML, MM and SLCA with t(11;14), WM/LPL, hairy cell leukemia, MDS, accelerated/blast phase myeloproliferative neoplasms, ALL, and CMML). Coverage is conditional on meeting regimen‑specific criteria and submission of required diagnostic/genetic documentation.

Definitions: Venclexta — brand name for venetoclax, a small‑molecule BCL‑2 inhibitor.

Revision History

status_summaryLatest

CURRENT — Policy 2374-A. No dated revision entries provided in brief. Policy lists FDA-approved indications and compendial hematologic malignancy uses and specifies indication-, regimen-, and diagnostic/genetic-documentation requirements for coverage and prior authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVenclexta (venetoclax) coverage and prior authorization criteria

Policy CodePolicy 2374-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit documentation of the presence of translocation t(11;14) and TP53-mutation where applicable to initiate prior authorization review.

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