CurrentNeighborhood Health Plan of Rhode IslandPolicy 2374-A

Venclexta (venetoclax) coverage and prior authorization criteria

Defines covered FDA-approved and compendial indications for venetoclax (Venclexta), documentation required for prior authorization, authorization durations, continuation criteria, and limits for certain combinations (CLL/SLL). Applies to adults as specified in indication criteria.

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 translocation t(11;14) and TP53-mutation (where applicable) to initiate prior authorization review.

POLICY UPDATE CHANGES

No material clinical/coverage changes

9Covered Indications Listed

1Documentation Requirement (t(11;14)/TP53)

12 monthsStandard Authorization Duration

Coverage Summary

This policy covers Venclexta (venetoclax) for its FDA-approved indications — chronic lymphocytic leukemia (CLL) and specified newly-diagnosed acute myeloid leukemia (AML) regimens — and for multiple compendial hematologic malignancy uses. Coverage and prior authorization criteria reference the Venclexta package insert and compendia such as the NCCN Drugs & Biologics Compendium and IBM Micromedex DRUGDEX.

Policy scope and standard duration

Scope SummaryDefines covered FDA-approved and compendial indications for venetoclax (Venclexta), documentation required for prior authorization, authorization durations, continuation criteria, and limits for certain combinations (CLL/SLL). Applies to adults as specified in indication criteria.

Standard Authorization Duration12 months

Covered Indications Listed9

Initial Therapy Criteria (Covered Indications and Authorization Criteria)

Covered Indications and Authorization Criteria

Venclexta is considered a covered benefit for the indications below when ALL applicable approval criteria are met and the member has no exclusions to the prescribed therapy.

Documentation requirement for PA: Submission of documentation of the presence of translocation t(11;14) and TP53-mutation (where applicable) is necessary to initiate prior authorization review

Exclusions: All other indications not listed above are considered experimental/investigational and not medically necessary

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy / Reauthorization

Criteria for continued treatment when reauthorization is requested.

Authorization of 12 months may be granted for continued treatment for indications listed when there is no evidence of unacceptable toxicity or disease progression while on the current regimen

CLL/SLL duration limits: For CLL/SLL members using Venclexta with rituximab, Venclexta will not be used longer than 24 months from cycle 1 of rituximab initiation; For CLL/SLL members using Venclexta with obinutuzumab (Gazyva), Venclexta will not be used longer than 12 cycles

Duration thresholds

Authorization duration12 months (standard for listed indications)

CLL with rituximab duration limitNot to be used longer than 24 months from cycle 1 of rituximab initiation

CLL with obinutuzumab (Gazyva) duration limitNot to be used longer than 12 cycles

Provider Actions

Prior Authorization

Prior authorization required with documentation

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

Include documentation of translocation t(11;14).
Include documentation of TP53-mutation when applicable.

Documentation Required

Evidence required for coverage

Document member age, specific indication, treatment combination (e.g., with azacitidine, decitabine, low-dose cytarabine, rituximab, obinutuzumab), and presence of qualifying cytogenetics (e.g., t(11;14), TP53 mutation) as applicable.

Member age (e.g., ≥75 years, ≥60 years, or <60 years where specified).
Specific indication (FDA-approved or compendial indication).
Treatment combination being used (azacitidine, decitabine, low-dose cytarabine, rituximab, obinutuzumab, etc.).
Qualifying cytogenetics when applicable (e.g., t(11;14), TP53 mutation).

Denial Risk

Not medically necessary for unlisted indications

Claims for indications not listed (non‑FDA and non‑compendial uses) are considered experimental/investigational and will be denied as not medically necessary.

Billing Rule

Authorization duration limits

Authorizations are typically issued for 12 months; specific combination regimens in CLL/SLL have maximum duration constraints (see thresholds).

For CLL/SLL with rituximab: Venclexta will not be used longer than 24 months from cycle 1 of rituximab initiation.
For CLL/SLL with obinutuzumab (Gazyva): Venclexta will not be used longer than 12 cycles.

Background

Policy references include the Venclexta package insert (AbbVie, June 2022) and compendial support from the NCCN Drugs & Biologics Compendium and IBM Micromedex DRUGDEX. The policy lists covered FDA-approved indications and additional compendial uses, and requires documentation (for example, t(11;14) and TP53 mutation where applicable) to initiate prior authorization review.

Definitions

Authorization of 12 monthsCoverage approvals are generally granted for a 12-month period subject to reauthorization criteria.

Compendial usesUses supported by compendia such as NCCN and DRUGDEX and included as covered when criteria are met.