CurrentNeighborhood Health Plan of Rhode IslandPolicy 2374-A

Venetoclax (Venclexta) — Coverage and Prior Authorization Criteria

Coverage and prior authorization criteria for venetoclax (Venclexta) for multiple hematologic malignancies and related disorders for members of Neighborhood Health Plan of Rhode Island as referenced by this document segment.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVenetoclax (Venclexta) — Coverage and Prior Authorization Criteria

Policy CodePolicy 2374-A

Change TypeRoutine review — no material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit required documentation (including t(11;14) or TP53 results where applicable) to support coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

t(11;14)required translocation

24 monthsmax with Rituxan (CLL/SLL)

Multiple hematologic malignanciesnamed covered indications

Coverage Criteria for Venetoclax (Venclexta)

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

Covered when ANY of the following CLL/SLL conditions are met:

CLL/SLL authorization: Authorization of 12 months may be granted when either: (1) the requested medication will be used as monotherapy or in combination with rituximab (Rituxan) or obinutuzumab (Gazyva); OR (2) the requested medication will be used as first-line therapy in combination with acalabrutinib (Calquence) with or without obinutuzumab, or ibrutinib (Imbruvica).

Includes limits on duration in continuation section.

Newly-Diagnosed Acute Myeloid Leukemia (AML)

Covered when ALL of the following for newly-diagnosed AML are met:

Newly-diagnosed AML authorization: Authorization of 12 months may be granted when venetoclax is used in combination with decitabine, azacitidine, or low-dose cytarabine; AND one of the following is met: the member is 75 years of age or older; OR the member has comorbidities that preclude intensive induction chemotherapy or is not a candidate for or declines intensive induction therapy; OR the member has poor/adverse risk disease and is a candidate for intensive induction therapy; OR the member will use venetoclax in a post-induction therapy regimen following response to a venetoclax-based regimen.

Authorization typically 12 months.

Relapsed or Refractory AML

Covered when ANY of the following for relapsed/refractory AML are met:

Relapsed/Refractory AML authorization: Authorization of 12 months may be granted when the requested medication will be used in combination with azacitidine, decitabine, or low-dose cytarabine; OR in combination with fludarabine, cytarabine, a granulocyte colony-stimulating factor (G-CSF), with or without idarubicin; OR in combination with cladribine, idarubicin, and cytarabine.

Authorization typically 12 months.

Mantle Cell Lymphoma (MCL)

Covered when ANY of the following for MCL are met:

MCL authorization: Authorization of 12 months may be granted when the requested medication will be used as subsequent treatment as a single agent or in combination with rituximab or ibrutinib; OR will be used as induction therapy for TP53-mutated disease in combination with obinutuzumab (Gazyva) and zanubrutinib (Brukinsa).

Authorization typically 12 months; document TP53 mutation where applicable.

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Covered when the following for BPDCN are met:

BPDCN authorization: Authorization of 12 months may be granted when venetoclax is used in combination with azacitidine, decitabine, or low-dose cytarabine for BPDCN.

Authorization typically 12 months.

Multiple Myeloma (MM) with t(11;14)

Covered when ALL of the following for Multiple Myeloma with t(11;14) are met:

MM with t(11;14): Authorization of 12 months may be granted for relapsed or progressive multiple myeloma when there is documented translocation t(11;14) and venetoclax will be used in combination with dexamethasone with or without daratumumab (including daratumumab with hyaluronidase-fihj) or a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib).presence of t(11;14)

Documentation of t(11;14) required per Documentation module.

Systemic Light Chain Amyloidosis (SLCA) with t(11;14)

Covered when ALL of the following for Systemic Light Chain Amyloidosis are met:

SLCA with t(11;14): Authorization of 12 months may be granted for relapsed or refractory systemic light chain amyloidosis with documented translocation t(11;14) when venetoclax is used as a single agent or in combination with dexamethasone.presence of t(11;14)

Documentation of t(11;14) required.

Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma (WM/LPL)

Covered when the following for WM/LPL are met:

WM/LPL authorization: Authorization of 12 months may be granted for subsequent treatment of Waldenström macroglobulinemia/lymphoplasmacytic lymphoma when venetoclax is used as a single agent.

Authorization typically 12 months.

Myelodysplastic Syndrome (MDS)

Covered when the following for Myelodysplastic Syndrome (MDS) are met:

MDS authorization: Authorization of 12 months may be granted for treatment of higher risk MDS (e.g., IPSS-R intermediate, high, very high) when venetoclax is used in combination with azacitidine or decitabine.higher risk per IPSS-R

Authorization typically 12 months.

Hairy Cell Leukemia

Covered when BOTH conditions for Hairy Cell Leukemia are met:

Hairy cell leukemia authorization: Authorization of 12 months may be granted when both: (1) the member has progressed on previous therapy for relapsed or refractory disease; AND (2) the member has disease resistant to BRAF inhibitor therapy.

Authorization typically 12 months; single agent or in combination with rituximab.

Myeloproliferative Neoplasms (accelerated/blast phase)

Covered when the following for myeloproliferative neoplasms are met:

MPN authorization: Authorization of 12 months may be granted for management of disease progression of accelerated or blast phase myeloproliferative neoplasms when venetoclax is used in combination with azacitidine or decitabine.

Authorization typically 12 months.

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

Covered when the following for B-ALL/T-ALL are met:

B-ALL/T-ALL authorization: Authorization of 12 months may be granted for relapsed or refractory B-cell or T-cell acute lymphoblastic leukemia when venetoclax is used in combination with vincristine, pegaspargase or calaspargase, and prednisone or dexamethasone.

Authorization typically 12 months.

Chronic Myelomonocytic Leukemia (CMML)-2

Covered when the following for CMML-2 are met:

CMML-2 authorization: Authorization of 12 months may be granted for CMML-2 when venetoclax is used in combination with a hypomethylating agent (e.g., azacitidine, decitabine).

Authorization typically 12 months.

Initial and Continuation Authorization Criteria

Covered when the following authorization and continuation conditions are met

CMML-2 initial authorization: Authorization of 12 months may be granted for CMML-2 when used in combination with a hypomethylating agent (e.g., azacitidine, decitabine).

From chunk 18

Continuation of therapy: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen; specific maximum durations for CLL/SLL combinations apply: Venclexta with Rituxan not longer than 24 months from cycle 1 day 1 of Rituxan initiation; Venclexta with Gazyva not longer than 12 cycles; Venclexta with Imbruvica or Calquence not longer than 13 cycles.

From chunk 19

All indications that are not listed among the FDA-approved indications or the compendial uses enumerated in this policy are considered experimental/investigational and are not medically necessary. The compendial uses referenced include multiple hematologic malignancies such as MCL, AML, BPDCN, MM with t(11;14), SLCA with t(11;14), WM/LPL, MDS, hairy cell leukemia, accelerated/blast phase myeloproliferative neoplasms, B-ALL/T-ALL, CLL/SLL, and CMML-2.

Continuation requests for CLL/SLL regimens must comply with specified maximum durations for combinations with anti-CD20 or BTK inhibitor therapy. Specifically, when used with rituximab, Venclexta will not be used longer than 24 months measured from cycle 1 day 1 of rituximab initiation. When used with obinutuzumab (Gazyva), Venclexta will not be used longer than 12 cycles. When used with ibrutinib (Imbruvica) or acalabrutinib (Calquence), Venclexta will not be used longer than 13 cycles.

Use of venetoclax for indications outside those listed as FDA-approved or compendial in this policy is considered not medically necessary and is excluded from coverage.

Provider Requirements and Authorization Instructions

Prior Authorization

Prior Authorization and Duration Limits

Prior authorization is required for initial and continuation therapy. Authorization periods are generally for up to 12 months; specific maximum durations apply by indication and regimen as detailed below. Requests for reauthorization must document ongoing benefit and absence of unacceptable toxicity or disease progression.

Prior authorization required for initial and continuation therapy (typical authorization = 12 months).
Authorization of up to 12 months may be granted for most indications; see indication-specific guidance for exceptions and regimen-based limits.

Denial Risk

Reauthorization Denial Triggers

Authorization may be denied on reauthorization if there is evidence of unacceptable toxicity or objective disease progression while on the current regimen. Continuation approvals require documentation that the member is deriving clinical benefit and is tolerating therapy.

Reauthorization may be denied for unacceptable toxicity or documented disease progression on the current regimen.
Continuation requests must include clinical status supporting ongoing benefit and tolerability.

Documentation Required

Required Molecular Documentation

Submit documentation of relevant molecular testing to initiate prior authorization review. At a minimum, provide results confirming presence of translocation t(11;14) when applicable and TP53 mutation status where relevant to the indication.

Document presence of translocation t(11;14) for indications that require it (e.g., multiple myeloma, systemic light chain amyloidosis).
Provide TP53-mutation status where applicable (e.g., for TP53-mutated disease scenarios).

Prior Authorization

CLL/SLL Regimen Options and Limits

For chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) include regimen-specific details with the authorization request. Authorization of up to 12 months may be granted when venetoclax (Venclexta) is used as monotherapy or in combination with rituximab (Rituxan) or obinutuzumab (Gazyva), or when used first-line in combination with acalabrutinib (with or without obinutuzumab) or ibrutinib (Imbruvica). Note regimen-specific maximum exposure limits for continuation therapy.

CLL/SLL: monotherapy, or in combination with rituximab or obinutuzumab — authorization may be granted for up to 12 months.
CLL/SLL first-line combination regimens allowed: acalabrutinib (± obinutuzumab) or ibrutinib.
Continuation limits: with Rituxan — Venclexta not used longer than 24 months from cycle 1 day 1 of Rituxan initiation; with Gazyva — Venclexta not used longer than 12 cycles; with Imbruvica or Calquence — Venclexta not used longer than 13 cycles.

Covered Venetoclax Regimens and Typical Authorization Durations

Indication	Example venetoclax-containing regimen(s)	Notes / authorization
Chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL)	Venetoclax with rituximab (Rituxan) or venetoclax with obinutuzumab (Gazyva); venetoclax monotherapy; venetoclax first-line in combination with acalabrutinib (Calquence) ± obinutuzumab or ibrutinib (Imbruvica)	Authorization of 12 months may be granted when criteria met; duration limits for some combinations apply (see continuation criteria).
Acute myeloid leukemia (AML) — newly diagnosed or relapsed/refractory	Venetoclax in combination with azacitidine, decitabine, or low‑dose cytarabine; multi‑agent AML salvage regimens (e.g., with fludarabine + cytarabine ± idarubicin; or cladribine + idarubicin + cytarabine)	Authorization of 12 months may be granted when used in indicated combinations and patient meets clinical eligibility (e.g., older or unfit for intensive induction for newly‑diagnosed).
Blastic plasmacytoid dendritic cell neoplasm (BPDCN)	Venetoclax with azacitidine, decitabine, or low‑dose cytarabine	Authorization of 12 months may be granted when used in combination with a hypomethylating agent or low‑dose cytarabine.
Multiple myeloma (MM) with t(11;14)	Venetoclax with dexamethasone ± daratumumab (with hyaluronidase‑fihj) or venetoclax with a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib)	Authorization of 12 months may be granted for relapsed/progressive MM with documented t(11;14). Documentation of t(11;14) required.
Myelodysplastic syndrome (MDS)	Venetoclax with azacitidine or decitabine	Authorization of 12 months may be granted for higher‑risk MDS when used with a hypomethylating agent.
Chronic myelomonocytic leukemia (CMML)-2	Venetoclax with azacitidine or decitabine	Authorization of 12 months may be granted when used in combination with a hypomethylating agent.

Indication	Regimen	Authorization duration / notes
Chronic myelomonocytic leukemia (CMML)-2	Venclexta (venetoclax) plus azacitidine or decitabine	Authorization of 12 months may be granted when used in combination with a hypomethylating agent (e.g., azacitidine, decitabine).

Indication	Combination regimen	Maximum Venclexta duration (when applicable)
Chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL)	Venclexta (venetoclax) with rituximab (Rituxan)	Venclexta not to be used longer than 24 months from cycle 1 day 1 of Rituxan initiation.
Chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL)	Venclexta (venetoclax) with obinutuzumab (Gazyva)	Venclexta not to be used longer than 12 cycles when given with Gazyva.
Chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL)	Venclexta (venetoclax) with acalabrutinib (Calquence) or ibrutinib (Imbruvica)	Venclexta not to be used longer than 13 cycles when given with Imbruvica or Calquence.

Population and Term Definitions

Newly-diagnosed AML eligible population

PopulationAdults 75 years or older, or those with comorbidities that preclude intensive induction chemotherapy

Treatment contextVenetoclax used in combination with azacitidine, decitabine, or low-dose cytarabine

Authorization periodAuthorization of 12 months may be granted

CMML-2

DefinitionChronic myelomonocytic leukemia, subtype CMML-2

Authorized regimenVenetoclax in combination with a hypomethylating agent (e.g., azacitidine, decitabine)

Authorization periodAuthorization of 12 months may be granted

Line of Therapy Specifications

first-line | subsequent

Line of therapy: Venetoclax as monotherapy or in combination (rituximab, obinutuzumab) for subsequent lines; or first-line in combination with acalabrutinib or ibrutinib.

Applies to CLL/SLL and referenced line-of-therapy guidance.

first-line

First-line AML: Venetoclax used in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine for newly-diagnosed AML in older adults or those unfit for intensive induction chemotherapy.

Authorization typically 12 months; aligns with definition of eligible newly-diagnosed AML population.

Biomarker and Molecular Documentation

t(11;14)

MarkerTranslocation t(11;14)

Required forMultiple myeloma (relapsed/progressive) and systemic light chain amyloidosis (relapsed/refractory)

DocumentationPresence of t(11;14) must be submitted to initiate prior authorization review

TP53-mutation

MarkerTP53-mutation

Where referencedRequested/documented where applicable for authorization (e.g., MCL TP53-mutated induction)

DocumentationSubmit documentation of TP53-mutation where applicable to initiate prior authorization review

Background

Venetoclax (Venclexta) is indicated and authorized under this policy for a range of hematologic malignancies and related disorders when the specific coverage criteria are met. Compendial uses listed in the policy include mantle cell lymphoma (MCL); acute myeloid leukemia (AML); blastic plasmacytoid dendritic cell neoplasm (BPDCN); multiple myeloma (MM) and systemic light chain amyloidosis (SLCA) with documented translocation t(11;14); Waldenström macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL); myelodysplastic syndrome (MDS); hairy cell leukemia; accelerated/blast phase myeloproliferative neoplasms; B-ALL/T-ALL; chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL); and chronic myelomonocytic leukemia (CMML)-2.

Authorization Durations and Key Metrics

12typical authorization duration (months)

24max Venclexta duration with Rituxan (months)

12max Venclexta duration with Gazyva (cycles)

t(11;14)required documented translocation for MM/SLCA

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVenetoclax (Venclexta) — Coverage and Prior Authorization Criteria

Policy CodePolicy 2374-A

Change TypeRoutine review — no material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit required documentation (including t(11;14) or TP53 results where applicable) to support coverage.

SourceLink

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