ModifiedPremera Blue Cross of WashingtonPolicy 5.01.568

BCL-2 Inhibitors

Customize your policy alerts

Sign up for premerabluecrossofwashington Policy 5.01.568 alerts

Get alerted when Policy 5.01.568 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs pharmacy-benefit coverage and prior authorization for Beqalzi (sonrotoclax) and Venclexta (venetoclax). It describes medically necessary uses, dosing limits, authorization durations, documentation requirements, and investigational uses for provider-submitted requests.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyBCL-2 Inhibitors

Policy CodePolicy 5.01.568

Change TypeModified

Effective DateNovember 1, 2026

Next Review DateN/A

Key ActionSubmit medical records documenting the diagnosis, relevant history, physical evaluation, medication history, and applicable medical-necessity criteria.

SourceLink

POLICY UPDATE CHANGES

The policy was expanded from Venclexta (venetoclax) to BCL-2 inhibitors and added criteria for Beqaldzi (sonrotoclax) for relapsed or refractory mantle cell lymphoma.

Venclexta criteria were updated for newly diagnosed acute myeloid leukemia to add Inqovi (decitabine and cedazuridine) as a medication with which Venclexta may be used in combination.

The initial authorization period for all other reviews was increased from 3 months to 6 months for drugs listed in the policy.

References to non-formulary exception reviews were removed from the policy.

Policy 5.01.590 Bruton Tyrosine Kinase Inhibitors was added to the related medical policies.

2BCL-2 inhibitor drugs covered

320 mg dailyDose limit

2+ lines

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedPremera Blue Cross of WashingtonPolicy 5.01.568

BCL-2 Inhibitors

Customize your policy alerts

Sign up for premerabluecrossofwashington Policy 5.01.568 alerts

Get alerted when Policy 5.01.568 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyBCL-2 Inhibitors

Policy CodePolicy 5.01.568

Change TypeModified

Effective DateNovember 1, 2026

Next Review DateN/A

Key ActionSubmit medical records documenting the diagnosis, relevant history, physical evaluation, medication history, and applicable medical-necessity criteria.

SourceLink

POLICY UPDATE CHANGES

The policy was expanded from Venclexta (venetoclax) to BCL-2 inhibitors and added criteria for Beqaldzi (sonrotoclax) for relapsed or refractory mantle cell lymphoma.

Venclexta criteria were updated for newly diagnosed acute myeloid leukemia to add Inqovi (decitabine and cedazuridine) as a medication with which Venclexta may be used in combination.

The initial authorization period for all other reviews was increased from 3 months to 6 months for drugs listed in the policy.

References to non-formulary exception reviews were removed from the policy.

Policy 5.01.590 Bruton Tyrosine Kinase Inhibitors was added to the related medical policies.

2BCL-2 inhibitor drugs covered

320 mg dailyDose limit

2+ lines

Required prior systemic therapy

6 monthsMaximum initial authorization

12 monthsMaximum reauthorization

Covered Uses and Investigational Uses

Beqalzi for relapsed or refractory mantle cell lymphoma

Beqalzi is medically necessary when all of the following are met.

Beqalzi for relapsed or refractory MCL

Age: The individual is aged 18 years or older.>=18 years
Diagnosis: The individual has relapsed or refractory mantle cell lymphoma.Relapsed or refractory MCL
Prior therapy: The individual has received at least 2 lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor such as acalabrutinib or zanubrutinib.>=2 lines including a BTK inhibitor
Dose: The dose is limited to 320 mg once daily.320 mg once daily

Venclexta for previously treated CLL or SLL

Venclexta is medically necessary for the specified previously treated CLL or SLL population when all of the following are met.

Age: The individual is aged 18 years or older.>=18 years
Prior therapy: The individual has received at least 2 lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor such as acalabrutinib or zanubrutinib.>=2 lines including a BTK inhibitor
Dose: The dose is limited to 320 mg once daily.320 mg once daily

Venclexta for CLL or SLL

Venclexta is medically necessary when all of the following are met.

Age: The individual is aged 18 years or older.>=18 years
Diagnosis: The individual is diagnosed with CLL or SLL.CLL or SLL

Venclexta for newly diagnosed acute myeloid leukemia

Venclexta is medically necessary for newly diagnosed AML when all of the following are met.

Venclexta for newly diagnosed AML

ONE of: eligibility for lower-intensity induction
- Age: The individual is aged 75 years or older.>=75 years
- Comorbidity: The individual has comorbidities that preclude use of intensive induction chemotherapy.Comorbidities precluding intensive induction chemotherapy
AML diagnosis: The individual has newly diagnosed acute myeloid leukemia.

All other uses of Beqalzi (sonrotoclax) or Venclexta (venetoclax) that are not outlined in this policy are considered investigational and may not be covered.

Dose, Therapy, and Safety Parameters

Prior systemic therapy

RequirementAt least 2 lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor such as acalabrutinib or zanubrutinib

Beqalzi dose

Dose limit320 mg once daily

Selected Venclexta dose

Dose limit320 mg once daily

AML age criterion

Eligibility threshold

Authorization, Documentation, and Coverage Rules

Prior Authorization

Pharmacy Benefit Prior Authorization

Beqalzi (sonrotoclax) and Venclexta (venetoclax) are managed through the pharmacy benefit. Submit a pharmacy benefit prior authorization request for drug-specific review against the applicable coverage criteria.

Pharmacy benefit management applies to both medications.
The request is reviewed using the drug-specific criteria in this policy.

Prior Authorization

Reauthorization Requires Continued Response

Reauthorization may be approved for up to 12 months when the applicable drug-specific coverage criteria continue to be met and there is evidence that the individual continues to show a positive response to therapy.

Maximum reauthorization period: 12 months.
Document continued positive response to therapy and continued satisfaction of drug-specific criteria.

Clinical Background

BCL-2 inhibitors block the anti-apoptotic BCL-2 protein, which can be overexpressed in malignant cells. By removing this survival signal, these medications can allow malignant cells to undergo programmed cell death (apoptosis).

Key Clinical Definitions

17p deletion

DefinitionThe shorter-arm portion of chromosome 17, designated as p, is missing in a cell with 17p deletion.

BCL-2

DefinitionBCL-2 is an anti-apoptotic protein that inhibits programmed cell death and is commonly overexpressed in some cancers, including CLL.

RelevanceBCL-2 inhibition is intended to counteract the protein's activity.

Tumor lysis syndrome

DefinitionLaboratory tumor lysis syndrome is identified when at least 2 of the following abnormalities occur within 24 hours of each other.

Initial Authorization Criteria

Initial authorization

Initial therapy is covered only when the applicable drug-specific criteria are met.

Covered initial use: The requested drug is Beqalzi or Venclexta, and the individual meets the corresponding diagnosis, age, prior-treatment, combination-treatment, and dose requirements specified in the policy.Applicable drug-specific criteria satisfied

Initial authorization may be approved for up to 6 months.

Reauthorization Criteria

Reauthorization

Reauthorization may be approved when all of the following are met.

Continuation authorization

Drug-specific criteria: The applicable drug-specific coverage criteria continue to be met.Criteria remain satisfied
Response: There is evidence the individual continues to show a positive response to therapy.Continued positive response

Policy Summary

PayerPremera Blue Cross of Washington

PolicyBCL-2 Inhibitors

Policy CodePolicy 5.01.568

Change TypeModified

Effective DateNovember 1, 2026

Next Review DateN/A

Key ActionSubmit medical records documenting the diagnosis, relevant history, physical evaluation, medication history, and applicable medical-necessity criteria.

SourceLink

On This Page

Combination therapy: Venclexta is used in combination with azacitidine, decitabine, low-dose cytarabine, or Inqovi (decitabine and cedazuridine).Combination with azacitidine, decitabine, low-dose cytarabine, or Inqovi

Age 75 years or older

High tumor burden hospitalization criteria during venetoclax ramp-up

Single-threshold criterionAny measurable lymph node ≥10 cm

Combined-threshold criterionBoth an absolute lymphocyte count (ALC) ≥25 × 10⁹/L and any measurable lymph node ≥5 cm

Laboratory tumor lysis syndrome

DefinitionAt least 2 laboratory abnormalities occurring within 24 hours of each other

Potassium>6 mmol/L

Uric acid>476 µmol/L

Calcium<1.75 mmol/L

Phosphorus>1.5 mmol/L

Note

Initial Authorization Period

For all other reviews, initial authorization for drugs listed in this policy may be approved for up to 6 months.

Initial authorization period: up to 6 months.

Unsupported block type: documentation

Denial Risk

Unoutlined or Non-FDA-Labeled Use

Uses of Beqalzi (sonrotoclax) or Venclexta (venetoclax) that are not outlined in this policy are considered investigational and may be denied. Use must also be consistent with the product's FDA dosage and administration prescribing information.

Non-FDA-labeled or otherwise unoutlined use is considered investigational.
Coverage is not established for uses outside the policy criteria.

Denial Risk

Failure to Meet Drug-Specific Criteria

Authorization may be denied when the requested medication does not meet the applicable drug-specific criteria, including requirements for the disease or indication, age, prior therapy, combination therapy, or dosing limits.

Disease-specific indication is required: relapsed or refractory mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, or newly diagnosed acute myeloid leukemia, as applicable.
Age requirements must be met, including age 18 years or older where specified and the qualifying age or comorbidity requirement for newly diagnosed acute myeloid leukemia.
Required prior therapy must be documented, including at least 2 lines of systemic therapy with a Bruton's tyrosine kinase inhibitor where applicable.
Required combination therapy must be documented for newly diagnosed acute myeloid leukemia.
Dose limits must be met, including the 320 mg once-daily limit where specified.

Note

Benefit and Policy Limitations

Coverage is subject to the member's benefit plan and its applicable limits and conditions. The member benefit booklet or a member service representative should be consulted to determine benefit limitations for the requested medication.

Coverage remains subject to medical-necessity criteria.
Member contracts may differ in benefits and limitations.
This medical policy does not apply to Medicare Advantage.

Billing Rule

FDA Dosing and Administration

The medications listed in this policy are subject to the product's US Food and Drug Administration (FDA) dosage and administration prescribing information.

Prescribe and administer each medication consistently with its current FDA prescribing information.

Qualifying abnormalitiesPotassium >6 mmol/L; uric acid >476 µmol/L; calcium <1.75 mmol/L; or phosphorus >1.5 mmol/L.