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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsPremera BCL-2 Inhibitor Prior Auth | OpenPayer
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    ModifiedPremera Blue Cross of WashingtonPolicy 5.01.568

    BCL-2 Inhibitors

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    This policy governs pharmacy-benefit coverage and prior authorization for Beqalzi (sonrotoclax) and Venclexta (venetoclax), including medically necessary uses, clinical criteria, documentation, dosing limits, authorization durations, and investigational uses for specified hematologic malignancies.

    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyBCL-2 Inhibitors
    Policy CodePolicy 5.01.568
    Change TypeModified
    Effective DateNovember 1, 2026
    Last ReviewNov 1, 2026
    Next Review DateN/A
    Key ActionSubmit medical records documenting medical necessity, including office notes with the diagnosis, relevant history, physical evaluation, and medication history.
    SourceLink
    POLICY UPDATE CHANGES

    The policy added coverage criteria for Beqalzi (sonrotoclax) for relapsed or refractory mantle cell lymphoma.

    The policy updated Venclexta (venetoclax) criteria for newly diagnosed acute myeloid leukemia and added Inqovi (decitabine and cedazuridine) to the medications with which it may be used in combination.

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

    2BCL-2 inhibitor drugs addressed
    6 monthsMaximum initial authorization
    12 months

    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.

    Maximum reauthorization period
    320 mgDose limit

    Covered Uses and Medical Necessity

    Beqalzi for relapsed or refractory mantle cell lymphoma

    Beqalzi may be considered medically necessary when all of the following are met.

    • Adult age: The individual is aged 18 years or older>=18 years
    • Diagnosis: The individual has relapsed or refractory mantle cell lymphoma
    • Prior therapy: The individual has received at least 2 lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor>=2 systemic therapy lines and BTK inhibitor exposure

      Examples of BTK inhibitors include acalabrutinib and zanubrutinib.

    • Dose limit: The dose is limited to 320 mg once daily320 mg once daily

    Venclexta for CLL or SLL after systemic therapy

    Venclexta may be considered medically necessary when all of the following are met.

    • Adult 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>=2 systemic therapy lines and BTK inhibitor exposure

      Examples of BTK inhibitors include acalabrutinib and zanubrutinib.

    • Dose limit: The dose is limited to 320 mg once daily320 mg once daily

    Venclexta for CLL or SLL

    Venclexta may be considered medically necessary when all of the following are met.

    • Adult age: The individual is aged 18 years or older>=18 years
    • Diagnosis: The individual is diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphomaDocumented CLL or SLL

    Venclexta for newly diagnosed AML

    Venclexta may be considered medically necessary for newly diagnosed AML when all applicable criteria are met.

    Venclexta for newly diagnosed acute myeloid leukemia

    • ONE of: qualifying age or comorbidity

      • Age criterion: The individual is aged 75 years or older>=75 years
      • Comorbidity criterion: The individual has comorbidities that preclude use of intensive induction chemotherapyComorbidities precluding intensive induction chemotherapy
    • Diagnosis: The individual has newly diagnosed acute myeloid leukemia

    Uses of Beqalzi (sonrotoclax) or Venclexta (venetoclax) that are not outlined in this policy are considered investigational.

    Authorization and Documentation Requirements

    Billing Rule

    Pharmacy Benefit Management

    Beqalzi (sonrotoclax) and Venclexta (venetoclax) are managed through the pharmacy benefit. Apply the product’s FDA dosage and administration prescribing information when reviewing requests.

    • Pharmacy benefit management applies to both medications.
    Prior Authorization

    Initial and Renewal Authorization Periods

    Initial authorization may be approved for up to 6 months. Reauthorization may be approved for up to 12 months when the drug-specific coverage criteria are met and the individual continues to show a positive response to therapy.

    • Initial authorization: Up to 6 months.

    BCL-2 Inhibitor Background

    BCL-2 inhibitors block BCL-2, an anti-apoptotic protein that helps malignant cells survive by inhibiting programmed cell death. Inhibiting this protein allows programmed cell death to resume and may help eliminate malignant cells.

    This policy addresses Beqalzi (sonrotoclax) and Venclexta (venetoclax) for selected hematologic malignancies, including mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, and acute myeloid leukemia. The clinical background is informational and does not itself establish coverage; coverage depends on the applicable criteria in the policy.

    Clinical Definitions

    17p deletion
    ChromosomeChromosome 17
    Affected portionThe shorter arm, designated as “p”
    DefinitionThe shorter arm of chromosome 17 is missing in a cell with 17p deletion.
    BCL-2
    Protein typeAnti-apoptotic protein
    Cellular functionInhibits programmed cell death and can prevent destruction of nonfunctional or malignant cells.
    Cancer relevanceCommonly overexpressed in some cancers, including chronic lymphocytic leukemia (CLL); BCL-2 inhibitors are intended to counteract its action.

    Initial Authorization

    Initial authorization

    Initial coverage is available only when the applicable drug-specific medical necessity criteria are met.

    Initial authorization: The individual meets the applicable diagnosis, age, prior-treatment or combination-treatment, and dosing requirements for the requested BCL-2 inhibitorDrug-specific criteria in the policy

    Initial authorization may be approved for up to 6 months.

    Reauthorization

    Reauthorization

    Reauthorization may be approved when the drug-specific coverage criteria continue to be met and there is evidence of ongoing positive response.

    Continuation therapy

    • Criteria remain met: Drug-specific coverage criteria remain satisfied
    • Clinical response: There is evidence the individual continues to show a positive response to therapyDocumented positive response

    Dose and Quantity Limits

    Beqalzi (sonrotoclax)
    MedicationBeqalzi (sonrotoclax)
    Maximum dose320 mg
    FrequencyOnce daily
    Venclexta (venetoclax)
    MedicationVenclexta (venetoclax)
    Maximum dose320 mg
    FrequencyOnce daily for the specified CLL/SLL prior-therapy pathway
    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyBCL-2 Inhibitors
    Policy CodePolicy 5.01.568
    Change TypeModified
    Effective DateNovember 1, 2026
    Last ReviewNov 1, 2026
    Next Review DateN/A
    Key ActionSubmit medical records documenting medical necessity, including office notes with the diagnosis, relevant history, physical evaluation, and medication history.
    SourceLink
    On This Page
    Covered Uses and Medical NecessityAuthorization and Documentation RequirementsBCL-2 Inhibitor BackgroundClinical DefinitionsInitial AuthorizationReauthorizationDose and Quantity Limits
    Newly diagnosed AML
  1. Combination therapy: Medication is used in combination with azacitidine, decitabine, low-dose cytarabine, or InqoviCombination with one listed agent or regimen

    Inqovi is decitabine and cedazuridine.

  2. Reauthorization: Up to 12 months when criteria remain met and there is evidence of continued positive response.
    3. Documentation Required

    Medical Records Required

    Submit medical records demonstrating that medical-necessity criteria are met. Records should include office visit notes documenting the diagnosis, relevant history, physical evaluation, and medication history.

    • Office visit notes with diagnosis
    • Relevant history
    • Physical evaluation
    • Medication history
    Denial Risk

    Unlisted Uses Are Investigational

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

    • Coverage is limited to uses described in the policy.
    • Prescribing must follow the product’s FDA dosage and administration information.
    Denial Risk

    Failure to Meet Drug-Specific Criteria

    Requests may be denied when drug-specific requirements are not met, including age, diagnosis, prior therapy, prior Bruton's tyrosine kinase (BTK) inhibitor use, required combination therapy, or dose limitations.

    • Beqalzi: Individual must be age 18 or older, have relapsed or refractory mantle cell lymphoma, have received at least 2 lines of systemic therapy including a BTK inhibitor such as acalabrutinib or zanubrutinib, and use a dose limited to 320 mg once daily.
    • Venclexta for CLL/SLL: Individual must be age 18 or older and have a diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma.
    • Venclexta for newly diagnosed AML: Individual must be age 75 or older or have comorbidities that preclude intensive induction chemotherapy, have newly diagnosed AML, and use the medication in combination with azacitidine, decitabine, low-dose cytarabine, or Inqovi (decitabine and cedazuridine).
    Tumor lysis syndrome
    Diagnostic ruleLaboratory tumor lysis syndrome requires at least 2 laboratory abnormalities within 24 hours of one another.
    PotassiumGreater than 6 mmol/L
    Uric acidGreater than 476 µmol/L
    CalciumLess than 1.75 mmol/L
    PhosphorusGreater than 1.5 mmol/L