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Fixed-duration VENCLEXTA:

Opportunity for cost management predictability in 1L CLL

1L CLL TREATMENT COST ANALYSIS

Modeled annual per-patient regimen cost based on January 2025 WAC for select therapies used in 1L CLL treatment14*†

  • The products listed here are not interchangeable. No safety or efficacy conclusions can be drawn from this information. The products differ in their ingredients, strength, dosage, administration, indications, efficacy, and safety
  • Selection of a treatment regimen should be individualized for each patient based on factors including, but not limited to, product efficacy, adverse events, dosage and administration, potential for drug interactions, laboratory test results, and comorbid conditions
  • Deciding which treatment options are medically necessary for an individual patient is solely the responsibility of the treating provider

All registered trademarks shown are the property of their respective owners.
All amounts in chart are rounded to the nearest dollar.

*Source: AnalySource. Pricing Compendia. https://www.analysource.com/logon/. Accessed January 13, 2025.
†BSA of 1.88 m2 was used in the cost of therapy calculation. BSA assumption is based on the patient population profile of the CLL14 trial.
‡Drug cost refers to the WAC. Coverage and patient OOP costs for VEN+G vary by health plan. Patients may still incur OOP costs for other treatments or tests as directed by their healthcare providers.
§IMBRUVICA therapy is until disease progression or unacceptable toxicity. Results from an 8-year follow-up analysis of the phase 3 RESONATE-2 study: median treatment duration was 6.2 years and 42% of patients in the ibrutinib arm remained on treatment at study end.8,15
llBRUKINSA therapy is until disease progression or unacceptable toxicity. Results from a 5-year follow up analysis of the phase 3 SEQUOIA study: median exposure was 60.5 months.7,16
CALQUENCE therapy is until disease progression or unacceptable toxicity. Results from a 6-year follow-up analysis of the phase 3 ELEVATE-TN study: median follow up of 74.5 months (range 0-89 months). Median treatment exposure was 74.4 months for acalabrutinib + obinutuzumab and 72 months for acalabrutinib monotherapy.6,17

VENCLEXTA, IMBRUVICA, BRUKINSA, and CALQUENCE are oral therapies and covered under the pharmacy benefit. GAZYVA is an IV therapy and covered under the medical benefit.1,6-8,18

Dosing Assumptions:

  • VENCLEXTA, GAZYVA, BRUKINSA, IMBRUVICA, and CALQUENCE regimens are based on the products’ respective PIs
  • Cost assumes no dose modifications

Treatment Assumptions1,6-8,14:

  • VENCLEXTA: Ten (10) 28-day cycles, following 5-week dose ramp-up (starter pack covers first 4 weeks); GAZYVA: Six (6) 28-day cycles
  • IMBRUVICA: 420 mg/day continuously until disease progression or unacceptable toxicity
  • BRUKINSA: 160 mg BID continuously until disease progression or unacceptable toxicity
  • CALQUENCE: 100 mg BID continuously until disease progression or unacceptable toxicity

Modeled annual pricing assumptions

  • WAC is used as a proxy for retail prices. WAC stands for Wholesale Acquisition Cost, which is an industry standard for the basis of manufacturer rebates and discount contracts. It is published and periodically updated by Truven Health Analytics, which is solely responsible for its accuracy. WAC information is current as of January 2025
  • The actual price paid by patients, third-party payers, and pharmacies may vary and may not correlate with WAC. Regimen costs presented may or may not include discounts, rebates, and other reductions in price

Review the annual costs for select R/R CLL regimens vs VENCLEXTA

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1L=first line; BID=twice daily; BSA=body surface area; CLL=chronic lymphocytic lymphoma; del(17p)=17p deletion; IV=intravenous; OOP=out-of-pocket; PI=Prescribing Information; R/R=relapsed/refractory; US=United States; VEN+G=VENCLEXTA + GAZYVA; WAC=Wholesale Acquisition Cost.

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Important Safety Information & Indication

Indication
  • VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Important Safety Information

Contraindication

  • Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during ramp-up phase is contraindicated in patients with CLL/SLL due to the potential for increased risk of tumor lysis syndrome (TLS).

Tumor Lysis Syndrome

  • Tumor lysis syndrome, including fatal events and renal failure requiring dialysis, has occurred in patients treated with VENCLEXTA. 

  • VENCLEXTA can cause rapid reduction in tumor and thus poses a risk for TLS at initiation and during the ramp-up phase in all patients, and during reinitiation after dosage interruption in patients with CLL/SLL. Changes in blood chemistries consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLEXTA and at each dose increase. TLS, including fatal cases, has been reported after a single 20 mg dose. 

  • In patients with CLL/SLL who followed the current (5 week) dose ramp-up and the TLS prophylaxis and monitoring measures, the rate of TLS was 2% in the VENCLEXTA CLL/SLL monotherapy trials. The rate of TLS remained consistent with VENCLEXTA in combination with obinutuzumab or rituximab. With a 2- to 3-week dose ramp-up and higher starting dose in patients with CLL/SLL, the TLS rate was 13% and included deaths and renal failure. 

  • The risk of TLS is a continuum based on multiple factors, particularly reduced renal function, tumor burden, and type of malignancy. Splenomegaly may also increase the risk of TLS in patients with CLL/SLL. 

  • Assess all patients for risk and provide appropriate prophylaxis for TLS, including hydration and anti-hyperuricemics. Monitor blood chemistries and manage abnormalities promptly. Employ more intensive measures (IV hydration, frequent monitoring, hospitalization) as overall risk increases. Interrupt dosing if needed; when restarting VENCLEXTA follow dose modification guidance in the Prescribing Information. 

  • Concomitant use of VENCLEXTA with P-gp inhibitors or strong or moderate CYP3A inhibitors increases venetoclax exposure, which may increase the risk of TLS at initiation and during the ramp-up phase, and requires VENCLEXTA dose reduction. 

Neutropenia

  • In patients with CLL, Grade 3 or 4 neutropenia developed in 63% to 64% of patients and Grade 4 neutropenia developed in 31% to 33% of patients when treated with VENCLEXTA in combination and monotherapy studies. Febrile neutropenia occurred in 4% to 6% of patients.

  • Monitor complete blood counts. Interrupt dosing for severe neutropenia and resume at same or reduced dose. Consider supportive measures including antimicrobials and growth factors (e.g., G-CSF).

Infections

  • Fatal and serious infections such as pneumonia and sepsis have occurred in patients treated with VENCLEXTA. Monitor patients for signs and symptoms of infection and treat promptly. Withhold VENCLEXTA for Grade 3 and 4 infection until resolution and resume at same or reduced dose.

Immunization

  • Do not administer live attenuated vaccines prior to, during, or after treatment with VENCLEXTA until B-cell recovery occurs. Advise patients that vaccinations may be less effective.

Embryo-Fetal Toxicity

  • VENCLEXTA may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for 30 days after the last dose.

Increased Mortality in Patients with Multiple Myeloma when VENCLEXTA is Added to Bortezomib and Dexamethasone

  • In a randomized trial (BELLINI; NCT02755597) in patients with relapsed or refractory multiple myeloma, the addition of VENCLEXTA to bortezomib plus dexamethasone, a use for which VENCLEXTA is not indicated, resulted in increased mortality. Treatment of patients with multiple myeloma with VENCLEXTA in combination with bortezomib plus dexamethasone is not recommended outside of controlled clinical trials.

Adverse Reactions

  • In patients with CLL receiving combination therapy with obinutuzumab, serious adverse reactions were most often due to febrile neutropenia and pneumonia (5% each). The most common adverse reactions (≥20%) of any grade were neutropenia (60%), diarrhea (28%), and fatigue (21%). Fatal adverse reactions that occurred in the absence of disease progression and with onset within 28 days of the last study treatment were reported in 2% (4/212) of patients, most often from infection.

  • In patients with CLL receiving combination therapy with rituximab, the most frequent serious adverse reaction (≥5%) was pneumonia (9%). The most common adverse reactions (≥20%) of any grade were neutropenia (65%), diarrhea (40%), upper respiratory tract infection (39%), fatigue (22%), and nausea (21%). Fatal adverse reactions that occurred in the absence of disease progression and within 30 days of the last VENCLEXTA treatment and/or 90 days of the last rituximab were reported in 2% (4/194) of patients.

  • In patients with CLL/SLL receiving monotherapy, the most frequent serious adverse reactions (≥5%) were pneumonia (9%), febrile neutropenia (5%), and sepsis (5%). The most common adverse reactions (≥20%) of any grade were neutropenia (50%), diarrhea (43%), nausea (42%), upper respiratory tract infection (36%), anemia (33%), fatigue (32%), thrombocytopenia (29%), musculoskeletal pain (29%), edema (22%), and cough (22%). Fatal adverse reactions that occurred in the absence of disease progression and within 30 days of venetoclax treatment were reported in 2% of patients in the VENCLEXTA monotherapy studies, most often (2 patients) from septic shock.

Drug Interactions

  • Concomitant use with a P-gp inhibitor or a strong or moderate CYP3A inhibitor increases VENCLEXTA exposure, which may increase VENCLEXTA toxicities, including the risk of TLS. Consider alternative medications or adjust VENCLEXTA dosage and monitor more frequently for adverse reactions. Resume the VENCLEXTA dosage that was used prior to concomitant use of a P-gp inhibitor or a strong or moderate CYP3A inhibitor 2 to 3 days after discontinuation of the inhibitor.

  • Patients should avoid grapefruit products, Seville oranges, and starfruit during treatment as they contain inhibitors of CYP3A.

  • Avoid concomitant use of strong or moderate CYP3A inducers.

  • Monitor international normalized ratio (INR) more frequently in patients receiving warfarin. 

  • Avoid concomitant use of VENCLEXTA with a P-gp substrate. If concomitant use is unavoidable, separate dosing of the P-gp substrate at least 6 hours before VENCLEXTA. 

Lactation

  • Advise women not to breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.

Females and Males of Reproductive Potential

  • Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for 30 days after the last dose.

  • Based on findings in animals, VENCLEXTA may impair male fertility.

Hepatic Impairment

  • Reduce the dose of VENCLEXTA for patients with severe hepatic impairment (Child-Pugh C); monitor these patients more frequently for adverse reactions. No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

Please see full Prescribing Information.

VENCLEXTA® and its design are registered trademarks of AbbVie Inc.
GAZYVA® is a registered trademark of Genentech, Inc.

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    • VENCLEXTA Prescribing Information.

      VENCLEXTA Prescribing Information.

    • Al-Sawaf O, Robrecht S, Zhang C, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study. Abstract presented at: European Hematology Association Hybrid Congress 2023; June 8-11, 2023; Frankfurt, Germany.

      Al-Sawaf O, Robrecht S, Zhang C, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study. Abstract presented at: European Hematology Association Hybrid Congress 2023; June 8-11, 2023; Frankfurt, Germany.

    • Data on file. AbbVie Inc. ABVRRTI76037.

      Data on file. AbbVie Inc. ABVRRTI76037.

    • Data on file. AbbVie Inc. ABVRRTI78947.

      Data on file. AbbVie Inc. ABVRRTI78947.

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 9, 2025. To view the most recent and complete version of the guidelines, go online to NCCN.org.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 9, 2025. To view the most recent and complete version of the guidelines, go online to NCCN.org.

    • Calquence Prescribing Information.

      Calquence Prescribing Information.

    • Brukinsa Prescribing Information.

      Brukinsa Prescribing Information.

    • Imbruvica Prescribing Information.

      Imbruvica Prescribing Information.

    • Greer JA, Amoyal N, Nisotel L, et al. A systematic review of adherence to oral antineoplastic therapies. Oncologist. 2016;21(3):354-376. doi:10.1634/theoncologist.2015-​0405

      Greer JA, Amoyal N, Nisotel L, et al. A systematic review of adherence to oral antineoplastic therapies. Oncologist. 2016;21(3):354-376. doi:10.1634/theoncologist.2015-​0405

    • Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009;59(1):56-66. doi:10.3322/caac.20004

      Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009;59(1):56-66. doi:10.3322/caac.20004

    • Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-​1120. doi:10.1056/NEJMoa1713976

      Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-​1120. doi:10.1056/NEJMoa1713976

    • Fischer K, Al-Sawaaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Eng J Med. 2019;380(23):2225-​2236. doi:10.1056/NEJMoa1815281

      Fischer K, Al-Sawaaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Eng J Med. 2019;380(23):2225-​2236. doi:10.1056/NEJMoa1815281

    • Data on file. AbbVie Inc. ABVRRTI76226.

      Data on file. AbbVie Inc. ABVRRTI76226.

    •  Data on file, AbbVie Inc.

       Data on file, AbbVie Inc.

    • Barr PM, Owen C, Robak T, et al. Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv. 2022;6(11):3440-​3450. doi:10.1182/bloodadvances.2021006434

      Barr PM, Owen C, Robak T, et al. Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv. 2022;6(11):3440-​3450. doi:10.1182/bloodadvances.2021006434

    • Shadman M, Munir T, Robak T, et al. Zanubrutinib versus bendamustine and rituximab in patients with treatment-naıve chronic lymphocytic leukemia/small lymphocytic lymphoma: median 5-year follow-up of SEQUOIA. J Clin Oncol. 2025;43(7):780-787. doi:10.1200/JCO-24-02265

      Shadman M, Munir T, Robak T, et al. Zanubrutinib versus bendamustine and rituximab in patients with treatment-naıve chronic lymphocytic leukemia/small lymphocytic lymphoma: median 5-year follow-up of SEQUOIA. J Clin Oncol. 2025;43(7):780-787. doi:10.1200/JCO-24-02265

    • Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naive chronic lymphocytic leukemia: 6-year follow-up of Elevate-TN. Blood. 2023;142(suppl 1):636-639. doi:10.1182/blood-2023-174750

      Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naive chronic lymphocytic leukemia: 6-year follow-up of Elevate-TN. Blood. 2023;142(suppl 1):636-639. doi:10.1182/blood-2023-174750

    • GAZYVA Prescribing Information.

      GAZYVA Prescribing Information.