VENCLEXTA Coverage

Benefits Investigations

VENCLEXTA Access Solutions can conduct a benefits investigation (BI) to help you determine if VENCLEXTA is covered, if prior authorizations (PAs) are required, which specialty pharmacy (SP) the health insurance plan prefers and if patient assistance might be needed.

Potential outcomes of a BI:

  • Treatment is covered
  • PA is required
  • Treatment is denied

A BI may be initiated once the SMN and PAN are submitted to VENCLEXTA Access Solutions.

These can be downloaded from Forms and Documents.

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. VENCLEXTA Access Solutions makes no representation or guarantee concerning coverage or reimbursement for any service or item.

Prior Authorization

VENCLEXTA Access Solutions can help you identify if a prior authorization (PA) is necessary and offer resources as you obtain it for your patient. PA support may be provided once the SMN and PAN are submitted to VENCLEXTA Access Solutions.

If your patient’s request for a PA is not granted, your VENCLEXTA Field Reimbursement Manager (FRM) or VENCLEXTA Access Solutions Specialist can work with you to determine your next steps. You can find more tips like this in Forms and Documents.

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. VENCLEXTA Access Solutions makes no representation or guarantee concerning coverage or reimbursement for any service or item.

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

SMN=Statement of Medical Necessity.

Important Safety Information & Indication

Indication

VENCLEXTA® (venetoclax tablets) is indicated:

  • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
  • In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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 with high tumor burden when treated with VENCLEXTA. 
  • In patients with CLL, with the current (5 week) dose ramp-up, TLS prophylaxis and monitoring, the rate of TLS was 2% in the VENCLEXTA CLL monotherapy studies. The rate of TLS remained consistent with VENCLEXTA in combination with 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.
  • VENCLEXTA poses a risk for TLS at initiation and during the ramp-up phase. 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.
  • Patients should be assessed for TLS risk, including evaluation of tumor burden and comorbidities, and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricemics. Reduced renal function further increases the risk. Monitor blood chemistries and manage abnormalities promptly. Interrupt dosing if needed. Employ more intensive measures (IV hydration, frequent monitoring, hospitalization) as overall risk increases.
  • Concomitant use of VENCLEXTA with strong or moderate CYP3A inhibitors or P-gp inhibitors may increase the risk of TLS at initiation and during the ramp-up phase, and requires dose adjustment due to increases in VENCLEXTA exposure.

Neutropenia

  • In patients with CLL, Grade 3 or 4 neutropenia developed in 64% of patients and Grade 4 neutropenia developed in 31% of patients treated with VENCLEXTA in combination with rituximab. Grade 3 or 4 neutropenia developed in 63% of patients and Grade 4 neutropenia developed in 33% of patients treated with VENCLEXTA monotherapy. Febrile neutropenia occurred in 4% of patients treated with VENCLEXTA in combination with rituximab and in 6% of patients treated with VENCLEXTA monotherapy.
  • In patients with AML, baseline neutrophil counts worsened in 97% to 100% of patients treated with VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine. Neutropenia can recur with subsequent cycles of therapy.
  • Monitor complete blood counts throughout the treatment period. Interrupt dosing or reduce dose for severe neutropenia. Consider supportive measures including antimicrobials for signs of infection and use of growth factors (e.g., G-CSF).

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 avoid pregnancy during treatment. 

Adverse Reactions

  • 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%), cough (22%), and nausea (21%).
  • 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%).
  • In patients with AML receiving combination therapy with azacitidine, the most frequent serious adverse reactions (≥5%) were febrile neutropenia, pneumonia (excluding fungal), sepsis (excluding fungal), respiratory failure, and multiple organ dysfunction syndrome. The most common adverse reactions (≥30%) of any grade were nausea (58%), diarrhea (54%), constipation (49%), neutropenia (49%), thrombocytopenia (49%), hemorrhage (46%), peripheral edema (46%), vomiting (40%), fatigue (36%), febrile neutropenia (36%), rash (33%), and anemia (30%).
  • In patients with AML receiving combination therapy with decitabine, the most frequent serious adverse reactions (≥5%) were febrile neutropenia, sepsis (excluding fungal), pneumonia (excluding fungal), diarrhea, fatigue, cellulitis, and localized infection. The most common adverse reactions (≥30%) of any grade were febrile neutropenia (69%), constipation (62%), fatigue (62%), thrombocytopenia (54%), abdominal pain (46%), dizziness (46%), hemorrhage (46%), nausea (46%), pneumonia (excluding fungal) (46%), sepsis (excluding fungal) (46%), cough (38%), diarrhea (38%), neutropenia (38%), back pain (31%), hypotension (31%), myalgia (31%), oropharyngeal pain (31%), peripheral edema (31%), pyrexia (31%), and rash (31%).
  • In patients with AML receiving combination therapy with low-dose cytarabine, the most frequent serious adverse reactions (≥5%) were febrile neutropenia, sepsis (excluding fungal), hemorrhage, pneumonia (excluding fungal), and device-related infection. The most common adverse reactions (≥30%) of any grade were nausea (64%), thrombocytopenia (59%), hemorrhage (49%), febrile neutropenia (46%), neutropenia (46%), diarrhea (44%), fatigue (44%), constipation (33%), and dyspnea (31%).

Drug Interactions 

  • Concomitant use with a strong or moderate CYP3A inhibitor or a P-gp inhibitor increases VENCLEXTA exposure, which may increase VENCLEXTA toxicities, including the risk of TLS. Adjust VENCLEXTA dosage and closely monitor patients for signs of VENCLEXTA toxicities. Resume the VENCLEXTA dosage that was used prior to concomitant use of a strong or moderate CYP3A inhibitor or a P-gp 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.
  • 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. 
  • Monitor international normalized ratio (INR) closely in patients receiving warfarin.

Lactation

  • Advise nursing women to discontinue breastfeeding during treatment with VENCLEXTA.

Females and Males of Reproductive Potential

  • Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for at least 30 days after the last dose.
  • Based on findings in animals, male fertility may be compromised by treatment with VENCLEXTA.

For additional safety information, please see the full Prescribing Information and Medication Guide.