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 BioOncology Field Reimbursement Manager (BFRM) 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 is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy
  • This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial

Important Safety Information

Contraindication

  • Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during ramp-up phase is contraindicated

Tumor Lysis Syndrome

  • Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in previously treated CLL patients with high tumor burden treated with VENCLEXTA
  • VENCLEXTA poses a risk for TLS in the initial 5-week 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 antihyperuricemics. Reduced renal function (CrCl<80mL/min) 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 and P-gp inhibitors may increase the risk of TLS at initiation and during the ramp-up phase, and may require dose adjustment due to increases in VENCLEXTA exposure

Neutropenia

  • Grade 3 or 4 neutropenia occurred in 41% (98/240) of patients treated with VENCLEXTA. Monitor complete blood counts throughout treatment. Interrupt dosing or reduce dose for severe neutropenia

Immunization

  • Do not administer live attenuated vaccines prior to, during, or after treatment with VENCLEXTA until B-cell recovery

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

  • Serious adverse reactions were reported in 43.8% of patients. The most frequent serious adverse reactions (≥2%) were pneumonia, febrile neutropenia, pyrexia, autoimmune hemolytic anemia, anemia, and TLS
  • The most common adverse reactions (≥20%) of any grade were neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue

Drug Interactions

For patients who have completed the ramp-up phase and are on a steady daily dose of VENCLEXTA, reduce the dose by at least 75% when used concomitantly with strong CYP3A inhibitors.

  • Avoid concomitant use of moderate CYP3A inhibitors or P-gp inhibitors. If an inhibitor must be used, reduce the VENCLEXTA dose by at least 50%
  • 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 narrow therapeutic index P-gp substrates. If these substrates must be used, they should be taken at least 6 hours before VENCLEXTA
  • Monitor international normalized ratio (INR) closely in patients receiving warfarin