VENCLEXTA Sample Coding
This coding information may assist you as you complete the payer forms for VENCLEXTA. These tables are provided for informational purposes only. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding for single-use vials and wastage.
Chronic Lymphocytic Leukemia
|Diagnosis: ICD-10-CM||C91.10||Chronic lymphocytic leukemia of B-cell
type not having achieved remission |
|C91.12||Chronic lymphocytic leukemia of B-cell type in relapse|
|Drug: NDC |
Note: Payer requirements regarding use of a 10-digit or 11-digit NDC may vary. Both formats are listed here for your reference.
|0074-0579-28||00074-0579-28||Starting pack (contains 4 weekly wallet blister packs)|
|0074-0561-14||00074-0561-14||10 mg wallet (14 x 10 mg tablets)|
|0074-0566-07||00074-0566-07||50 mg wallet (7 x 50 mg tablets)|
|0074-0576-22||00074-0576-22||100 mg bottle (120 x 100 mg tablets)|
|0074-0561-11||00074-0561-11||10 mg unit dose (2 x 10 mg tablets)|
|0074-0566-11||00074-0566-11||50 mg unit dose (1 x 50 mg tablet)|
|0074-0576-11||00074-0576-11||100 mg unit dose (1 x 100 mg tablet)|
ICD-10-CM=International Classification of
Diseases, 10th Revision, Clinical Modification.
NDC=National Drug Code.
These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. VENCLEXTA Access Solutions does not make any representation or guarantee concerning reimbursement or coverage for any service or item.
Many payers will not accept unspecified codes. If you use an unspecified code, please check with your payer.
If your patient’s health insurance plan has issued a denial, your BioOncology Field Reimbursement Manager (BFRM) or VENCLEXTA Access Solutions Specialist can provide resources as you prepare an appeal submission, as per your patient’s plan requirements.
If a plan issues a denial:
- The denial should be reviewed, along with the health insurance
plan’s guidelines to determine what to include in your patient’s
- Your BFRM or Genentech
BioOncology® Access Solutions Specialist has local payer coverage
expertise and can help you determine specific requirements for your
A sample appeal letter, checklist and additional tips are available in Forms and Documents.
Appeals cannot be completed or submitted by VENCLEXTA Access Solutions on your behalf.
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
- 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
- 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
- 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
- Do not administer live attenuated vaccines prior to, during, or after treatment with VENCLEXTA until B-cell recovery
- VENCLEXTA may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during treatment
- 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
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