Reimbursement

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.

You can generate a PDF of these coding tables by selecting either the "Download All" or the "Download Section" button:

  • "Download All" lets you download or print a coding table for all indications
  • "Download Section" lets you download or print a coding table for a specific indication
TYPE CODE DESCRIPTION
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.
10-digit 11-digit  
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.

TYPE CODE DESCRIPTION
Diagnosis: ICD-10-CM C83.00
Small cell B-cell lymphoma, unspecified site
C83.01
Small cell B-cell lymphoma, lymph nodes of head, face, and neck
C83.02
Small cell B-cell lymphoma, intrathoracic lymph nodes
C83.03
Small cell B-cell lymphoma, intra-abdominal lymph nodes
C83.04
Small cell B-cell lymphoma, lymph nodes of axilla and upper limb
C83.05
Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb
C83.06
Small cell B-cell lymphoma, intrapelvic lymph nodes
C83.07
Small cell B-cell lymphoma, spleen
C83.08 Small cell B-cell lymphoma, lymph nodes of multiple sites
C83.09 Small cell B-cell lymphoma, extranodal and solid organ sites
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.
10-digit 11-digit  
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.

Appeals

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:

  1. The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
  2. Your BFRM or Genentech BioOncology® Access Solutions Specialist has local payer coverage expertise and can help you determine specific requirements for your patient.

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

Indication and Important Safety Information

Indication

  • VENCLEXTA® (venetoclax tablets) is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

Important Safety Information

Contraindication 

  • Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during ramp-up phase is contraindicated 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 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 anti-hyperuricemics. Reduced renal function (CrCl <80 mL/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 developed in 64% (124/194) of patients treated with VENCLEXTA in combination with rituximab and in 63% (216/344) 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. Monitor complete blood counts throughout treatment. 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. 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 combination with rituximab, serious adverse reactions were reported in 46% of patients, with the most frequent (≥5%) being 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%).
  • As monotherapy, serious adverse reactions were reported in 52% of patients, with the most frequent (≥5%) being 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%).

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. Resume the VENCLEXTA dose that was used prior to initiating the CYP3A inhibitor 2 to 3 days after discontinuation of the inhibitor.
  • 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%. Monitor patients more closely for signs of VENCLEXTA toxicities. Resume the VENCLEXTA dose that was used prior to initiating the CYP3A inhibitor or 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 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. 

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.