Reimbursement

ZELBORAF Sample Coding

This coding information may assist you as you complete the payer forms for ZELBORAF. 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 C43.0*—C43.9 Malignant melanoma of skin, by site
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  
50242-090-02 50242-0090-02 240 mg (112 film-coated tablets)

ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification.
NDC=National Drug Code.

TYPE CODE DESCRIPTION
Diagnosis: ICD-10-CM E88.89
Other specified metabolic disorders
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  
50242-090-02 50242-0090-02 240 mg (112 film-coated tablets)

 

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. Genentech 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.

*This range of codes does not include melanoma in situ (D03.-), malignant melanoma of the skin of genital organs (C51–52, C60.-, C63.2), Merkel cell carcinoma (C4A.-), vermillion border of the lip (C00.0–C00.2), malignant neoplasm of the anus (C21.0), malignant neoplasm of scrotum (C63.2); plus, for melanoma of sites other than the skin (not previously specified), code to the malignant neoplasm of that site.

Appeals

If your patient’s health insurance plan has issued a denial, your BioOncology Field Reimbursement Manager (BFRM) or ZELBORAF 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 ZELBORAF Access Solutions Specialist has local payer coverage expertise and can help you determine specific requirements for your patient.

A sample appeal letter and additional considerations for appeals are available in Forms and Documents.

Appeals cannot be completed or submitted by ZELBORAF Access Solutions on your behalf.

Important Safety Information & Indication

Indication

Unresectable or Metastatic Melanoma

ZELBORAF® (vemurafenib) is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma.

Erdheim-Chester Disease

ZELBORAF® is indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.

Important Safety Information

WARNINGS AND PRECAUTIONS

The following can occur in patients treated with ZELBORAF:

  • New primary malignancies including cutaneous squamous cell carcinoma, noncutaneous squamous cell carcinoma, new primary melanoma, and other malignancies
  • Tumor promotion in BRAF wild-type melanomas
  • Serious hypersensitivity reactions including anaphylaxis
  • Severe dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
  • QT prolongation
  • Hepatotoxicity including liver injury leading to functional hepatic impairment (including coagulopathy or other organ dysfunction); increases in transaminases and bilirubin when concurrently administered with ipilimumab
  • Photosensitivity
  • Ophthalmologic reactions
  • Embryo-fetal toxicity
  • Radiation sensitization and radiation recall, including fatal cases in patients with visceral involvement
  • Renal failure, including acute interstitial nephritis and acute tubular necrosis
  • Dupuytren’s contracture and plantar fascial fibromatosis

DRUG INTERACTIONS

Avoid concurrent use of ZELBORAF with strong CYP3A4 inhibitors, strong CYP3A4 inducers, and CYP1A2 and P-glycoprotein substrates with a narrow therapeutic window.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed while taking ZELBORAF and for 2 weeks after the final dose.

Most Common Adverse Reactions

The most common adverse reactions of any grade (≥30%) reported were arthralgia (53%), rash (37%), alopecia (45%), fatigue (38%), photosensitivity reaction (33%), nausea (35%), pruritus (23%), and skin papilloma (21%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying Full Prescribing Information for additional Important Safety Information.