COTELLIC and ZELBORAF Sample Coding
This coding information may assist you as you complete the payer forms for COTELLIC and 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
|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.
|50242-717-01||50242-0717-01||20 mg (63 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.
If your patient’s health insurance plan has issued a denial, your BioOncology Field Reimbursement Manager (BFRM) or Genentech BioOncology® Access Solutions for COTELLIC and ZELBORAF 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 and additional considerations for appeals are available in Forms and Documents.
Appeals cannot be completed or submitted by Genentech BioOncology
Access Solutions on your behalf.
Important Safety Information & Indication
Indications and Usage
COTELLIC (cobimetinib) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with ZELBORAF (vemurafenib).
Important Safety Information
WARNINGS AND PRECAUTIONS
Review the Full Prescribing Information for ZELBORAF for information on the serious risks of ZELBORAF.
The following can occur in patients treated with COTELLIC:
- New primary malignancies, including cutaneous and non-cutaneous malignancies
- Hemorrhage, including major hemorrhages
- Cardiomyopathy, defined as symptomatic and asymptomatic decline in left ventricular ejection fraction
- Severe dermatologic reactions, including rash and other skin reactions
- Serous retinopathy and retinal vein occlusion
- Severe photosensitivity
- Embryo-fetal toxicity
The following can occur in patients treated with ZELBORAF:
- New primary malignancies including cutaneous squamous cell carcinoma, non-cutaneous 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
- Ophthalmologic reactions, including uveitis, blurry vision, and photophobia
- 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
USE IN SPECIFIC POPULATIONS: Lactation
Advise women not to breastfeed during treatment with COTELLIC and ZELBORAF and for 2 weeks after the final dose of COTELLIC or ZELBORAF (whichever is taken later).
- Avoid concomitant administration of COTELLIC with strong or moderate CYP3A inducers or inhibitors.
- Avoid concurrent use of ZELBORAF with strong CYP3A4 inhibitors, strong CYP3A4 inducers, and CYP1A2 and P-glycoprotein substrates with narrow therapeutic windows.
Most Common Adverse Reactions
The most common (≥20%) adverse reactions with COTELLIC were diarrhea (60%), photosensitivity reaction (46%), nausea (41%), pyrexia (28%), and vomiting (24%). The most common (≥5%) Grade 3-4 laboratory abnormalities were increased GGT (21%), increased CPK (14%), hypophosphatemia (12%), increased ALT (11%), lymphopenia (10%), increased AST (8%), increased alkaline phosphatase (7%), and hyponatremia (6%).
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.