Reimbursement

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
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  
50242-717-01 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.

Appeals

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:

  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 Genentech BioOncology 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

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
  • Hepatotoxicity
  • Rhabdomyolysis
  • Severe photosensitivity
  • Embryo-fetal toxicity

USE IN SPECIFIC POPULATIONS: Lactation

Do not breastfeed while taking COTELLIC and for 2 weeks after the final dose.

DRUG INTERACTIONS

Avoid concomitant administration of COTELLIC with strong or moderate CYP3A inducers or inhibitors.

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.

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