COTELLIC and ZELBORAF Coverage

Benefits Investigations

Genentech BioOncology® Access Solutions for COTELLIC and ZELBORAF can conduct a benefits investigation (BI) to help you determine if a Genentech medicine is covered, if prior authorizations (PAs) are required, which specialty pharmacy (SP) the health insurance plan prefers and if patient assistance might be needed.

Potential outcomes of a BI:

  • Treatment is covered
  • PA is required
  • Treatment is denied

A BI may be initiated once the Prescriber Service Form and PAN are submitted to Genentech BioOncology Access Solutions.

These can be downloaded from Forms and Documents or submitted online via My Patient Solutions.

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.

Prior Authorization

Genentech BioOncology® Access Solutions for COTELLIC and ZELBORAF can help you identify if a prior authorization (PA) is necessary and offer resources as you obtain it for your patient. PA support may be provided once the Prescriber Service Form and PAN are submitted to Genentech BioOncology Access Solutions.

If your patient’s request for a PA is not granted, your BioOncology Field Reimbursement Manager (BFRM) or Genentech BioOncology Access Solutions Specialist can work with you to determine your next steps. You can find more tips like this in Forms and Documents

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

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.