Exelixis Access Services

Access. Assistance. Along the Journey.

Exelixis Access Services® (EASE) provides a variety of support to help your patients get started on treatment as soon as possible. EASE can help meet the unique needs of your patients and practice at each step along the access journey.

HELP YOUR PATIENTS GET STARTED ON CABOMETYX® (cabozantinib)

Your EASE Case Manager

Case Manager

EASE offers regionally dedicated Case Managers as a single point of contact.

  • Can provide the status of your patient's access journey
  • Offers prompt support with payer coverage, financial assistance, and treatment coordination
  • Provides proactive follow-up
Get to know your EASE Case Manager
Call for EASE Support
CALL: 1-844-900-EASE
(1-844-900-3273)
Monday to Friday, 8:00 AM to 8:00 PM ET

EASE PATIENT AUTHORIZATION FORM (PAF)

EASE will confirm your patient's eligibility for requested services.

Option 1: Download the Exelixis Access Services (EASE) Enrollment Form

Complete and submit the EASE enrollment form to the right of this page.

Option 2: Enroll through CoverMyMeds

Cover My Meds

EASE will confirm your patient's eligibility for requested services. Click on the link to the right to access the online tool.

To Enroll Your Patients in EASE Services, Please Complete the Patient Authorization Form (PAF)

Patients can complete and sign the PAF in one of two ways:

computer

Complete online form and
e-submit by clicking here

OR

printer

Click here to download, then
print and fax completed form to
1-844-901-EASE (1-844-901-3273)


California residents: Click here for important disclosures.

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Exelixis Access Services (EASE) Enrollment, including 15-Day Free Trial, Quick Start, and Patient Assistance Program (PAP)

Download the form
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15-Day Free Trial Only (No other EASE services)

Download the form

Enroll your patients in EASE through CoverMyMeds

Get Started Now

PROGRAMS TO HELP PATIENTS START AND STAY ON CABOMETYX

15 Day Free Trial Program
15-Day Free Trial Program

Provides free drug to help patients start treatment quickly.*

CABOMETYX Quick Start Program
CABOMETYX Quick Start Program*

Provides free drug to eligible patients who experience a payer decision delay of 5 days or more.*

CABOMETYX EASE Copay Program
EASE $0 Co-Pay Program

Eligible commercially insured patients pay $0 per month, for a maximum benefit of $25,000 per year.

EASE Dose Exchange Program
Dose Exchange Program

Provides a free 15-tablet supply in the lower dose to help patients who require a dose reduction.

EASE Patient Assistance Program
EASE Patient Assistance Program (PAP)

Eligible patients who cannot afford their drug costs may receive CABOMETYX free of charge.

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$0 Co-Pay Program

Enroll eligible patients
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Dose Exchange Form

Download the form

SUPPORT FOR COVERAGE DETERMINATION

At your request, EASE can provide support with:

EASE Support Coverage
  • Benefits investigation
  • Prior authorization (PA) assistance
  • Appeals support and follow-up

*Limited to on-label indications. Additional restrictions and eligibility rules apply.Additional restrictions and eligibility rules apply.

This description of the Exelixis Access Services® (EASE) program is for informational purposes only. Exelixis* makes no representation or guarantee concerning reimbursement or coverage for any service or item. Information provided through the Exelixis Access Services program does not constitute medical or legal advice and is not intended to be a substitute for a consultation with a licensed healthcare provider, legal counsel, or applicable third-party payer(s). Exelixis reserves the right to modify the program at any time without notice.

CoverMyMeds is a registered trademark of CoverMyMeds LLC.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) support the use of cabozantinib (CABOMETYX) in the treatment of both aRCC and HCC

National Comprehensive Cancer Network® (NCCN®)

Kidney
FIRST- AND SECOND-LINE CLEAR CELL aRCC RECOMMENDATIONS

Cabozantinib (CABOMETYX) is THE ONLY NCCN "PREFERRED" SINGLE-AGENT TKI OPTION for 1L intermediate/poor risk clear cell aRCC1

Cabozantinib (CABOMETYX) is THE ONLY NCCN "PREFERRED" SINGLE-AGENT TKI OPTION for 2L clear cell aRCC1

As defined by the NCCN Guidelines®, preferred interventions are based on superior efficacy, safety, and evidence; and when appropriate, affordability.

 
Liver
SECOND-LINE HCC RECOMMENDATION

NCCN Category 1Following disease progression on first-line systemic treatment
Cabozantinib (CABOMETYX) is RECOMMENDED AS A CATEGORY 1, SUBSEQUENT-LINE TREATMENT OPTION for HCC (Child-Pugh A)2*

*Data reflect use after sorafenib. Lenvatinib is recommended by the NCCN as a first-line systemic therapy option, but there are no data to define optimal treatment for those who progress on lenvatinib.2Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 1L=first-line; 2L=second-line; aRCC=advanced renal cell carcinoma; HCC=hepatocellular carcinoma; TKI=tyrosine kinase inhibitor.

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INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

CABOMETYX® (cabozantinib) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced RCC.

CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Hepatotoxicity: CABOMETYX in combination with nivolumab can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone.

Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes than when the drugs are administered as single agents. For elevated liver enzymes, interrupt CABOMETYX and nivolumab and consider administering corticosteroids.

With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. ALT or AST >3 times ULN (Grade ≥2) was reported in 83 patients, of whom 23 (28%) received systemic corticosteroids; ALT or AST resolved to Grades 0-1 in 74 (89%). Among the 44 patients with Grade ≥2 increased ALT or AST who were rechallenged with either CABOMETYX (n=9) or nivolumab (n=11) as a single agent or with both (n=24), recurrence of Grade ≥2 increased ALT or AST was observed in 2 patients receiving CABOMETYX, 2 patients receiving nivolumab, and 7 patients receiving both CABOMETYX and nivolumab.

Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold CABOMETYX and/or nivolumab depending on severity.

Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of CABOMETYX and nivolumab in 0.9% and withholding of CABOMETYX and nivolumab in 2.8% of patients with RCC.

Approximately 80% (12/15) of patients with adrenal insufficiency received hormone replacement therapy, including systemic corticosteroids. Adrenal insufficiency resolved in 27% (n=4) of the 15 patients. Of the 9 patients in whom CABOMETYX with nivolumab was withheld for adrenal insufficiency, 6 reinstated treatment after symptom improvement; of these, all (n=6) received hormone replacement therapy and 2 had recurrence of adrenal insufficiency.

Proteinuria: Proteinuria was observed in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions are:

CABOMETYX as a single agent: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation, and dysphonia.

CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

1L=first-line; ALT=alanine aminotransferase; AR=adverse reaction; AST=aspartate aminotransferase; aRCC=advanced renal cell carcinoma; BICR=blinded independent central review; CI=confidence interval; CR=complete response; HCC=hepatocellular carcinoma; HR=hazard ratio; IMDC=International Metastatic RCC Database Consortium; ITT=intent to treat; IV=intravenous; NR=not reached; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PO=by mouth; PPE=palmar-plantar erythrodysesthesia; PR=partial response; RTI=respiratory tract infection.

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.2.2020. ©National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed August 14, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers V.3.2019. ©National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed August 14, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.