ACCESSING LENVIMA® (lenvatinib)
HAVE QUESTIONS ABOUT YOUR INSURANCE COVERAGE?
LENVIMA may be covered by commercial insurance companies, Medicare, and Medicaid. Coverage may vary significantly by insurance company, specific health insurance plan, and patient. Insurance companies can base coverage decisions on formal policies or make decisions on a case-by-case basis. Ask your pharmacist or insurance company whether your insurance will cover LENVIMA.
TYPES OF INSURANCE
Commercial insurance is provided by nongovernment health plans such as health maintenance organizations (HMOs) and preferred provider organizations (PPOs). Many people purchase commercial health insurance through their employer’s health plan, or you can purchase an individual policy directly from commercial insurance providers. The exact coverage you receive depends on the specific policy that you purchase.
Several plans may provide coverage for LENVIMA. Contact your pharmacist or insurance company to find out if you will have coverage for LENVIMA.
Commercially insured patients may be eligible for the LENVIMA Co-Pay Program.
Medicare is a federal health insurance program for people who are 65 years or older, certain younger people with disabilities, and people with end-stage renal disease. Part D covers prescription drugs that you get at a pharmacy and take at home, including LENVIMA. Your healthcare provider will be able to help you understand how Medicare may cover LENVIMA.
Medicaid is a joint federal and state program that helps with medical costs for some people with limited income and resources. Each state sets its own coverage and eligibility rules for Medicaid programs. However, coverage and patient out-of-pocket costs vary from state to state. Your healthcare provider will be able to help you understand how your state Medicaid plan may cover LENVIMA.
Insurance plans are not affiliated with or offered by Eisai.
DETERMINING YOUR COVERAGEIf you are planning to see your doctor to determine if LENVIMA is right for you, or if you have recently received a prescription for LENVIMA, you may want to investigate your health insurance coverage for this type of drug prior to visiting the pharmacy.
Before speaking with your insurance company, be sure to have your policy number or employer’s plan number handy. When speaking with the claims representative, here are some important questions to ask:
- Is prior authorization required for LENVIMA?
- Are there any cancer treatments I’m required to have tried prior to authorizing coverage of LENVIMA?
- Will you require any documentation of treatments that I’ve tried but failed?
- If approved, what is the patient out-of-pocket cost for the drug?
WHAT CAN YOU DO IF YOU RECEIVE A DENIAL OF COVERAGE?
“PRIOR AUTHORIZATION REQUIRED” CATEGORIZATION
Prior authorization is a requirement for your physician to obtain approval from your health insurance plan prior to prescribing LENVIMA. Speak to your healthcare provider for additional resources to address any prior authorization requirements.
“STEP THERAPY” CATEGORIZATION
Your insurer may ask if you have tried and failed another cancer therapy before approving coverage for LENVIMA. In this case, it is important to include documentation of any previous treatments in your appeal letter. Ask your healthcare provider about documentation needs to address step therapy requirements.
APPEALING A DENIAL
If you called your insurance company and were told that LENVIMA is not covered under your plan, or if you tried to fill a prescription for LENVIMA and learned that the drug is not covered, this is called a denial of coverage or denial of claim. You may have the right to appeal this decision and request a detailed explanation in writing as to why you were denied.
WHERE TO GET LENVIMA
LENVIMA® is available through the following authorized Specialty Pharmacies that will mail the medication directly to you. If your medicine is being supplied by a Specialty Pharmacy, your health care team will tell you which one. It is important to know the name of your specialty pharmacy and to respond promptly to their phone calls and communications.
ACCESSING LENVIMA THROUGH PHYSICIAN OFFICES, CLINICS, OR HOSPITAL PHARMACIES
You can also obtain LENVIMA directly from select eligible physician offices, clinics, or hospital pharmacies. For more information about how you will receive LENVIMA, please contact your doctor.
Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. For additional information, customers should consult with their payers for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.
What is LENVIMA?
LENVIMA is a prescription medicine that is used to treat certain kinds of cancer.
LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing
LENVIMA is used to treat adults with a type of kidney cancer called advanced renal cell carcinoma (RCC), along with the medicine everolimus after one course of treatment with another anti-cancer medicine
- LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery
It is not known if LENVIMA is safe and effective in children.
IMPORTANT SAFETY INFORMATIONLENVIMA may cause serious side effects, including:
high blood pressure (hypertension): High blood pressure is a common side effect of LENVIMA and can be serious. Your blood pressure should be well controlled before you start taking LENVIMA. Your healthcare provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure
heart problems: LENVIMA can cause serious heart problems that may lead to death. Call your healthcare provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles
problem with blood clots in your blood vessels (arteries): Get emergency medical help right away if you get any of the following symptoms: severe chest pain or pressure; pain in your arms, back, neck, or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; sudden severe headache; sudden vision changes
liver problems: LENVIMA may cause liver problems that may lead to liver failure and death. Your healthcare provider will check your liver function before and during treatment with LENVIMA. Tell your healthcare provider right away if you have any of the following symptoms: your skin or the white part of your eyes turns yellow (jaundice); dark “tea-colored” urine; light-colored bowel movements (stools); feeling drowsy, confused or loss of consciousness
kidney problems: Kidney failure, which can lead to death, has happened with LENVIMA treatment. Your healthcare provider should do regular blood tests to check your kidneys
increased protein in your urine (proteinuria): Proteinuria is a common side effect of LENVIMA and can be serious. Your healthcare provider should check your urine for protein before and during your treatment with LENVIMA
diarrhea: Diarrhea is a common side effect of LENVIMA and can be serious. If you get diarrhea, ask your healthcare provider about what medicines you can take to treat your diarrhea. It is important to drink more water when you get diarrhea. Tell your healthcare provider or go to the emergency room, if you are unable to drink enough liquids and your diarrhea is not able to be controlled
an opening in the wall of your stomach or intestines (perforation) or an abnormal connection between two or more body parts (fistula): Get emergency medical help right away if you have severe stomach (abdomen) pain
changes in the electrical activity of your heart called QT prolongation: QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider will do blood tests before and during your treatment with LENVIMA to check the levels of potassium, magnesium, and calcium in your blood, and may check the electrical activity of your heart with an ECG
low levels of blood calcium (hypocalcemia): Your healthcare provider will check your blood calcium levels during treatment with LENVIMA and may tell you to take a calcium supplement if your calcium levels are low
a condition called Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Call your healthcare provider right away if you get severe headache, seizures, weakness, confusion, or blindness or change in vision
bleeding: LENVIMA may cause serious bleeding problems that may lead to death. Tell your healthcare provider if you have any signs or symptoms of bleeding during treatment with LENVIMA, including severe and persistent nose bleeds; vomiting blood; red or black (looks like tar) stools; blood in your urine; coughing up blood or blood clots; heavy or new onset vaginal bleeding
change in thyroid hormone levels: Your healthcare provider should check your thyroid hormone levels before starting and every month during treatment with LENVIMA
wound healing problems: Wound healing problems have happened in some people who take LENVIMA. Tell your healthcare provider if you plan to have any surgery before or during treatment with LENVIMA.
You should stop taking LENVIMA at least 1 week before planned surgery
Your healthcare provider should tell you when you may start taking LENVIMA again after surgery
severe jaw bone problems (osteonecrosis): Severe jaw bone problems have happened in some people who take LENVIMA. Certain risk factors such as taking a bisphosphonate medicine or the medicine denosumab, having dental disease, or an invasive dental procedure may increase your risk of getting jaw bone problems. Your healthcare provider should examine your mouth before you start and during treatment with LENVIMA. Tell your dentist that you are taking LENVIMA. It is important for you to practice good mouth care during treatment with LENVIMA. Tell your healthcare provider right away if you have any signs or symptoms of jaw bone problems during treatment with LENVIMA, including jaw pain, toothache, or sores on your gums and if you plan to have any dental procedures before or during treatment with LENVIMA.
You should stop taking LENVIMA at least 1 week before planned dental surgery or invasive dental procedures
Your healthcare provider should tell you when you may start taking LENVIMA again after dental procedures
The most common side effects of LENVIMA in people treated for thyroid cancer include tiredness, joint and muscle pain, decreased appetite, weight loss, nausea, mouth sores, headache, vomiting, rash, redness, itching, or peeling of your skin on your hands and feet, stomach (abdomen) pain, and hoarseness.
The most common side effects of LENVIMA when given with everolimus in people treated for kidney cancer include tiredness, joint and muscle pain, decreased appetite, vomiting, nausea, mouth sores, swelling in your arms and legs, cough, stomach (abdomen) pain, trouble breathing, rash, weight loss, and bleeding.
The most common side effects of LENVIMA in people treated for liver cancer include tiredness, decreased appetite, joint and muscle pain, weight loss, stomach (abdomen) pain, rash, redness, itching, or peeling of your skin on your hands and feet, hoarseness, bleeding, change in thyroid hormone levels, and nausea.
LENVIMA may cause fertility problems in males and females and can harm your unborn baby.
Tell your healthcare provider if you are:
Your healthcare provider may need to reduce your dose of LENVIMA, or delay or completely stop treatment if you have certain side effects.
These are not all the possible side effects of LENVIMA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.For more information about LENVIMA, please see full Prescribing Information.