Understand Coverage | IncyteCARES for ZYNYZ®
IncyteCARES and ZYNYZ® (retifanlimab-dlwr) logo linking back to the homepage.

IncyteCARES is a program for residents 
of the United States and Puerto Rico.

For Healthcare Professionals

When you have a new prescription or a new insurance plan, navigating the details of what’s covered can be stressful. A representative from our team can help walk you through it, so you can focus on taking care of yourself.

Here’s how we help eligible patients enrolled in IncyteCARES:

Step 1 of 3:

We receive your prescription and insurance information.

This information is included on your IncyteCARES program enrollment form. If you’re already enrolled in the program,  
you can call us directly to report any insurance changes and request help.

Step 2 of 3:

A team member will contact your insurance company.

We will:

  • Find out if your plan will cover ZYNYZ and how much you may need to pay out of pocket
  • Determine whether your insurer requires a prior authorization before approving coverage (Many plans require this!)

What is a prior authorization?

If your insurance company requires a prior authorization, it means they require your Healthcare Professional to send them more information about your health condition and why ZYNYZ has been prescribed. Based on the additional details, they will determine your coverage. Some insurers call this process precertification or prior approval. Many prescription drug insurers require prior authorization for ZYNYZ.

These steps usually take up to 3 business days to complete.

Step 3 of 3:

We call you to review the information for your insurer.

On this call, we can also explain any savings or financial assistance programs* that may be available to you.

  • We can coordinate with your infusion location to ensure that your ZYNYZ is ready and waiting when you arrive for your treatment, whether that is your doctor’s office, an infusion clinic, or hospital
  • You don’t need to take any action
  • We notify your Healthcare Professional of this requirement and what’s needed
  • Your Healthcare Professional will send the required information to your insurer
  • We monitor the process, and communicate as needed with your Healthcare Professional and insurance company, until a coverage decision is made
  • On our call with you, we’ll share information about the status of your prior authorization and estimated timing on when to expect a coverage decision. (It usually takes just a few days.) We can also share your estimated out-of-pocket costs for ZYNYZ

In most cases, your insurer will approve your coverage. Then, we can help with coordinating the delivery of your ZYNYZ.

  • Your insurer will notify you and your Healthcare Professional by mail with an explanation for the denial
  • We will provide information about how you and your Healthcare Professional can file an appeal on your behalf and have it reviewed by an independent third party as required by law
  • Once your Healthcare Professional submits the appeal, we will monitor the process, and communicate as needed with them and with your insurance company, until a final coverage decision is made
  • You don’t need to take any action. On our call with you, we’ll share information about the status of your appeal, and if available, estimated timing on when to expect a final decision from your insurer
  • Your insurer will notify both you and your Healthcare Professional by mail of their appeal decision
  • If the appeal is unsuccessful (coverage is denied), we can assess your eligibility for a financial assistance program*
  • If your appeal for coverage is approved, we can help with coordinating the delivery of your ZYNYZ
*Eligibility terms and conditions apply and may change at any time.
 
 
IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ZYNYZ?

ZYNYZ is a medicine that may treat certain types of cancers by working with your immune system. ZYNYZ can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your doctor right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, chest pain

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdomen) pain or tenderness

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal

WHAT IS ZYNYZ?

ZYNYZ is a prescription medicine used to treat adults with:

  • a type of anal cancer called squamous cell carcinoma of the anal canal (SCAC).
    • ZYNYZ may be used in combination with the chemotherapy medicines carboplatin and paclitaxel as your first treatment when your anal cancer:
      • has returned and cannot be removed by surgery, or
      • has spread.
    • ZYNYZ may be used alone when your anal cancer:
      • has returned or has spread and
      • you have received chemotherapy that contains platinum, and it did not work, is no longer working, or you could not tolerate it.
  • a type of skin cancer called Merkel cell carcinoma (MCC). ZYNYZ may be used alone to treat your skin cancer when it has spread or returned.

It is not known if ZYNYZ is safe and effective in children.

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, loss of appetite

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with ZYNYZ. Call or see your doctor right away for any new or worsening signs or symptoms, which may include:

  • chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
  • confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • persistent or severe muscle pain or weakness, muscle cramps
  • low red blood cells, bruising

Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain.

Rejection of a transplanted organ or tissue. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with ZYNYZ. Your doctor will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during your treatment with ZYNYZ. Your doctor may treat you with corticosteroid or hormone replacement medicines and may also need to delay or completely stop treatment with ZYNYZ if you have severe side effects.

Before you receive ZYNYZ, tell your doctor about all of your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ or tissue transplant, including corneal transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to your chest area
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. ZYNYZ can harm your unborn baby.
    Females who are able to become pregnant:
    • Your doctor should do a pregnancy test before you start treatment with ZYNYZ.
    • You should use an effective method of birth control during your treatment and for 4 months after your last dose of ZYNYZ. Talk to your doctor about birth control methods that you can use during this time.
    • Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with ZYNYZ.
  • are breastfeeding or plan to breastfeed. It is not known if ZYNYZ passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of ZYNYZ.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of ZYNYZ when given with the chemotherapy medicines carboplatin and paclitaxel in people with SCAC include tiredness; numbness, pain, tingling, or burning in your hands or feet; nausea; hair loss; diarrhea; muscle and bone pain; constipation; bleeding; rash; vomiting; decreased appetite; itching; stomach-area pain.

The most common side effects of ZYNYZ when used alone in people with SCAC include tiredness, muscle and bone pain, diarrhea, infection, rectal or genital-area pain, bleeding, urinary tract infection (UTI), rash, nausea, loss of appetite, constipation, stomach-area pain, shortness of breath, fever, vomiting, cough, itching, low levels of thyroid hormone, headache, decreased weight.

The most common side effects of ZYNYZ when used alone in people with MCC include muscle and bone pain, tiredness, itching, diarrhea, rash, fever, nausea, constipation.

These are not all the possible side effects of ZYNYZ. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ZYNYZ

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about ZYNYZ, talk with your doctor. You can ask your doctor for information about ZYNYZ that is written for health professionals.

Please see the Full Prescribing Information, including the Medication Guide, for ZYNYZ.