Understand Coverage | IncyteCARES for Niktimvo™ Skip to main content

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

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 Niktimvo 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 Niktimvo 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 Niktimvo.

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 transplant center to ensure that your Niktimvo is ready and waiting when you arrive for your infusion
  • 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 Niktimvo
  • In most cases, your insurer will approve your coverage. Then, we can help with coordinating the delivery of your Niktimvo
  • 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 Niktimvo
*Eligibility terms and conditions apply and may change at any time.
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INDICATIONS AND USAGE

Niktimvo™ (axatilimab-csfr) is a prescription medicine used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (cGVHD) after receiving at least 2 prior treatments (systemic therapy) and they did not work.

It is not known if Niktimvo is safe and effective in adults and children weighing less than 88.2 pounds (40 kg).

IMPORTANT SAFETY INFORMATION

What are the possible side effects of Niktimvo™ (axatilimab-csfr)?

Niktimvo may cause serious side effects, including:

Infusion-related reactions. Infusion-related reactions are common with Niktimvo and can be serious. Your healthcare provider will monitor you for infusion-related reactions during your treatment. If you have a reaction, your healthcare provider may temporarily or completely stop your treatment with Niktimvo. Tell your healthcare provider right away if you have fever, chills, rash, flushing, shortness of breath, trouble breathing, nausea, vomiting, or symptoms of high blood pressure such as chest pain, headaches, or blurred vision during an infusion of Niktimvo.

The most common side effects of Niktimvo include:

  • infections
  • increased blood level of liver enzymes
  • decreased blood level of phosphate
  • low red blood cell count (anemia)
  • muscle, bone, or joint pain
  • increased blood level of pancreatic enzymes
  • low energy
  • increased blood level of calcium
  • increased blood level of a muscle enzyme
  • increased blood level of a bone enzyme
  • nausea
  • headache
  • diarrhea
  • cough
  • fever
  • shortness of breath

These are not all the possible side effects of Niktimvo. Call your doctor for medical advice about side effects.

Before receiving Niktimvo, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had liver problems.
  • are pregnant or plan to become pregnant. Niktimvo may harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Niktimvo.
    • You should use an effective method of birth control during your treatment and for 30 days after your last dose of Niktimvo. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Niktimvo.
  • are breastfeeding or plan to breastfeed. It is not known if Niktimvo passes into your breast milk. Do not breastfeed during treatment and for 30 days after your last dose of Niktimvo.

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

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.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.

Expand section Collapse section

INDICATIONS AND USAGE

Niktimvo™ (axatilimab-csfr) is a prescription medicine used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (cGVHD) after receiving at least 2 prior treatments (systemic therapy) and they did not work.

It is not known if Niktimvo is safe and effective in adults and children weighing less than 88.2 pounds (40 kg).

IMPORTANT SAFETY INFORMATION

What are the possible side effects of Niktimvo™ (axatilimab-csfr)?

Niktimvo may cause serious side effects, including:

Infusion-related reactions. Infusion-related reactions are common with Niktimvo and can be serious. Your healthcare provider will monitor you for infusion-related reactions during your treatment. If you have a reaction, your healthcare provider may temporarily or completely stop your treatment with Niktimvo. Tell your healthcare provider right away if you have fever, chills, rash, flushing, shortness of breath, trouble breathing, nausea, vomiting, or symptoms of high blood pressure such as chest pain, headaches, or blurred vision during an infusion of Niktimvo.

The most common side effects of Niktimvo include:

  • infections
  • increased blood level of liver enzymes
  • decreased blood level of phosphate
  • low red blood cell count (anemia)
  • muscle, bone, or joint pain
  • increased blood level of pancreatic enzymes
  • low energy
  • increased blood level of calcium
  • increased blood level of a muscle enzyme
  • increased blood level of a bone enzyme
  • nausea
  • headache
  • diarrhea
  • cough
  • fever
  • shortness of breath

These are not all the possible side effects of Niktimvo. Call your doctor for medical advice about side effects.

Before receiving Niktimvo, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had liver problems.
  • are pregnant or plan to become pregnant. Niktimvo may harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Niktimvo.
    • You should use an effective method of birth control during your treatment and for 30 days after your last dose of Niktimvo. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Niktimvo.
  • are breastfeeding or plan to breastfeed. It is not known if Niktimvo passes into your breast milk. Do not breastfeed during treatment and for 30 days after your last dose of Niktimvo.

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

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.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.