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

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About IncyteCARES

IncyteCARES is a program to help your eligible patients start and stay on therapy with Niktimvo™ (axatilimab-csfr) by assisting with access and as-needed support.

IncyteCARES offers an array of services and programs to Healthcare Professionals and their patients prescribed Niktimvo, which may include:

  • Benefits verification for Niktimvo
  • Prescription drug coverage guidance for patients
  • Information about savings and financial support options, such as the:
    • IncyteCARES Savings Program, which allows eligible patients with commercial prescription drug coverage to pay as little as $15 for their Niktimvo, subject to certain limits
    • Patient Assistance Program, which provides free medication for eligible patients who do not have prescription drug insurance or have trouble affording their out-of-pocket costs for Niktimvo. No purchase contingencies or other obligations apply
  • Education and support resources, including symptom tracking tools
  • Information about organizations or independent foundations that may be able to assist with treatment-related costs, counseling, support groups, and more
  • ICD-10-CM codes for Niktimvo
  • Sample Letter of Medical Necessity, Letter of Appeal, and Medical Exception templates for your use to help address insurer coverage denials

You can enroll your patient by completing an IncyteCARES enrollment form, which can also serve as your patient’s prescription for Niktimvo. You can download and fax the IncyteCARES Program Enrollment Form PDF. Note that not all patients who are prescribed Niktimvo are eligible for enrollment or for all services we provide. Contact us at 1-855-452-5234 for more information.

A patient can call IncyteCARES themselves to start the enrollment process. In that case, an IncyteCARES team member will reach out to the provider to get some of the information necessary for completing enrollment.

Yes, any patient who has been prescribed Niktimvo can enroll in IncyteCARES but may not be eligible to receive some of the services or support we offer. Contact IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET
for more information.

If you are requesting only a benefits investigation for Niktimvo, your patient’s signature on the enrollment form is not necessary. If you are enrolling your eligible patient in IncyteCARES for our other services to support their treatment with Niktimvo, the patient’s or the patient’s legal guardian’s authorization is required. If neither is available to sign an enrollment form with you, you can submit it without the signature and IncyteCARES will call the patient or legal guardian to request a verbal authorization.

Yes, you can enroll a patient in IncyteCARES while waiting for insurance approval. In fact, once your patient is enrolled, the IncyteCARES team can assist with benefits verification or provide support in the event that coverage is denied.

Call us at 1-855-452-5234. Our IncyteCARES team is available Monday through Friday, 8 AM–8 PM ET.

Benefits Investigation

Yes, IncyteCARES can assist with benefits verification for enrolled patients. We can contact the insurer to get information about the patient’s coverage, out-of-pocket costs, and any special requirements, such as prior authorization. We will provide this information to both you and your patient.

We can complete most benefit verifications within 3 business days. If we encounter a delay, we will notify you and your patient within that time period.

If a patient’s insurer denies coverage, IncyteCARES will provide information to Healthcare Professionals and patients about filing an appeal. Our team will monitor the appeal process and facilitate communication with the insurance company. If the appeal is delayed or unsuccessful, IncyteCARES will assess the patient’s eligibility to receive the medication free of charge.

If a patient’s insurance changes during treatment, they should call IncyteCARES at 1-855-452-5234. We can determine any changes in their coverage or their out-of-pocket costs.

Savings Program

Yes, IncyteCARES offers a Savings Program for eligible patients with commercial prescription drug coverage. Patients enrolled in the Savings Program can receive their medication for as little as $15 per month, subject to certain limits.*

*Uninsured, cash-paying, or Alternate Funding Program (AFP) patients are not eligible. Not valid for patients insured through Medicare Part B, Medicare Advantage, Medicaid, TRICARE, or any state medical or pharmaceutical assistance program. Patient enrollment in a copay adjustment program, such as a maximizer or accumulator program, may impact the value of this offer. Annual benefit maximum applies, as may other restrictions. Program benefit applies to medication cost only and does not cover any costs to administer the medication. Valid prescription for Niktimvo™ (axatilimab-csfr) for an FDA-approved indication or compendia-recognized use is required. Please see the full Patient Terms and Conditions or call IncyteCARES for Niktimvo at 1-855-452-5234. Update effective as of September 1, 2024.

To qualify, patients must:

  • Have commercial prescription drug coverage. Patients insured under federal or state government prescription drug programs—including Medicare Part B or D, Medicare Advantage, Medicaid, or TRICARE—are not eligible. Patients without prescription drug coverage are also not eligible
  • Be a resident of the United States or Puerto Rico
  • Have a valid prescription for Niktimvo for an FDA-approved use

Enrolled patients pay as little as $15 per month for their prescription, subject to certain limits. See the complete terms and conditions.

When your patient is enrolled in IncyteCARES, our team immediately enrolls that patient in the Savings Program if they are eligible. Another option is to enroll an eligible patient for the Savings Program yourself at IncyteCARESsavings.Niktimvo.com. Either way, a program member number is immediately issued and can be used right away. We will also mail your patient a welcome letter that shows their member number. Your patient does not need to be enrolled in IncyteCARES to access the Savings Program.

No. The patient’s enrollment in the Savings Program will automatically renew each year. However, they should contact IncyteCARES if their prescription insurance changes, so we can update their information and confirm that they are still covered.

Patient Assistance Program

Patients who have Medicare Part B but no Medicare Supplement (Medigap) coverage may be eligible to receive Niktimvo free of charge through the IncyteCARES Patient Assistance Program as long as they meet household income requirements and other criteria.* This program helps eligible patients who are uninsured or underinsured and need help affording the out-of-pocket cost for their medication. Call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET to find out more.

*Terms and conditions apply. Terms of this program may change at any time.

To qualify for the Patient Assistance Program (PAP), patients must:

  • Be confirmed as eligible for and enrolled in IncyteCARES
  • Be a resident of the United States or Puerto Rico
  • Have a valid prescription for Niktimvo for an FDA-approved use
  • Meet one of these 3 criteria:

Uninsured

    1. Have no prescription drug coverage and meet household income criteria

Underinsured†

    1. text
    2. Have Medicare Part B, Medicare Part D, or Medicare Advantage and meet household income criteria
    3. Have any other type of health insurance (commercial, Medicaid, etc) but have exhausted or been denied coverage for Niktimvo and meet household income criteria

*Terms and conditions apply. Terms of this program may change at any time.

†Patients who are enrolled in an Alternate Funding Program (AFP) are not eligible to receive free drug.

Once we receive the completed enrollment form, we can provide conditional approval within 3 business days. If we encounter a delay, we will notify you and your patient within that time period.

We provide conditional approval for the program, lasting up to 90 days, based on the patient’s enrollment form information. During this period, the patient must provide their income documentation to IncyteCARES before they can receive full approval for the PAP.

Acceptable documents for supporting current household income include the patient’s most current tax return, W-2 earnings statements, or one month of recent pay stubs.

Nurse Navigator Program

Through the Nurse Navigator Program, an IncyteCARES nurse holds biweekly phone check-ins with the patient. The program is designed to help the patient stay engaged, informed, and supported throughout their chronic graft-versus-host disease (cGVHD) treatment journey. Nurse Navigators provide structured outreach, symptom tracking guidance, and access support—helping patients recognize changes earlier and communicate more effectively with their care team.

IncyteCARES Nurse Navigators provide support to patients in between their health care visits. They can help your patients understand their insurance coverage and assist with enrolling them in savings programs. They reinforce the importance of thorough symptom tracking and reporting and provide guidance on how to use tracking tools. They can also listen for potential barriers to continued care and facilitate solutions so that patients stay on therapy.

Continuity of Care Program

When patients face challenges getting to their infusion location, that can put them at risk of not staying on therapy. If you determine that your patient could benefit from moving to a different infusion location, IncyteCARES can help identify a center that is closer to their home through the Continuity of Care program. You would still oversee your patient’s treatment, but we can work with you and the new provider to transition your patient to that location for their Niktimvo infusions.

Using your patient’s ZIP code, IncyteCARES can help you identify an infusion center near their home through the Alternate Infusion Site Locator.

IncyteCARES can work with you and the new provider to ensure that they have all the information and tools necessary to administer Niktimvo to your patient with chronic graft-versus-host disease (cGVHD). We can provide education on Niktimvo and cGVHD as well as on all aspects of administration and monitoring.

Education and Support

Through our call center, our nurses can answer patients’ questions about Niktimvo, their coverage, and basic questions about cGVHD. We make it clear that we don’t provide medical advice and that the information we provide does not replace any provided by their Healthcare Professionals.

IncyteCARES itself does not offer this kind of support; however, we share information about certain nonprofit organizations that may be able to assist with medical-related travel or transportation expenses. Patient eligibility would be determined by the organization.

We can connect patients to nonprofit organizations that provide social and emotional support as well as information about other counseling services and support groups in their areas. Please contact us for current information about these support services. In some cases, Incyte provides grants or funding to certain organizations so that programs or activities are offered to patients free of charge.

INDICATIONS AND USAGE

Niktimvo™ (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

Niktimvo™ (axatilimab-csfr) can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in 18% of patients who received Niktimvo in the clinical trial (AGAVE-201), with Grade 3 or 4 reactions in 1.3%.

Premedicate with an antihistamine and an antipyretic for patients who have previously experienced an infusion-related reaction to Niktimvo. Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, rash, flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or permanently discontinue Niktimvo based on severity of the reaction.

Embryo-Fetal Toxicity

Based on its mechanism of action, Niktimvo may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 44% of patients who received Niktimvo (N=79). Serious adverse reactions in > 2 patients included infection (pathogen unspecified) (14%), viral infection (14%), and respiratory failure (5.1%). Permanent discontinuation of Niktimvo due to an adverse reaction occurred in 10% of patients and dose reduction due to adverse reaction occurred in 8% of patients. Dose interruptions due to an adverse reaction occurred in 44% of patients. The adverse reactions leading to dose interruption in > 2 patients were viral infection, infection (pathogen unspecified), bacterial infection, musculoskeletal pain, and pyrexia.

The most common (≥ 15%) adverse reactions, including laboratory abnormalities, were increased aspartate aminotransferase (AST), infection (pathogen unspecified), increased alanine aminotransferase (ALT), decreased phosphate, decreased hemoglobin, viral infection, increased gamma glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase (ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.

Clinically relevant adverse reactions in < 10% of patients who received Niktimvo included:

  • Eye disorders: periorbital edema
  • Skin and subcutaneous skin disorders: pruritus
  • Vascular disorders: hypertension

Immunogenicity: Anti-Drug Antibody–Associated Adverse Reactions

Across treatment arms in patients with cGVHD who received Niktimvo in clinical trials, among the patients who developed anti-drug antibodies (ADAs), hypersensitivity reactions occurred in 26% (13/50) of patients with neutralizing antibodies (NAb) and in 4% (2/45) of those without NAb.

USE IN SPECIFIC POPULATIONS

Lactation

Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 30 days after the last dose of Niktimvo.

Females and Males of Reproductive Potential

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating Niktimvo.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose of Niktimvo.

DOSAGE AND ADMINISTRATION

Dosage Modifications for Adverse Reactions

Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the start of Niktimvo therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved. See Table 1 in the Prescribing Information for more recommendations.

Please see Full Prescribing Information for Niktimvo.

INDICATIONS AND USAGE

Niktimvo™ (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

Niktimvo™ (axatilimab-csfr) can cause infusion-related reactions. Infusion-related reactions, including hypersensitivity reactions, occurred in 18% of patients who received Niktimvo in the clinical trial (AGAVE-201), with Grade 3 or 4 reactions in 1.3%.

Premedicate with an antihistamine and an antipyretic for patients who have previously experienced an infusion-related reaction to Niktimvo. Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, rash, flushing, dyspnea, and hypertension. Interrupt or slow the rate of infusion or permanently discontinue Niktimvo based on severity of the reaction.

Embryo-Fetal Toxicity

Based on its mechanism of action, Niktimvo may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 44% of patients who received Niktimvo (N=79). Serious adverse reactions in > 2 patients included infection (pathogen unspecified) (14%), viral infection (14%), and respiratory failure (5.1%). Permanent discontinuation of Niktimvo due to an adverse reaction occurred in 10% of patients and dose reduction due to adverse reaction occurred in 8% of patients. Dose interruptions due to an adverse reaction occurred in 44% of patients. The adverse reactions leading to dose interruption in > 2 patients were viral infection, infection (pathogen unspecified), bacterial infection, musculoskeletal pain, and pyrexia.

The most common (≥ 15%) adverse reactions, including laboratory abnormalities, were increased aspartate aminotransferase (AST), infection (pathogen unspecified), increased alanine aminotransferase (ALT), decreased phosphate, decreased hemoglobin, viral infection, increased gamma glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase (ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.

Clinically relevant adverse reactions in < 10% of patients who received Niktimvo included:

  • Eye disorders: periorbital edema
  • Skin and subcutaneous skin disorders: pruritus
  • Vascular disorders: hypertension

Immunogenicity: Anti-Drug Antibody–Associated Adverse Reactions

Across treatment arms in patients with cGVHD who received Niktimvo in clinical trials, among the patients who developed anti-drug antibodies (ADAs), hypersensitivity reactions occurred in 26% (13/50) of patients with neutralizing antibodies (NAb) and in 4% (2/45) of those without NAb.

USE IN SPECIFIC POPULATIONS

Lactation

Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 30 days after the last dose of Niktimvo.

Females and Males of Reproductive Potential

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating Niktimvo.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with Niktimvo and for 30 days after the last dose of Niktimvo.

DOSAGE AND ADMINISTRATION

Dosage Modifications for Adverse Reactions

Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to the start of Niktimvo therapy, every 2 weeks for the first month, and every 1 to 2 months thereafter until abnormalities are resolved. See Table 1 in the Prescribing Information for more recommendations.

Please see Full Prescribing Information for Niktimvo.