IncyteCARES and Niktimvo™ (axatilimab-csfr) logo links to homepage

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

For Patients Arrow

We’re Here to Support Your Eligible Patients During Treatment

Our mission is to help your patients start and stay on therapy by assisting with access and as-needed support.

When You Enroll a Patient, an IncyteCARES for Niktimvo Representative Will:

  • Call your patient to welcome them and explain their insurance coverage for Niktimvo™ (axatilimab-csfr)
  • Assess your patient’s eligibility for savings or financial assistance programs,* and help them enroll
  • Explain the additional support and resources available to them during treatment

*Terms and conditions apply. Program terms may change at any time.

Enroll Your Eligible Patients in IncyteCARES for Niktimvo

Completing the IncyteCARES for Niktimvo enrollment form takes about
15 minutes. Simply download, complete, and fax it.

Print Enrollment Form
Icon of call center representative
Contact Us

Call IncyteCARES for Niktimvo

at 1-855-452-5234,

Monday through Friday, 8 AM–8 PM ET

Savings, Financial Assistance, and Support Options for Niktimvo

Eligible patients can receive Niktimvo for as little as $15, subject to certain limits†

To qualify, patients must:

  • Have commercial healthcare coverage. Patients insured under federal or state government healthcare programs—including Medicare Part B, Medicare Advantage, Medicaid, TRICARE, or any state medical or pharmaceutical assistance program—are not eligible. Patients without healthcare 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

†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.

†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.

How to enroll your patients:

Complete an application at IncyteCARESsavings.Niktimvo.com.

Once you submit it, a patient Member ID number is immediately issued. Your patient can begin receiving their Niktimvo for as little as $15 out-of-pocket cost right away.

For questions about the Savings Program application process, call the Help Desk at 1-833-415-4436,
Monday through Friday, 8 AM–8 PM ET.

 

How to request payment of your Savings Program patient’s coinsurance responsibility

Once your patient has been treated with Niktimvo, you can submit the documentation for your patient’s coinsurance responsibility by fax. We will match their Savings Program Member ID to the documentation for processing, then issue you a check referencing your patient’s name.

Be sure to submit the following proofs of purchase:

  • CMS-1500 claim form
  • Explanation of Benefits (EOB) from the primary commercial payer showing patient name and date of birth, medication name or NDC, patient responsibility amount, and date of service
Submit Payment Request

or Fax payment requests and documentation to 1-833-970-3589.

For questions about this process, call 1-833-415-4436.

Eligible patients can receive medication free of charge‡

The IncyteCARES for Niktimvo Patient Assistance Program (PAP) helps eligible patients who do not have medical insurance or who have trouble affording their out-of-pocket costs for Niktimvo. The program provides free medication, but does not cover the cost to administer infusions. No purchase contingencies or other obligations apply.

To qualify, patients must:

  • Be confirmed as eligible for and enrolled in IncyteCARES for Niktimvo
  • 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 medical coverage and meet household income criteria

Underinsured§

    1. text
    2. Have Medicare Part B but no Medicare Supplement (Medigap) coverage and meet household income criteria
    3. Have any other type of healthcare insurance (commercial, Medicaid, etc) but have exhausted or been denied coverage for Niktimvo and meet household income criteria

How to enroll your patients:

First, you must enroll your patient in IncyteCARES for Niktimvo.

If you’re not able to provide the patient’s required income information and/or authorizations on the form, a program representative will contact the patient by phone to gather this information.

For questions, call IncyteCARES for Niktimvo at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET.

‡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.

Patients may be eligible for help with medicine, treatment-related travel, and other costs.

If patients do not qualify for our IncyteCARES for Niktimvo Savings or Patient Assistance Programs, we may be able to provide information about other organizations or independent foundations that offer support. If eligible, these independent organizations sometimes provide help with medicine costs, transportation or lodging expenses related to treatment, or counseling services offered at reduced or no cost. Eligibility and availability of these programs are determined by the individual organizations.

To learn more:

Call IncyteCARES for Niktimvo at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET.

We can give patients contact information and website addresses to find more information on other organizations and independent foundations that may be able to help with specific needs.

Practice Resources: ICD-10-CM Codes

The following codes are from the International Classification of Diseases, Clinical Modification
10th Revision (ICD-10-CM), which have been in effect since October 1, 2015.

Diagnosis

ICD-10-CM Code
for Niktimvo

Chronic GVHD

D89.811

Acute or Chronic GVHD

D89.812

GVHD, Unspecified

D89.813

Other complications of bone marrow transplant

D89.81

Incyte has provided these codes as background information. They are some of the available ICD-10-CM codes that relate to this disease state. They are not intended to encourage or address the use of any specific ICD-10-CM codes for individual patients. Using the codes provided does not guarantee or support payment, coverage, or reimbursement decisions.

For more information about ICD-10-CM codes, visit CMS.gov.

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.