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IncyteCARES for PEMAZYRE is a program for residents
of the United States and US territories.

IncyteCARES: A Patient Assistance and Support Program IncyteCARES: A Patient Assistance and Support Program IncyteCARES: A Patient Assistance and Support Program

Healthcare Professionals

Enroll a Patient

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.

PEMAZYRE is dispensed by Biologics by McKesson specialty pharmacy.

Biologics will work with you and your patient to provide therapeutic expertise and individualized support.

For Eligible Patients, Our Team Can Provide:

  • Benefits verification and as-needed prior authorization or appeal support
  • Pharmacy outreach call to help patients get started on treatment
  • Flexibly scheduled support calls from a pharmacy care team specialist
  • Treatment history and medication monitoring
  • Text message refill reminders
  • Education and support resources
  • Information about financial assistance options

Enroll Your Eligible Patients in IncyteCARES for PEMAZYRE

Completing the IncyteCARES for PEMAZYRE enrollment form takes about 15 minutes.

Simply complete the online enrollment form or download and fax the print enrollment form.

Biologics will conduct a benefits verification and contact your patient to coordinate delivery of the filled prescription.

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To Submit Via Fax
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Via Secure Website
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Contact Us

Call IncyteCARES for PEMAZYRE at 1-866-708-8806

Monday through Friday, 8 am–8 pm ET

Financial Assistance Options for Your Patients

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For Eligible Patients With Commercial Prescription Insurance
IncyteCARES for PEMAZYRE Savings Program

Eligible patients can receive PEMAZYRE for as little as $0 out-of-pocket cost, subject to certain limits*

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To qualify, patients must:

  • Have commercial prescription drug coverage. Patients insured under federal or state government prescription drug programs—including Medicare Part 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 a US territory
  • Have a valid prescription for PEMAZYRE for an FDA-approved use

*Amount of savings on PEMAZYRE will not exceed $9,000 per claim and $25,000 per year. Uninsured, cash-paying patients are not eligible. Not valid for patients insured through Medicare Part D, Medicare Advantage, Medicaid, and TRICARE or any state medical or pharmaceutical assistance program. Valid prescription for PEMAZYRE for an FDA-approved indication or compendia-recognized use is required. Please see complete Terms and Conditions or call IncyteCARES. Update effective as of January 1, 2021.

*Amount of savings on PEMAZYRE will not exceed $9,000 per claim and $25,000 per year. Uninsured, cash-paying patients are not eligible. Not valid for patients insured through Medicare Part D, Medicare Advantage, Medicaid, and TRICARE or any state medical or pharmaceutical assistance program. Valid prescription for PEMAZYRE for an FDA-approved indication or compendia-recognized use is required. Please see complete Terms and Conditions or call IncyteCARES. Update effective as of January 1, 2021.

To enroll a patient, you can either:

  • Contact IncyteCARES for PEMAZYRE at 1-866-708-8806, Monday through Friday, 8 am–8 pm ET to request a savings card for your qualifying patient.

  • Complete an application at IncyteCAREScopayPEMAZYRE.

    Once you submit it, a patient membership number is immediately issued and accessible by Biologics, the specialty pharmacy for PEMAZYRE. Your patient can begin receiving their PEMAZYRE for as little as $0 out-of-pocket cost right away.

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For Eligible Patients Who Are Uninsured or Underinsured for PEMAZYRE
IncyteCARES for PEMAZYRE Patient Assistance Program

Eligible patients can receive medication free of charge

The IncyteCARES for PEMAZYRE Patient Assistance Program (PAP) helps eligible patients who do not have prescription drug insurance or who have trouble affording their out-of-pocket costs for PEMAZYRE. No purchase contingencies or other obligations apply.

To qualify, patients must:

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

    Uninsured

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

    3. Have Medicare Part D and meet household income criteria and additional program requirements
    4. Have any other type of prescription drug insurance (commercial, Medicaid, etc) but have exhausted or been denied coverage for PEMAZYRE and meet household income criteria

How to enroll your patients:

Enroll online or download, complete, and submit the IncyteCARES for PEMAZYRE form.

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

Within 2 business days of receiving the IncyteCARES for PEMAZYRE form, patients are notified of "conditional approval" for the program. This allows them to receive free medication for 90 days. Full approval is only granted once your patient’s proof of income is submitted and confirmed.

Terms and conditions apply. Terms of these programs may change at any time.

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For Patients Whose Insurance Coverage is Delayed
IncyteCARES for PEMAZYRE Temporary Access Program

Eligible patients receive a free short-term supply of medication

If a patient’s prescription drug insurer requires more than a 3-day wait for determining coverage approval, we may be able to provide a free short-term supply of PEMAZYRE in the meantime. To be eligible, the patient must submit a proof of insurance claim verifying the delay. Free product is offered to eligible patients without any purchase contingency or other obligation.

To qualify, the patient must:

  • Have commercial prescription drug coverage or a healthcare exchange plan. Patients insured under federal or state government prescription drug programs—including Medicare Part 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 a US territory
  • Have a valid prescription for an Incyte medication for an FDA-approved use
  • Provide proof of the coverage delay. This may be a notice you or your patient receive from the insurance company

Terms and conditions apply. Terms of these programs may change at any time.

How to enroll your patients:

Enroll online or download, complete, and submit the IncyteCARES for PEMAZYRE form.

Indications and Usage

PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Practice Resources: ICD-10 Codes for PEMAZYRE

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

Disease State

PEMAZYRE
ICD-10 Code

Intrahepatic Bile Duct Carcinoma

C22.1

Malignant Neoplasm of Extrahepatic Bile Duct

C24.0

Incyte has provided these codes as background information. They are some of the available ICD-10-CM codes that relate to these disease states. 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 codes, visit CMS.gov.

Forms

IncyteCARES for PEMAZYRE Form (PDF)

Complete this form to:

  • Enroll your patients in either the IncyteCARES for PEMAZYRE Patient Assistance Program or Temporary Access Program
  • Write a prescription for PEMAZYRE to submit by fax

Letter of Medical Necessity (PDF)

Some payers require documentation of medical necessity for certain medications before approving coverage. This sample letter, with fillable fields, can be used for this requirement.

Letter of Appeal (PDF)

This sample letter, with fillable fields, can be used to appeal an insurer’s denial of coverage for an Incyte medication.

Questions About Billing or Reimbursement?

Email a Field Access Manager for assistance with information about coding, prior authorization, appeals, or for answers to other reimbursement-related questions.
Someone will respond within 2 business days.

INDICATIONS AND USAGE

PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Ocular Toxicity

Retinal Pigment Epithelial Detachment (RPED): PEMAZYRE can cause RPED, which may cause symptoms such as blurred vision, visual floaters, or photopsia. Clinical trials of PEMAZYRE did not conduct routine monitoring including optical coherence tomography (OCT) to detect asymptomatic RPED; therefore, the incidence of asymptomatic RPED with PEMAZYRE is unknown.

Among 466 patients who received PEMAZYRE across clinical trials, RPED occurred in 6% of patients, including Grade 3-4 RPED in 0.6%. The median time to first onset of RPED was 62 days. RPED led to dose interruption of PEMAZYRE in 1.7% of patients, and dose reduction and permanent discontinuation in 0.4% and in 0.4% of patients, respectively. RPED resolved or improved to Grade 1 levels in 87.5% of patients who required dosage modification of PEMAZYRE for RPED.

Perform a comprehensive ophthalmological examination including OCT prior to initiation of PEMAZYRE and every 2 months for the first 6 months and every 3 months thereafter during treatment. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of PEMAZYRE. Modify the dose or permanently discontinue PEMAZYRE as recommended in the prescribing information for PEMAZYRE.

Dry Eye: Among 466 patients who received PEMAZYRE across clinical trials, dry eye occurred in 27% of patients, including Grade 3-4 in 0.6% of patients. Treat patients with ocular demulcents as needed.

Hyperphosphatemia and Soft Tissue Mineralization

PEMAZYRE can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcification, calcinosis, and non-uremic calciphylaxis. Increases in phosphate levels are a pharmacodynamic effect of PEMAZYRE. Among 466 patients who received PEMAZYRE across clinical trials, hyperphosphatemia was reported in 92% of patients based on laboratory values above the upper limit of normal. The median time to onset of hyperphosphatemia was 8 days (range 1-169). Phosphate lowering therapy was required in 29% of patients receiving PEMAZYRE.

Monitor for hyperphosphatemia and initiate a low phosphate diet when serum phosphate level is >5.5 mg/dL. For serum phosphate levels >7 mg/dL, initiate phosphate lowering therapy and withhold, reduce the dose, or permanently discontinue PEMAZYRE based on duration and severity of hyperphosphatemia as recommended in the prescribing information.

Embryo-Fetal Toxicity

Based on findings in an animal study and its mechanism of action, PEMAZYRE can cause fetal harm when administered to a pregnant woman. Oral administration of pemigatinib to pregnant rats during the period of organogenesis caused fetal malformations, fetal growth retardation, and embryo-fetal death at maternal exposures lower than the human exposure based on area under the curve (AUC) at the clinical dose of 13.5 mg.

Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose.

Adverse Reactions

Serious adverse reactions occurred in 45% of patients receiving PEMAZYRE. Serious adverse reactions in ≥2% of patients who received PEMAZYRE included abdominal pain, pyrexia, cholangitis, pleural effusion, acute kidney injury, cholangitis infective, failure to thrive, hypercalcemia, hyponatremia, small intestinal obstruction, and urinary tract infection. Fatal adverse reactions occurred in 4.1% of patients, including failure to thrive, bile duct obstruction, cholangitis, sepsis, and pleural effusion.

Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received PEMAZYRE. Adverse reactions requiring permanent discontinuation in ≥1% of patients included intestinal obstruction and acute kidney injury.

Dosage interruptions due to an adverse reaction occurred in 43% of patients who received PEMAZYRE. Adverse reactions requiring dosage interruption in ≥1% of patients included stomatitis, palmar-plantar erythrodysesthesia syndrome, arthralgia, fatigue, abdominal pain, AST increased, asthenia, pyrexia, ALT increased, cholangitis, small intestinal obstruction, alkaline phosphatase increased, diarrhea, hyperbilirubinemia, electrocardiogram QT prolonged, decreased appetite, dehydration, hypercalcemia, hyperphosphatemia, hypophosphatemia, back pain, pain in extremity, syncope, acute kidney injury, onychomadesis, and hypotension.

Dose reductions due to an adverse reaction occurred in 14% of patients who received PEMAZYRE. Adverse reactions requiring dosage reductions in ≥1% of patients who received PEMAZYRE included stomatitis, arthralgia, palmar-plantar erythrodysesthesia syndrome, asthenia, and onychomadesis.

Clinically relevant adverse reactions occurring in ≤10% of patients included fractures (2.1%). In all patients treated with pemigatinib, 1.3% experienced pathologic fractures (which included patients with and without cholangiocarcinoma [N=466]). Soft tissue mineralization, including cutaneous calcification, calcinosis, and non-uremic calciphylaxis associated with hyperphosphatemia were observed with PEMAZYRE treatment.

Within the first 21-day cycle of PEMAZYRE dosing, serum creatinine increased (mean increase of 0.2 mg/dL) and reached steady state by Day 8, and then decreased during the 7 days off therapy. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

The most common adverse reactions (incidence ≥20%) were hyperphosphatemia (60%), alopecia (49%), diarrhea (47%), nail toxicity (43%), fatigue (42%), dysgeusia (40%), nausea (40%), constipation (35%), stomatitis (35%), dry eye (35%), dry mouth (34%), decreased appetite (33%), vomiting (27%), arthralgia (25%), abdominal pain (23%), hypophosphatemia (23%), back pain (20%), and dry skin (20%).

Drug Interactions

Avoid concomitant use of strong and moderate CYP3A inhibitors with PEMAZYRE. Reduce the dose of PEMAZYRE if concomitant use with a strong or moderate CYP3A inhibitor cannot be avoided. Avoid concomitant use of strong and moderate CYP3A inducers with PEMAZYRE.

Special Populations

Advise lactating women not to breastfeed during treatment with PEMAZYRE and for 1 week after the final dose.

Reduce the recommended dose of PEMAZYRE for patients with severe renal impairment as described in the prescribing information.

Reduce the recommended dose of PEMAZYRE for patients with severe hepatic impairment as described in the prescribing information.

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.