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IncyteCARES 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

WE’RE HERE TO SUPPORT YOUR ELIGIBLE PATIENTS DURING TREATMENT

Our mission is to help eligible patients access their prescribed PEMAZYRE and to offer information and resources that provide support during treatment.

PEMAZYRE is dispensed exclusively 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

SUBMIT A PEMAZYRE PRESCRIPTION BY FAX

For prescribers who prefer not to submit an electronic prescription, simply complete and fax the IncyteCARES for PEMAZYRE form. Biologics will conduct a benefits verification and contact your patient to coordinate delivery of the filled prescription.

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CONTACT US

Call IncyteCARES 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 OR PRIVATE PRESCRIPTION INSURANCE
IncyteCARES for PEMAZYRE COPAY/COINSURANCE PROGRAM

Eligible patients can receive PEMAZYRE for as little as $0 copay, subject to certain limits*

Image of PEMAZYRE Copay/Coinsurance Assistance Card

To qualify, patients must:

  • Have commercial or private 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 is required. Please see complete Terms and Conditions or call IncyteCARES.

HOW TO ENROLL YOUR PATIENTS

Two options:

  • Contact IncyteCARES at 1-866-708-8806

    , Monday through Friday, 8 am–8 pm ET to request a copay/coinsurance card for your qualifying patient.

  • Complete an application at incytecarescopaypemazyre.com.

    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 copay/coinsurance 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 an insurance plan that will not cover their treatment with PEMAZYRE.

To qualify, patients must:

  • Be a resident of the United States or a US territory
  • Have a valid prescription for PEMAZYRE for an FDA-approved use
  • Meet certain household size and annual income criteria, including earning less than $125,000 per year or less than 600% of the Federal Poverty Level (whichever amount is higher)
  • Patients with prescription coverage through government programs—including Medicare Part D, Medicare Advantage, Medicaid, TRICARE—or by a healthcare exchange plan are not eligible

HOW TO ENROLL YOUR PATIENTS

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 this program may change at any time.

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FOR PATIENTS WHOSE INSURANCE COVERAGE APPROVAL 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 or private 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 this program may change at any time.

HOW TO ENROLL YOUR PATIENTS

You may include proof of the coverage delay when you submit the form by fax. Otherwise, a program representative will follow up with you or your patient to gather that required documentation.

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

Printable IncyteCARES for PEMAZYRE Form

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

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

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

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

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]).

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.

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.