POTELIGEO Copay Assistance Program

  • Most commercially insured patients pay as little as a $0 copay
  • This offer is valid toward out-of-pocket expenses for POTELIGEO
  • Subject to complete terms and conditions—see below
  • Maximum annual benefit is $10,000 per calendar year

To learn more or to enroll a patient, call 1-833-KKCARES (1-833-552-2737) or visit www.KyowaKirinCares.com.

Terms and conditions

The Kyowa Kirin Cares Copay Assistance Program for POTELIGEO® (mogamulizumab-kpkc) Injection (the “Program”) helps commercially insured individuals who are permanent residents of the United States (including the United States territories) and who are prescribed POTELIGEO for a use approved by the Food and Drug Administration (FDA) pay for their eligible out-of-pocket costs for the drug, up to a $10,000 maximum benefit per calendar year. The Program is limited to patients 18 years of age or older. The Program does not subsidize patient cost-sharing for administration of the drug, including copays, co-insurance, and deductibles. The Program does not cover the costs of physician office visits or evaluations, blood work or other testing, or transportation or other related services. The Program is NOT insurance.

Eligible individuals must have commercial insurance coverage for POTELIGEO. Uninsured and cash-paying individuals are NOT eligible for the Program, nor are individuals with commercial insurance coverage that does not provide coverage for POTELIGEO. Individuals with coverage for POTELIGEO, in whole or in part, under any state or federally funded healthcare program, including but not limited to, Medicare, Medicare Advantage Plans, Medicare Part D (including qualified retiree prescription drug plans), Medicaid, Medigap, VA, DoD, TRICARE, and the Puerto Rico Government Health Insurance Plan, are NOT eligible for the Program. Patients who move from commercial to state or federally funded insurance will no longer be eligible for the Program.

Void if copied, transferred, purchased, altered, or traded, and where prohibited and restricted by law.

Eligible patients will receive a maximum of $10,000 in out-of-pocket assistance per calendar year, eg, January 1 through December 31. Each eligible patient is responsible for their out-of-pocket costs for POTELIGEO above this amount. Patients enrolled in the Program will be automatically enrolled in the Program for the next calendar year for a period of 5 years, unless they opt out of the Program or their insurance coverage changes at any time during the enrollment period. At the end of the 5-year enrollment period, eligible patients can reenroll to continue receiving assistance via submission of a new complete Program Enrollment Form, with a current patient signature.

To complete Program approval, treating providers of eligible patients are required to furnish an Explanation of Benefits (EOB) and/or Remittance Advice to the Program for the first treatment with POTELIGEO by faxing it to 844-267-5848, and must furnish an updated EOB/remittance to the Program at the start of each new calendar year within the 5-year enrollment period.

All coverage requirements of the eligible patient that are mandated by the insurance company must be satisfied for the Program to take effect. When submitting claims under the Program, patients and their treating providers are certifying that they understand the Program rules, regulations, and terms and conditions, and will comply with the Program terms as set forth herein. Additionally, you are certifying that a claim has not been submitted under a state or federally funded healthcare program, including but not limited to, Medicare, Medicare Advantage Plans, Medicare Part D (including qualified retiree prescription drug plans), Medicaid, Medigap, VA, DoD, TRICARE, and the Puerto Rico Government Health Insurance Plan.

Kyowa Kirin reserves the right to make eligibility determinations, to set Program benefit maximums, to monitor participation, and to change, rescind, revoke, or discontinue the Program at any time without notice. Limit one Program enrollment per individual. If you have any questions regarding this Program, your eligibility or benefits, or if you wish to discontinue your participation, call 1-833-KKCARES (1-833-552-2737) Monday through Friday, 8am to 8pm, Eastern Time (ET).

POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information

SEE LESS

Warnings and Precautions

  • Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).
  • Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.
  • Infections: Monitor patients for signs and symptoms of infection and treat promptly.
  • Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.
  • Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

Adverse Reactions

  • The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).
  • You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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POTELIGEO is a registered trademark of
Kyowa Hakko Kirin Co., Ltd.
© 2018 Kyowa Kirin, Inc. All rights reserved.
PRC-MOG-0129 August 2018