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Full Terms, Conditions, and Eligibility Rules

ANZUPGO® Copay Program – Program Summary and Terms & Conditions

LEO Pharma Inc. (“LEO Pharma”) is the distributor of ANZUPGO® (delgocitinib) (the “Product”). LEO Pharma provides access and savings programs to help ensure that medically appropriate patients, who have been prescribed the Product by their treating healthcare provider (“HCP”), have access to the Product.

The ANZUPGO® Copay Program (the “Program”) will provide reimbursement for eligible, commercially insured patients’ cost-sharing obligations (including deductibles, copayments, coinsurance, or amounts in excess of out-of-pocket maximums) for the Product, up to an annual maximum limitation specified by the Program and may be adjusted from time to time at the Program’s sole discretion. The amount of reimbursement may vary, including based on an eligible patient’s insurance coverage. Patients may pay as little as $0 per fill of the Product after application of Program reimbursement. Patients remain responsible for any remaining costs for the Product after application of Program reimbursement or reaching the annual maximum limitation.

A patient or their legal representative may enroll in the Program either by enrolling via the ANZUPGO® Let’s GO™ Support Program (“ANZUPGO® Let’s GO™”) operated by LEO Pharma’s designated service provider, or via other means provided by LEO Pharma, such as via the Product website or via a pharmacy contracted with LEO Pharma to dispense the Product.

 

Eligibility Requirements and Limitations

  • For eligible patients, the Program benefits are limited and subject to a maximum support amount. Eligible patients will be responsible for all amounts that exceed the maximum support amount provided by the Program.
  • The patient must be eighteen (18) years of age or older and have a valid prescription for an approved use of the Product.
  • The patient must be a resident of the United States or the United States territories.
  • The patient must have commercial insurance, either directly or through dependent coverage.
  • The patient must not have prescription drug coverage for the Product, in whole or in part, either directly or through dependent coverage, under any federal or state health program that is a “federal healthcare program” as defined under 42 U.S.C. § 1320a-7b(f), including but not limited to Medicare, Medicaid, TRICARE, the Indian Health Service, the Department of Veterans Affairs Health Benefit Program, state Children’s Health Insurance Programs under the Title XIX or Title XXI of the Social Security Act, state block grant programs under Title V or Title XX of the Social Security Act, or state pharmaceutical assistance programs. This Program is not available for patients within a deductible or similar cost sharing periods under such federal healthcare programs.
  • Uninsured and cash-paying patients are not eligible.

 

Additional Terms and Conditions

  • The Program does not constitute insurance.
  • The availability of benefits under the Program does not constitute any guarantee of coverage under any prescription benefit insurance or program.
  • The benefits under this Program may not be combined with any third‑party rebate, coupon, or offer.
  • The Program is not available for patients whose health insurance plans, or their employers, vendors or third parties, use alternative funding programs or such similar programs (collectively “AFP”) which LEO Pharma determines may apply to or affect the Program. The patient understands, acknowledges, and agrees that the Program will verify the existence of and/or use of an AFP upon the patient’s enrollment, and any time the patient is a recipient of Product through the Program. Further, by seeking benefits under the Program, the patient authorizes the Program to contact their insurer, employer, or third‑party, as necessary, solely for the purposes of determining their health insurance plan benefit design with respect to the use of an AFP.
  • LEO Pharma reserves the right to exclude specific payers from the Program, including but not limited to payers that have implemented AFPs or payers that have implemented clear noncoverage policies with respect to the Product.
  • By submitting a request for benefits under the Program or by participating in the Program, the HCP acknowledges and agrees that the HCP: (1) will not submit any claim or other request for payment or reimbursement for benefits provided under the Program to the patient or any third‑party plan or program, including any commercial or government assistance program; and (2) will advise the patient that the patient may not submit a claim to any third‑party plan or program but should report their receipt of benefits to the patient’s insurer if required by their plan.
  • By submitting a request for benefits under the Program or by participating in the Program, the patient (or their legal representative) acknowledges and agrees that the patient: (1) will not submit any claim or other request for payment or reimbursement for benefits provided under the Program to any third‑party plan or program, including any commercial or government assistance program; and (2) will report their receipt of benefits to their insurer if required by their plan.
  • Patients and/or their HCPs must submit complete information and/or documentation required under the Program and attest to the truthfulness and accuracy of the information and/or documentation.
  • By submitting a request for benefits under the Program or by participating in the Program, the patient (or their legal representative) and HCP individually acknowledge, understand, and agree to the benefit, eligibility, and other Program limitations, terms, and conditions as set forth herein.
  • The availability of benefits under the Program is not conditioned on any past, present, or future purchase, including any potential future refills of Product.
  • The Health Insurance Portability and Accountability Act of 1996 grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about the patient, LEO Pharma will use and disclose it according to the patient authorization that the patient (or legal representative) completed for the patient’s HCP in connection with the Program. For more information about how the patient’s PHI is used and disclosed by the patient’s HCP, please review the patient’s HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about the patient that is not PHI, LEO Pharma will use and disclose that personal data as disclosed in the LEO Pharma privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us/privacy-policy). By participating in the Program, the patient acknowledges that LEO Pharma may collect health information from the patient, which may be considered “sensitive” data under some U.S. state laws.
  • The copay card, whether issued virtually or physically, has no cash value.
  • Offer void where prohibited by law, taxed, or restricted.
  • LEO Pharma has sole discretion to determine Program eligibility. LEO Pharma may unilaterally amend, modify, or terminate Program benefits and eligibility criteria at any time and without notice.

ANZUPGO® Bridge Program – Program Summary and Terms & Conditions

LEO Pharma Inc. (“LEO Pharma”) is the distributor of ANZUPGO® (delgocitinib) (the “Product”). LEO Pharma provides access and savings programs to help ensure that medically appropriate, who have been prescribed the Product by their treating healthcare provider (“HCP”), have access to the Product.

One of the offerings available for the benefit of patients is the ANZUPGO® Bridge Program (the “Program”). Under the Program, a pharmacy contracted with LEO Pharma (“Pharmacy”) or the ANZUPGO® Let’s GO™ Support Program (“ANZUPGO® Let’s GO™”), operated by LEO Pharma’s designated service provider (“LEO Service Provider”), will provide the Product, consistent with its prescribing information, without charge to commercially insured patients who have been prescribed the Product by their HCP for an approved use and who satisfy the Program’s eligibility criteria, after experiencing an “Initial Delay” (defined below) in securing a determination of insurance coverage for the Product. A patient, or their legal representative, may enroll in the Program by completing, signing, and submitting the applicable portion of the ANZUPGO® Let’s GO™ Program Enrollment and Prescription Form. A HCP may prescribe the Product to a Pharmacy or complete, sign, and submit the applicable portion of the Enrollment and Prescription Form, which includes a prescription for the Product that will be processed by a non-commercial dispensing pharmacy (“NCDP”) affiliated with the LEO Service Provider, to dispense the Product.

After the prescription is received by the Pharmacy, or NCDP, and the patient’s eligibility for the Program is verified, the Product will be delivered to the patient’s address of record, or other location mutually agreed upon by the Pharmacy or ANZUPGO® Let’s GO™ and the patient or patient’s caregiver, and the Pharmacy or ANZUPGO® Let’s GO™ will coordinate the shipment of the Product.

 

Eligibility Requirements and Limitations

  • The patient must be eighteen (18) years of age or older and have a valid prescription for an approved use of the Product.
  • The patient must be a resident of the United States or the United States territories.
  • The patient must have commercial insurance, either directly or through dependent coverage.
  • The patient must not have prescription drug coverage for the Product, in whole or in part, either directly or through dependent coverage, under any federal or state government subsidized health program that is a “federal healthcare program” as defined under 42 U.S.C. § 1320a-7b(f), including but not limited to Medicare, Medicaid, TRICARE, the Indian Health Service, the Department of Veterans Affairs Health Benefits program, state Children’s Health Insurance Programs under the Title XIX or Title XXI of the Social Security Act, state block grant programs under Title V or Title XX of the Social Security Act, or state pharmaceutical assistance programs. This Program is not available for patients within a deductible or similar cost sharing periods under such federal healthcare programs.
  • Uninsured and cash-paying patients are not eligible.
  • The patient must experience an “Initial Delay”, which is defined as either:
    • A delay of three (3) or more business days in securing an insurance coverage determination (i.e., a response to the actual submission of a request for coverage determination, such as a prior authorization request, or claim), either at therapy initiation or in connection with a change in insurance provider or coverage (i.e., due to a change in employment); or
    • A denial of insurance coverage based on a prior authorization request or claim, together with proof of such denial, either at therapy initiation or in connection with a change in insurance provider or coverage (i.e., due to a change in employment), for which an appeal (or subsequent appeal) of the coverage denial, on behalf of the patient, has been submitted or will be submitted within thirty (30) days of such denial.
    • An NDC block from the patient’s commercial insurance, or the patient’s commercial insurance plan has formally denied coverage for the Product through its coverage policy or a decision as part of a benefits inquiry or prior authorization process and has provided a copy or proof of the denial. Once a patient subsequently receives prior authorization approval, then such patient will no longer qualify for the Program, except that LEO Pharma in its discretion may furnish an additional quantity of Product under the Program to avoid a gap in therapy.
  • Product is not available for patients whose health insurance plans, or their employers, vendors or third parties, use alternative funding programs or such similar programs (collectively “AFP”) which LEO Pharma determines may apply to or affect the Program. The patient understands, acknowledges, and agrees that the Program will verify the existence of and/or use of an AFP upon the patient’s enrollment, and any time the patient is a recipient of Product through the Program. Further, by seeking benefits under the Program, the patient authorizes the Program to contact the patient’s insurer, employer, or third party, as necessary, solely for the purposes of determining the patient’s health insurance plan benefit design with respect to the use of an AFP.
  • LEO Pharma reserves the right to exclude specific payers from the Program, including but not limited to payers that have implemented AFPs or payers that have implemented clear noncoverage policies with respect to the Product.

 

Additional Terms and Conditions

  • The Program does not constitute insurance.
  • The provision of Product under the Program does not constitute any guarantee of coverage under any prescription benefit insurance or program.
  • For each eligible patient, the Program provides Product for such patient without charge during the period of Initial Delay.
  • An eligible patient's enrollment in the Program cannot exceed six (6) months during such patient's lifetime, with a maximum of three (3) tubes of Product dispensed within such six (6) month period, provided the patient meets the eligibility criteria for the Program.
  • After eligibility is verified and the prescription is received by the Pharmacy or NCDP, the Pharmacy or NCDP will ship a supply of Product, in amounts to be determined at the sole discretion of the Program to the patient, as explained above.
  • On a regular basis, the Program will verify whether the patient has secured a coverage determination or, if a noncoverage determination has been issued, whether the patient has submitted an appeal and its status. The Pharmacy or the NCDP will ship additional supplies of Product, in amounts to be determined in the sole discretion of the Program, provided the patient remains eligible to receive Product under the Program.
  • By submitting a request for Product under the Program or by participating in the Program, the HCP acknowledges and agrees that the HCP: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to the patient or any third‑party plan or program, including any commercial or government assistance program; (2) will advise the patient that the patient may not submit a claim to any third‑party program or plan but should report their receipt of Product to the patient’s insurer if required by their plan; (3) will dispense or administer Product solely to the eligible patient for whom such Product was requested; and (4) will not sell, transfer, or otherwise dispense Product to any other third party.
  • By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) acknowledges and agrees that the patient: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to any third‑party plan or program, including any commercial or government assistance program; (2) will report their receipt of Product to their insurer if required by their plan; and (3) will not sell, transfer, or otherwise dispense Product to any other third party.
  • The Pharmacy or the NCDP only dispenses Product pursuant to the Program. Product prescriptions subject to third‑party insurance, including refill prescriptions, may be dispensed by the pharmacy of the patient’s choice, subject to product distribution and third‑party payer limitations.
  • Patients and/or their HCPs must submit complete information and/or documentation required under the Program and attest to the truthfulness and accuracy of the information and/or documentation. Patients may be asked to reverify insurance coverage or appeal status during their participation in the Program. Failure to verify status or to file a required appeal may result in termination of the dispensing of Product under the Program in the sole discretion of the Program.
  • By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) and the HCP individually acknowledge, understand, and agree to the benefit, eligibility, and other program limitations, terms and conditions as set forth herein.
  • The availability of Product under the Program is not conditioned on any past, present, or future purchase, including any potential future refills of Product.
  • The Health Insurance Portability and Accountability Act of 1996 grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about the patient, LEO Pharma will use and disclose it according to the patient authorization that the patient (or legal representative) completed for the patient’s HCP in connection with the Program. For more information about how the patient’s PHI is used and disclosed by the patient’s HCP, please review the patient’s HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about the patient that is not PHI, LEO Pharma will use and disclose that personal data as disclosed in the LEO Pharma privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us/privacy-policy). By participating in the Program, the patient acknowledges that LEO Pharma may collect health information from the patient, which may be considered “sensitive” data under some U.S. state laws.
  • Offer void where prohibited by law, taxed, or restricted.
  • LEO Pharma has sole discretion to determine Program eligibility.
  • LEO Pharma may unilaterally amend, modify, or terminate Program benefits and eligibility criteria at any time without notice.

ANZUPGO® Patient Assistance Program – Program Summary and Terms & Conditions

LEO Pharma Inc. (“LEO Pharma”) is the distributor of ANZUPGO® (delgocitinib) (the “Product”). LEO Pharma sponsors the ANZUPGO® Let’s GO™ Support Program (“ANZUPGO® Let’s GO™”), which is operated by LEO Pharma’s designated service provider (“LEO Service Provider”). The purpose of ANZUPGO® Let’s GO™ is to help ensure that medically appropriate patients, who have been prescribed the Product by their treating healthcare provider (“HCP”), have access to the Product.

One of the offerings available for the benefit of patients under ANZUPGO® Let’s GO™ is the ANZUPGO® Patient Assistance Program (the “Program” or “PAP”). Under the Program, ANZUPGO® Let’s GO™ will provide the Product, without charge, to patients who: a) demonstrate financial need; and b) do not have insurance for the Product or who are underinsured, and who otherwise satisfy the eligibility requirements for the Program. ANZUPGO® Let’s GO™ will provide the Product without charge to eligible patients on a periodic basis and consistent with the prescribing information for the Product. A patient or their legal representative may enroll in the Program by completing, signing, and submitting the applicable portion of the ANZUPGO® Let’s GO™ Program Enrollment and Prescription Form. A HCP may prescribe the Product by completing, signing, and submitting the applicable portion of the Enrollment and Prescription Form which includes a prescription for the Product that will be processed by a non-commercial dispensing pharmacy (“NCDP”) affiliated with the LEO Service Provider. A patient requesting assistance under the PAP (or their legal representative) is required to submit information and documentation concerning household size and income and insurance status to allow ANZUPGO® Let’s GO™ to evaluate the patient’s eligibility under the Program.

After the prescription is received by the NCDP and the patient’s eligibility for the Program is verified, the Product will be delivered to the patient’s address of record or other location mutually agreed upon by ANZUPGO® Let’s GO™ and the patient or patient’s caregiver. ANZUPGO® Let’s GO™ will coordinate the shipment of the Product, which will be dispensed from the NCDP via overnight delivery.

 

Eligibility Requirements and Limitations

  • The patient must be eighteen (18) years of age or older and have a valid prescription for an approved use of the Product.
  • The patient must be a resident of the United States or the United States Territories.
  • The patient’s annual household income must be less than or equal to three hundred percent (300%) of the federal poverty level for the applicable household size and the patient must lack insurance coverage or have commercial insurance coverage which does not cover the Product. The patient understands, acknowledges, and agrees that the Program will verify the patient’s household size, income, and insurance status, throughout the duration of the patient’s receipt of Product through the Program.
  • For patients eligible, and who have applied, for Medicare Part D coverage, the patient’s annual household income must be less than or equal to three hundred percent (300%) of the federal poverty level for the applicable household size and either: (a) the patient has applied for and been denied Medicare Part D coverage and has no insurance coverage, has no benefits for prescription medicines, or the patient’s insurance plan has formally denied coverage for the Product through a written coverage policy or a written decision as part of a benefits inquiry or prior authorization process and has provided a copy of the denial; or (b) has obtained Medicare Part D coverage for the Product and has applied for the Low Income Subsidy (“LIS”) from the Social Security Administration and has been denied from LIS.
  • The patient must not have insurance coverage for the Product, in whole or in part, either directly or through dependent coverage, under any federal or state government-subsidized health program that is a “federal healthcare program” as defined under 42 U.S.C. § 1320a-7b(f), including, but not limited to, Medicare, Medicaid, TRICARE, the Indian Health Service, the Department of Veterans Affairs Health Benefits, state Children’s Health Insurance Programs under the Title XIX or Title XXI of the Social Security Act, state block grant programs under Title V or Title XX of the Social Security Act, or state pharmaceutical assistance programs, except that, if the patient is a Medicare Part D enrollee, the patient may be eligible if the patient has applied for and been denied the LIS and meets the further conditions specified herein. This Program is not available for patients within a deductible or similar cost sharing periods under such federal healthcare programs.
  • If the patient is a Medicare Part D enrollee that has been denied the LIS, the patient is subject to the following additional conditions in order to receive assistance under the Program: (1) the patient’s annual household income must be less than or equal to three hundred percent (300%) of the federal poverty level for the applicable household size; (2) the patient shall not submit any claim for reimbursement for the Product to any third party, including a Medicare Part D plan or another public or private plan or program, during the period of assistance; (3) the cost of the Product shall not apply or be applied toward the patient’s Medicare Part D True Out-of-Pocket Costs; (4) the patient must inform their Medicare Part D plan about enrollment in the Program and that the patient will receive the Product for free under the Program for the remainder of the coverage year; and (5) the patient must receive free Product through the Program through the end of the calendar year in which assistance is first provided, even if the patient’s use of the Product is periodic during the year.
  • For eligible patients, the Program benefits are limited and subject to a maximum amount of Product within a twelve (12) month period during which the patient meets the eligibility criteria. Eligible patients with Medicare Part D coverage will receive Product through the end of the coverage year. Annual re‑enrollment is required.
  • If the patient may be eligible for Medicaid, either directly or through dependent coverage, then the patient (or their legal representative) is required to provide documentation of Medicaid denial before being assessed for Program eligibility.
  • Product is not available for patients whose health insurance plans, or their employers, vendors or third parties, use alternative funding programs or such similar programs (collectively “AFP”) which LEO Pharma determines may apply to or affect the Program. The patient understands, acknowledges, and agrees that the Program will verify the existence of and/or use of an AFP upon the patient’s enrollment, and any time the patient is a recipient of Product through the Program. Further, by seeking benefits under the Program, the patient authorizes the Program to contact its insurer, employer, or third party, as necessary, solely for the purposes of determining the health insurance plan benefit design with respect to the use of an AFP. LEO Pharma reserves the right to exclude specific payers from the Program, including but not limited to payers that have implemented AFPs or payers that have implemented clear noncoverage policies with respect to the Product.

 

Additional Terms and Conditions

  • The Program does not constitute insurance.
  • The provision of Product does not constitute any guarantee of coverage under any prescription benefit insurance or program.
  • By submitting a request for Product under the Program or by participating in the Program, the HCP acknowledges and agrees that the HCP: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to the patient or any third‑party plan or program, including any commercial or government assistance program; (2) will advise the patient that the patient may not submit a claim to any third‑party program or plan but should report their receipt of Product to the patient’s insurer if required by their plan; (3) will dispense or administer Product solely to the eligible patient for whom such Product was requested; and (4) will not sell, transfer, or otherwise dispense Product to any other third party.
  • By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) acknowledges and agrees that the patient: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to any third‑party plan or program, including any commercial or government assistance program; (2) will report their receipt of Product to their insurer if required by their plan; and (3) will not sell, transfer, or otherwise dispense Product to any other third party.
  • The NCDP only dispenses Product pursuant to the Program. Product prescriptions subject to third‑party insurance, including refill prescriptions, may be dispensed by the pharmacy of the patient’s choice, subject to product distribution and third‑party payer limitations.
  • Patients and/or their HCPs must submit complete information and/or documentation required under the Program and attest to the truthfulness and accuracy of the information and/or documentation.
  • By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) and the HCP individually acknowledge, understand, and agree to the benefit, eligibility, and other program limitations, terms, and conditions as set forth herein.
  • The Health Insurance Portability and Accountability Act of 1996 grants individuals’ rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about the patient, LEO Pharma will use and disclose it according to the patient authorization that the patient (or legal representative) completed for the patient’s HCP in connection with the Program. For more information about how the patient’s PHI is used and disclosed by the patient’s HCP, please review the patient’s HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about the patient that is not PHI, LEO Pharma will use and disclose that personal data as disclosed in the LEO Pharma privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us/privacy-policy). By participating in the Program, the patient (or legal representative) acknowledges that LEO Pharma may collect health information from the patient, which may be considered “sensitive” data under some U.S. state laws.
  • The availability of Product under the Program is not conditioned on any past, present, or future purchase, including any potential future refills of Product.
  • Offer void where prohibited by law, taxed, or restricted.
  • LEO Pharma has sole discretion to determine Program eligibility.
  • LEO Pharma may unilaterally amend, modify, or terminate Program benefits and eligibility criteria at any time and without notice.