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Full Terms, Conditions, and Eligibility Rules

Adbry® Rapid Access™ Program – Program Summary and Terms & Conditions.

LEO Pharma Inc. (“LEO Pharma”) is the distributor of Adbry® (tralokinumab-ldrm) injection (the “Product”). LEO Pharma sponsors the Adbry® Advocate™ patient access programs (Adbry Advocate) which are operated by LEO Pharma’s service provider – PharmaCord LLC. The purpose of Adbry Advocate is to help ensure that medically appropriate patients have access to the medication that has been prescribed for them by their treating healthcare providers.

One of the offerings available for the benefit of patients under Adbry Advocate is the Adbry Rapid Access Program (the “Program”). Under the Program, Adbry Advocate will provide the initial or “loading” dose of the Product, consistent with the prescribing information for the Product, without charge, to commercially insured patients that have been prescribed the Product for an approved use and who meet the Program eligibility criteria. A patient may enroll in the Program by completing, signing, and submitting the applicable portion of the Adbry Advocate Program Enrollment and Prescription Form. A healthcare provider (“HCP”) may prescribe the initial dose of 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 the non-commercial dispensing pharmacy (NCDP) affiliated with PharmaCord LLC.

After the prescription is received by the NCDP and the patient’s eligibility for the Program is verified, the Product may be delivered to the prescribing HCP’s office. Alternatively, if: a) the HCP decides that the patient or caregiver may properly give injections of the Product; and b) the patient or caregiver has received training on the proper preparation and injection of the Product, then the Product may be delivered to the patient’s address of record or other location mutually agreed upon by Adbry Advocate and the patient or patient’s caregiver. In the event of delivery to the prescribing HCP’s office, the Product can usually be delivered in as little as forty-eight (48) hours. In the event of delivery to the patient’s address of record or other mutually agreed upon location, Adbry Advocate will coordinate the shipment of the Product which may extend the delivery time. Product will be dispensed from the NCDP via overnight delivery.

Eligibility Requirements and Limitations

  • Patients who have been initiated on therapy with samples are not eligible for Rapid Access Program Product.
  • The patient must be 18 years of age or older with a valid prescription for an approved use of the Product.
  • The patient must be a resident of the United States or Puerto Rico.
  • The patient must have commercial insurance.
  • The patient must not have prescription drug coverage for the Product, in whole or in part, 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

  • Good for the initial dose only. Limit of one shipment of Product per eligible patient.
  • The Program does not constitute insurance.
  • The provision of the initial dose 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 healthcare provider acknowledges and agrees that he or she: (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 he or she may not submit a claim to any third-party plan or program but should report his or her receipt of Product to the patient’s insurer if required by his or her 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 acknowledges and agrees that he or she: (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 his or her receipt of Product to his or her insurer if required by his or her plan; and (3) will not sell, transfer, or otherwise dispense Product to any other third party.
  • The NCDP only dispenses Product pursuant to the Adbry Advocate patient access programs. 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 healthcare providers 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, each of the patient and the healthcare provider acknowledges, understands and agrees 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.
  • Offer void where prohibited by law, taxed, or restricted.
  • LEO Pharma has sole discretion to determine Program eligibility.
  • LEO Pharma may amend, modify, or terminate Program benefits and eligibility criteria at any time and without notice.

Adbry® Bridge Care™ Program – Program Summary and Terms & Conditions

LEO Pharma Inc. (“LEO Pharma”) is the distributor of Adbry® (tralokinumab-ldrm) injection (the “Product”). LEO Pharma sponsors the Adbry® Advocate™ patient access programs (Adbry Advocate) which are operated by LEO Pharma’s service provider – PharmaCord LLC. The purpose of Adbry Advocate is to help ensure that medically appropriate patients have access to the medication that has been prescribed for them by their treating healthcare providers.

One of the offerings available for the benefit of patients under Adbry Advocate is the Adbry® Bridge Care™ Program (the “Program”). Under the Program, Adbry Advocate will provide the Product, consistent with the prescribing information for the Product, without charge and on a periodic basis, to commercially insured patients that have been prescribed the Product for an approved use and who satisfy the Program’s eligibility criteria, after experiencing an initial delay, as defined below, in securing a determination of insurance coverage for the Product. A patient may enroll in the Program by completing, signing, and submitting the applicable portion of the Adbry Advocate Program Enrollment and Prescription Form. A healthcare provider (“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 the non-commercial dispensing pharmacy (NCDP) affiliated with PharmaCord LLC.

After the prescription is received by the NCDP and the patient’s eligibility for the Program is verified, the Product may be delivered to the prescribing HCP’s office. Alternatively, if: a) the HCP decides that the patient or a caregiver may properly give injections of the Product; and b) the patient or caregiver has received training on the proper preparation and injection of the Product, then the Product may be delivered to the patient’s address of record or other location mutually agreed upon by Adbry Advocate and the patient or patient’s caregiver. In the event of delivery to the patient’s address of record or other mutually agreed upon location, Adbry Advocate will coordinate the shipment of the Product which may extend the delivery time. Product will be dispensed from the NCDP via overnight delivery.

Eligibility Requirements and Limitations

  • The patient must be 18 years of age or older with a valid prescription for an approved use of the Product.
  • The patient must be a resident of the United States or Puerto Rico.
  • The patient must have commercial insurance.
  • The patient must not have prescription drug coverage for the Product, in whole or in part, 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
  • Uninsured and cash-paying patients are not eligible.
  • The patient must experience either:
    • A delay of more than five (5) days in securing an insurance coverage determination (i.e. the actual submission of a request for coverage determination, such as a prior authorization request) either at therapy initiation or in connection with a change in insurance provider or coverage (e.g., due to a change in employment); or
    • A denial of insurance coverage based on a prior authorization request — either at therapy initiation or in connection with a change in insurance provider or coverage (e.g., due to a change in employment) – for which an appeal of the coverage denial, on behalf of the patient, has been submitted or will be submitted within thirty (30) days of such denial.

Additional Terms and Conditions

  • The Program does not constitute insurance.
  • The provision of the initial dose of Product does not constitute any guarantee of coverage under any prescription benefit insurance or program.
  • For each eligible patient, the Program provides Product, without charge, on a periodic basis, to such patient for up two (2) years or until the patient receives insurance coverage approval, whichever occurs earlier.
  • After eligibility is verified and the prescription is received by the NCDP, the NCDP will ship a supply of Product, in amounts to be determined in the sole discretion of Adbry Advocate, to the prescribing HCP’s office, or to the patient, as explained above.
  • On a regular basis, Adbry Advocate 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. The NCDP will ship additional supplies of Product, in amounts to be determined in the sole discretion of Adbry Advocate, 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 healthcare provider acknowledges and agrees that he or she: (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 he or she may not submit a claim to any third-party plan or program but should report his or her receipt of Product to the patient’s insurer if required by his or her 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 acknowledges and agrees that he or she: (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 his or her receipt of Product to his or her insurer if required by his or her plan; and (3) will not sell, transfer, or otherwise dispense Product to any other third party.
  • The NCDP only dispenses Product pursuant to the Adbry Advocate patient access programs. 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 healthcare providers 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, each of the patient and the healthcare provider acknowledges, understands and agrees 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.
  • Offer void where prohibited by law, taxed, or restricted.
  • LEO Pharma has sole discretion to determine Program eligibility.
  • LEO Pharma may amend, modify, or terminate Program benefits and eligibility criteria at any time and without notice.

Adbry® Copay Program – Program Summary and Terms & Conditions

LEO Pharma Inc. (“LEO Pharma”) is the distributor of Adbry® (tralokinumab-ldrm) injection (“the “Product”). LEO Pharma sponsors the Adbry® Advocate™ patient access programs (Adbry Advocate) which are operated by LEO Pharma’s service provider – PharmaCord LLC. The purpose of Adbry Advocate is to help ensure that medically appropriate patients have access to the medication that has been prescribed for them by their treating health care providers.

The Adbry® 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 as may be adjusted from time to time in the sole discretion of the Program. 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 may enroll in the Copay Program either through enrolling in Adbry Advocate or via other means provided by LEO Pharma, such as via the Product website or via specialty pharmacies contracted with LEO Pharma to dispense the Product.

Eligibility Requirements and Limitations

  • The current annual maximum benefit available under the Program is fifteen thousand dollars ($15,000.00) per eligible patient.
  • The patient must be 18 years of age or older with a valid prescription for an approved use of the Product.
  • The patient must be a resident of the United States or Puerto Rico.
  • The patient must have commercial insurance.
  • The patient must not have prescription drug coverage for the Product, in whole or in part, 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
  • 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.
  • By submitting a request for Product under the Program or by participating in the Program, the healthcare provider acknowledges and agrees that he or she: (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 he or she may not submit a claim to any third-party plan or program but should report his or her receipt of Product to the patient’s insurer if required by his or her 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 healthcare provider acknowledges and agrees that he or she: (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 he or she may not submit a claim to any third-party plan or program but should report his or her receipt of Product to the patient’s insurer if required by his or her 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.
  • Patients and/or their healthcare providers 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, each of the patient and the healthcare provider acknowledges, understands and agrees 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 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 amend, modify, or terminate Program benefits and eligibility criteria at any time and without notice.

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

LEO Pharma Inc. (“LEO Pharma”) is the distributor of Adbry® (tralokinumab-ldrm) injection (the “Product”). LEO Pharma sponsors the Adbry® Advocate™ patient access programs (“Adbry Advocate”) which is operated by LEO Pharma’s service provider – PharmaCord LLC. The purpose of Adbry Advocate is to help ensure that medically appropriate patients have access to the medication that has been prescribed for them by their treating healthcare providers.

One of the offerings available for the benefit of patients under Adbry Advocate is the Adbry® Patient Assistance Program (the “Program” or “PAP”). Under the Program, Adbry Advocate 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. Adbry Advocate will provide the Product without charge to eligible patients on a periodic basis and consistent with the prescribing information for the Product. A patient may enroll in the Program by completing, signing, and submitting the applicable portion of the Adbry Advocate Program Enrollment and Prescription Form. A healthcare provider (“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 the noncommercial dispensing pharmacy (NCDP) affiliated with PharmaCord LLC. A patient requesting assistance is also required to submit information and documentation concerning household size and income and insurance status to allow Adbry Advocate 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 may be delivered to the prescribing HCP’s office. Alternatively, if: a) the HCP decides that the patient or a caregiver may properly give injections of the Product; and b) the patient or caregiver has received training on the proper preparation and injection of the Product, then the Product may be delivered to the patient’s address of record or other location mutually agreed upon by Adbry Advocate and the patient or patient’s caregiver. In the event of delivery to the patient’s address of record or other mutually agreed upon location, Adbry Advocate will coordinate the shipment of the Product which may extend the delivery time. Product will be dispensed from the NCDP via overnight delivery.

Eligibility Requirements and Limitations

  • The patient must be 18 years of age or older with a valid prescription for an approved use of the Product.
  • The patient must be a resident of the United States or Puerto Rico.
  • The patient’s annual income must be less than or equal to 600% of the federal poverty level for the applicable household size.
  • The patient either: (a) has Medicare Part D coverage and has applied for and been denied the Low Income Subsidy (LIS) from the Social Security Administration and meets the further conditions below; or (b) has no insurance coverage, 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.
  • The patient must not have insurance coverage for the Product, in whole or in part, 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 below. 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 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; (2) the cost of the Product shall not apply or be applied toward the patient’s Medicare Part D True Out-of-Pocket Costs (“TrOOP”); (3) the patient must inform his/her 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; (4) the patient must spend at least four percent (4%) of his or her annual household income on prescription medications covered through the Part D plan in the current calendar 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.
  • Eligible patients without Medicare Part D coverage will receive up to twelve months of Product without charge from the date of enrollment. 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, then the patient is required to provide documentation of Medicaid denial before being assessed for Program eligibility.

Additional Terms and Conditions

  • The Program does not constitute insurance.
  • The provision of services under the Program 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 healthcare provider acknowledges and agrees that he or she: (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 he or she may not submit a claim to any third-party plan or program but should report his or her receipt of Product to the patient’s insurer if required by his or her 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 acknowledges and agrees that he or she: (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 his or her receipt of Product to his or her insurer if required by his or her plan; and (3) will not sell, transfer, or otherwise dispense Product to any other third party.
  • The NCDP only dispenses Product pursuant to the Adbry Advocate patient access programs. 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 healthcare providers 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, each of the patient and the healthcare provider acknowledges, understands and agrees 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.
  • Offer void where prohibited by law, taxed, or restricted.
  • LEO Pharma has sole discretion to determine Program eligibility.
  • LEO Pharma may amend, modify, or terminate Program benefits and eligibility criteria at any time and without notice.