Adbry Terms and Conditions | Adbry®

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 designated service provider (“LEO Service Provider”). 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 (each, an “HCP”).

One of the offerings available for the benefit of patients under Adbry Advocate is the Adbry^® Rapid AccessTM 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 who have been prescribed the Product for an approved use and who satisfy the Program eligibility criteria. A patient or their legal representative may enroll in the Program by completing, signing, and submitting the applicable portion of the Adbry Advocate Program Enrollment and Prescription Form. A 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 a non-commercial dispensing pharmacy (“NCDP”) affiliated with the LEO Service Provider. Alternatively, a patient’s HCP may e-prescribe the Product directly to the NCDP, provided the HCP has completed, signed, and submitted an annual Healthcare Provider eRx Program Certification Form. If the HCP e-prescribes the Product directly to the NCDP, the patient or their legal representative must complete, sign, and submit a patient authorization and any other information reasonably requested by the Program in order for Adbry Advocate to verify eligibility and for the patient to receive assistance 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 caregiver may properly inject the Product; and b) the patient or caregiver 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 12 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, 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

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 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 plan or program 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 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 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 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 (“HIPAA”) grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about you, we will use and disclose it according to the patient authorization that you (or legal representative) have completed for your HCP in connection with the LEO Pharma Adbry Advocate Program. For more information about how your PHI is used and disclosed by your HCP, please review your HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about you that is not PHI, we will use and disclose that personal data as disclosed in our privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us). By participating in the LEO Pharma Adbry Advocate Program, you acknowledge that we may collect health information from you, which may be considered “sensitive” data under some U.S. state laws. Moreover, if you are a parent or guardian of a minor participating in the program, you (or legal representative) acknowledge that we may collect data about the participating minor/s, which may also 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 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 designated service provider (“LEO Service Provider”). 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 provider (“HCP”).

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 its prescribing information, without charge and on a periodic basis, to commercially insured patients who have been prescribed the Product 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 Adbry Advocate 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. Alternatively, a patient’s HCP may e-prescribe the Product directly to the NCDP, provided the HCP has completed, signed, and submitted an annual Healthcare Provider eRx Program Certification Form. If the HCP e-prescribes the Product directly to the NCDP, the patient or their legal representative must complete, sign, and submit a patient authorization and any other information reasonably requested by the Program in order for Adbry Advocate to verify eligibility and for the patient to receive assistance 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 caregiver may properly inject the Product; and b) the patient or caregiver 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 12 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, 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 more than seven (7) business 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 (i.e., 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 (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.

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, for a maximum of six (6) months of shipment of Product, on a periodic basis, within a twenty-four (24) month consecutive time period commencing on the initial date of dispense for such patient’s lifetime, or until such 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 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 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 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 Adbry Advocate.
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 (“HIPAA”) grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about you, we will use and disclose it according to the patient authorization that you (or legal representative) have completed for your HCP in connection with the LEO Pharma Adbry Advocate Program. For more information about how your PHI is used and disclosed by your HCP, please review your HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about you that is not PHI, we will use and disclose that personal data as disclosed in our privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us). By participating in the LEO Pharma Adbry Advocate Program, you acknowledge that we may collect health information from you, which may be considered “sensitive” data under some U.S. state laws. Moreover, if you are a parent or guardian of a minor participating in the program, you acknowledge that we may collect data about the participating minor/s, which may also 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.

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 designated service provider. 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 provider (“HCP”).

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 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 Copay Program either by 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 thirteen thousand U.S. dollars ($13,000.00) per eligible patient.
The patient must be 12 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, 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.
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 (“HIPAA”) grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about you, we will use and disclose it according to the patient authorization that you (or legal representative) have completed for your HCP in connection with the LEO Pharma Adbry Advocate Program. For more information about how your PHI is used and disclosed by your HCP, please review your HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about you that is not PHI, we will use and disclose that personal data as disclosed in our privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us). By participating in the LEO Pharma Adbry Advocate Program, you acknowledge that we may collect health information from you, which may be considered “sensitive” data under some U.S. state laws. Moreover, if you are a parent or guardian of a minor participating in the program, you (or legal representative) acknowledge that we may collect data about the participating minor/s, which may also 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.

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 are operated by LEO Pharma’s designated service provider (“LEO Service Provider”). 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 provider (“HCP”).

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 or their legal representative may enroll in the Program by completing, signing, and submitting the applicable portion of the Adbry Advocate 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. Alternatively, a patient’s HCP may e-prescribe the Product directly to the NCDP, provided the HCP has completed, signed, and submitted an annual Healthcare Provider eRx Program Certification Form. If the HCP e-prescribes the Product directly to the NCDP, the patient or their legal representative must complete, sign, and submit a patient authorization and any other information reasonably requested by the Program in order for Adbry Advocate to verify eligibility and for the patient to receive assistance under the Program. A patient requesting assistance under the PAP (or their legal representative) 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 caregiver may properly inject the Product; and b) the patient or caregiver 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 12 years of age or older with a valid prescription for the Product.
The patient must be a resident of the United States or Puerto Rico.
The patient’s annual household income must be less than or equal to four hundred percent (400%) 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, 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 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; (3) 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; (4) the patient must spend at least four percent (4%) of their 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 (12) 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, 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.

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 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 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 (“HIPAA”) grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about you, we will use and disclose it according to the patient authorization that you (or legal representative) have completed for your HCP in connection with the LEO Pharma Adbry Advocate Program. For more information about how your PHI is used and disclosed by your HCP, please review your HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about you that is not PHI, we will use and disclose that personal data as disclosed in our privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us). By participating in the LEO Pharma Adbry Advocate Program, you (or legal representative) acknowledge that we may collect health information from you, which may be considered “sensitive” data under some U.S. state laws. Moreover, if you are a parent or guardian of a minor participating in the program, you acknowledge that we may collect data about the participating minor/s, which may also 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.

SMS Terms of Use

By registering for the Adbry® Advocate™ Program, you are agreeing to receive an opt-in SMS message from Adbry Alerts. Opt-in to Adbry Alerts to receive patient support SMS messages by replying "ADBRY". You will then receive a message confirming your enrollment. Message and data rates may apply. Message frequency may vary.
You can opt out of Adbry Alerts at any time by replying "STOP". You will receive a message confirming that you have unsubscribed from Adbry Alerts and will no longer be sent marketing messages about Adbry from LEO Pharma Inc.
You can reply "HELP" at any time to receive additional information about Adbry Alerts. You can also call 844-MY-ADBRY (844-692-3279) & visit Adbry.com.
T-Mobile is not liable for delayed or undelivered messages.
LEO Pharma Inc. will not be liable for any delayed or undelivered SMS messages.
Consent to receive marketing text messages about Adbry from LEO Pharma Inc. is not required as a condition of purchasing any goods or services. Texts may be sent using an automatic telephone dialing system.
Message and data rates may apply for any messages sent to you from LEO Pharma Inc. and to LEO Pharma Inc. from you throughout your participation in Adbry Advocate Alerts. If you have any questions about your text plan or data plan, please contact your wireless provider.
Support carriers include but are not limited to AT&T, Sprint/Boost/Virgin, T-Mobile/MetroPCS, Verizon Wireless.

INDICATION

What is ADBRY?

ADBRY® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
It is not known if ADBRY is safe and effective in children under 12 years of age.

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

Please see full Prescribing Information, including Patient Information and Instructions for Use.

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

What should I discuss with my healthcare provider before starting ADBRY?

Tell your healthcare provider about all your medical conditions, including if you:

have eye problems.
have a parasitic (helminth) infection.
are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ADBRY?

See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes and autoinjectors.
Use ADBRY exactly as prescribed by your healthcare provider.
Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector.
ADBRY is given as an injection under the skin (subcutaneous injection).
If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult.
If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
If you inject too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects, including:

Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
- breathing problems
- itching
- skin rash
- swelling of the face, mouth, and tongue
- fainting, dizziness, feeling lightheaded (low blood pressure)
- hives

Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

Upper respiratory tract infections
Eye and eyelid inflammation, including redness, swelling, and itching
Injection site reactions
High count of a certain white blood cell (eosinophilia)

These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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