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.