Terms and Conditions

BRONCHITOL^® (mannitol) inhalation powder $0 Co-Pay Assistance Program Terms and Conditions

The Chiesi CareDirect BRONCHITOL $0 Co-Pay Assistance Program (the “Co-pay Program”) may pay for eligible out-of-pocket medication, up to $10,320 per calendar year. After reaching the maximum Co-pay Program benefit, the patient will be responsible for any remaining out-of-pocket costs incurred during that calendar year.

The Co-pay Program is valid only for patients with commercial insurance who have a valid prescription for a US Food and Drug Administration-approved indication for the product. A patient who receives health care benefits under any plan or program funded in whole or in part by federal or state governments including Medicare, Medicaid, TRICARE, Veterans Affairs (VA), State Prescription Assistance Plans (SPAPs) (other than health insurance for federal government employees) or any state health care program such as Medicaid, Children’s Health Insurance Program, programs funded under Maternal and Child Health Program or programs funded under Social Services Block Grant are not eligible for the Co-pay Program. A patient covered under a commercial health plan purchased through a health insurance marketplace or exchange is not a Government Program Beneficiary even if the costs of such coverage are subsidized by the federal government.

To enroll in the Co-pay Program, the eligible patient must fill their prescription at a Specialty Pharmacy contracted with Chiesi to provide co-pay services, or enroll in Chiesi CareDirect, a patient services support program offered by Chiesi. The patient must also be a resident of the US or one of its territories. If the Patient is incapable of acting on their own behalf or if the Patient is under 18 years old, enrollment into Chiesi CareDirect may be completed by another person acting on their behalf (such as a caregiver).

If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to participate in the Co-pay Program and patient must notify their Specialty Pharmacy or Chiesi CareDirect to stop participation.

Patients residing in or receiving treatment in certain states may not be eligible for the Co-pay Program. Co-pay Program is not available in California or Massachusetts when an AB-rated equivalent to the product is commercially available. Patients may not seek reimbursement for value received from Chiesi CareDirect or from the Co-pay Program. The Co-pay Program does not obligate the use of any specific medication or health care provider. Participation in the Co-pay Program is not conditioned on any past, present, or future purchase.

The Co-pay Program benefits may not be sold, purchased, traded, or offered for sale, purchase, or trade. The Co-pay Program is not valid where prohibited by law, taxed, or otherwise restricted. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance.

This is a voluntary program. Patients who choose not to enroll in the Co-pay Program will still be able to receive medication. Patients may participate in Chiesi CareDirect without participating in the Co-pay Program. After enrolling in the Co-pay Program or in Chiesi CareDirect, participants may opt out by contacting Chiesi CareDirect, as outlined in the Consent and HIPAA Authorization section of the Chiesi CareDirect Service Request and Prescription Form or by contacting the TrialCard Help Desk at 866-762-6235. Patients must renew their eligibility by December 31 of each year to continue to receive support under the Co-pay Program.

By participating in the Co-pay Program, participants acknowledge that they understand and agree to comply with these Terms and Conditions.

BRONCHITOL Chiesi CareDirect Patient Assistance Program Eligibilty and Terms and Conditions

• Patient must be enrolled in Chiesi CareDirect. To enroll, please click here. For additional details, please see the Chiesi CareDirect Patient Assistance Program Application
• Patient has a valid prescription for a US Food and Drug Administration (FDA)-approved indication for BRONCHITOL. To access Prescribing Information for BRONCHITOL click here
• Patient does not receive health care benefits from a federal or state-funded plan or program. Patients with Medicare Part D may be eligible for this program. Please see additional requirements for Medicare Part D patients below
• Patient is uninsured or underinsured (lack of coverage for their medication)
  • If patient has commercial insurance, they may be eligible for the BRONCHITOL $0 Co-Pay Assistance Program
• Patient must have an annual household income that does not exceed 450% of the current Federal Poverty Level (FPL)*
  • Click here to access current FPL guidelines in the United States (US) and its territories
• Patient must be a resident of the US or one of its territories

*Please refer to the full Terms and Conditions below for additional eligibility requirements.

Qualified patients may be eligible to receive medication at no cost through the Chiesi CareDirect Patient Assistance Program (“Patient Assistance Program”). Financial eligibility of uninsured or underinsured patients who are permanent residents of the United States or one of its territories will be determined by the US Federal Poverty Guidelines https://aspe.hhs.gov/poverty-guidelines. Patient must attest that no change in their income has occurred and a verification of coverage will occur before each prescription fill. Patient must notify Chiesi CareDirect if there is a change in their insurance or their prescription drug plan.

A patient who receives health care benefits under any plan or program funded in whole or in part by federal or state governments including Medicaid, TRICARE, Veterans Affairs (VA), State Prescription Assistance Plans (SPAPs) (other than health insurance for federal government employees) or any state health care program such as Medicaid, Children’s Health Insurance Program, programs funded under Maternal and Child Health Program or programs funded under Social Services Block Grant are not eligible for the Patient Assistance Program. A patient covered under a commercial health plan purchased through a health insurance marketplace or exchange is not a Government Program Beneficiary even if the costs of such coverage are subsidized by the federal government. Medicare Part D Patients: A patient receiving health care benefits under a Medicare Part D, and if approved for assistance under the Chiesi CareDirect Patient Assistance Program, agrees that they will not apply the cost of the BRONCHITOL (the “Product”) toward any insurance benefit or seek reimbursement for the cost of the Product received under the program from the insurer. Patient also agrees that they will not seek to have the Product, or any cost associated with the Product applied towards true out-of-pocket (“TrOOP”) costs. Patient understands that eligible Medicare Part D enrollees will receive the Product at no charge under the Patient Assistance Program for the remainder of the current calendar year. Patient also understands that Chiesi CareDirect will notify the Medicare Part D plan that the patient is receiving the Product at no charge under the program and no payments should be made for the Product by the Medicare Part D Plan and no part of the costs of the Product should be applied toward the TrOOP accrued by the patient. This notice is provided for plan information purposes – Chiesi CareDirect will never submit a claim for Product provided under the program to the patient’s Medicare Part D plan.

To enroll in the Patient Assistance Program, the patient must also enroll in Chiesi CareDirect, a patient services support program offered by Chiesi. The patient must also be a resident of the US or one of its territories. If the Patient is incapable of acting on their own behalf or if the Patient is under 18 years old, enrollment into Chiesi CareDirect may be completed by another person acting on their behalf (such as a caregiver).

If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to participate in the Patient Assistance Program and patient must notify Chiesi CareDirect to stop participation.

To determine financial eligibility, patient will be asked to provide the size of the household, annual household income, and proof of income. Proof of income may include W2 form(s), paycheck stubs, and/or prior year tax returns.

Patients residing in or receiving treatment in certain states may not be eligible for the Patient Assistance Program. Patients may not seek reimbursement for value received from Chiesi CareDirect or from the Patient Assistance Program. The Patient Assistance Program does not obligate the use of any specific medication or health care provider. Participation in the Patient Assistance Program is not conditioned on any past, present, or future purchase.

The Patient Assistance Program benefits may not be sold, purchased, traded, or offered for sale, purchase, or trade. The Patient Assistance Program is not valid where prohibited by law, taxed, or otherwise restricted. Offer subject to change or discontinuance without notice. Restrictions may apply. This is not health insurance.

This is a voluntary program. Patients who choose not to enroll in the Patient Assistance Program will still be able to receive medication. Patients may participate in Chiesi CareDirect without participating in the Patient Assistance Program. After enrolling in the Patient Assistance Program or in Chiesi CareDirect, participants may opt out by contacting Chiesi CareDirect, as outlined in the Chiesi CareDirect Enrollment and Authorization Form. Patients must renew their eligibility by December 31 of each year to continue to receive support under the Patient Assistance Program.

By participating in the Patient Assistance Program, participants acknowledge that they understand and agree to comply with these Terms and Conditions.