The Alpha-1 Foundation proudly joins the broad coalition of more than 200 organizations endorsing the Safe Step Act and stand ready to support this bipartisan leadership in championing this critical patient protection.
Dear Representatives Rick, Ruiz, Miller-Meeks, McBath, and Onder:
On behalf of the Alpha-1 Foundation and the more than 100,000 Americans affected by Alpha-1 Antitrypsin Deficiency (“Alpha-1”), I write to express our strong support for HR 5509.
Alpha-1 is a genetic condition that can cause severe, early-onset chronic obstructive pulmonary disease (COPD) and liver disease. For individuals living with Alpha-1-related COPD, timely access to the right medications—including inhalers, augmentation therapy, and other supportive treatments—can mean the difference between stability and rapid decline. Step therapy protocols, which require patients to “fail first” on cheaper or less effective drugs before gaining access to the therapy their physician prescribes, can have devastating consequences for Alpha-1 patients.
For example, many Alphas rely on specific inhaled medications to manage breathlessness, prevent exacerbations, and maintain quality of life. Forcing patients to cycle through inappropriate inhalers or systemic drugs not only delays effective care but can also cause adverse reactions, unnecessary hospitalizations, or irreversible loss of lung function. Once lung tissue is destroyed in Alpha-1-related COPD, it cannot be restored. Delays in access to proper medication can therefore have lifelong consequences. Your legislation provides essential protections for patients by:
· Establishing a clear and transparent exemption process for step therapy requirements.
· Allowing exceptions when a patient has already tried and failed a drug, faces risk of harm, or is stable on their current therapy; and
· Requiring timely responses to exemption requests—72 hours under normal circumstances and 24 hours in urgent, life-threatening cases. These reforms will ensure that Alpha-1 patients and others living with chronic and rare diseases can access the therapies their physicians know are most effective for them, without unnecessary delays or risks. The Alpha-1 Foundation thanks you for your bipartisan leadership in championing this critical patient protection. We are proud to join the broad coalition of more than 200 organizations endorsing the Safe Step Act and stand ready to support its passage in any way we can.
Sincerely,
Scott Santarella, President and CEO, Alpha-1 Foundation
