Dear HAEA Friends,

Dear HAEA Friends,

As highlighted in a previous communication, we are facing unfortunate and unprecedented circumstances that threaten access to HAE medicine for some members of our community. The situation is driven by sudden changes in the availability of charitable financial assistance – until now, an uninterrupted resource for helping HAEA friends afford their medicine and insurance premiums for the past 15 years. These changes are due to (1) Accessia Health (formerly PSI) dramatically decreasing the amount of financial assistance they offer, and (2) The Assistance Fund significantly reducing the number of people with HAE that they support.

The HAEA has vigorously engaged in direct and urgent communication with these charitable organizations to understand the reason for the sudden changes in assistance that threaten access to life-saving therapies. Despite our best efforts, the only information we have been able to obtain was included in one of the letters sent to our community that stated “…patients seeking assistance have increased significantly…”

As your advocates, fellow patients, and caregivers, we are gravely concerned when an HAEA friend loses access to their medicine. The HAEA Health Team has contacted a variety of charitable organizations with the hope of finding alternative sources of financial assistance for our community. At this time, however, none of the charities have resources available for people with HAE.

We do have some important information and suggestions based on the work we have performed to date.

The most immediate threat appears to be the loss of charitable financial assistance for copays. It is very important to note that the rules governing copays for HAE medicines are very different for people who have (1) commercial, employer-based insurance (including the Affordable Care Act Exchange plans), versus (2) public programs such as Medicare and Medicaid. Below, we address each situation separately.

Commercial / Employer-Based Insurance Plans

If you can no longer afford your copay due to changes in charitable assistance provided by Accessia Health and/or The Assistance Fund, you are eligible for the manufacturer’s copay assistance program. We recommend you contact the manufacturer of the product you have been prescribed through their hub (contact information provided below) and request to be part of their copay assistance program.

  • BioCryst - Empower (866) 536-7693
  • CSL Behring - Haegarda Connect (844) 423-4273
  • Pharming - Ruconest Solutions (855) 613-4423
  • Takeda - One Path (866) 888-0660

Public Insurance Programs -- Medicare and Medicaid

Unfortunately, the situation is very different for HAEA friends that are insured through Medicare or Medicaid because federal law prohibits manufacturers from providing you with copay assistance. Financial assistance for HAEA community members on public insurance programs can only be provided by charitable organizations.

Below are some steps that can be taken by our fellow HAEA friends on Medicare/Medicaid.

  1. Some pharmaceutical companies have programs available to provide medicines when one of their patients encounters a circumstance when therapy can no longer be afforded. Publicly available information doesn’t indicate which, if any, manufacturers of HAE therapies offer this form of assistance. It would appear that HAEA friends on Medicare and Medicaid who can no longer pay for their therapy would be eligible for this type of manufacturer program because it is a donation and not a copay assistance program. We recommend you call the manufacturer’s hub (see list provided above) and ask if the Company will help when THEIR patients, due to circumstances beyond anyone’s control, can no longer afford medicine.

  2. Clinical Trials can offer free access to HAE medicines being studied until they are approved and commercially available. Please contact our HAE Health Advocates at (877) 839-4232 to learn more about one of the 3 clinical trials taking place. We can provide a referral to whatever trial you choose.

    • The Ionis OASIS-HAE Plus trial is a phase 3, open-label (medicine is provided, there is no placebo) study testing the safety and effectiveness of donidalorsen, the company’s preventive HAE therapy that is delivered by subcutaneous injection. Trial participants must be 12 years of age and older. Data from clinical trials already completed showed that patients given donidalorsen once every 4 weeks had a mean reduction in attack rate of 98.3% after taking a second dose. No serious adverse events were reported and there were no abnormalities observed in laboratory measurements.

    • The KalVista Konfident trial is a Phase 3 placebo controlled clinical trial, evaluating the safety and efficacy of two different doses of sebetralstat as an on-demand oral tablet for HAE attacks. The trial is open to adults and adolescents 12 years of age and older who have had at least 2 HAE attacks in the previous 3 months. Data from clinical trials already completed show that when compared to placebo, attacks treated with sebetralstat achieved symptom relief more quickly, and significantly reduced time to onset of symptom relief. There were no serious adverse events reported in trials and no patients withdrew due to adverse events.

    • The BioMarin HAERMONY1 study is a phase 1 / 2 trial testing an investigational gene therapy called BMN 331 to improve HAE symptoms. To qualify for the HAERMONY1 study, participants must be 18 years of age or older; diagnosed with HAE due to C1-INH deficiency; have 6 months of a continuous prophylaxis or on-demand treatment regimen (prior to study enrollment); and a documented attack frequency of at least 1 attack per month on average.

  3. If you are receiving Social Security you can register with the ‘Extra Help’ program HERE. According to the eligibility requirements, you can complete an application for ‘Extra Help’ if, “Your combined savings, investments, and real estate are not worth more than $33,240, and you are married and living with your spouse, or $16,660 if you are not currently married or not living with your spouse.”

  4. Make sure you are on the waitlist for both Accessia Health and The Assistance Fund. Although these organizations are not accepting new applications at this time, you will be on the waitlist should additional funds become available, and they will be able to contact you directly.

    • Accessia Health - (800) 366-7741
    • The Assistance Fund - (855) 845-3663

Finally, your health is of the utmost importance. Please let your HAE physician know about the situation you are facing, especially if you are not able to access your medication(s). It is important you have a copy of your current treatment plan and a letter from your physician in case of an emergency.

The HAEA will keep in touch as we continue working feverishly on your behalf to resolve this truly awful situation. Please do not hesitate to contact our Health Team at (877) 839-4232 should you have any questions.

Warm regards,

Tony Castaldo

Tony Castaldo

US HAEA President & CEO

The HAEA is an advocacy and research organization committed to actively engaging our community in a wide variety of grassroots activities that promote HAE education and awareness. We provide personalized services to address the unique needs of people with HAE and their families, which includes helping them secure access to and reimbursement for modern HAE medicines. Our great success in supporting clinical research has resulted in a variety of FDA-approved therapeutic options. We work closely with expert physicians to continuously upgrade our community’s quality of life through improving diagnosis and knowledge of the condition, and encourage an individualized approach to selecting an optimal treatment. The HAEA is product and company neutral and continues to enthusiastically support drug discovery research aimed at the next generation of HAE therapies. Copyright © (2023) US Hereditary Angioedema Association All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, mechanical, electronic, photocopying, recording, or otherwise without the prior written permission of the US Hereditary Angioedema Association. For information, send an email to