Advocacy Corner: Court Ruling Favors Access to Therapies for Rare Disease

On October 2nd, 2023, a federal court struck down a rule that allowed health insurers to exclude manufacturer and charitable assistance organization copay assistance from counting toward a health plan’s deductible or maximum out-of-pocket limit. The court ruling is a positive step to ensure access to affordable therapies for the rare disease and HAE communities.To read the final order of this ruling, click here.

However, we must continue to push for the HELP Copays Act to ensure that copay accumulator policies are permanently removed. You can support this legislation by writing a letter to your legislators on VoterVoice here.

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Don’t Miss the Deadline to Re-Enroll In Charitable Assistance

If you are enrolled with a charitable assistance program such as The Assistance Fund (TAF) or Accessia Health, you are required to re-enroll each calendar year. It is important to know when your re-enrollment dates are coming up, and ensure you complete the necessary steps during the process to secure continued assistance. Below is a list of helpful information and reminders about the re-enrollment process and requirements.

The Assistance Fund (TAF)
Re-enrollment for TAF assistance occurs in the last quarter of the year (November – December). People with HAE currently enrolled in the program must submit their re-enrollment applications between November 1 and November 17, and will be notified by December 31, 2023 if the application has been accepted.

All patients will receive re-enrollment information and instructions from TAF on November 29 by email.

If you are currently enrolled in charitable assistance with TAF, please keep an eye out for re-enrollment communications in early October. If you have any questions, you can reach out to TAF directly at (833) 343-2148 or by visiting their website at www.tafcares.org.

Accessia Health

HAEA friends already receiving active assistance from Accessia Health must go through an eligibility review every 24 months. Everyone receiving assistance from Accessia Health can find their eligibility review date by logging into the patient portal at www.accessiahealth.org and clicking on “patient portal” at the top. You can also reach Accessia Health directly at (800) 366-7741 with any questions.

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Choose the Best Health Insurance Option for You in 2024

We encourage you to take some time to evaluate and compare your options to figure out which one is most suitable for you. The HAEA Health Team is available to help you navigate the selection process and find the best option available to you.

Medicare recipients:
Open Enrollment Period is from October 15th – December 7th each year, when you can join, switch, or drop a plan. Your coverage will begin on January 1st (as long as the plan gets your request by December 7th).

Medicare Advantage Open Enrollment Period: January 1st – March 31st each year. If you're enrolled in a Medicare Advantage Plan, you can switch to a different Medicare Advantage Plan or switch to Original Medicare (and join a separate Medicare drug plan) once during this time. Note: You can only switch plans once during this period.

ACA (Affordable Care Act):

Open Enrollment runs from Wednesday, November 1st through Friday, December 15th with coverage beginning on January 1, 2024.

If you don’t enroll in a plan by December 15th, you will be unable to get 2024 coverage unless you qualify for a Special Enrollment Period.

Employer sponsored plans: Each employer sets their enrollment dates so it is important to review and research the plans offered with your Human Resources department to ensure the plan you choose offers the best coverage for you.

The HAEA Health Team is ready to lend you a hand as you review, research and select an insurance plan.

With the holidays fast approaching, it is important to plan ahead to ensure your medications arrive on time during the busy shipping season. Connect with your manufacturer’s patient support team as well as your specialty pharmacy to reorder your medications before the holiday season gets too busy.

The HAEA Health Team is always here for you! Please reach out to us at 866-798-5598 for assistance with: 1) insurance issues, 2) finding an HAE expert physician, 3) updating your member information, 4) joining a virtual support group, or 5) an HAE-related question.

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Brighten the Future for HAEA Youth Through the Families4HAE Campaign

HAE can be painful, disfiguring, and even life-threatening. But with the right support and resources, young people with HAE can lead happy, healthy lives.

That's where the HAEA youth programs can help by:

• Offering educational resources, mentorship programs, and scholarships that enable young people with HAE to live their best lives;
• Connecting young people with mentors who offer guidance and support; and
• Hosting community events and advocacy training workshops that bring young people with HAE together to learn, connect, and build lasting friendships.

Please consider donating to the #Families4HAE end-of-year fundraiser today. Your support is critical to the wellbeing and success of young people with HAE.

Will you help create a world where children, teens, and young adults affected by HAE can thrive?

Click HERE to donate

Or send a check to:
Hereditary Angioedema Association
10560 Main Street Suite PS40
Fairfax City, VA 22030
*Please write “Families for HAE” in the memo!*

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You Are Not Alone: Meet HAEA Friends in your Community

The US Hereditary Angioedema Association invites HAEA members from Boston, MA and Hershey, PA to join us for two in-person Meet and Greet events in December.

Attendees will have the opportunity to connect and chat with other HAEA members and caregivers to reflect on their challenges and triumphs. At each event, an expert HAE physician will offer a short presentation to share valuable information about HAE and clinical trials near you. HAEA staff will be present to answer questions and offer guidance on the topics discussed.

Boston, MA Meet and Greet Luncheon
Date: Saturday, December 2nd, 2023
Time: 12:30 PM ET
Guest Speaker: Aleena Banerji, MD
Location: Il Massimo - Legacy Place: 400 Legacy Pl, Dedham, MA 02026
Register here!

Hershey, PA Meet and Greet Luncheon
Date: Saturday, December 16th, 2023
Time: 12:30 PM ET
Guest Speaker: Timothy Craig, DO
Location: The Mill 810 Old West Chocolate Ave, Hershey, PA 17033
Register here!

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HAEA Community Blog: Sheena’s First-Time Experience at the 2023 US HAEA National Summit

In this month’s HAEA Community Blog featured article, HAE community member, Sheena, describes her and her family's first-time experience at the 2023 US HAEA National Summit!

Access the HAEA Community Blog and read My First-Time Experience at the 2023 US HAEA National Summit by clicking HERE!

Would you like to share a unique story or opinion about your HAE? The HAEA Community Blog is the ideal platform to share your personal story with other members of the HAE community. You can share your story HERE!

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HAE Speaks Podcast

HAE Speaks Podcast - Episode 42: Finding a Diagnosis After 25 Years

Dusty struggled for 25 years to find an HAE diagnosis. She was fortunate to find Mark who has been a great caregiver. The HAE journey has been full of highs and lows. Listen in as they share their stories.

Listen Now!

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#BeyondHAE Youth Podcast: A Parent’s Heartfelt Experience as an HAE Caregiver

November is National Family Caregivers Month. This month's #BeyondHAE Digging Deeper Interview Series features HAEA Youth Leadership Council Member Sophia, who interviews Kia, who is both diagnosed with HAE and a caregiver to her son, Noah. This episode focuses on Kia's experiences as a parent caring for their child.

Listen to the Podcast here!

HAE Speaks and #BeyondHAE are available to download on Apple Podcasts, Spotify, or wherever you get your latest podcasts!

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HAEA CARE GROUPS (Community, Acceptance, Respect, Empathy)

Struggling to cope with HAE during the holiday season? The HAEA CARE Groups can help.

CARE group sessions are held virtually three times a month through Zoom. During the month of November, HAEA friends will share ways that we prepare for the hustle and bustle of the holidays while navigating the unique challenges associated with HAE.

Join us in December when we reflect on the year 2023 and celebrate the personal victories or positive growth experienced by our community members!

Upcoming HAEA CARE Groups:

• Thursday, November 9, 2023 - 11:00 AM ET / 8:00 AM PT
• Tuesday, November 21, 2023 - 10:00 PM ET / 7:00 PM PT
• Wednesday, December 6, 2023 - 7:30 PM ET / 4:30 PM PT

These virtual group meetings offer opportunities for our community to share experiences and support others. Interested in joining one of these monthly support groups? Contact the HAEA Health Team for more information by calling 866-798-5598 or emailing an advocate at health@haea.org.

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What is a Clinical Trial?

Clinical trials are research studies conducted to evaluate whether a medicine to treat HAE is safe and effective in humans. Clinical trials are a critical part of drug development and are required before a treatment can be approved by the Federal Drug Administration (FDA) and become available by prescription.

What are the benefits of participating in a Clinical Trial?

Clinical trials can offer an open-label extension, which means free access to HAE medicines being studied until they are approved and commercially available. Participation in a clinical trial also provides regular touchpoints with an HAE physician throughout the trial period, and allows you to have a more active role in your health care.

Following is a list of clinical trials currently underway. If you are interested in receiving more information on clinical trials, or are interested in participating in any of the trials listed below, please reach out to the HAEA Research Team at research@haea.org.

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The ALPHA-STAR Trial

The US HAEA is currently assisting Astria Pharmaceuticals in recruiting people for the ALPHA-STAR trial, a Phase 1 study evaluating a new medicine (STAR-0215) for long acting prevention of HAE attacks. STAR-0215 is delivered subcutaneously once every 3 months or in some cases even less frequently. This trial is not placebo controlled, so each participant will receive the trial medication.

You may qualify for the ALPHA-STAR study if you are 18 years of age or older and diagnosed with HAE Type I or II, have had at least 4 attacks in the past year, and are not on preventative therapy. Individuals currently on preventative therapy and interested in participating should consult with their physician to discuss the risks and benefits before discontinuing medication.

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The OASIS-HAE Plus Study

The US HAEA is currently assisting IONIS in recruiting people with HAE for the OASIS-HAE Plus study.

The OASIS-HAE Plus study is an open-label extension study without placebo, evaluating the safety and effectiveness of an investigational subcutaneous preventive medicine called donidalorsen, which is given either once every 4 or 8 weeks. This investigational drug uses a technology called antisense, which targets the kallikrein generating system using messenger RNA to suppress the protein that produces kallikrein.

To qualify for the OASIS-HAE Plus study, participants must be 12 years of age or older with a documented diagnosis of HAE. This study will help researchers learn if the study drug is safe and effective for people with HAE when given over a long-term period. Participants in the OASIS-HAE Plus study are either switching over from a different prophylaxis therapy, or continuing on from another donidalorsen study.

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HAERMONY₁ Study

The US HAEA is currently assisting BioMarin in recruiting people with HAE for the HAERMONY1 study, an investigational gene therapy called BMN 331 to improve HAE symptoms in adults 18 years of age and older diagnosed with HAE due to C1-INH deficiency.

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.
*Additional study requirements apply.

For those who qualify, participation lasts about 5 years after receiving the study drug. There are weekly and monthly visits during the first year. After the first year, the visits occur every three or every six months.

If you have HAE Type I, Type II, or HAE with Normal C1-Inhibitor and are interested in learning about new clinical studies to prevent attacks, please contact an HAE advocate at 866-798-5598 to see if there will be an active clinical trial site in your area.

Wednesday, November 15th at 7:00 PM ET / 4:00 PM PT

• HAEA Treatment Education Series Webinar: The Right Therapy Matters
• Speaker: Jay Kashkin, MD
  Leah Weisbecker, Patient Advocate
• Sponsored by: CSL BehringÍ
• Link Webinar: https://haea.zoom.us/j/89165234602
• Phone: +1 309 205 3325
  (Webinar ID: 891 6523 4602)

 REGISTER HERE 

Upcoming HAEA CARE GROUPS:

• Thursday, November 9, 2023 - 11:00 AM ET / 8:00 AM PT
• Tuesday, November 21, 2023 - 10:00 PM ET / 7:00 PM PT
• Wednesday, December 6, 2023 - 7:30 PM ET / 4:30 PM PT

If you are interested in joining a virtual support group, please reach out to an advocate by calling 866-798-5598 or emailing health@haea.org.


Boston, MA Meet and Greet Luncheon
Date: Saturday, December 2nd, 2023
Time: 12:30 PM ET
Guest Speaker: Aleena Banerji, MD
Location: Il Massimo - Legacy Place: 400 Legacy Pl, Dedham, MA 02026
Register here!


Hershey, PA Meet and Greet Luncheon
Date: Saturday, December 16th, 2023
Time: 12:30 PM ET
Guest Speaker: Timothy Craig, DO
Location: The Mill 810 Old West Chocolate Ave, Hershey, PA 17033
Register here!

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Social Media Snapshots

Don’t miss the latest HAEA news and announcements, connect with us on social media!


Update your HAEA membership information HERE!

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10560 Main Street, Suite PS40 Fairfax City, VA 22030		CONTACT AN HAE ADVOCATE: (877) 839-4232
DONATE		JOIN HAEA
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 info@haea.org.