In Case You Missed It! – November 2022

If you’ve missed any of the latest news we’ve shared through our social media this month, don’t worry! Get up to date with this edition of “In Case You Missed It!”

  • Two ways you can support the Hypersomnia Foundation this holiday season
  • Save the Date for the HF 2023 #BeyondSleepy conference in Indianapolis
  • Avadel Pharmaceuticals will accelerate FDA’s final approval decision for LUMRYZ™
  • U.S. FDA grants Orphan Drug Designation for Quilience® for the treatment of idiopathic hypersomnia
  • IRS expands eligibility for ACA marketplace insurance plans
  • U.S. House of Representatives passes 2-year telehealth extension
  • Researchers find possible link between long-COVID and the development of sleep disorders
  • A family shares their personal journey for answers and an accurate diagnosis for their daughter’s sleep disorder
  • INTUNE is a currently recruiting participants for a clinical study in adults with idiopathic hypersomnia
  • Pinpoint Patient Recruiting is looking for people to share their experience with idiopathic hypersomnia
  • Northwestern University recruiting participants for their EXPLAIN Study
  • Do you have an Emergency Anesthesia/Hospitalization Plan?
  • How to strengthen appeal arguments if you’ve been denied insurance coverage for medication
  • Meet Dr. Ana Krieger, Dr. Dale Edgar, and Dr. Isabelle Arnulf – Members of HF’s Medical and Scientific Advisory Boards

Don’t worry if you’ve missed anything. We’ve got you covered!


Two ways you can support the Hypersomnia Foundation this holiday season

Help us kick-off our end-of-year fundraising campaign as we raise funds to help support the Hypersomnia Foundation’s efforts to enhance our programming and improve the lives of people in our community. We cannot do it alone and rely on your generous donations in support.

Here are two ways you can help:

  1. Support the Hypersomnia Foundation on Cyber Monday, November 28th. Simply shop through Amazon Smile and designate the Hypersomnia Foundation as your charity of choice. AmazonSmile will send us a donation from every eligible purchase you make! It’s free and easy to set up! Amazon Smile is also available on the Amazon app for your smartphone or tablet! Link to Amazon Smile HERE.
  1. Make a donation to the Hypersomnia Foundation on Giving Tuesday, November 29th. Take part in this global day of giving that celebrates generosity! Your donation will improve the lives of people with idiopathic hypersomnia and related sleep disorders. Donate through our Facebook page or using the DONATE button on our website.

We are making progress on our vision to fulfill the dream of restorative nighttime sleep and wide-awake days. Thank you for joining us as a champion for those with IH and related sleep disorders!


Save the date for the HF 2023 #BeyondSleepy conference in Indianapolis!

Plan on joining us in Indianapolis, Indiana from June 2 to 4, 2023 for the Hypersomnia Foundation’s 2023 #BeyondSleepy conference for people with idiopathic hypersomnia, narcolepsy, and Kleine-Levin syndrome and their supporters.

For updates and details:

Mark your calendars, and we’ll see you in Indianapolis in 2023!


Avadel Pharmaceuticals will accelerate FDA’s final approval decision for LUMRYZ™

Avadel has announced that it will be accelerating the FDA’s final approval decision for LUMRYZ™, a once-at-bedtime investigational formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

This announcement comes on the heels of the U.S. Food and Drug Administration (FDA) delisting the REMS patent from the FDA’s Orange Book, a publication that identifies drug products approved on the basis of safety and effectiveness by FDA. Risk Evaluation and Mitigation Strategy, aka REMS, is a formal plan required by the FDA for certain “riskier” drugs to ensure that the benefits of these drugs outweigh their risks.

“We are pleased with the court’s decision in favor of delisting the REMS Patent from the FDA’s Orange Book, potentially accelerating a final approval. Upon the delisting of the REMS Patent, we are prepared to work collaboratively with the FDA to move to a final approval decision for LUMRYZ,” said Greg Divis, Chief Executive Officer at Avadel Pharmaceuticals. “We are fully committed to bringing LUMRYZ to all eligible people with narcolepsy and look forward to providing updates on our progress.”

Read Avadel’s complete press release HERE.

Additional Information:

  • In January 2018, the U.S. Food and Drug Administration (FDA) granted LUMRYZ Orphan Drug Designation for the treatment of narcolepsy based on the plausible hypothesis that LUMRYZ may be safer than the twice-nightly formulation of sodium oxybate already approved by the FDA due to the ramifications associated with dosing regimen of that product.
  • In March 2020, Avadel completed the REST-ON study, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of LUMRYZ in patients with narcolepsy. Among the three co-primary endpoints, LUMRYZ demonstrated statistically significant and clinically meaningful results in EDS, the clinician’s overall assessment of the patient’s functioning, and reduction in cataplexy attacks, for all three evaluated does when compared to placebo.
  • On July 18, 2022, the FDA tentatively approved the LUMRYZ NDA for the treatment of cataplexy or EDS in adults with narcolepsy.

U.S. FDA grants Orphan Drug Designation for Quilience® for the treatment of idiopathic hypersomnia

NLS Pharmaceutics announced that it has received Orphan Drug Designation from the U.S. FDA for Mazindol, the active ingredient in its lead product candidate, Quilience® for the treatment of idiopathic hypersomnia.

“We are very pleased to receive Orphan Drug Designation for Mazindol in the U.S. for the IH indication, given the potential versatility of this active ingredient in treating multiple sleep-wake disorders,” said Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics. “In our recently reported Phase 2a top-line results, Quilience® (Mazindol ER), our novel formulation and lead product candidate, demonstrated the ability to significantly promote wakefulness in narcolepsy patients with Type II disorder, which has strong similarities to IH.”

Read the complete announcement HERE.


IRS expands eligibility for ACA marketplace insurance plans

A newly finalized IRS regulation has been approved expanding eligibility for insurance premium tax credits for Affordable Care Act (ACA) marketplace plans bringing down healthcare costs and expanding access to affordable coverage for couples and families. This new ruling means that families who get expensive health insurance through employers could see a price break if they sign up instead for private health insurance plans through the Affordable Care Act marketplace.

“[This] action resolves a flaw in prior ACA regulations to bring more affordable coverage to about one million Americans,” Health and Human Services Secretary Xavier Becerra said in a statement. “Our goal is simple: leave no one behind and give everyone the peace of mind that comes with health insurance.”

The new interpretation of the Obama-era health law aims to fix the “family glitch,” which determines a family’s eligibility for ACA tax credits based on the cost of an individual’s work-sponsored health insurance plan rather than the cost of the plan for the whole family. It is estimated that approximately 1 million Americans will gain coverage or see their insurance become more affordable as a result of this new rule.

The enrollment period for health insurance plans for under the Affordable Care Act is open through December 15th for coverage beginning January 1, 2023.

For information about ACA coverage, visit Healthcare.gov.


U.S. House of Representatives passes 2-year telehealth extension

On July 27, the U.S. House of Representatives overwhelmingly passed with a 416-12 vote, the Advancing Telehealth Beyond COVID-19 Act, legislation that would continue Medicare patient access to telehealth services for two additional years.

The bill would extend key Medicare pandemic telehealth flexibilities until 2024, including geographic and originating site flexibilities, increase the types of providers eligible to provide telehealth, waive in-person requirements for behavioral health services, allow coverage of audio-only telehealth and let telehealth satisfy face-to-face requirements for hospice care. The bill also would allow for qualified health centers and rural health clinics to cover and receive reimbursements from CMS for telehealth services.

Learn more about the H.R. 4040—Advancing Telehealth Beyond COVID-19 Act, using this LINK.


Researchers find possible link between long COVID and the development of sleep disorders

A team of Brazilian researchers have published study results linking a possible relationship between long COVID and the development of hypersomnia sleep disorders.

While insomnia has been a recognized feature of long COVID, previous researchers have not noted the development of hypersomnia for people experiencing long COVID, except for one case study documenting a patient with KLS who may have suffered a relapse linked to long COVID.

In this Brazilian study of 189 people with long COVID, six were experiencing excessive sleepiness. While two of the six refused to undergo further testing, four completed actigraphy and sleep studies to confirm a hypersomnia diagnosis. Of the four patients tested, two tested positive for IH and one tested positive for narcolepsy.

The patients responded to wakefulness medications. Of the four patients tested, one had their symptoms resolve in six months and another had symptoms resolve in 15 months. (It was not stated if the patients whose symptoms resolved were the ones who tested positive for IH, NT2, or neither.)

Read the complete study report HERE.


A family’s personal journey for answers and an accurate diagnosis for their daughter’s sleep disorder

Read about a family’s struggle searching for an accurate diagnosis for their daughter’s rare sleep disorder. For 2 1/2 years, these parents consulted pediatric neurologists, a neurosurgeon, an obstetrician-gynecologist and other specialists in a largely fruitless search to identify the condition that drastically alters the personality and temporarily shuts down the life of their teenage daughter two or three times a year. The ultimate diagnosis was Kleine-Levin syndrome (KLS), a rare and little-known sleep disorder.

They saw their role as advocates for their daughter, although they often felt unsure about what to do or where to turn. They routinely asked for referrals and when a doctor appeared disinterested, they moved on. “We were determined to find the right doctor and not to just settle for an easy answer or start random drugs,” they said.

The neurologist who ultimately correctly diagnosed their daughter with KLS said that while he knew of the disorder, he had never seen a patient with it. The family has found it reassuring to connect with other families through the KLS Foundation and hopes to have their daughter participate in a Stanford University study of the disorder.

Read more about KLS and one family’s journey for answers in a recent online edition of the Washington Post.


INTUNE is a currently recruiting clinical study in adults with idiopathic hypersomnia

The INTUNE study is being conducted by Harmony Biosciences to evaluate the safety and efficacy of pitolisant, an investigational medication for treating excessive daytime sleepiness in people with IH age 18 years or older.

This study is also evaluating the effect of pitolisant on overall symptoms and severity of IH, sleep inertia, cognition, and general sleep-related impairment.

This clinical study consists of a screening period (up to 28 days), an 8-week Open-Label Phase in which all eligible study participants will receive pitolisant, followed by a 4-week Double-Blind Randomized Withdrawal Phase in which study participants and doctors won’t know who is receiving pitolisant or a placebo.

For more information about the INTUNE study, visit our “Currently Recruiting Studies” web page.


Pinpoint Patient Recruiting is looking for people to share their experience with idiopathic hypersomnia

Pinpoint Patient Recruiting, a market research recruitment company, is looking to speak with people who have been diagnosed with idiopathic hypersomnia (IH) to participate in a 60-minute online interview about their experience.

If you are a U.S. resident living with IH and have experience with Xywav, you may be eligible to participate. Those who qualify and participate in the study will receive $125 as a thank you. All information and responses will remain confidential.

Interested?  To see if you qualify for the study or to get more information, please visit the Pinpoint Patient Recruiting website using this LINK.


Northwestern University recruiting participants for their EXPLAIN Study

The Behavioral Sleep Medicine Lab at Northwestern University is seeking participants for their EXPLAIN Study (Examination of Partners and Loved Ones of Adults with Idiopathic Hypersomnia and Narcolepsy), to learn how family members are affected by their loved one’s IH/narcolepsy, how family members provide support, and the types of support family members themselves need.

You may be eligible if:

  • You live in the United States
  • You are an adult (18 or older)
  • Your partner or adult family member has IH or narcolepsy

Eligible volunteers will be asked to complete an online survey that will take approximately 15 minutes.

Participants will not receive any compensation. For more information, visit our “Research Studies” web page.


Do you have an Emergency Anesthesia/Hospitalization Plan?

People who have IH or a related sleep disorder may face a unique set of challenges around the time of anesthesia or hospitalization, which may impact their symptoms and medications.

To help create an emergency anesthesia and hospitalization care plan for yourself or a loved one, check out the tool kit on our “Anesthesia, Hospitalization and Idiopathic Hypersomnia: A Guide” web page.

Get a quick summary of things to consider when making your plan by visiting our “Make an Emergency Anesthesia/Hospitalization Plan Now!” web page.


How to strengthen appeal arguments if you’ve been denied insurance coverage for medication

If you’ve been denied insurance coverage for a medication or other medical claim, you are not alone. To get an overview of the appeals process and information on how to strengthen your appeal arguments, visit our “Health and Prescription Medication Insurance Denials and Appeals” web page.

In addition to articles, videos, books, and links to multiple resources, we’ve even collected example letters that others have used to win appeals for hypersomnia medications.


Meet Dr. Ana Krieger, Dr. Dale Edgar, and Dr. Isabelle Arnulf—members of HF’s Medical and Scientific Advisory Boards

Meet Dr. Ana Krieger — member of the Hypersomnia Foundation’s Medical Advisory Board

Ana Krieger, MD, MPH, is Associate Professor of Clinical Medicine in the Departments of Medicine, Neurology, and Genetic Medicine at Weill Cornell Medical College. She is board certified in sleep medicine and the Medical Director of the Weill Cornell Center for Sleep Medicine. Dr. Krieger also holds board certification in internal medicine and pulmonary medicine and is a faculty member in the Division of Pulmonary and Critical Care Medicine, Department of Medicine, at Weill Cornell Medical College and an Associate Attending at the New York Presbyterian Hospital/Weill Cornell Medical Center and at Rockefeller University Hospital.

Over the past 17 years, Dr. Krieger has been actively involved in clinical care and education, training sleep specialists, and conducting collaborative multidisciplinary research projects in sleep medicine. She serves as the Chair of the Sleep Deprivation Committee of the American Academy of Sleep Medicine and the President of the Northeast Sleep Society. Dr. Krieger is a Robert Wood Johnson Scholar, a Fellow of the Royal Society of Medicine, and a Fellow and Policy Advisor at the New York Academy of Medicine. She regularly contributes to media efforts aiming at achieving public awareness of sleep problems and a better understanding of their multifaceted consequences and treatment alternatives.

Watch a video of Dr. Krieger talking about the importance of sleep using this LINK. To learn more about Dr. Krieger and the other members of our Medical Advisory Board, visit our “Medical Advisory Board” web page.

 

Meet Dr. Dale M. Edgar — member of the Hypersomnia Foundation’s Scientific Advisory Board

Dale M. Edgar, PhD, is an accomplished scientist, educator, drug hunter, and entrepreneur in the field of sleep medicine. His distinguished career spans nearly 30 years and the breadth of academia to industry. During his 15 years at Stanford University’s School of Medicine, Dr. Edgar achieved international recognition as a leader in discovering how the brain and its chemistry modulate sleep/wake and bodily rhythms.

Dr. Edgar is the Senior Vice President of Discovery Research at Neumora Therapeutics (Cambridge/Watertown, Massachusetts). Dr. Edgar joined Neumora in connection with their acquisition of the company he co-founded, Alairion, Inc. – a start-up biotech focused on the discovery and development of novel treatments for sleep disorders and sleep related comorbidity.

For more information about Dr. Edgar and the other members of our Scientific Advisory Board, visit our “Scientific Advisory Board” web page.

 

Meet Dr. Isabelle Arnulf — member of the Hypersomnia Foundation’s Medical Advisory Board

Having authored more than 150 publications in peer-reviewed scientific journals, Isabelle Arnulf, MD, PhD, is a Professor of Neurology at the Sorbonne University, Paris and Head of the Sleep Disorders Clinic at Pitie-Salpetriere Hospital. Her research thematic is focused on neurological sleep disorders, mainly parasomnias (sleepwalking, REM sleep behavior disorder, lucid dreaming), sleep in Parkinson’s disease and central hypersomnias (idiopathic hypersomnia and Kleine-Levin syndrome), and what these disorders tell us about dreaming.

At the SLEEP 2022 annual meeting of the Associated Professional Sleep Societies in Charlotte, North Carolina, Dr. Arnulf discussed the list of difficulties related to defining, diagnosing, and treating IH that remain despite a growing body of research in her presentation entitled “Sleeping too much: the challenges of idiopathic hypersomnia.”

Dr. Arnulf began by calling for more attention to devoted to studying IH in a similar fashion to how we study narcolepsy, a related sleep disorder. “[IH is] not that rare of a disorder and it’s a neglected disorder… Narcolepsy is like the big brother, attracting all the attention of the parents, while idiopathic hypersomnia is like the little sister. I think we must all fight to increase the attention to the little sister,” Arnulf remarked.

Read more about Dr. Arnulf’s SLEEP 2022 presentation in an online edition of The American Journal of Managed Care (AJMC) HERE.

Watch a quick interview with Dr. Arnulf as she discusses findings of significant improvement observed in patients with idiopathic hypersomnia undergoing lower-sodium oxybate treatment HERE.

For more information about Dr. Arnulf and the other members of our Medical Advisory Board, visit our “Medical Advisory Board” web page.

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