Excitement for new ALS treatment dulled by astronomical price tag

Local patient, advocates working with company, foundations, government to lower cost

SAN ANTONIO – A new treatment for ALS was approved by the U.S. Food and Drug Administration two months ago and is already available to patients.

The release has pulsed excitement and hope through the ALS community.

Juan Reyes worked hard in the U.S. Air Force, and for the past seven years, he’s worked even harder to battle ALS while advocating for new treatments.

ALS is a terminal disease that affects voluntary muscle movements like chewing, walking and talking.

Much of the research’s funding and momentum came from the viral Ice Bucket Challenge.

“What got it over the finish line was the ALS community,” Reyes said, acknowledging the grassroots effort among patients and their supporters.

Two months ago, the FDA finally approved the third-ever ALS treatment - Relyvrio. The successful trial data was published in the peer-reviewed medical journals New England Journal of Medicine, Muscle & Nerve, and the Journal of Neurology, Neurosurgery, and Psychiatry.

Riluzole and Radicava are the two current treatments for ALS that extend life by a certain number of months. Riluzole is an oral pill. Radicava was approved as an oral suspension formulation that can be taken orally or via feeding tube.

The new treatment, Relyvrio created by the company Amylyx, does the same thing and comes in a powder form.

The goal for patients is to use many treatments together to extend life by as many months as possible.

Every ALS patient is different regarding their disease progression and life expectancy, but the typical prognosis is two to five years.

“When you have a two to five-year prognosis, and it takes you two years to be diagnosed, you’ve already lost half of the prognosis, so extending your life by months is exponentially meaningful,” Reyes said.

While the drug may be beneficial, the price tag is steep for patients.

Without insurance, Riluzole (or Rilutek) costs around $20,000-$25,000 annually. Radicava costs about $146,000, and Relyvrio will cost about $158,000.

Medicare covers 80 percent of the cost, so an ALS patient taking all three would pay close to $5,500 per month, or $66,000 per year.

“Patients are having to make tough decisions. Unfortunately, they’re having to choose between, ‘Do I pay for this medication, or do I use my money to pay a caregiver to come in my home and help with my daily activities?’” said Steve Morse, vice president of Mission Delivery for the ALS Association of Texas.

Morse said the company making Relyvrio is currently working with foundations and the government to lower costs.

Reyes said he had a positive meeting with the Amylyx owners in person, talking about affordability.

As a veteran, Reyes gets these treatments at no cost through the U.S Department of Veterans Affairs. That being said, he explained the VA is divided into regions, with each region having a different budget and may provide different funding.

Reyes started each treatment as soon as it came out. He started Riluzole 7 years ago when he was diagnosed and began Radicava four years ago. He hopes to start taking Relyvrio this month.

“Juan is in the queue, but he hasn’t started it yet,” said Meg Reyes, Juan Reyes’ wife, caretaker and fellow advocate.

Juan and Meg Reyes believe the treatments are working, and they’re now fighting to make them more affordable for everyone else. They travel the country testifying for funding, new treatments and patient resources.

Juan Reyes testified for the Act for ALS bill passed last year. He was there when President Joe Biden signed it into law.

The law establishes grant programs to address neurodegenerative diseases like ALS.

“There are many organizations that are trying to fill the gap, not just financially but to support individuals emotionally for mental health and respite care,” Juan Reyes said.

“There’s an organization called the Healthwell Foundation, and they’ve been giving pretty significant grants to our patients that have helped with the cost,” Morse said.

Those grant programs have been used to help patients afford these treatments, and advocates hope they will help with Relyvrio too.

“We cherish every moment that we can have with our loved ones just to make more memories and be present for them and ourselves,” Juan Reyes said.

In the following statement, Amylyx explained they are committed to addressing price concerns:

“We met with many stakeholders throughout the ALS community, including leading doctors, people living with ALS, and leaders in advocacy to discuss potential pricing of RELYVRIO. We also talked with every major insurance company in the U.S. and did extensive modeling to understand impacts to people’s potential out of pocket expenses. Taking all of that into account, we made the decision to price RELYVRIO below the latest FDA-approved product available to people with ALS; however, this does not reflect the price people living with ALS can expect to pay:

  • For people with ALS who have commercial insurance, Amylyx is committed to providing financial assistance by bringing co-pays to $0.
  • While pharmaceutical manufacturers cannot offset copayments for people covered by government insurance, we are working to ensure that people with government-funded insurance, like Medicare or Medicaid, will have access to RELYVRIO as quickly as possible. The Amylyx Care Team will be able to provide people with government-funded insurance information on potential options for financial assistance with co-pays.
  • In addition, for U.S. residents with ALS that are uninsured or underinsured, meet certain financial eligibility criteria, and who have exhausted all other options, we intend to provide RELYVRIO at no cost.

We believe this price balances the needs of and input from the ALS community, will be supported by insurers, allows Amylyx to sustain programs to ensure that anyone who can benefit from RELYVRIO can access it, and enables us to continue our mission – doing everything we can to help people with ALS today and continuing to invest in new treatments so that ALS first becomes a manageable, chronic condition, and, ultimately, is cured.”

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About the Authors:

Courtney Friedman is a KSAT anchor and reporter. She has an ongoing series called Loving in Fear, confronting Bexar County’s domestic violence epidemic. She's also covered Hurricane Harvey, the shootings in Sutherland Springs and Santa Fe, and tornadoes throughout Texas. She’s a California native and proud Longhorn who loves calling SA home.