Becky Mourey fought the Food and Drug Administration for two years to get an experimental medication approved for Lou Gehrig’s disease.

She advocated for Relyvrio before members of Congress and health regulators until patient advocates won out in the end.

Amyotrophic lateral sclerosis, also known as ALS, is an untreatable neurological condition that typically results in death within five years. Relyvrio was approved as the third medication for ALS in the United States in September. Patients and doctors, who had previously cheered Relyvrio’s clearance, now have to deal with challenges brought on by the American healthcare system.

Their trip serves as a case study for the skyrocketing price of speciality medications and the convoluted mechanisms that insurance has put in place to try and manage them.

Patients who have an insurance claim that Amylyx Pharmaceutical’s $158,000 annual price tag is to blame for insurance delays or denials as well as occasionally astronomical out-of-pocket costs.

Relyvrio coverage was initially denied by Mourey’s insurer, but after seven weeks of online pressure, including social media posts from Mourey and other ALS activists, they changed their minds.

“Amylyx priced it way too high,” said Mourey, 58, a former music teacher, who now communicates using a vision-controlled speech computer. “They could cut the price in half and still make a hefty profit.”

Some patients anticipate having to pay co-payments of between $1,000 and $4,000 per month even when Relyvrio is covered.

The Journeys, in contrast to those patients, have not had to pay copays thanks to a combination of employer-managed Medicare and Medicaid coverage.

While some ALS patients have private insurance, others are covered by government programs like Medicare.

Before insurance companies will cover an expensive new treatment, patients and their doctors may have to comply with onerous documentation requirements in both situations. Additionally, a lot of insurance companies demand that their clients pay a portion of their pharmacy expenses.

Even a 5% copay can become unsustainable given that several drugmakers already charge more than $100,000 for medications licensed for treating difficult-to-treat diseases. The pharma sector in the United States is now extremely disliked as a result of this tendency.

The years of expensive clinical trials required to obtain FDA approval, according to drugmakers, are reflected in their prices.

According to Amylyx, the delays in Relyvrio coverage are typical given that many insurers are currently drafting their policies for the medication.

The business also touted its various cost-saving initiatives for patients, including free drug distribution to uninsured people and copay coverage for those who qualify.

Relyvrio’s price controversy brings to light business practices that have long been held responsible for raising healthcare prices in the United States. These policies allow drugmakers to patent novel combinations of existing components and then charge whatever the market will bear.

In response, insurers have added more review barriers. Patients with ALS experience significant delays, which are quantified by the monthly loss of abilities including walking, speaking, and swallowing.

Jim Mourey, who provides full-time care for his wife at their home in Hopkinton, Massachusetts, said that receiving so many denial letters was “simply frustrating and aggravating.”

Relyvrio is a powder-based formulation that combines two more conventional ingredients: a prescription medication for liver diseases and a traditional Chinese medicine supplement. It costs roughly $1 for a day’s supply on Amazon.com.

Due to the prescription ingredient’s unapproved use for ALS patients, insurers frequently refuse to cover its costs. But other people have managed to have their insurance to pay for it or have discovered cheaper alternatives at speciality pharmacies that cost less than $600 per month.

This has caused some patients to completely forego the new medication in favour of buying its two components individually.

By 2024, analysts project that Relyvrio will bring Amylyx yearly sales of $450 million. It is the business’s initial offering.

Relyvrio’s reasonable price, according to one organization that examines drug pricing, should fall between $9,100 and $30,700 annually. Based on patient questionnaires, the medication appeared to have some impact in delaying the course of ALS.

Amylyx is launching a larger research to address unresolved issues with its efficacy, such as whether it increases survival.

Layne Oliff, 63, isn’t sure if he will use his Medicare plan or not. He would probably have to spend $7,400 in copays for Relyvrio under the federal program in order to avoid exceeding his out-of-pocket maximum. Additionally, there are nearly $600 in monthly administrative expenses.

However, Oliff claims that he can purchase the drug’s prescription ingredient from a speciality pharmacy for $550 per month, or $6,600 per year if he pays cash. Online, he can purchase the supplement for roughly $30 per month.

“You’re talking about a drug that’s not a cure, though it has helped slow the progression,” said Oliff, who trained as a pharmacist. “But I don’t want to leave my wife someday in a financial hole; I’m not going to spend all my money on this drug.”

For patients with private insurance, Amylyx has established a scheme to offset the copay expenses. Although many ALS patients are covered by Medicare and the Veterans Administration, financial aid cannot be used with these programs. The VA recently expanded eligibility after initially limiting coverage.

Other insurers first deny coverage or demand numerous rounds of doctor documentation.

Making patients go through these numerous rounds of assessment when their life expectancy is limited to months, according to Neil Thakur of the ALS Association, is cruel.

Before receiving the medication, Heiman-Patterson cautions her patients to anticipate weeks of back and forth.

The Science and Educational Media Group of the Howard Hughes Medical Institute supports the Associated Press’s health and science coverage. All content is the exclusive responsibility of the AP.