By Amber Dance

FDA, CDC will likely back another booster for at-risk groups

After weeks of rumors about spring boosters, the FDA is expected to approve a second round of omicron-specific shots for people who are 65 and older or immunocompromised, report Laurie McGinley and Lena H. Sun at The Washington Post.

The official announcement and CDC endorsement is expected within weeks, officials told the reporters.

The FDA will not specifically recommend the shots, but will allow anyone in those high-risk groups who is at least four months out from their first omicron booster to get another.

About 42% of people 65 and older have received the initial omicron booster shot.

These shots will be free since the federal government still has an ample stockpile of the boosters.

POC, non-English speakers at higher risk to lose Medicaid

As of April 1, a handful of states have begun removing people from Medicaid rolls for the first time in three years, as a pandemic-aid program that prevented them from doing so has come to an end.

Other states are expected to begin cutting people from their Medicaid lists this spring or summer.

Medicaid and the Children’s Health Insurance Program gained about 20 million enrollees during the pandemic, reports Noah Weiland at The New York Times.

An estimated 15 million stand to lose that coverage over the next 14 months as states gradually step up programs to verify eligibility.

Many of those kicked off Medicaid will likely sign up for other coverage via the Affordable Care Act, but others will likely wind up without insurance. Those who earn too much for Medicaid but not enough for Obamacare subsidies are particularly at risk.

About 7 million of those who are likely to lose coverage are probably still eligible for Medicaid but will fail to reenroll for one reason or another.

For example, if they’ve moved, crucial letters might not reach their new address.

“Whenever these sorts of moments happen, it’s people of color, it’s kids, it’s people that don’t speak English that are always hit the hardest,” Natalie Davis of the nonpartisan advocacy group United States of Care told The Times.

As pandemic-era benefits like Medicaid and food stamps return to their pre-COVID levels, low-income Americans will spend less, which could damage the economy overall, notes Abha Bhattaraj at The Washington Post.

FDA authorizes new medication for severe cases

Physicians have a new option for severely ill COVID patients, reports Ingrid Hein at MedPage Today.

The FDA has granted emergency use authorization for an antibody that should tamp down the overactive immune response that endangers people with severe COVID.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, called the medicine a “potentially life-saving treatment option for the sickest COVID-19 patients.”

While the immune system is needed to fight off the virus, too much immune activity can worsen the disease, causing inflammation and blood clots.

The new antibody, called vilobelimab, sticks to one of the early cellular activators of that inflammation to stop it.

In an international trial, vilobelimab reduced the death rate for critically ill COVID patients by about 19%.

It’s authorized for hospitalized patients who require machines to support their breathing or blood circulation.

The FDA warned the medicine comes with downsides: It can lower the body’s ability to fight off other infections and cause allergic reactions.

Long COVID researchers push for more funding

Investigators studying long COVID have called for a much larger investment in the problem, which they say affects one in 13 U.S. adults.

The researchers, part of the NIH’s Researching COVID-19 to Enhance Recovery (RECOVER) Initiative, say the current health care system isn’t set up to help people with long COVID. 

There are no best practices for clinical care of long COVID, nor is there a coordinated national effort to develop such practices.

“Long COVID sufferers must navigate health care resources on their own,” write the collaborators in their call to action. “Many don’t know where to go or whom to call.”

The investigators are calling for $37.5 million from Congress to establish a network of long COVID care centers to study the condition, educate other providers, reach out to people with long COVID, and help coordinate their treatment.

The RECOVER program has also drawn fire for planned studies on exercise therapy, reports Rachel Fairbank at Nature.

Patient advocates note that many people with long COVID have symptoms that are exacerbated by exercise, so the study could put them at risk.

“In a world where there’s hundreds of things to trial, why are we choosing this one thing that we know has the potential to cause harm to a substantial portion of patients?” asked Lisa McCorkell, co-founder of the Patient-Led Research Collaborative advocacy group.

Advocates asked the NIH to release the exercise study’s rationale and protocol, and invite public commentary, before proceeding. They also urged researcher to screen out patients whose symptoms are likely to get worse after exertion.

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WASHINGTON (AP) — For two years, Becky Mourey pushed the Food and Drug Administration to approve an experimental drug for her Lou Gehrig’s disease.

She went to members of Congress and health regulators to make the case for Relyvrio, until patient-advocates finally prevailed.

In September, Relyvrio became only the third drug approved in the U.S. for ALS, or amyotrophic lateral sclerosis, an incurable neurodegenerative disease that is usually fatal within five years. But patients and physicians who celebrated Relyvrio’s approval several months ago are now contending with the obstacles posed by the U.S. health care system.

Their odyssey is an object lesson in the soaring cost of specialty drugs and the byzantine systems that insurers have created to try and control them.

Patients with insurance coverage say the $158,000 per year price tag set by drugmaker Amylyx Pharmaceutical is fueling insurance delays or denials, and sometimes exorbitant out-of-pocket expenses.

Mourey’s insurer initially refused to cover Relyvrio, but reversed itself seven weeks later after online pressure— including social media posts by Mourey and other ALS advocates.

“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.”

Even when Relyvrio is covered, some patients see themselves shouldering co-payments between $1,000 and $4,000 per month.

Unlike those patients, the Moureys have been exempt from copays due to a combination of company-managed Medicare and Medicaid coverage.

Some ALS patients are covered by private plans, while others receive government coverage through programs like Medicare.

In both cases, patients and their doctors can face onerous requirements to document their condition before insurers will pay for an expensive new treatment. Additionally, many insurers require patients to pay a percentage of their pharmacy costs. With many drugmakers now charging upwards of $100,000 for drugs approved for hard-to-treat illnesses, even a 5% copay can become unaffordable. The trend has increasingly made the drug industry deeply unpopular in the U.S.

Drugmakers say their prices reflect the years of costly clinical trials needed to win FDA approval.

Amylyx said the delays in coverage for Relyvrio are normal because many insurers are still writing their policies for the drug. The company also highlighted its multiple programs to help patients with costs, including providing the drug for free to the uninsured and covering copays for those who qualify for assistance.

The issues surrounding Relyvrio’s price highlight industry practices that have long been blamed for driving up U.S. health costs: drugmakers can patent new combinations of old ingredients and then charge whatever price the market will bear.

Insurers have responded with extra review hurdles. Those delays weigh heavily on patients with ALS which is measured in the monthly loss of functions like walking, speaking and swallowing.

“It’s just stressful and aggravating to get these multiple denial letters,” said Jim Mourey, who cares for his wife full time at their home in Hopkinton, Massachusetts.

Relyvrio is a powder-based formulation that combines two older ingredients: a prescription drug for liver disorders and a supplement used in traditional Chinese medicine that’s available on Amazon.com for about $1 per day’s supply.

Insurers typically won’t pay for ALS patients to receive the prescription ingredient, because it’s not approved for their disease. But some patients have gotten their plans to cover it or have found lower-price versions — for less than $600 a month— at specialty pharmacies. That’s led some patients to skip the new drug entirely by obtaining its two ingredients separately.

Analysts expect Relyvrio to generate $450 million in annual sales for Amylyx by 2024. It’s the company’s first product.

One group that analyzes drug pricing said a fair price for Relyvrio would be between $9,100 and $30,700 per year. The drug showed some effectiveness in slowing the progression of ALS, based on patient questionnaires. Amylyx is conducting a larger study to answer lingering questions about its effectiveness, including whether it extends survival.

Layne Oliff, 63, hasn’t yet decided whether to seek coverage from his Medicare plan. Under the federal program, he would likely owe $7,400 in copays for Relyvrio before reaching his out-of-pocket maximum. That’s on top of monthly administration fees of over $600.

But if he pays cash, Oliff says he can buy the prescription ingredient in the drug for $550 per month, or $6,600 per year, from a specialty pharmacy. He can get the supplement online for about $30 a 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.”

Amylyx has set up a program to cover the copay costs for patients with private insurance. But that financial assistance cannot be used for federal plans like Medicare and the Veterans Administration, which cover many ALS patients. After initially restricting coverage, the VA recently broadened its eligibility.

Other insurers are initially rejecting coverage or requiring multiple rounds of documentation from doctors.

“When someone’s lifespan is measured in months, making people go through these multiple rounds of review is just cruel,” said Neil Thakur of the ALS Association. The group invested in Amylyx’s early research and stands to recoup that investment.

Dr. Terry Heiman-Patterson, a neurologist at Temple University, says it’s taken about four to six hours of phone calls with insurers to get each new patient on Relyvrio.

Heiman-Patterson warns her patients to expect weeks of back-and-forth before getting the drug.

“This is the process we’re going to have to go through and I don’t know what your copay is going to be in the end,’” she says.

Some patients who are already taking a do-it-yourself approach to the treatment see little reason to change.

Sarah Nauser, a former police officer, says her insurance has covered the prescription ingredient in Relyvrio — sodium phenylbutyrate — for a $10 copay since 2020.

“After seeing all the difficulties that people are having, I’m not going to mess with what’s working,” said Nauser, 34, who credits the combination with slowing her disease and helping her to maintain her ability to walk, talk and feed herself.

The co-founders of Cambridge, Massachusetts.-based Amylyx theorize that the two chemicals in their drug work together to shield cells from premature death. But there’s little agreement among scientists about how the drug works, or even which ingredient is responsible for its benefit.

A small European study of the supplement contained in Relyvrio showed a larger effect on slowing ALS than Amylyx’s study. And researchers there are conducting a larger, 300-patient study of the ingredient.

“That study could be hugely important in telling us whether this one ingredient–which is very inexpensive– is actually effective,” said Diana Zuckerman of the non-profit National Center for Health Research, which analyzes medical research.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter

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