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Cancellation Of Kids' Asthma Medication Continues To Cause Turmoil For Mass. Families

"January 1, those formulary lists are going to change again, and we don't know what's on them," said Dr. Robyn Cohen, associate medical director of asthma initiatives at Boston Medical Center. "I'm worried we're going to be back to where we were last year."

The root of families' distress is a 2021 federal initiative intended to keep medications affordable by adding penalties when a drug's price increase outpaces inflation. The penalties went into effect at the beginning of this year. Most companies responded by cutting their drug's list prices. GSK instead subbed out Flovent for the generic, which is not subject to the same penalties. (GSK also said it had for some time intended to discontinue Flovent.)

Professors at Johns Hopkins estimated in a study in November that if GSK had simply reduced the price of Flovent to avoid the new federal penalties, it would have cost at least $30 less than the generic, around $150 compared to the authorized average sale price for the generic of almost $184. One reason is the generic doesn't come with the same level of discounts and rebates that insurers got for Flovent.

The Massachusetts Department of Public Health issued an advisory in November that described GSK's decision to discontinue Flovent as an additional barrier to people already struggling to access health care.

Senator Elizabeth Warren accused GSK of "price gouging," arguing the company switched to a generic as a way to avoid federal price controls on medications. The switch has hammered Medicaid providers, Warren said. Without the rebates and discounts that accompanied Flovent, Medicaid administrators, including MassHealth, are now paying about four times more for essentially the same drug, according to a letter Warren sent Wednesday to GSK chief executive Emma Walmsley.

The Johns Hopkins study estimated switching from Flovent to the licensed generic could add more than half a billion dollars to Medicaid net spending this year.

"GSK's actions appear to be intended to circumvent new provisions passed by Congress to hold drug manufacturers accountable for years of historical price increases," Warren wrote.

The British company reported operating profit of more than $8 billion in 2023.

Flovent was manufactured by a second company, Prasco Laboratories, under a license from GSK. A spokesperson for GSK deferred comment to Prasco, which did not respond to a call.

Warren's letter also castigated the company for failing to respond to requests for detailed information about the profit sharing between GSK and the manufacturer.

"It's shameless of the company to point fingers and try to shift the blame while kids across the country are suffering at the hands of clear, indisputable corporate greed," Warren said in a statement Friday.

Flovent, a corticosteroid treatment now sold under its generic name fluticasone propionate, was one of the most commonly prescribed pediatric asthma treatments, in particular because the inhaler used to deliver the medication was designed for young children's small lungs. Alternate medications, such as Asmanex and Symbicort, are either in short supply or more difficult to get covered by insurers.

Other pharmaceutical companies have yet to follow GSK's example, said Jeromie Ballreich, an associate research professor at Johns Hopkins's Bloomberg School of Public Health and an author of the report on Flovent, probably due to the bad publicity the move attracted. It is an open question though, he said, whether such maneuvers could become more common under the incoming Trump administration. Some of Trump's nominees, including Robert F, Kennedy Jr., are critical of big pharma. Others are likely to be more pro-business and antiregulation.

"I don't know how that increasing regulation, increasing pressure against pharma versus less pressure against pharma, is going to play out," Ballreich said. "It's a very cloudy crystal ball."

Hamilton O'Rourke, of Acton, is one of many whose care has suffered since the switch. Until last year, the 10-year-old routinely received prescriptions for Flovent. Near the end of 2023, his mother, Sarah O'Rourke, got her insurance company to cover a prescription for Symbicort as a Flovent replacement. In 2024, though, that drug was no longer included in the insurer's formulary.

For months, she and her son's doctor, Ben Nelson of Massachusetts General Hospital, exchanged calls with her insurer, trying to get coverage for the boy's prescription. Her son attempted to use a powdered medication that didn't work before the insurer relented in November and covered Symbicort. Even then, she had to sign up with a mail delivery company to avoid being charged $425 at her local pharmacy and still ended up paying out-of-pocket for an air chamber to help direct the medication into Hamilton's lungs.

The scramble for alternative asthma treatments puts significant demands on his staff, Nelson, a pediatric pulmonologist, said.

"If I'm worried about a delay getting their medicine, then I have to prescribe a secondary medicine and also have prednisone on hand, give them a script [for prednisone] for them to avoid the ER or the hospital," he said.

An October review of hospital admissions data by a medical industry researcher points to a rise in pediatric asthma-related hospital cases following the withdrawal of Flovent. In the second quarter of this year, hospital admissions nationally for asthma-related complications among children prescribed some version of fluticasone propionate, including Flovent in earlier years, increased 24 percent compared to the same periods in 2022 and 2023, according to Epic Research, the public research branch of a medical software company. Intensive care unit admissions increased more than 21 percent in the same span.

"It's very frustrating," said Dr. Timothy Lax, a physician with Central Mass Allergy & Asthma Care in Worcester. "Especially during the winter when there are a lot of environmental components that can contribute to their conditions, it's really important for them to have their inhalers."

Three times this year, Hamilton had asthma flare-ups, dry coughing severe enough to make him vomit. When he was on Flovent, attacks that serious typically happened just once a year.

"They think they're saving money, but what they're making people do is making people go to the emergency room because their kids can't breathe," Sarah O'Rourke said.

O'Rourke now has enough Symbicort to get her son through March or April, she said. She is hoping for the best after that.

"I don't know if we're going to have to go through this again next year," she said. "I'm guessing we will."

Jason Laughlin can be reached at jason.Laughlin@globe.Com. Follow him @jasmlaughlin.

Doctors Urged To Ditch Blue Inhalers For Asthma Treatment Over Climate Concerns

The carbon footprint of blue inhalers is being compared to a long car trip (PA Archive)

The carbon footprint of blue inhalers is being compared to a lengthy car trip in advice released to asthma patients as British doctors are told to switch out the sprays for a more effective treatment.

In a "true pivot" in asthma care across the UK, new guidelines urge medics to offer inhalers that both relieve and prevent symptoms to newly diagnosed sufferers who are 12 and over, rather than the widely used, traditional inhalers that relieve symptoms only.

The joint guidelines for doctors, provided by the British Thoracic Society, National Institute for Health and Care Excellence (NICE), and the Scottish Intercollegiate Guidelines Network, have been issued alongside directions for patients that explain the environmental damage caused by the traditional inhalers.

"Most people with asthma have one or more preventer inhalers (which control your asthma) and a reliever or rescue inhaler (usually blue), which relieves symptoms," the patient advice brochure published online said.

"Some types of inhalers contain a propellant (gas) to carry the medicine into the lungs. The propellant has a greenhouse gas effect, which contributes to climate change (global warming)."

Doctors have been issued new guidelines for prescribing asthma inhalers (PA Wire)

The advice compared the carbon footprint of different types of inhalers, showing the carbon dioxide equivalent in kilograms between the various treatments and a journey of a motor vehicle fueled by petrol.

It said the Ventolin Evohaler brand of salbutamol, a common asthma reliever, contained more gas per puff than other salbutamol metered dose inhalers, comparing it to a 115-mile journey in a petrol car, as both contributed 35kg of carbon dioxide to the atmosphere.

"Flutiform and Symbicort metered dose inhalers contain a type of propellant that has a more powerful greenhouse effect than other metered dose inhalers that contain similar medicines. Dry powder inhalers do not contain propellant," the advice said.

The advice said switching to dry powder inhalers will have a beneficial effect on climate change, however stressed that asthma sufferers should choose or stick with the treatment that worked best for them.

The new guidelines for doctors recommend against prescribing short-acting, blue reliever inhalers without the corticosteroids contained in preventative medication, saying patients should instead be offered a low-dose combination of corticosteroids and formoterol, which they said led to people suffering "fewer severe asthma attacks."

The new guidelines have been described as a 'true pivot' in asthma care (PA Archive)

The directions say simple respiratory tests should be used to diagnose asthma when people first show symptoms, before prescribing the newly recommended treatment.

British Thoracic Society chair Paul Walker said the changes would have an impact on asthma care across the UK.

"The treatment changes represent a true pivot in the principles of asthma care and will contribute to improved outcomes," Dr Walker said.

Professor Jonathan Benger, chief medical officer and interim director of the Centre for Guidelines at NICE, said the updated guidelines would ease the pressure on the health service by reducing hospital admissions.

Health charity Asthma and Lung UK has previously warned about a million people with asthma were relying on reliever inhalers instead of preventers to manage their condition, increasing risk of serious illnes.

The charity's chief executive, Sarah Woolnough, urged the National Institute for Health and Care Excellence in 2022 to update its guidelines so relievers were no longer prescribed without preventative treatments.

How Pulmonary Rehab Can Help Improve Asthma Symptoms

Nearly 8% of Americans have asthma. Given that there's no cure for the condition, it's important that if you have it, you find ways to manage your breathing symptoms and limit your flare-ups in order to maintain as high a quality of life as possible.

Treatments for asthma include reliever inhalers, long-term inhalers, and pills—and in many cases, these are enough to keep the condition in check. But when a person's asthma is severe or isn't managed well by typical protocols, they may be a good candidate for pulmonary rehabilitation.

What is pulmonary rehab?

You might benefit from pulmonary rehab if your asthma disrupts your ability to perform daily activities, even while you're taking asthma medications. Pulmonary rehab is a supervised intervention that helps people live—and even thrive—with chronic breathing-related conditions. Many assume that the program mostly involves exercises designed to strengthen the lungs. While physical activity is indeed generally involved, pulmonary rehab involves a range of other interventions, including education about respiratory diseases, stress management, psychological counseling, and nutrition coaching from a multidisciplinary team, says Dr. Seyedmohammad Pourshahid, medical director of pulmonary rehabilitation at Temple University Hospital-Main Campus, in Philadelphia.

That's a lot to cover, so pulmonary rehab is usually conducted two to three times a week over eight to 12 weeks. It commonly takes place in person and in a group setting rather than virtually or via individual care, Pourshahid says.

Still, the plan is tailored to a specific patient's diagnosis and needs. "Somebody with asthma might actually have a different program than someone who doesn't have asthma," but instead has another respiratory condition like chronic obstructive pulmonary disease (COPD), says Dr. Michelle M. Freemer, program director of the division of lung diseases at the National Heart, Lung, and Blood Institute.

Read More: How Complementary Medicine Can Help People With Asthma

When you're just starting out with pulmonary rehab, you'll share a thorough health history with a nurse, during which you'll discuss medications, supplemental oxygen use, any other health conditions you have, your exercise habits, and more, says Katrina A. Roux-Bernstein, a certified registered nurse practitioner in pulmonology at the University of Maryland Baltimore Washington Medical Center. The nurse will work with the patient to set up a convenient schedule for rehab over the next several months.

Over the course of the program, youll have factors like your pulse oximetry, heart rate, and blood pressure monitored so your health care team can see what improvements have been made by the end of rehab, Roux-Bernstein says.

One additional measurement is a six-minute walking test. Early on in pulmonary rehab, you'll walk as far as you can in six minutes to see how your lungs and heart respond to the exertion. At the end of the program, the goal is to be able to walk farther in those same six minutes with a gradual increase in heart rate rather than a dramatic spike, Roux-Bernstein says.

How does pulmonary rehab help with asthma?

While larger and more robust research is needed, a 2021 review of existing studies on pulmonary rehab for adults with asthma found it generally improves quality of life, increases the ability to exercise, and eases some breathing problems. A 2023 review found a need for more asthma-specific research on pulmonary function outcomes like oxygen uptake, asthma symptom control, and asthma exacerbations (also called flare-ups or asthma attacks).

That said, the quality-of-life improvements seen with pulmonary rehab for people with asthma are robust. For example, pulmonary rehab can be encouraging for people with exercise-induced asthma. Throughout the program, these patients can work out while being monitored to see if the steps they take before exercise to prevent symptoms actually help, Freemer says. Plus, they have the emotional safety net that they can stop under a professional's care if and when they need to.

"There's the comfort of being observed, because you've got respiratory therapists, nurses, occupational therapists—you have all that support," Roux-Bernstein says. "Pulmonary rehab has been shown to reduce that anxiety that comes with movement and [the fear of] having another exacerbation."

Read More: What to Know About the Latest Advances in Managing Severe Asthma

Pulmonary rehab may be even more helpful for people with asthma who also have another breathing-related condition, Roux-Bernstein says. Someone with asthma may have been managing their symptoms well until getting Long COVID, for example, and now suddenly they're short of breath after minimal effort, she says. Or perhaps someone has asthma and COPD, pulmonary hypertension, pulmonary fibrosis, or sarcoidosis. Pulmonary rehab can help restore some lung function and improve quality of life for people facing these or similar comorbidities, she says.

That's at least in part because asthma can be a bit of a vicious cycle: The steroid medications commonly used for asthma treatment can lead to muscle loss over time, and muscle loss makes it harder to breathe, Pourshahid says. When a person is already having trouble breathing, they're less likely to exercise, which reduces their general physical fitness, makes them even more short of breath, and contributes to more muscle loss. Pulmonary rehab can help break that cycle by building muscle, improving cardiovascular endurance, and educating the patient on dietary choices that support muscle growth, he adds.

Mental health improves too

Living with a chronic diagnosis like asthma is associated with higher rates of anxiety and depression, which can in turn trigger more exacerbations of asthma symptoms, Pourshahid says. But if you aren't feeling your best mentally and are worried about having an asthma attack while out in public, you might be inclined to isolate and not engage with your community, furthering your risk for mental health consequences and a generally lower quality of life, he says.

Pulmonary rehab may function as a comforting, welcoming space where those worries can be lifted—at least temporarily. For example, "you're able to bring your oxygen and not feel looked at because everybody's got their oxygen with them, too," Roux-Bernstein says.

A pulmonary rehab program typically teaches patients mindfulness, breathing techniques, stress reduction, and other coping mechanisms that can help them better manage both physical and mental symptoms. "People learn to see how they can live a life where they're still able to go for the goals that they have and activities that they would like [to try]" despite breathing difficulties, Pourshahid says.

There's a built-in community in pulmonary rehab, too, which helps fight the desire to isolate. "I hear from a lot of my patients that when they graduate [from pulmonary rehab] they exchange numbers with their friends. They are not in the same program anymore, but it still is a community," Pourshahid says.

Read More: How Air Quality Affects Asthma—and What to Do About It

And adopting mindfulness techniques can help in the moment of asthma flares, as well. Getting short of breath often brings on anxiety that causes some people to start to hyperventilate. Pulmonary rehab teaches you how to deal with this kind of situation before it escalates into a full-blown asthma attack, and gives you the tools to use outside of the program when such a scenario arises.

"The whole idea is basically trying to equip and empower the patients who have this chronic respiratory disease with some useful techniques and skills," Pourshahid says. "In a way, pulmonary rehab is more like a school than a few gym sessions."

For all of its effectiveness, pulmonary rehab does have a couple of small downsides. The biggest may be the time commitment: A patient has to have the availability to go to sessions every week. "Pulmonary rehab takes time and effort," Freemer says. "It's not the same as: 'Here's the medication, take the pill or use your inhaler,' and it's over." 

And just by the nature of the program, which includes physical activity, it's possible you could suffer a minor injury. But Pourshahid sees these risks as no greater than the risk of any daily activity.

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