Patents, Rebates, and a Policy Patchwork Keep Inhalers Costly, Panelists Say

For patients with asthma or chronic obstructive pulmonary disease (COPD), whether to use an inhaler can turn on how much it costs. And for some, that can mean life or death. This was the case in 2024, when a decision by one manufacturer to shift availability of an inhaler popular with pediatric patients contributed to deaths of several children, a Senate investigation found.¹

At CHEST 2026, the annual meeting of the American College of Chest Physicians in Phoenix, Arizona, speakers examined this incident—and how it is emblematic of why respiratory medications remain so expensive, decades after they reached the market. They also looked at federal, state, and industry efforts have done about it, and how clinicians can stand up for their patients.

“We have a health care system in the US that is characterized by high spending on pharmaceuticals, covered by a range of different payers, flowing through a complex supply chain with markups and rebates, concentrated on brand-name drugs with long durations of market protection,” said William Feldman, MD, DPhil, MPH, associate professor at the David Geffen School of Medicine at UCLA, who moderated the session, “The Price of Breathing: Addressing High Medication Costs Through Policy and Practice.”

The High Cost of Inhalers

Feldman, a pulmonary and critical care physician, said the US spends $5.3 trillion on health care,² 18% of gross domestic product, with 13%, or $711 billion, going to prescription drugs.³ About half of drug spending comes from government payers, and 12% comes from patients out of pocket. Rebates negotiated by pharmacy benefit managers (PBMs) make true prices “opaque,” he said, with spending at list prices reaching about $1 trillion in 2024, while manufacturers netted $487 billion.⁴

Generic drugs account for 90% of prescription fills but only about 12% of spending, and every state and the District of Columbia has mandatory or permissive substitution laws.⁵ "Generic competition remains the key way that we lower pharmaceutical prices in the US," Feldman said.

Patents are the main barrier, he said. The FDA cannot approve a generic until patents listed in its Orange Book expire or are successfully challenged, and Feldman's research found that more than half of inhaler patents in the Orange Book cover delivery devices, most without mentioning the active ingredient. Brand-name inhaler manufacturers earned $178 billion from 2000 to 2021, two-thirds of it after patents on active ingredients expired.⁶

The Federal Trade Commission (FTC), starting under the Biden administration and continuing under the Trump administration, has declared improper listing of device-only patents illegal. Of 34 products it flagged, 74% were inhalers; others included glucagon-like peptide-1 drugs and epinephrine pens. Compliance is now near 100%, the median patent portfolio shrank to a single patent, and expected protection shortened for 19 products.⁷

Still, only 8 of 37 brand-name inhaler products face generic competition, Feldman said, and most have just 1 or 2 rivals—with prices falling sharply only when that number reaches 6 or more. Feldman said he priced Trelegy Ellipta (GSK) at a Phoenix pharmacy the day before the session at $695, even with a discount coupon.

He warned that the coming shift to metered-dose inhalers with low–global-warming propellants could repeat the earlier transition from chlorofluorocarbon to hydrofluoroalkane (HFA) inhalers, after which companies earned $14 billion on brand-name albuterol over 15 years.⁸ "My worry is that we could be at CHEST in 2040, and we may have a new graph where we see something similar."

A Patchwork of Price Fixes

Stephen Mein, MD, an instructor at Harvard Medical School and a pulmonary and critical care physician and health services researcher at Beth Israel Deaconess Medical Center, said pharmaceuticals are now the largest category of COPD spending. Patients pay about $1000 a year for 1 inhaler and $2000 to $3000 for multiple inhalers, and about 1 in 3 with asthma or COPD report cost-related nonadherence, which drives emergency visits and hospitalizations.

Mein called the Inflation Reduction Act (IRA) "arguably the most important drug policy that we've had," citing its $2000 annual out-of-pocket (OOP) cap for Part D, its expanded low-income subsidy, and the provision for Medicare drug price negotiation. His group projected that about 360,000 Medicare beneficiaries with asthma or COPD, or 7%, would save roughly $1000 a year under the OOP cap—more than $500 million annually—and that more than 200,000 would newly qualify for the subsidy.⁹ However, they predicted that Black, Hispanic, and low-income patients were less likely to reach the cap.

Early results, however, are more encouraging. After the 2024 provisions, cost-related nonadherence fell 5% among Medicare beneficiaries vs privately insured adults, and 10% among those with asthma or COPD. Use of high-cost drugs, including nintedanib (Ofev; Boehringer Ingelheim), also rose. Trelegy, Ofev, and Breo Ellipta are among the 15 drugs with 2027 negotiated prices, which are 50% to 83% lower. But launch prices have not budged, Mein said, and insurers may respond with higher premiums, deductibles, and prior authorization.

At the state level, 5 states have capped inhaler copays at $25 to $50, though only for state-regulated plans, and their effect is unknown. Mein highlighted Missouri Medicaid, which in 2022 promoted single maintenance and reliever therapy (SMART), made inhaled corticosteroid (ICS)–formoterol inhalers preferred, and limited short-acting β-agonist (SABA) prescriptions. By year 3, ICS-formoterol use rose 50% relative to 7 Midwest control states, while SABA inhalers fell 29% and nebulizers 23%.

After the FTC's patent challenges and a Senate investigation, AstraZeneca and Boehringer Ingelheim in June 2024, and GSK in January 2025, capped inhaler costs at $35 a month. Mein's team estimated about 1.7 million privately insured patients could benefit, with mean savings near $250 a year.¹⁰ But the caps exclude Medicare and Medicaid, about 40% of the population, as well as authorized generics, and no ICS-only HFA inhaler is covered—leaving a major gap for children. Direct-to-consumer platforms, including TrumpRx, still list inhalers at $100 to $200 a month.

“We've created this patchwork of solutions that don't actually get to the root cause,” Mein said, urging clinicians to ask about cost as routinely as inhaler technique.

From the Exam Room to Capitol Hill

Robyn Cohen, MD, MPH, a pediatric pulmonologist and associate professor of pediatrics at Boston University, framed her talk around finding appropriate treatment solutions for children. “I'm not giving a 4-year-old a dry powder inhaler,” she said.

She recounted January 2024, when the American Rescue Plan Act removed the cap on Medicaid inflation rebates. Rather than cut the price of Flovent, GSK discontinued it and licensed the identical product to Prasco as an authorized generic, which could launch at a higher price with smaller rebates. Insurers and PBMs dropped coverage, families faced bills of $200 or more.¹ As she recalled for the audience, “Chaos totally ensued,” putting Cohen on her advocacy path.

She advised asking patients, “Do you have a separate card for your prescriptions?” That’s because the “Big 3” PBMs—namely Express Scripts, OptumRx, and CVS Caremark—serve 80% of commercially insured patients. Practical tips included:

• Look up the PBM's formulary online to check tiers, prior authorization, quantity limits, and step therapy.
• Use EHR cost estimators, since sending a prescription to the wrong pharmacy can triple a patient's cost.
• Work with IT staff on brand-agnostic prescriptions, which have worked at her institution for 4 years.

Cohen also described what advocacy accomplished. A letter to the Massachusetts Medicaid program removed a prior authorization requirement the next day. A letter about the Flovent crisis signed by 65 pediatric pulmonologists crisis in the New England Pediatric Pulmonary Consortium prompted US Sen. Maggie Hassan (D, New Hampshire) to hold a press conference, generating national coverage. Op-eds written with media support from the American Lung Association and steady social media posts led to a meeting with a GSK leader. Arizona's attorney general later sued GSK.

Still, Cohen noted that none of the 3 available ICS metered-dose inhalers are made by companies offering caps, and some 2-year-olds were switched to Symbicort. She called for universal coverage of SMART and patent reform, noting that no new mechanism of action has entered inhaled therapy in about 40 years. “You have a voice,” she said. “We have to be the change we seek.”

Starting Small and Thinking Big

During a brief question-and-answer session, Cohen said that a request to remove prior authorization for ICS-formoterol for her hospital's employees led her to ask the PBM to drop it for all subscribers. “Go after the low-hanging fruit,” she said. Mein pointed to collective advocacy through CHEST and the American Thoracic Society, patent reform, and cost-effectiveness-based pricing used in other countries. Asked about state action, Feldman said prescription drug affordability boards face legal challenges and much of the change “has to happen at the federal level.”

References

1. Senate Investigation: Flovent Discontinuation Profited GSK, Harmed Kids. Respiratory Therapy. March 17, 2024. Accessed October 19, 2026. https://respiratory-therapy.com/public-health/healthcare-policy/senate-investigation-flovent-discontinuation-profited-gsk-harmed-kids/
2. Hartman M, Martin AB, Lassman D, Catlin A; National Health Expenditure Accounts Team. National health care spending increased 7.2 percent in 2024 as utilization remained elevated. Health Aff (Millwood). 2026;45(2):110-120.
3. Fein AJ. Latest CMS data reveal six trends reshaping U.S. drug spending. Drug Channels. February 3, 2026. Then drop or attribute the $711 billion.
4. https://www.fiercepharma.com/pharma/2024-us-drug-market-rose-114-historic-growth-backed-spending-obesity-oncology-meds-iqvia
5. 2026 U.S. Generic & Biosimilar Medicines Savings Report. Biosimilars Council. September 10, 2026. Accessed October 19, 2026. https://biosimilarscouncil.org/resource/2026-generic-biosimilar-medicines-savings-report/
6. Feldman WB, Tu SS, Alhiary R, Kesselheim AS, Wouters OJ. Manufacturer revenue on inhalers after expiration of primary patents, 2000-2021. JAMA. 2023;329(1):87-89. doi:10.1001/jama.2022.19691
7. Leon J, Tu SS, Kesselheim AS, Feldman WB. Delisting of pharmaceutical patents challenged by the Federal Trade Commission. JAMA Intern Med. Published online May 11, 2026.
8. Wouters OJ, Feldman WB, Tu SS. Product hopping in the drug industry—lessons from albuterol. N Engl J Med. 2022;387(13):1153-1156.
9. Mein SA, Tale A, Rice MB, Narasimmaraj PR, Wadhera RK. Out-of-pocket prescription drug savings for Medicare beneficiaries with asthma and COPD under the Inflation Reduction Act. J Gen Intern Med. 2024.
10. Mein SA, Kludze AK, Feldman WB, Tale AP, Stevens JP, Wadhera RK. Out-of-pocket savings under the inhaler price cap. JAMA Intern Med. 2025;185(3):339-341.