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News|Articles|September 30, 2026
FDA Accepts Inhaled Treprostinil sNDA for IPF: 4 FAQs for Payers
Author(s)Sabrina McCrear
Fact checked by: Steven D. Nathan, MD, Giuliana Grossi
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Key Takeaways
- FDA review of nebulized treprostinil for IPF is underway based on TETON-1/2, which met the primary endpoint of 52-week absolute FVC change with a 111.8 mL advantage.
- Unlike nerandomilast, nintedanib, and pirfenidone (all oral), inhaled treprostinil would add a lung-targeted delivery option that could expand regimen selection and sequencing.
FDA accepted United Therapeutics' sNDA for inhaled treprostinil in IPF. Here's what it could mean for patient access, coverage, and costs
United Therapeutics
If approved, it would be the first and only inhaled antifibrotic treatment for IPF, a prospect that could bring significant changes to IPF care.1 The filing follows through on the
"I think this further opens the door for other inhaled therapies," Steven D. Nathan, MD, Schar Chair of Advanced Lung Disease and Lung Transplant and medical director of the Advanced Lung Disease and Lung Transplant Program, Inova Schar Heart and Vascular, said in
As Pulmonary Fibrosis Awareness Month comes to a close, here are 4 FAQs on what inhaled treprostinil could mean for patients and payers, should it be approved.
How Could Inhaled Treprostinil Expand Access for Patients With IPF?
IPF is estimated to affect between 2.4 and 2.98 people per 10,000 persons in North America, and United Therapeutics estimates that at least 100,000 people are living with IPF in the US.1 Current therapies for IPF are limited, and the arrival of another therapy, delivered directly to the lungs, could stir competition, prompting payers to reevaluate coverage and manufacturers to revisit pricing.
All 3 currently approved IPF therapies are taken orally, so inhaled treprostinil would fill a gap in delivery methods for this disease.1,4 That gap underscores Nathan's point that the inhaled route has been underused for fibrotic lung disease.3
What IPF Treatments Are Available Now, and How Would Inhaled Treprostinil Differ?
There are
1. Nerandomilast (Jascayd; Boehringer Ingelheim), an oral phosphodiesterase-4B inhibitor approved in 2025, was the first new IPF therapy approved in more than 10 years.
2. Nintedanib (Ofev; Boehringer Ingelheim), approved in 2014, is a tyrosine kinase inhibitor that targets multiple growth factor receptors.
3. Pirfenidone (Esbriet; Genentech), also approved in 2014, is an oral antifibrotic and anti-inflammatory therapy.
All 3 have been shown to slow the rate of FVC decline in patients with IPF, but all 3 are oral.4 Inhaled treprostinil would give clinicians a fourth antifibrotic, one delivered directly to the lungs, Nathan said.5
"And I think having choice is great for providers and especially for patients, and I think it will have a firm place in current treatment management of patients with IPF," he said.5
Does Medicare Cover Nebulized Treprostinil Differently Than Oral Antifibrotics?
United Therapeutics has not announced pricing for inhaled treprostinil in IPF. However, the therapy is already approved to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), so pricing data for those indications exist.1,6
Commercial insurers have negotiated a median rate of about $794 per 1.74-mg unit when the drug is billed from a physician practice and about $1023 when billed from a hospital outpatient department, according to price transparency data from 64 carriers. These are negotiated rates, not what patients pay out of pocket.7
The Healthcare Common Procedure Coding System (HCPCS) lists inhaled treprostinil under code J7686 as a drug administered through durable medical equipment (DME). Medicare Part B covers medically necessary DME, and beneficiaries pay 20% of the Medicare-approved amount after the Part B deductible, whereas the oral antifibrotics are covered under Medicare Part D.8,9
How Much Could Inhaled Treprostinil for IPF Cost Patients and Payers?
Patient and payer costs for inhaled treprostinil in IPF cannot yet be predicted, but prior research on Medicare Part D spending for the oral antifibrotics shows how quickly the market can shift. Between 2019 and 2023, total Part D spending on nintedanib rose from $789 million to more than $1.8 billion, an increase of more than 128%, while spending on pirfenidone fell about 85%, from $617 million to $93 million, driven mainly by a drop in claims. Average cost per claim rose for both drugs over the same period.9
The authors attributed the divergence to evolving prescribing patterns, which could shift again should inhaled treprostinil be approved.9
References
1. United Therapeutics Corporation announces FDA acceptance of supplemental new drug application for nebulized Tyvaso to treat idiopathic pulmonary fibrosis. News release. United Therapeutics. September 2, 2026. Accessed September 29, 2026.
2. McCrear S. United Therapeutics plans FDA submission for inhaled treprostinil in IPF. AJMC®. June 16, 2026. Accessed September 29, 2026.
3. McCrear S, Nathan SD. Emerging inhaled IPF therapies show promise: Steven D. Nathan, MD. AJMC. August 5, 2026. Accessed September 29, 2026.
4. McCrear S. FAQs on IPF therapies: current, emerging, and combination strategies. AJMC. March 20, 2026. Accessed September 29, 2026.
5. McCrear S, Nathan SD. Inhaled treprostinil improves FVC in IPF phase 3 trial: Steven D. Nathan, MD. AJMC. April 24, 2026. Accessed September 29, 2026.
6. Tyvaso (treprostinil) inhalation solution. United Therapeutics. Accessed September 29, 2026.
7. Tyvaso – treprostinil inhalation solution (HCPCS J7686). Tynbil. Updated July 2026. Accessed September 29, 2026.
8. Durable medical equipment (DME) coverage. Medicare.gov. Accessed September 29, 2026.
9. Rizly S, Vaithiswaran D, Lorenzana A, Saleh A. Trends in Medicare Part D spending on antifibrotic therapies for pulmonary fibrosis: 2019–2023. medRxiv. Preprint posted online August 2, 2025. doi:10.1101/2025.08.01.25332591
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