MORRISVILLE – Morrisville airway products company Circassia is breathing a sigh of relief over a decision by the giant AETNA health insurance company that one of Circassia’s key asthma products is “medically necessary.”

The ruling supporting the use of fractional exhaled nitric oxide (FeNO) testing means one of the largest health insurers in the nation promotes the use of Circassia’s NIOX device in the management and treatment of asthma.

The device, which is covered by a variety of other health insurance companies, but so far without the “medically necessary” imprimatur, measures FeNO levels in patients age 7 and older as an indicator of underlying airway inflammation.

In December 2017, the U.S. Agency for Healthcare Research and Quality (AHRQ) issued a new clinical evidence report, “The Clinical Utility of Fractional Nitric Oxide (FeNO) in Asthma Management,” highlighting FeNO testing as a valuable part of comprehensive asthma diagnosis and management.

Circassia photo

A NIOX VERO device

“FeNO results can predict which patients will respond to inhaled corticosteroid therapy. Using FeNO to manage long-term control medications including dose titration, weaning and monitoring of adherence, reduces the frequency of exacerbations,” according to the report.

“The ability to predict which asthma patients will respond to corticosteroid therapy, and how well that therapy is working to reduce the frequency of exacerbations is powerful information for clinicians,” said Bradley Chipps, M.D., FAAP, FAAA, FCCP, pediatric pulmonologist, allergist, and president of the American College of Allergy, Asthma and Immunology. “It is exciting to see the AHRQ report support FeNO testing as a tool that can truly benefit asthma patients and improve outcomes, particularly for children.”

Circassia is the only maker of a FeNO testing device approved for use at the point of care in the United States.

The science of asthma


Asthma is a chronic inflammatory respiratory disease that often begins in childhood, but it can affect people of any age. Attacks, or exacerbations, of breathlessness and wheezing of varying severity and frequency can be life-threatening if left untreated. The World Health Organization estimates 235 million people suffer the condition worldwide and that it affects approximately 25 million in the U.S. It is a leading cause of missed school days by children each year.

Genetics in combination with allergic reaction to environmental triggers are the cause of the most common form of asthma, called atopic, or type 2, asthma. The immune system overreacts to a perceived threat from an allergen – such as dust, cat dander, air pollution or a food – and sends a plethora of T-helper 2 immune cells to thwart the adversary. The result is inflammation (swelling of the lining) and constriction (bronchospasm) of the airways, which reduce airflow, and overproduction of mucus, which further clogs airways making it difficult to breathe.

The goal of successful asthma treatment is to control inflammation, often with use of daily inhaled corticosteroid medications (inhalers), and to limit exposure to allergic triggers and other factors, including cold and flu viruses. Good control of asthma is defined by fewer and less intense exacerbations.
Not all asthma is the same, however. Different molecular mechanisms drive the two major subtypes of the condition, known as type 1 and type 2 asthma. Treatments vary in terms of their effectiveness by what type of asthma a person has. Type 2 is the most common in children as well.

The role of FeNO testing

NIOX technology is based on the discovery that patients with Th2 (T-helper 2 immune cells) or type 2-driven airway inflammation generally have higher than normal levels of nitric oxide in their exhaled breath. By measuring the concentration of this fractional exhaled nitric oxide, NIOX enables clinicians to evaluate airway inflammation in patients. The device is non-invasive; patients as young as age 7 simply breathe into the mouthpiece. It provides results at the point of care in approximately one minute. Thus, clinicians can make evidence-based treatment decisions with the results during the same patient visit.

Circassia photo

Testing a NIOX device

The Swedish company Aerocrine introduced the first version of NIOX, the FLEX model, in 2005 as a global product. That company’s founders commercialized discoveries from Sweden’s prestigious Karolinska Institute that identified nitric oxide as a diagnostic tool, or marker, for measuring airway inflammation.

NCBiotech helped recruit company to NC from NJ

Initially, Aerocrine’s U.S. headquarters were in New Jersey. However, in 2012, the North Carolina Biotechnology Center provided $100,000 in economic development funding that enabled the Town of Morrisville to leverage matching One North Carolina Fund money, to attract the firm’s move. The funds depended upon Aerocrine’s meeting three-year job-creation goals anticipated to bring up to 45 jobs to the new Morrisville operation. Other partners that helped bring the headquarters to North Carolina included the N.C. Department of Commerce, N.C. Community Colleges, Wake County and the Morrisville Chamber of Commerce.

Circassia, headquartered in Oxford, England, was established in 2006. In March 2014 it completed an initial public offering on the London Stock Exchange. The company also has operations in Uppsala, Sweden. In June 2015, it completed acquisition of Aerocrine. In 2017, it established a collaboration with AstraZeneca in the United States to commercialize a COPD product.

The company markets two products globally — NIOX MINO and NIOX VERO — for the diagnosis and management of airway disease. According to David Acheson, Circassia’s senior vice president commercial U.S., over 18 million FeNO tests, or uses, of NIOX have occurred worldwide so far in both clinical and research settings.

Physicians or other providers make a one-time purchase of the $1,500 NIOX VERO device, which is shipped out of the Morrisville distribution center. It has an expected lifespan of five years or 15,000 tests. Each test to detect FeNO in a patient’s breath then uses a disposable kit, which costs $8.50, also sold by Circassia, explained Acheson. The potential for reimbursement from more insurance companies for that test is what makes use of the device more affordable and potentially more widespread throughout the U.S.

Total insurance claims specifically for asthma management – not for treatment in clinics or hospital emergency departments or for medications — in the U.S., said Acheson, exceed $26 million annually. The opening of the market of AETNA to Circassia, with its total of 22 million lives covered by the insurer, gives the company a significant boost in potential revenue. Classification as “medically necessary,” is a statement by the insurer stronger than a recommendation, said Acheson.

“It is telling clinicians, ‘This is a test you should be doing regularly to help manage asthma patients.’”

Circassia has 300 employees nationwide, the majority in sales. About 60 employees are based in the Morrisville headquarters. Acheson said talks are underway with Blue Cross Blue Shield Association, Florida Medicaid and Cigna insurers to also cover FeNO testing.

(C) N.C. Biotechnology Center