Friday, May 16, 2008

NIOX MINO for asthma monitoring

The NIOX MINO is a hand held machine that can analyze a person's exhaled air for fractional exhaled nitric oxide (FENO) content. This thought to be important because it should correlate with the amount of bronchial airways inflammation, which leads to asthmatic symptoms such as chest tightness, shortness of breath, cough, and wheezing. If physicians and patients work to keep the FENO low enough, then theoretically the patients should have much less or ideally minimal asthma symptoms. The FDA approved the machine in March of 2008. The manufacturer, Aerocrine, Inc., hopes that the machine will become widely used to help health care professionals monitor the status of a person's asthma. The current gold standard is pulmonary spirometry, which itself is very rarely used by primary care physicians. Allergists and pulmonologists use spirometry routinely to measure how much the airways are narrowed by inflammation. This useage is recommended by medical guidelines around the world.

I have had the opportunity to work with the NIOX MINO during clinical drug trials. It is certainly small, about the size of a shoe box, and light. It is also pretty simple to use. There are some logistic problems I foresee before it enters widespread use. First is the price which ranges from $2,500 to $5,000, depending on the purchasing arrangement. Naturally every machine will need replacement parts also. Most spirometers cost at least $3,000, in my experience, so this is not out of range for medical office equipment. Second is the lack of any reimbursement. There is a CPT code, 95012, specifically for this machine. However, every insurance carrier that I checked with stated there would be no reimbursement. The patient would be responsible for any charges. This means both physicians and patients will be quite reluctant to measure the FENO. Physicians and clinics will be reluctant to even buy the NIOX MINO. This is a real hurdle in NIOX MINO's entering the daily practice of medicine. Third is a comfort factor with using the NIOX MINO. I expect with time and aggressive marketing, this limiting factor can be overcome. Fourth and most importantly is that while theoretically convenient to those uncomfortable with doing spirometry the value of following of asthma patients solely with NIOX MINO has never been proven or even studied to my knowledge. So until then patients should still have spirometry done simultaneously. There is tremendous potential for sales once these factors have been overcome.

The NIOX MINO machine is a notable step forward for measuring airways inflammation. However, at this time, I cannot recommend that any practice purchase a machine unless the physician and patient are simply interested in the pateint's FENO.

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