New NICE Guidelines for Asthma: FeNO Testing and the NObreath® Device in Adult and Paediatric Care

On Wednesday, 27th November, the National Institute for Health and Care Excellence (NICE), the British Thoracic Society (BTS), and the Scottish Intercollegiate Guidelines Network (SIGN) updated and published a joint guideline on asthma diagnosis, monitoring, and chronic asthma management. 

Streamlining asthma management

BTS/SIGN and NICE published guidelines independent of each other. To align approaches to asthma care throughout the UK, NICE has undertaken a joint review with BTS and SIGN to bring harmonisation across the board. This review brings significant changes to asthma care approaches, including applying fractional exhaled nitric oxide (FeNO) testing- an objective airway inflammation test for aiding in asthma diagnosis and management.

Previously, NICE, BTS and SIGN recommended the following:NICE:

  • FeNO testing was recommended for use in adults and children during asthma diagnosis.
  • FeNO levels, should be measured in conjunction with other diagnostic tests (e.g., spirometry).
  • For adults: A FeNO level of 40 parts per billion (ppb) or more was regarded as a positive test.
  • For children and young people (5–16 years): A FeNO level of 35 ppb or more was regarded as a positive test.

BTS and SIGN:

  • FeNO testing can support asthma diagnosis, particularly when the diagnosis is uncertain or symptoms suggest eosinophilic inflammation in adults and children.
  • FeNO levels, should be measured in conjunction with other diagnostic tests (e.g., spirometry).
  • For adults: A FeNO level of 40 ppb or more was regarded as a positive test.
  • For children and young people (5–16 years): A FeNO level of 35 ppb or more was regarded as a positive test.

What is new? NICE/BTS/SIGN guideline on asthma: diagnosis, monitoring and chronic asthma management

Asthma diagnosis (adults):

The new NICE/BTS/SIGN guidelines recommend that adults with symptoms and a history suggestive of asthma undergo blood eosinophil count or FeNO testing as initial diagnostic steps. Asthma can be diagnosed if the blood eosinophil count exceeds the laboratory reference range or if FeNO levels are 50 ppb or higher. If these initial tests are inconclusive, bronchodilator reversibility (BDR) testing with spirometry is advised. When asthma remains clinically suspected despite inconclusive results from blood eosinophil count or FeNO, BDR, or peak expiratory flow (PEF) measurements, a referral for a bronchial challenge test is recommended to confirm the diagnosis if bronchial hyper-responsiveness is detected.

Asthma diagnosis (children and young people aged 5-16):

For children with symptoms suggestive of asthma, the new NICE/BTS/SIGN guidelines recommend measuring FeNO levels as a first-line diagnostic test, provided it is available. Asthma can be diagnosed if FeNO levels are 35 ppb or higher. A NICE literature review highlighted the higher specificity of FeNO testing in children, further reinforcing its use as a first-line option for both children and adults.

Asthma management (adults):

FeNO testing provides a significant advantage to health care professionals when monitoring asthma patients, including assessment of response to newly prescribed asthma therapies and regular review of adherence to medications. FeNO monitoring applications have been acknowledged globally in other well-recognised clinical guidelines, including the American Thoracic Society (ATS) and the Global Initiative for Asthma (GINA). Not acknowledged in previous asthma clinical guidelines by NICE or BTS/SIGN, a recommendation has been made to include FeNO evaluations as part of regular yearly asthma reviews in adults, alongside reviewing before and after any changes to patients’ asthma therapy.

Economic Evaluation of asthma care

Cost of exacerbations to the NHS:

NICE calculated that on average a mild to moderate exacerbation cost the NHS on average £42 per patient. This includes a GP visit (£38) and a salbutamol metered-dose inhaler (MDI) with a spacer (£4).

For severe exacerbations, the average estimated cost was thought to increase to £102 per patient. This includes 80% of patients requiring systemic glucocorticoid steroids (adults £1.88 and children £0.60), 13% of patients visiting A&E (£113), and 7% of patients needing hospitalisation (adults £1,181 and children £1,223).

FeNO cost analysis:

NICE conducted an economic evaluation of FeNO testing, factoring in the volume of tests performed on average across the UK. On average, taking into account the resource allocation of staff time and the cost of a FeNO test, an average total cost to the NHS would be £22.21 per patient. Among the eight diagnostic tests evaluated during NICE’s review, FeNO ranked as the third most cost-effective after adult blood eosinophil count and children’s blood eosinophil count.

NICE also highlighted the potential economic advantage of performing multiple tests during the same appointment, which could save time and reduce overall costs. The most cost-effective combination was spirometry and FeNO with a total cost of £34.29, followed by BDR and FeNO (£50.52) and skin prick test and FeNO, which ranked fourth most cost-effective (£50.66). These findings suggest strategic test combinations could optimise economic and clinical outcomes.

Carol Stonham, a member of Bedfont® Scientific Limited Medical Advisory Board and policy lead for Policy Care Respiratory Society (PCRS), comments “The new NICE/BTS/SIGN asthma guidelines introduce a positive step change in the diagnosis and management of asthma for adults and children. For diagnosis the necessity to perform numerous diagnostic tests has been reduced if initial testing confirms asthma, based on the evidence and cost effectiveness. In management the step away from using short acting bronchodilators to anti-inflammatory (AIR) and Maintenance and Reliever Therapy (MART) regimes should see better asthma control, less people with symptoms, and a reduction in asthma mortality.”

FeNO testing in asthma: Key takeaways from NICE guidelines

Diagnosis:

  • For adults, asthma can be diagnosed if FeNO levels are 50 ppb or higher, an increase from the previous NICE guideline’s 40 ppb or higher threshold.
  • For children, asthma can be diagnosed if FeNO levels are 35 ppb or higher. This has remained the same as the previous NICE guidelines.
  • FeNO testing recommended first-line testing in asthma diagnosis for adults and children.
  • If the first test is diagnostic further diagnostic testing is not required.

Management:

  • FeNO testing has been acknowledged as a tool in asthma management.
  • Aids to inform healthcare professionals when changing or adjusting asthma therapy.
  • Recommending FeNO use for asthma monitoring in adults.

Costs:

NICE’s economic evaluation revealed the average FeNO test to be on average £22.21, this includes an average consumable cost of £6.37. The NObreath® device, manufactured by Bedfont® Scientific Limited prides itself on being one of the most cost-effective products on the market. On average, NObreath® consumables (£3.70 per mouthpiece) are 42%* less than the FeNO testing consumables pricing highlighted in the NICE economic evaluation (£6.37), making the overall cost for FeNO testing 12%* less than what has originally been highlighted in the NICE economic evaluation, ensuring fair and accessible pricing for both primary and secondary care alike.  

To read the full NICE guidelines, please visit: https://www.nice.org.uk/guidance/ng244

*Based on UK pricing.

References:

  • Asthma pathway (BTS, NICE, SIGN) [Internet]. National Institute for Health and Care Excellence. 2024. [Cited Wednesday 27th November 2024]. Available from: https://www.nice.org.uk/guidance/ng244