NICE publishes update on triple therapy for COPD

NICE has published an updated COPD guideline which makes recommendations on inhaled triple therapy, and oral corticosteroids for managing exacerbations.

It updates the NICE December 2018 guideline on diagnosing and managing COPD which had omitted recommendations on triple therapy. PCRS and other organisations advised that this omission would render the guideline out of date on publication. So NICE decided to update immediately.

NICE guidance on triple therapy (paras 1.2.14-18)

The guideline recommends that prior to initiating triple therapy with ANY COPD patients – the following should be done -

• a clinical review of the patient before initiating triple therapy in order to
  • ensure that non-pharmacological management of the patient is optimised including treating tobacco dependency
  • exclude any non-COPD related causes of acute episodes or day to day symptoms,

For people with COPD with asthmatic features on LABA+ICS who are still having symptoms or exacerbations, offer to add LAMA

For people with COPD on LAMA+LABA, who are still having exacerbations, consider adding ICS

For people with COPD on LAMA+LABA who are still having symptoms – greater caution is advised in terms of progressing to triple therapy

• a 3 month trial initially for patients on LAMA+LABA,
• a clinical review at 3 months to determine benefit and discontinuing ICS if no improvement in symptoms

For all patients on triple therapy -

• undertake an annual review for any patients on ‘continuing’ triple therapy
• document the reasons for using triple therapy

An updated algorithm has been developed to reflect these three COPD patient types.

In common with the global GOLD 2019 guidance PCRS suggests a stepped approach to COPD treatment for patients with predominant breathlessness - starting initially with LAMA (or LABA)alone before stepping up if necessary to a LAMA/LABA combination. This is set out in the PCRS ‘All that Glitters is not Gold nor is it even NICE’ consensus statement.

Vince Mak, integrated respiratory physician and lead author of the consensus statement commented,

“The addition of triple therapy to the NICE algorithm for COPD management is welcomed since it is now a more complete guideline than the 2018 update, which omitted triple therapy. NICE now aligns more closely with the pragmatic advice that PCRS has developed for primary care. It is good that appropriate cautions have been built in where there is less evidence of benefit for certain patient types.

“However, our guidance differs from NICE in that we continue to advise that triple therapy is not generally beneficial for COPD patients with predominant breathlessness. NICE advises considering a three month trial in these patients.We question the evidence base for this treatment step and fear that in practice many patients will be moved onto triple therapy and not reviewed to assess the benefit. We would still recommend seeking advice and guidance from a respiratory specialist (GP/nurse/consultant) if triple therapy is being considered.“

Policy lead for PCRS and GP, Duncan Keeley added:

“The latest NICE guideline provides greater clarity about when the evidence is strongest for using triple therapy and when we should use this option with caution due to limited evidence and risk of side effects.

“PCRS argues for careful review of all aspects of diagnosis and management - before initiating triple therapy.GOLD suggests that treatment should be guided by whether patients are primarily experiencing breathlessness or exacerbations, and should include inhaled steroids initially only if the patient with persisting symptoms has co-existing features of asthma or a raised eosinophil count ( > 300 cells per microlitre).PCRS will continue for the present to look to GOLD rather than NICE, and urges caution in moving to triple therapy unless the benefits for individual patients having exacerbations are clear.”

NICE has also clarified the duration of OCS treatment during an exacerbation should be 5 days, rather than 7. This is in line with GOLD, though the two guidelines developers recommend slightly different dosages: GOLD – 40mg, NICE – 30mg. (para 1.3.16)