Real-world Effectiveness and Cost-effectiveness of HFA-beclometasone Compared With ICS/LABA Combination Therapy
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of
      asthma management in patients with evidence of persistent asthma following an increase in
      asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS)
      using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised
      metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS
      plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone
      propionate / salmeterol [FP/SAL] or budesonide / formoterol [BUD/FOR]) or separate pMDIs and
      BAIs.
    

Detailed description: 
      Current asthma guidelines in the UK are underpinned by evidence derived from randomised
      controlled trials (RCTs). Although RCT data are considered the gold standard, the patients
      recruited to asthma RCTs are estimated to represent less than 10% of the United Kingdom's
      (UK's) asthma population. The poor representation of the asthma population is due to a number
      of factors, such as tightly-controlled inclusion criteria for RCTs. There is therefore a need
      for more representative RCTs and real-life observational studies to inform existing
      guidelines and help optimise asthma outcomes.

      The fixed combination asthma inhalers, FP/SAL (Seretide) and BUD/FOR (Symbicort) are
      indicated for use in asthma when adequate asthma control is not achieved with low/medium dose
      ICS therapy and as-needed (prn) reliever therapy (a short-acting beta-agonist [SABA]). Fixed
      combination inhalers are also indicated in patients already adequately controlled on separate
      ICS/LABA therapy. However, emerging trends in asthma prescribing indicate increasing use of
      add-on therapies (particularly in the form of combination inhalers) in the early stages of
      asthma therapy, even as first-line therapy.

      In practice, there is significant pressure (supported by asthma guidelines) to use the least
      expensive, effective inhaled therapies available. While the effect of increased use of add-on
      and combination therapies in terms of patient benefits remains uncertain, the impact on the
      UK's National Health Service (NHS) treatment costs is unequivocal.

      Short, randomised trials of the effectiveness of asthma monotherapies have demonstrated that
      extrafine HFA-BDP is at least as effective at half the dose as BDP pMDI, and equivalent to
      same-dose FP pMDI. There is also evidence to suggest that extrafine HFA-BDP optimises
      deposition in the lung and affords greater tolerance of poor coordination of breathing and
      inhaler actuation. In addition, one long-term, prospective, randomised, open-labelled trial
      comparing extrafine HFA-BDP with BDP over the course of one year demonstrated greater
      improvements in symptom-free days and quality of life in the extrafine HFA-BDP treatment
      group, at a lower cost per symptom-free day.

      The hypothesis for this study, therefore, is that extrafine HFA-BDP may be a suitable, and
      cost-effective, alternative to combination therapy (as fixed or separate inhalers) in
      children and adults with evidence of persistent asthma.
    

Intervention name(s): Extra-fine hydrofluoroalkane-beclometasone dipropionate; ICS / LABA via separate pMDI and / or BAI inhalers
Intervention type(s): Drug; Drug
Intervention description(s): Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI; A step-up from baseline ICS therapy via the addition of a separate long-acting beta-agonist with no change in baseline ICS drug or dose
Other intervention name(s): Qvar; ICS+LABA separates
Intervention MeSH terms: Beclomethasone
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care asthma patients who were receiving ICS therapy (any of BDP, extrafine BDP-HFA,
        BUD or FP as pMDI or BAI) who, at an index prescription date, underwent either:

        (i) an increase in ICS as extrafine HFA-BDP (pMDI or BAI); (ii) a change to combination
        therapy with a separate LABA pMDI or BAI (no change in drug, device or daily BDP-equivalent
        dose) (iii) a change to combination therapy via a fixed-combination inhaler (with no
        increase in daily BDP-equivalent dose).
      
Keywords: Primary care; Asthma management; Inhaled corticosteroids; Extra-fine hydrofluoroalkane; Long-acting beta-agonist; Fixed-dose combination therapy