Fluticasone furoate/vilanterol (FF/VI) is a newly licensed treatment for asthma and chronic obstructive pulmonary disease (COPD). It was launched in the UK in early 2014, as a once-daily inhaler which comes in both lower dose (FF/VI 100/25), and higher dose (FF/VI 200/25) versions. The higher dose is not licensed for treatment of COPD. Neither version is licensed for children aged under 12y.
This study will describe the characteristics of patients who start taking either FF/VI, or similar treatments - known as inhaled corticosteroid/long acting beta agonists fixed dose combinations (ICS/LABA FDC) - during 2014-2015.
Key questions include:
• How many new users of FF/VI have a diagnosis of COPD, asthma, or neither.
• How similar are new users of FF/VI to new users of similar treatments (i.e. other ICS/LABA FDC).
• How many patients with COPD receive an ‘off-label’ prescription for higher dose FF/VI; how many patients aged under 12y are prescribed FF/VI.
• In the year after their first prescription, how many patients continue to take FF/VI, and how many stop taking it, or switch to a different treatment, or start taking an additional COPD or asthma treatment.
The results will provide valuable information about whether FF/VI is being prescribed as recommended.
Fluticasone furoate/vilanterol (FF/VI) is a once-daily inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) fixed dose-combination (FDC) medication approved for the treatment of asthma and COPD. It is available in a lower dose (FF/VI 100/25 – numbers indicate dispensed dose of active substance in micrograms), and higher dose (FF/VI 200/25) version. In the 24-month period immediately following the availability of FF/VI in the United Kingdom, a drug utilisation review will be conducted with the following objectives:
1. among new users of FF/VI: describe patient characteristics, and diagnosis groups (asthma, COPD-including an asthma history stratification, other).
2. among new users of other ICS/LABA FDC: describe patient characteristics, and diagnosis groups.
3. among new users of FF/VI only: describe off-label prescribing, including prescription of FF/VI 200/25 formulation in patients with a COPD diagnosis, and FF/VI (any dose) in children <12 years of age.
4. among new users of FF/VI only: describe treatment patterns, and adherence to therapy.
Participants will be patients with a first ever prescription for FF/VI or other ICS/LABA FDC between January 1, 2014 and December 31, 2015, with at least 12 months of up-to-standard (UTS) follow-up prior to their index prescription date.
In a subset of patients eligible for linkage, hospital episode statistics (HES) data will be used to help delineate between moderate and severe asthma and COPD exacerbation history at baseline (index date).
COPD: defined as the presence of a relevant Read code at any time up to and including the end of their follow-up in the study, AND aged 35year or older at the time of their first diagnosis. See Codelist 3 in the Appendix for a list of COPD Read codes based on a published validation study [Quint 2014]. Patients in the COPD category will be further stratified according to asthma history (yes/no), defined as the presence of a Read coded asthma diagnosis in their primary care record at any time up and including their index prescription date. • Asthma: defined as those who DO NOT meet criteria for inclusion in the COPD diagnosis group AND (a) have an asthma diagnosis recorded any time in their CPRD history up to and including their end of follow-up in the study AND (b) are classified as “never smokers”. See Codelist 4 in the Appendix for a list of asthma Read codes. • ‘Other’ (neither COPD nor asthma): defined as those patients who do not meet the criteria for either the COPD or asthma groups above. This group will therefore include patients with evidence of possible asthma and/or possible COPD, but who smoke(d) and/or were aged less than 35 years at the time of first COPD record.
Daniel Dedman - Chief Investigator - CPRD
Daniel Dedman - Corresponding Applicant - CPRD
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.
HES Admitted Patient Care