Introduction
Currently, 5.4 million people in the UK are receiving treatment for asthma [
1], which is associated with a substantial economic burden: the annual National Health Service (NHS) expenditure associated with treating and caring for asthma patients, in terms of drug costs, hospital admissions and general practitioner (GP) visits, was estimated to be approximately £1 billion in the UK [
1].
There are a number of treatments available for asthma patients, and combination inhaled corticosteroid (ICS) and long-acting beta agonists (LABA) inhalers are recommended for the treatment of patients with asthma who are not controlled with ICS alone [
2]. These combination inhalers are as effective at delivering the drug as individual component inhalers but may provide additional benefits in terms of safety (by ensuring the LABA component is not taken without the ICS component) and patient adherence [
3,
4]. There are two main types of combination ICS/LABA inhaler devices: the pressurized metered-dose inhaler (pMDI) and dry powder inhaler (DPI). Of these two main options, there may be benefits of using pMDIs over DPIs. For example, a recent study demonstrated that pMDIs, as opposed to DPIs, are associated with increased adherence in clinical practice, fewer exacerbations and lower health costs [
5].
Within the UK, Seretide
® (GlaxoSmithKline, Brentford, UK) (fluticasone propionate and salmeterol xinafoate; [FP/SAL]) has the greatest volume of ICS/LABA units prescribed for the treatment of patients diagnosed with asthma, accounting for 51.8% of the market, and is available within Accuhaler
® (GlaxoSmithKline, Brentford, UK) (DPI) and Evohaler
® (GlaxoSmithKline, Brentford, UK) (pMDI) device types [
6].
flutiform
® (Jagotec AG, Cambridge, UK) (FP and formoterol fumarate; FP/FORM) pMDI entered the UK market in 2013, and currently accounts for 4.6% of overall ICS/LABA units prescribed for patients with an asthma diagnosis [
6].
Prior to the introduction of FP/FORM, a budget impact model was developed to evaluate the impact for the NHS of using FP/FORM as an alternative treatment to FP/SAL [
7]. The comparable efficacy of FP/FORM to FP/SAL had been previously demonstrated in patients aged ≥18 years with persistent asthma for ≥6 months in an open-label, randomized, active-controlled, parallel-group, multicenter, Phase III non-inferiority study [
8,
9]. Based on projected FP/FORM uptake scenarios, the previous model demonstrated that switching from FP/SAL to FP/FORM could result in savings to the NHS [
7]. Since the introduction of FP/FORM to the UK market, data demonstrating the effectiveness and resource use impact of FP/FORM in real-world settings have become available, which may impact upon the previously modeled outputs [
10]. The real-world data showed that patients who switched from FP/SAL to FP/FORM had fewer asthma consultations (with or without prescription of oral steroids) (1.4 for FP/FORM versus 1.8 for FP/SAL;
p = 0.001) and also confirmed that FP/FORM is non-inferior to FP/SAL in terms of preventing severe exacerbations [
10].
Aims
The aims of this update to the budget impact analysis were twofold: to update the existing budget impact model with prescription volume data since the introduction of FP/FORM to the UK market, and to compare the results of the budget impact model base-case with newly available real-world evidence to evaluate the use of FP/FORM in clinical practice, as compared to FP/SAL.
Discussion
This study demonstrates that the use of FP/FORM as an alternative to FP/SAL can result in cost savings compared to FP/FORM not being available (based on 12–100% prescription volumes of FP/FORM) for the NHS when assessing drug, administration, monitoring and AE costs.
The results from this analysis are consistent with those of the previous analysis [
7]. In addition, the specific description of the Patient Data used to ascertain prescription volume has been improved as compared to that used in the previous publication. A recent case study demonstrated that in one Northern Ireland community, 88.3% (
n = 53) of patients were successfully switched from the FP/SAL Evohaler to FP/FORM, which resulted in savings of £111.89 per patient over an 18-month period [
17]. Furthermore, in August 2015, FP/FORM prices decreased (after the publication of the case study). This is likely to further increase savings associated with a successful switch to FP/FORM. Given that the proportion of patients within the community who underwent a successful switch reached 88.3% of patients in the case study from Northern Ireland [
17], the scenario presented in this paper with an FP/FORM share of 50% is a realistic scenario for clinical practice.
Consideration of data from Lim et al. included within the real-world evidence scenario (scenario 1) resulted in a saving to the NHS, indicating that the use of FP/FORM as an alternative to FP/SAL is associated with greater savings in clinical practice, than the costs predicted by the RCT data, subject to a successful switch [
10]. The difference in costs between the base-case and the real-world scenario was driven by monitoring costs. Patients in the Lim et al. study had fewer GP visits than recommended by the GINA guidelines at the time of the study [
10]. However, there were still fewer GP consultations associated with FP/FORM than FP/SAL and, therefore, less resource consumption. As the patient population on FP/FORM was the same as that on FP/SAL it is likely that this difference is therapy related, rather than driven by behavior.
Further to this, data from Lim et al. demonstrated that FP/FORM is associated with a lower percentage of severe exacerbations than FP/SAL [
10,
18]. This suggests that FP/FORM may be associated with fewer hospitalizations and requirements of rescue therapy than FP/SAL [
10]. However, due to the limited detail within the published Lim et al. data, direct comparisons to the RCT data for the base-case scenario could not be made and as such, exacerbation data from Lim et al. were not considered within the model. Furthermore, separate analyses based on this dataset which have been presented at a conference demonstrated that switching patients from FP/SAL to FP/FORM results in non-inferior prevention of severe asthma exacerbations but at a statistically significant lower cost (total respiratory-related healthcare cost per patient was £64 lower for FP/FORM), which is in line with the findings of our analysis [
18].
Another recent study in Spain noted that when comparing the price of FP/FORM with other combinations of ICS/LABA, the price of FP/FORM was significantly lower [
19]. Furthermore, over the first 3 years, the Spanish National Health Service is expected to save nearly €4.4 million from its pharmacy budget with the introduction of FP/FORM for the treatment of moderate to severe asthma [
19]. Furthermore, a non-interventional study on safety and effectiveness in Germany reinforced the findings from the clinical trials by demonstrating that FP/FORM improves lung function, asthma control, and asthma related quality of life in a real-world setting: there was a statistically significant improvement compared with baseline in asthma control (as measured by the Asthma Control Test) of patients being treated with FP/FORM over a 3-month period, and there were also improvements seen in terms of quality of life and other secondary efficacy measures [
20].
As noted, our analysis demonstrates that an increased uptake of FP/FORM can result in overall cost savings to the NHS without adversely affecting clinical outcomes; there have been several studies comparing FP/FORM with FP/SAL [
8,
9] and Phase III clinical trials have demonstrated that FP/FORM is at least as effective as, and has a faster onset of action, than FP/SAL [
8,
9]. In addition, FP/FORM has been recommended as a suitable alternative to other first-line ICS/LABA treatments, including FP/SAL and BUD/FORM, by the Midlands Therapeutics Review and Advisory Committee [
21]. The Scottish Medicines Consortium has also recommended treatment with FP/FORM in patients for which FP and FORM are appropriate choices of ICS and LABA [
22]. The National Institute for Healthcare and Clinical Excellence recommend that for patients in whom treatment with an ICS is considered appropriate, the least costly product should be chosen (within its marketing authorization) [
23]. In comparison to FP/SAL, FP/FORM is likely to be the least costly option in terms of list price, and overall budget impact to the NHS.
Acknowledgments
Sponsorship, article processing charges, and the open access charge for this study were funded by Mundipharma, UK. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.