Andrea Manfrin

Randomised evaluation of the Italian medicines use review provided by community pharmacists using asthma as a model (RE I-MUR)

BackgroundThe Italian Ministry of Health decided to introduce community professional services in 2010. This trial provides an opportunity to evaluate the outcomes of a new professional pharmacy service: Italian Medicines Use Review (I-MUR) aimed at reducing the severity of asthma and its associated costs.Methods/DesignThis is a cluster randomised controlled trial of the I-MUR service. Data will be collected over time before, during and after pharmacists’ intervention. Fifteen Italian regions will be involved and it is aimed to recruit 360 community pharmacists and 1800 patients. Each pharmacist will receive training in medicines use review, recruit five patients, administer the Asthma Control Test and provide the I-MUR service. Pharmacists will be allocated to different groups, one group will be trained in and provide the I-MUR service immediately after completion of the baseline ACT score, the other group will receive training in the I-MUR and provide this service three months later. Group allocation will be random, after stratification by region of Italy. The I-MUR service will involve gathering data following each patient consultation including demographic details, patients regular medications, including those used for asthma, their attitude towards their medications and self-reported adherence to treatments. In addition, pharmacists will identify and record pharmaceutical care issues and any advice given to patients during the I-MUR, or recommendations given to doctors. Pharmacists will upload trial data onto a web platform for analysis. The primary outcome measure is the severity of asthma before, during and after the I-MUR assessed using the Asthma Control Test score. Secondary measures: number of all active ingredients used by patients during and after the I-MUR, number of pharmaceutical care issues identified during the I-MUR, patients’ self-reported adherence to asthma medication during and after the I-MUR, healthcare costs based on the severity of asthma, before, during and after the I-MUR service provision.DiscussionThis study has been developed because of the need for a new way of working for pharmacists and pharmacies; it is the first trial of any community pharmacy-based pharmaceutical care intervention in Italy. The results will inform future policy and practice in Italian community pharmacy.Trial registration numberISRCTN72438848.

A cluster randomised control trial to evaluate the effectiveness and cost-effectiveness of the Italian medicines use review (I-MUR) for asthma patients

BackgroundThe economic burden of asthma, which relates to the degree of control, is €5 billion annually in Italy. Pharmacists could help improve asthma control, reducing this burden. This study aimed to evaluate the effectiveness and cost-effectiveness of Medicines Use Reviews provided by community pharmacists in asthma.MethodsThis cluster randomised, multi-centre, controlled trial in adult patients with asthma was conducted in 15 of the 20 regions of Italy between September 2014 and July 2015. After stratification by region, community pharmacists were randomly allocated to group A (trained in and delivered the intervention at baseline) or B (training and delivery 3 months later), using computerised random number generation in blocks of 10. Each recruited up to five patients, with both groups followed for 9 months.The intervention consisted of a systematic, structured face-to-face consultation with a pharmacist, covering asthma symptoms, medicines used, attitude towards medicines and adherence, recording pharmacist-identified pharmaceutical care issues (PCIs). The primary outcome was asthma control, assessed using the Asthma-Control-Test (ACT) score (ACT ≥ 20 represents good control). Secondary outcomes were: number of active ingredients, adherence, cost-effectiveness compared with usual care. Although blinding was not possible for either pharmacists or patients, assessment of outcomes was conducted by researchers blind to group allocation.ResultsNumbers of pharmacists and patients enrolled were 283 (A = 136; B = 147) and 1263 (A = 600; B = 663), numbers completing were 201 (A = 97; B = 104) and 816 (A = 400; B = 416), respectively. Patients were similar in age and gender and 56.13% (458/816) had poor/partial asthma control. Pharmacists identified 1256 PCIs (mean 1.54/patient), mostly need for education, monitoring and potentially ineffective therapy. Median ACT score at baseline differed between groups (A = 19, B = 18; p < 0.01). Odds ratio for improved asthma control was 1.76 (95% CI 1.33–2.33) and number needed to treat 10 (95% CI 6–28). Number of active ingredients reduced by 7.9% post-intervention (p < 0.01). Adherence improved by 35.4% 3 months post-intervention and 40.0% at 6 months (p < 0.01). The probability of the intervention being more cost-effective than usual care was 100% at 9 months.ConclusionsThis community pharmacist-based intervention demonstrated both effectiveness and cost-effectiveness. It has since been implemented as the first community pharmacy cognitive service in Italy.Trial registrationTRN: ISRCTN72438848 (registered 5th January 2015, retrospectively).

Novel pharmacist-led intervention secures the minimally important difference (MID) in Asthma Control Test (ACT) score: better outcomes for patients and the healthcare provider

Introduction A key priority in asthma management is achieving control. The Asthma Control Test (ACT) is a validated tool showing a numerical indicator which has the potential to provide a target to drive management. A novel pharmacist-led intervention recently evaluated and introduced in the Italian setting with a cluster randomised controlled trial (C-RCT) showed effectiveness and cost-effectiveness. This paper evaluates whether the intervention is successful in securing the minimally important difference (MID) in the ACT score and provides better health outcomes and economic savings. Methods Clinical data were sourced from 816 adult patients with asthma participating in the C-RCT. The success of the intervention was measured looking at the proportion of patients reaching MID in the ACT score. Different levels of asthma control were grouped according to international guidelines and graded using the traffic light rating system. Asthma control levels were linked to economic (National Health Service (NHS) costs) and quality-adjusted life years outcomes using published data. Results The median ACT score was 19 (partially controlled) at baseline, and 20 and 21 (controlled) at 3-month and 6-month-follow up, respectively (p<0.01). The percentage of patients reaching MID at 3 and 6 months was 15.8% (129) and 19.9% (162), respectively. The overall annual NHS cost savings per 1000 patients attached to the shift towards the MID target were equal to €346 012 at 3 months and increased to €425 483 at 6 months. Health utility gains were equal to 35.42 and 45.12 years in full health gained, respectively. Discussion The pharmacist-led intervention secured the MID in the ACT score and provided better outcomes for both patients and providers.

P200 The clinical, utility and economic benefits of securing minimal important difference in asthma control test using a novel tool: the a.b.o.v.e. asthma (achieving-better-outcomes-and-value-for- everybody-in-asthma)

Introduction and Objectives Asthma accounts for an economic loss of €72 billion annually in the 28 countries of the European Union with a monetised value of DALYs cost of €38 billion. One of the key priorities in asthma management is achieving asthma control. It is crucial to understand whether providing a minimally clinical important difference (MID) of the asthma control test (ACT) score can bring better clinical, utility and economic outcomes. Aim To test whether the A.B.O.V.E. ASTHMA (Achieving-Better-Outcomes-and-Value-for-Everybody-in-Asthma) tool works in terms of securing the MID in ACT and, in doing so, we can provide positive outcomes for patients, payers, providers and policy makers. Methods Using the data obtained from the Italian Medicines Use Review (I-MUR) cluster randomised controlled trial (C-RCT; 2014–2015) involving 1263 asthma patients and 283 pharmacists in Italy, we tested whether A.B.O.V.E. ASTHMA was able to (1) link a clinical outcome (ACT score) to economic and utility dimensions; (2) secure a MID improvement in ACT and the outcomes attached in terms of cost savings for the healthcare provider and gains in health utility (% of being in perfect health). Results Data from the C-RCT showed that after receiving the A.B.O.V.E. ASTHMA intervention, patients improved their asthma control, assessed by the ACT, shifting from not controlled (RED) towards partially controlled (YELLOW), and fully controlled (GREEN) groups. Asthma control improved in the vast majority of patients (median ACT score was 19 at baseline, 20 at 3 month and 21 at 6 month post intervention). The number of patients who were on MID target and reached the GREEN group at 3 and 6 months were 129 (15.8%) and 162 (19.9%) respectively. The overall annual cost savings per 1000 patients attached to the shift towards the MID target was equal to: 3 46 012 euros (NHS) at 3 months and increased to 4 25 483 euros (NHS) at 6 months (see Table). Health utility gains were equal to 0.9 and 0.29 years in full health, respectively. Conclusions The A.B.O.V.E. ASTHMA tool can secure MID in ATC and, in doing so, better outcomes in terms of clinical, utility and economic results. The calculation of the cost-saving for the NHS was estimated for a population of 1000 asthma patients Abstract P200 Table 1 Annual cost savings and utility gains when securing clinical target in asthma control (MID) with A.B.O.V.E. ASTHMA intervention Possible shifts* (current to target scenario) @ 3 months Total n= 1000 @ 6 months Total n= 1000 Current scenario (ACT) Target scenario (ACT) % of success Cost savings NHS (euros) Utility gains (years in full health saved) % of success Cost savings NHS (euros) Utility gains (years in full health saved) 1 RED to RED → 5–10 8–13 2.6 0 0 1.6 0 0 2 RED to YELLOW → 15–16 14–17 5.4 1 00 132(CI 75,099; 130,172) 4.9(CI 4.85; 4.94) 5.5 1 02 408(CI 76,806; 133,130) 4.96(CI 4.91; 5.00) 3 YELLOW to YELLOW → 15–16 18–19 2.2 0 0 0.9 0 0 4 YELLOW to GREEN → 18–19 20–21 10.5 2 45 880(CI 184,410; 319,644) 30.56(CI 30.29; 30.83) 13.8 3 23 075(CI 242,306; 419,998) 40.16(CI 39.80; 40.52) 5 GREEN to GREEN → 20–21 ≥23 5.3 0 0 6.0 0 0 Total (1+2+ 3+4+ 5) 31.07 3 46 012 (CI 259,509; 449,816) 35.42 (CI 35.11; 35.73) 27.82 4 25 483 (CI 319,112; 553,128) 45.12 (CI 44.72; 45.52) The calculation of the cost-saving for the NHS was estimated for a population of 1,000 asthma patients.

VP164 Applying health technology assessment to pharmacy: the Italian-Medicine-Use-Review-Health Technology Assessment

There is a lack of Health-Technology-Assessment (HTA) tools in pharmacy practice and the collection of real-world-evidence (RWE) in community pharmacy to populate longer-term-disease-progression-modelling (1). This project is looking at the development and application of a novel Patient-Reported-Outcome- Measure (PROM) in community pharmacy that can enable: the evaluation of the quality of care delivered from the patient perspective in terms of economic impact, patient health outcomes and ‘utilities’; the collection of RWE and evaluate long-term effect of care; to provide different stakeholders with unique evidence-based information that help formulate health policies in community pharmacy that are safe, effective, patient-focused and cost-effective, balancing access to innovation and cost containment. Evidence from the Italian-Medicine-Use-Review (I-MUR) trial (2) showed that the I-MUR intervention provided by community pharmacists to asthma patients is effective, cost-saving and cost-effective (3). The trial allowed to model a framework (I-MUR-HTA) that would enable to routinely deliver the intervention, but also collect and analyse PROM data on its clinical-effectiveness, quality-of-life and cost-effectiveness. I-MUR-HTA was discussed within three expert-panel discussions including policy-makers, commissioners, academics, healthcare-professionals and patient-representatives in Italy, United Kingdom and Europe. Current plan include testing the use of the tool in the real world environment. Evidence collected from the panel discussions confirmed that I-MUR-HTA evidence-based information is relevant to meet current National-Health-Care-System plans and this is what is needed to support the evaluation of innovative effective and cost-effective health policies and promote their implementation across nations. Current Italian law on pharmacy services provides the appropriate institutional framework to regulate the introduction of I-MUR-HTA across the territory. Its implementation is underway and a real-world pilot is planned to take place in Italy. I-MUR-HTA appears to be an innovative tool to promote active patient involvement into policy-decision-making and pharmacy-service.