The effect of new biosimilars in rheumatology and gastroenterology specialities on UK healthcare budgets: Results of a budget impact analysis.

BACKGROUND: The approval of new biosimilars of infliximab, etanercept and adalimumab by the European Medicines Agency is expected to produce further cost savings to the healthcare system budget. OBJECTIVES: This study aimed to estimate the budget impact of the introduction of new biosimilars Flixabi®, Erelzi®, Solymbic®, Amgevita® and Imraldi® in rheumatology and gastroenterology specialities in the UK. METHODS: A published budget impact model was adapted to estimate the expected cost savings following the entry of new biosimilars Flixabi®, Erelzi®, Solymbic®, Amgevita® and Imraldi® in the UK over three-year time horizon. This model was based on retrospective market shares of biologics used in rheumatology and gastroenterology which were derived from DEFINE Software and healthcare professional perspectives. RESULTS: The model predicted that infliximab and etanercept biosimilars would replace their corresponding reference agents by 2020. Adalimumab biosimilars were predicted to achieve 19% of the rheumatology and gastroenterology market by 2020. Without the introduction of further biosimilars, the model predicted a reduction in expenditure of £44 million on biologics over the next three years. With the entry of Flixabi®, Erelzi®, Solymbic®, Amgevita® and Imraldi® the model estimates cumulative savings of £285 million by 2020. CONCLUSIONS: The introduction of new infliximab, etanercept and adalimumab biosimilars will be associated with considerable cost savings and have a substantial favourable impact on the UK NHS budget. The number of biosimilars and time of entry of is critical to create competition which will result in maximum cost savings.

Differences in UK healthcare professionals' knowledge, attitude and practice towards infliximab and insulin glargine biosimilars.

OBJECTIVES: To investigate knowledge and attitudes of different healthcare professionals in UK towards infliximab and insulin glargine biosimilars METHODS: UK medical consultants/registrars, nurses and pharmacists participated in anonymised, self-administered web-based survey distributed by professional associations. KEY FINDINGS: There were 234 respondents: medical consultants/registrars (150), nurses (58) and pharmacists (26). 76% of medical consultants/registrars, 84% of pharmacists and 53% of nurses understood what biosimilars were. Medical consultants/registrars and pharmacists had safety and efficacy concerns when switching patients compared to initiation. Nurses had similar levels of safety and efficacy concerns about initiation. CONCLUSION: Healthcare professionals were more comfortable with the initiation of biosimilars than switching current patients. Medical consultants/registrars and pharmacists were more informed than nurses.

Impact of Infliximab and Etanercept Biosimilars on Biological Disease-Modifying Antirheumatic Drugs Utilisation and NHS Budget in the UK.

OBJECTIVE: Biological disease-modifying antirheumatic drugs (bDMARDs) are effective but expensive options for treating rheumatoid arthritis. The introduction of infliximab and etanercept biosimilars presents a significant potential cost saving in a financially constrained health system such as the National Health Service (NHS) in the UK. This study examines the impact of the introduction of infliximab and etanercept biosimilars on the utilisation of bDMARDs and subsequent budget impact. METHODS: We conducted an interrupted time series analysis of secondary care utilisation data in rheumatology specialities from the DEFINE database, between March 2014 and February 2017. RESULTS: The cumulative cost savings from the introduction of infliximab and etanercept biosimilars was £38.8 million over 2 years. There was a statistically significant increase in average monthly utilisation of bDMARDs for adalimumab (0.48%), certolizumab pegol (1.90%), golimumab (3.06%), abatacept (2.97%) and tocilizumab (2.24%), but not for etanercept. In contrast, the overall utilisation of infliximab decreased slightly by an average of 0.03% per month. The introduction of infliximab biosimilars negatively affected the monthly utilisation of branded infliximab significantly. Similarly, the introduction of an etanercept biosimilar negatively affected the monthly utilisation of branded etanercept significantly. CONCLUSIONS: The introduction of bDMARDs biosimilars has resulted in considerable cost savings to the NHS, with the branded products reducing their prices in response to the availability of less expensive biosimilars and competition between the biosimilars themselves. Our results also suggest that when a biosimilar is available for a directly comparable branded molecule, price is the key influencing factor in the prescribing of a specific product.

Patients' Understanding and Attitudes Towards Infliximab and Etanercept Biosimilars: Result of a UK Web-Based Survey.

BACKGROUND: Infliximab and etanercept biosimilars present significant potential cost savings to the NHS. Patients need to be involved in the decision to use these medicines but there is limited published literature on their knowledge and attitudes about these biosimilars. OBJECTIVES: The aim of this study was to investigate ankylosing spondylitis and rheumatoid arthritis patients' knowledge and attitudes towards infliximab and etanercept biosimilars in the UK. METHODS: A self-administered web survey was conducted among the members of the National Rheumatoid Arthritis Society and the National Ankylosing Spondylitis Society in the UK between 2 March 2017 and 2 June 2017. RESULTS: A total of 182 patients participated in this survey. The majority of participants (73%) were on etanercept, and 66 and 80% of patients on originator biologic and biosimilars, respectively, understood what biosimilars were. Patients who were currently on biosimilars had greater confidence in their effectiveness and the doctor's decision to initiate than those who were originally on originator biologics that doctors proposed to switch to biosimilars. The majority (82%) of participants on biosimilars thought that biosimilars help to save money for the NHS, while just over half (54%) of participants on the originator biologics thought the cost of treatment should not be considered when prescribing biosimilars. CONCLUSIONS: Survey participants had a good knowledge and understanding of biosimilars. Participants on biosimilars were confident and positive about biosimilars' safety, efficacy and switching, whereas participants on the originator biologics were more reluctant to switch to biosimilars. Those patients who expressed concerns felt that more clinical trials on switching biosimilars, better communication and reassurance by healthcare professional teams and further involvement in decision making would increase their acceptance of biosimilars.

Has cost inhibited the uptake of more potent statins in England?

BACKGROUND: The use of statins has increased substantially over the last 2 decades in England and represents a significant cost burden to the National Health Service. Therefore, it is important to understand what influences prescribers' choice. OBJECTIVES: This study examines the changes in use pattern of all statins in England (1998-2015). The study focuses on the use of simvastatin and atorvastatin before and after their patent expiry and rosuvastatin, to investigate the impact of the reduced acquisition costs on prescribing. METHODS: Interrupted time series analysis of primary care use data from the health and social care information centre database from 1998 to 2015. RESULTS: Primary care expenditure on statins increased by 125% during the period 1998 to 2004 driven by branded simvastatin and atorvastatin. Before 2003, the rate of use of more potent branded atorvastatin exceeds branded simvastatin. Between 2004 and 2011, the less potent but less expensive agent generic simvastatin has the higher utilisation rate (66%). Since 2012, the more potent agent but less expensive generic atorvastatin has the higher utilisation rate (50%). The more potent branded rosuvastatin failed to make a significant impact on the English statins market. CONCLUSIONS: The availability of generic statins has reduced overall expenditure significantly. When there is a significant price difference, acquisition cost appears to be the main influencing factor in prescribing statins, but, when costs are similar, potency is a key factor. This suggests that English prescribers are cost sensitive and appear to be prepared to trade marginal benefit for savings.

Knowledge, attitude and practice of healthcare professionals towards infliximab and insulin glargine biosimilars: result of a UK web-based survey.

OBJECTIVE: To investigate healthcare professionals' knowledge and attitudes towards infliximab and insulin glargine biosimilars and the factors influencing their prescribing. Then, to compare healthcare professionals' attitudes with the utilisation of these biosimilars in UK hospitals. DESIGN: Self-administered, one-time web-based survey and drug utilisation analysis. SETTING AND DATA SOURCES: Professional associations and societies in the field of dermatology, diabetology, gastroenterology and rheumatology in the UK, between 8 August 2016 and 8 January 2017. The volume of utilisation of branded and biosimilar infliximab and insulin glargine in UK hospitals was derived from the DEFINE database, between 2015 and 2016. OUTCOMES: Participants' knowledge and awareness of biosimilars and factors influencing their use and corresponding usage of infliximab and insulin glargine biosimilars. RESULTS: Responses were obtained from 234 healthcare professionals across dermatology, diabetology, gastroenterology and rheumatology specialties. 75% of respondents were aware that biosimilars were available on their local formulary. 77% of respondents considered biosimilars extremely or very important to save costs for the NHS. Gastroenterologists had the highest utilisation of infliximab biosimilars (14%) in 2015 rising to (62%) in 2016. Healthcare professionals had greater concerns about safety and efficacy when switching patients to biosimilars than when starting biosimilars in biological naïve patients. Guidance from National Institute for Health and Care Excellence and robust pharmacovigilance studies on biosimilars were both considered important factors in increasing biosimilars use. CONCLUSION: British healthcare professionals are well informed about biosimilars with high level of awareness. Safety and efficacy concerns were higher in switching than in initiating biosimilars among some prescribers. It is probable that personal experience of biologics as well as discipline-specific guidance influenced prescribers' responses.

What drives the prescribing of growth hormone preparations in England? Prices versus patient preferences.

OBJECTIVE: The patent expiry of a number of biological medicines and the advent of biosimilars raised the expectations of healthcare commissioners that biosimilars would reduce the high cost of these medicines and produce potential savings to the NHS. We aimed to examine the prescribing pattern of different growth hormone preparations (ready to use and reconstitution requiring) in primary and secondary care in England to determine relative rates of decrease or increase and identify the possible factors influencing prescribing following the introduction of biosimilar growth hormone in 2008. DESIGN: Longitudinal observational study. SETTING AND DATA SOURCES: Primary care prescribing cost and volume data was derived from the NHS business services authority website, and for secondary care from the DEFINE database, between April 2011 and December 2015. OUTCOMES: Quarterly prescribing analysis to examine trends and measure the relationship between usage and price. RESULTS: Expenditure and usage of growth hormone in primary care decreased by 17.91% and 7.29%, respectively, whereas expenditure and usage in secondary care increased by 68.41% and 100%, respectively, between April 2011 and December 2015. The usage of reconstitution requiring products significantly declined in primary care (R²=0.9292) and slightly increased in use in secondary care (R²=0.139). In contrast, the usage of ready-to-use products significantly increased in use in primary (R²=0.7526) and secondary care (R²=0.9633), respectively. Weak or no correlation existed between the usage and price of growth hormone preparations in primary and secondary care. CONCLUSIONS: The price of growth hormone products was not the key factor influencing the prescribing of the biological medicines. The main driver for specific product selection was the ease of use and the number of steps in dose preparation. Prescribers appear to be taking into account patient preferences rather than cost in their prescribing decisions.

Hospital pharmacy staffing levels in England: has anything changed in the last 5†years?

OBJECTIVE: To undertake an analysis of hospital pharmacy staffing levels in England comparing national and regional averages for 2007/2008 and 2012/2013. METHODS: Individual hospital pharmacy staffing establishment data were extracted from the National Health Service (NHS) Pharmacy Education and Development Committee's National NHS Pharmacy Staffing Establishment and Vacancy Survey for 2007/2008 and 2012/2013. Hospital activity data for the 2 years were extracted from the NHS Health and Social Care Information Centre website. For each hospital, the number of whole time equivalent (WTE) pharmacy staff was divided by the number of admissions and a percentage WTE/admission calculated. Acute hospitals were analysed separately from mental health hospitals. RESULTS: The mean % WTE pharmacy staff/admission in acute hospitals in England 2012/2013 was 0.114 compared with 0.112 in 2007/2008 (p>0.05). The means for individual staff groups have either remained unchanged or have reduced slightly. There were also changes by region with some increasing and others decreasing. The changes in mental health and social care trusts were more marked with the median % WTE pharmacy staff/admission almost doubling in 2012/2013 compared with 2007/2008. This increase in establishment was seen in all pharmacy staff groups. CONCLUSIONS: The number of pharmacy staff per admission in acute hospitals in England between 2007/2008 and 2012/2013 has not changed significantly. This indicates that pharmacy services have kept pace with increasing activity. In contrast, pharmacy staffing levels in mental health trusts have almost doubled in the intervening 5 years as a result of a national initiative to develop the workforce in mental health services.

Evaluation of a tool to benchmark hospital antibiotic prescribing in the United Kingdom.

OBJECTIVE: To investigate whether Defined Daily Dose/Finished Consultant Episode (DDD/FCE) ratio is sensitive to changes in prescribing patterns and could be used as a prescribing indicator in hospitals. METHOD: The study comprised two phases. In phase 1 the weekly DDD/FCE ratios for two antibiotics were calculated and monitored in one acute NHS hospital before and after the implementation of prescribing guidelines, which impacted on the use of the antibiotics. In phase 2 data on the use of four antibiotics over one year was collected from fifty-eight medium to large acute hospitals in England, together with corresponding FCE data. DDD/FCE ratios for each antibiotic in each hospital were compared. MAIN OUTCOME MEASURE: Whether the DDD/FCE ratio for two antibiotics changed in one hospital following the introduction of prescribing guidelines for these antibiotics. The variability in DDD/FCE ratio for two broad spectrum antibiotics compared to two narrow spectrum antibiotics across a number of acute hospitals in England. RESULTS: In phase 1 the DDD/FCE ratios for the two antibiotics were lower post implementation of the guidelines indicating that the ratio was sensitive to changes in prescribing. In phase 2 the median DDD/FCE ratios of the two broad spectrum antibiotics from all fifty eight hospitals were much higher (0.126, and 0.265) than for the two narrow spectrum antibiotics (0.048, and 0.021), indicating higher use of the broad spectrum antibiotics. Furthermore, the variation in prescribing between the hospitals, as indicated by the inter-quartile range about the median, was greater for the two broad spectrum agents (0.201 and 0.193), than for the narrow spectrum agents (0.06, and 0.042), as was expected. CONCLUSION: The DDD/FCE ratio is sensitive to changes in prescribing and can reflect differences in the use of antibiotics between hospitals, after accounting for differences in activity. DDD/FCE ratio has the potential to be used to also account for differences in case mix between hospitals although further work is needed in this area.