Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis.

OBJECTIVE: We aimed to assess whether the introduction of the first infliximab biosimilar was associated with changes in overall infliximab consumption (originator and biosimilars) and price changes to the originator infliximab. METHODS: An interrupted time series analysis using infliximab sales data from 2010 to 2020 from the IQVIA Multinational Integrated Data Analysis System for eight selected regions: Australia, Canada, Hong Kong, Korea, India, Japan, the UK, and the USA. Quarterly measures of infliximab consumption and list prices were respectively defined as the number of standard units (SU)/1000 inhabitants and as 2020 USA dollars (USD)/SU. RESULTS: Following the introduction of infliximab biosimilars, overall infliximab consumption increased in Australia [immediate change: 0.145 SU/1000 inhabitants (P = 0.014); long-term change: 0.022 SU/1000 inhabitants per quarter (P < 0.001)], Canada [immediate change 0.415 (P = 0.008)], the UK [long-term change 0.024 (P < 0.001)], and Hong Kong [immediate change: 0.042 (P < 0.001)]. The list price of originator infliximab also decreased following biosimilar introduction in Australia [immediate change: - 187.84 USD/SU (P < 0.001); long-term change - 6.46 USD/SU per quarter (P = 0.043)], Canada [immediate change: - 145.58 (P < 0.001)], the UK [immediate change: - 34.95 (P = 0.010); long-term change: - 4.77 (P < 0.001)], and Hong Kong [long-term change: - 4.065 (P = 0.046)]. Consumption and price changes were inconsistent in India, Japan, Korea, and the USA. CONCLUSIONS: Introduction of the first infliximab biosimilar was not consistently associated with increased consumption across regions. Additional policy and healthcare system interventions to support biosimilar infliximab adoption are needed.

Utilization of targeted disease-modifying anti-rheumatic drugs (DMARDs) for managing rheumatoid arthritis in the last decade: A two-country comparison.

OBJECTIVE: To compare trends in the use of targeted disease-modifying anti-rheumatic drugs (DMARDs) for rheumatoid arthritis (RA), between Korea and Australia. MATERIALS AND METHODS: Using sampled claims databases in Korea and Australia (2010 - 2018), we analyzed the trends in the use of individual targeted DMARDs (biologic and targeted synthetic) for RA in both countries. RESULTS: The use of targeted DMARDs for the management of RA showed an increase of over 200 and 300% in Australia and Korea, respectively. The tumor necrosis factor inhibitors (TNFis) etanercept and adalimumab were the most commonly prescribed drugs in 2010 in both countries, with non-TNFi use increasing over the study period. The introduction of tofacitinib in 2015 led to 10 and 15% market share uptake in Korea and Australia, respectively. CONCLUSION: Trends in the use of targeted DMARDs for RA were similar in Korea and Australia, and the use of non-TNFis, including tofacitinib, increased in both countries.

The Medicines Intelligence Centre of Research Excellence: Co-creating real-world evidence to support the evidentiary needs of Australian medicines regulators and payers.

Regulators and payers play a pivotal role in facilitating timely and affordable access to safe and efficacious medicines. They use evidence generated from randomised clinical trials (RCTs) to support decisions to register and subsidise medicines. However, at the time of registration and subsidy approval, regulators and payers face uncertainty about how RCT outcomes will translate to real-world clinical practice. In response to this situation, medicines policy agencies worldwide have endorsed the use of real-world data (RWD) to derive novel insights on the use and outcomes of prescribed medicines. Recent reforms around data availability and use in Australia are creating unparalleled data access and opportunities for Australian researchers to undertake large-scale research to generate evidence on the safety and effectiveness of medicines in the real world. Highlighting the critical importance of research in this area, Quality Use of Medicines and Medicine Safety was announced as Australia's 10th National Health Priority in 2019. The National Health and Medical Research Council, Medicines Intelligence Centre of Research Excellence (MI-CRE) has been formed to take advantage of the renewed focus on quality use of medicines and the changing data landscape in Australia. It will generate timely research supporting the evidentiary needs of Australian medicines regulators and payers by accelerating the development and translation of real-world evidence on medicines use and outcomes. MI-CRE is developing a coordinated approach to identify, triage and respond to priority questions where there are significant uncertainties about medicines use, (cost)-effectiveness, and/or safety and creating a data ecosystem that will streamline access to Australian data to enable researchers to generate robust evidence in a timely manner. This paper outlines how MI-CRE will partner with policy makers, clinicians, and consumer advocates to leverage real-world data to co-create real-world evidence, to improve quality use of medicines and reduce medicine-related harm.

Pharmacist-Initiated Management of a Suspected Case of Risperidone-Induced Neuroleptic Malignant Syndrome in an Aged-Care Resident. The Role of Residential Medication Management Reviews in Medication Safety.

A 70-year-old female aged-care resident was referred by her general practitioner for a residential medication management review after nurses reported difficulties with swallowing, episodes of hyperthermia, elevated blood pressure, and tachycardia. These symptoms were accompanied by increasing confusion and drowsiness. Risperidone had recently been prescribed to treat behavioral and psychological symptoms of dementia. This case study describes the pharmacist-initiated management of the symptoms through a national medication review program. It demonstrates the valuable role collaborative medication reviews play in managing adverse drug reactions in aged-care.

Disease burden, comorbidity and geriatric syndromes in the Australian aged care population.

OBJECTIVE: To describe the burden of disease in the Australian residential aged care population. METHODS: Cross-sectional analysis of Aged Care Funding Instrument data. RESULTS: Dementia (48%), depression (22.5%) and arthritis (14.2%) were the most prevalent chronic diseases in this population. Unclassified conditions such as falls, pain and urinary incontinence were also significant burdens in this population (17.1%). Circulatory, musculoskeletal and unclassified conditions were the most prevalent comorbidities across all common medical groups. Dementia and depression were the most common comorbid mental health conditions across all medical groups. CONCLUSION: The challenges for evaluating clinical care in Australian residential aged care are many. Delivering good clinical care should be a priority for aged care providers given the high burden of chronic disease and comorbidity. An informative starting point could be to target management of the most prevalent and burdensome conditions and comorbidities.