European Physician Survey Characterizing the Clinical Pathway and Treatment Patterns of Patients Post-Myocardial Infarction.

INTRODUCTION: The 2019 European Society of Cardiology and European Atherosclerosis Society (2019 ESC/EAS) guidelines stress the importance of managing low-density lipoprotein cholesterol (LDL-C) after myocardial infarction (MI) to reduce the risk of cardiovascular events. Information on guideline implementation is limited. The aim of this survey was to describe current clinical practice regarding LDL-C management in the first year post-MI across Europe, improving understanding of the role of ESC/EAS guidelines on clinical practice. METHODS: A qualitative web-based cross-sectional physician survey about the patient pathway and LDL-C management post-MI was conducted in 360 physicians from France, Italy, Germany, The Netherlands, Spain, and the UK (n = 60/country) between December 2019 and June 2020. Secondary and primary care physicians (SCPs/PCPs) described their experiences treating patients post-MI over the preceding 2 months. RESULTS: Physicians reported that on average 90.7% of patients not prescribed lipid-lowering therapy (LLT) before an MI initiated LLT as inpatients; for patients already taking LLT, treatment was intensified for 64.7% of inpatients post-MI. SCPs reported prescribing higher-intensity statins and/or ezetimibe for between 72.3% (Italy) and 88.6% (UK) of patients post-MI. More than 80.0% of SCPs and 51.2% of PCPs stated that they would initiate a change in LLT immediately if patients did not achieve their LDL-C treatment goal by 12 weeks post-MI; 82.0% of SCPs and 55.1% of PCPs reported referring to 2019 ESC/EAS guidelines for management of patients post-MI. Barriers to initiating PCSK9 inhibitors (PCSK9is) included prior prescription of a maximally tolerated dose of statin (49.4%) and/or ezetimibe (38.9%), requirement to reach threshold LDL-C levels (44.9%), and pre-authorization requirements (30.4%). CONCLUSION: Differences in clinical practice post-MI were reported across the countries surveyed, including divergence between 2019 ESC/EAS and local guidelines. Increased use of innovative medicines to achieve LDL-C goals should reduce risk of subsequent cardiovascular events in very high-risk patients post-MI.

Cost-minimization and budget impact analysis of certolizumab pegol for patients with Crohn's disease, moderate or severe, with relapse after conventional treatment from the perspective of the Brazilian private payer / Análises de custo-minimização e impacto orçamentário do certolizumabe pegol para pacientes com doença de Crohn moderada a grave com falha ao tratamento convencional, sob a perspectiva do pagador privado no Brasil

Objectives: Budget impact and cost-effectiveness analysis are often required by payers when discussing drug reimbursement. We hereby present a cost-minimization (CMA) and budget impact analysis (BIA) regarding the incorporation of certolizumab pegol (CZP) for the treatment of patients with Crohn's disease, a debilitating condition that affects the digestive tract. Methods: Considering that the scientific literature demonstrates CZP as effective as the alternatives (infliximab and adalimumab), a CMA was conducted, including a Markov 10-year time horizon modeling. Focusing on the assumptions for both CMA and BIA, a total of 36 stakeholders from the private sector were surveyed regarding treatment and disease-related costs. For the BIA, drug acquisition costs, administration costs, no population growth and an immunobiologic drug (bDMARD) switching rate of 5% were also considered. We assumed that CZP would gradually gain market share until it reaches 20% of new or switching patients in the fourth year. In addition, probability sensitivity analyses were performed. Results: In the cost-minimization, the calculated costs for 10-year treatment were BRL149k (infliximab); BRL118k (adalimumab) and BRL83k (CZP). Probabilistic sensitivity analysis was conducted with 1,000 random simulations, with CZP being less costly than its comparators in all simulations. Additionally, the BIA result indicates that CZP is a cost-saving intervention, with a predicted five-year impact of BRL317k for every 100-patient cohort. Conclusions: Certolizumab pegol was shown to be not only effective but also a cost-saving drug when compared to other anti-TNF drugs available for the Brazilian private healthcare system.

Objetivos: Análises de impacto orçamentário e de custo-efetividade são, com frequência, exigidas por pagadores para a decisão sobre incorporação de drogas. Por esse motivo, apresentaremos uma análise de custo-minimização e de impacto orçamentário do certolizumabe pegol (CZP) para o tratamento de pacientes com doença de Crohn, doença crônica e debilitante que afeta o trato digestivo. Métodos: Trinta e seis pagadores privados foram entrevistados para que fosse possível compreender os custos de tratamento e aqueles relacionados à doença. Para a análise de impacto orçamentário, foram assumidos: custos de aquisição e administração das drogas, nenhuma taxa de crescimento populacional, taxa de troca de medicamento biológico (bDMARD) de 5% e market share de 20% para o CZP em seu pico. Visto que o CZP é tão eficaz e seguro quanto os comparadores disponíveis, optou-se pela análise de custo-minimização, assumindo horizonte temporal de 10 anos. Resultados: A análise de impacto orçamentário mostra que o CZP é capaz de gerar redução de custos no valor de R$ 317 mil em cinco anos, para cada cem pacientes. Para a custo-minimização, os custos calculados no horizonte de dez anos foram: R$ 149 mil para o infliximabe; R$ 118 mil para o adalimumabe e R$ 83 mil para o CZP. A análise de sensibilidade probabilística mostrou CZP menos custoso em 100% das 1.000 simulações. Conclusões: Certolizumabe pegol mostrou-se não apenas efetivo, mas também uma opção que pode gerar redução de custos quando comparada às outras drogas biológicas no Brasil sob a perspectiva do pagador privado.

The impact of persistence with bisphosphonates on health resource utilization and fracture risk in the UK: a study of patient records from the UK Clinical Practice Research Datalink.

RATIONALE, AIMS AND OBJECTIVES: Clinical trial data suggest that patients who have received bisphosphonates continue to benefit from them after discontinuation. However, data from real-world clinical practice are inconclusive. We assessed the impact of persistence and discontinuation on health resource utilization (HRU) and fracture rate in women who were prescribed oral bisphosphonates. METHOD: The study used data from the UK Clinical Practice Research Datalink. Women aged 50 years or older with a first prescription of oral bisphosphonate therapy between January 2000 and December 2007 were included. Multivariate modelling compared rate ratios for fracture and HRU between patients who had discontinued medication (shorter persistence group) and patients who took their medication for longer (longer persistence group). The interactions of elapsed time (measured as 6-month intervals) with HRU and with fracture rate for all patients within paired groups were also assessed. RESULTS: Overall, 36 320 patients were included. Pairwise comparisons showed that HRU and fracture rates were lower in longer persistence groups than in shorter persistence groups. Analysis by 6-month interval showed that, across all patients in persistence group pairs, HRU significantly increased for each additional 6 months elapsed; trends towards increased risk of fracture were also seen. CONCLUSION: In contrast to results from clinical trials, in this patient population the protective effect of oral bisphosphonates after discontinuation was not sufficient to reduce HRU and fracture rates to the levels that would be seen if patients had continued on therapy. Reducing the rate of treatment discontinuation may decrease the burden that osteoporosis places on both patients and health care systems.

Switch patterns of osteoporosis medication and its impact on persistence among postmenopausal women in the U.K. General Practice Research Database.

OBJECTIVE: This study aims to describe the switch patterns of osteoporosis medication in postmenopausal women and to explore the impact of switching on persistence. METHODS: This study used a cohort of postmenopausal women who initiated the first treatment with osteoporosis medication between 1995 and 2008. Selected women had switched at least once to a different frequency or type of osteoporosis medication during follow-up. For each study woman, we identified the first therapy (initial osteoporosis medication), second therapy (medication received at first switch), and, where available, third therapy (medication received at second switch), regardless of how many times she switched during follow-up. Persistence was defined as the number of days from the index date to the end of the last prescription within each episode of use. The Kaplan-Meier method was used to calculate persistence rates at 6 months, 1 year, 3 years, and 5 years. RESULTS: Of 20,638 women who switched osteoporosis treatment at least once in the study period, approximately 67% switched once, 21% switched twice, and 12% switched three times or more. Persistence rates for the second therapy were highest (% [95% CI], 46.6 [46.1-47.1], 35.0 [34.5-35.5], 18.8 [18.3-19.3], and 11.4 [10.9-11.7] at 6 mo, 1 y, 3 y, and 5 y, respectively), whereas persistence rates for the first therapy were lowest (% [95% CI], 34.3 [33.9-34.8], 21.6 [21.2-21.9], 5.90 [5.68-6.13], and 1.57 [1.45-1.69], respectively). CONCLUSIONS: Among women who switch their initial medication, even though switching to the second medication improves persistence during the initial therapy, persistence on the second and subsequent therapies remains suboptimal.