The Current Situation Regarding Long-Acting Insulin Analogues Including Biosimilars Among African, Asian, European, and South American Countries; Findings and Implications for the Future.

Background: Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers. Objective: To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders. Our approach: Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries. Results: There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production. Conclusions: There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities.

Influence of pharmaceutical services organization on the availability of essential medicines in a public health system.

Objective: To evaluate the influence of organizational structure and technical-management activities on the availability of essential medicines in the primary healthcare. Materials & methods: Cross-sectional, exploratory and evaluative study. The availability was evaluated according to parameters established by the WHO. Results: The average availability of standardized essential medicines was 83.3 and 73.3% for medicines purchased centrally by the Brazilian government. Among the therapeutic groups evaluated, the lowest average availability were for the tuberculostatics (24.1%) and psychotropic/special control medicines (30.3%). Conclusion: The availability of essential medicines was positively influenced by the presence of the pharmacist and by the computerized system deployed, and negatively associated with essential medicines purchased centrally by the federal government, especially in the smaller municipalities.

Real-world evaluation of the impact of statin intensity on adherence and persistence to therapy: A Scottish population-based study.

AIM: To assess associations between statin intensity and adherence, persistence and discontinuation of statin therapy in Scotland. METHOD: Retrospective cohort study, using linked electronic health records covering a period from January 2009 to December 2016. The study cohort included adult patients (≥18 years) newly initiating statins within Greater Glasgow and Clyde, Scotland. Study outcomes comprised adherence, discontinuation and persistence to treatment, stratified by three exposure groups (high, moderate and low intensity). Discontinuation and persistence were calculated using the refill-gap and anniversary methods, respectively. Proportion of days covered (PDC) was used as a proxy for adherence. Kaplan-Meier survival curves and Cox proportional hazard models were used to evaluate discontinuation, and associations between adherence/persistence and statin intensity were assessed using logistic regression. RESULTS: A total of 73 716 patients with a mean age of 61.4 ± 12.6 years were included; the majority (88.3%) received moderate intensity statins. Discontinuation rates differed between intensity levels, with high-intensity patients less likely to discontinue treatment compared to those on moderate intensity (prior cardiovascular disease [CVD]: HR 0.43 [95% CI 0.34-0.55]; no prior CVD: 0.80 [0.74-0.86]). Persistence declined over time, and high-intensity patients had the highest persistence rates. Overall, 52.6% of patients were adherent to treatment (PDC ≥ 80%), but adherence was considerably higher among high-intensity patients (63.7%). CONCLUSION: High-intensity statins were associated with better persistence and adherence to treatment, but overall long-term persistence and adherence remain a challenge, particularly among patients without prior CVD. This needs addressing.

The use of probiotics as a supplementary therapy in the treatment of patients with asthma: a pilot study and implications.

OBJECTIVES: Evaluate the use of probiotics as an additional therapy in the treatment of children and adolescents with asthma in Belo Horizonte, MG-Brazil. METHODS: A pilot longitudinal, experimental and nonrandomized study with 30 patients from six to 17 years old from Belo Horizonte. In the baseline appointment, all patients received beclomethasone, and one group also received a probiotic containing Lactobacillus reuteri (n=14). The patients were reassessed after at least 60 days with the Asthma Control Test, spirometry and self-report of the symptoms they experienced associated with asthma. RESULTS: A predominance of male patients (56.7%) and a mean age of 10.6 years were observed. The groups using probiotics did not differ in terms of sex, age or atopy. In the longitudinal evaluation, an increase in the Asthma Control Test scores and a reduction in the number of symptoms were observed in the probiotic group. There was an increase in the peak expiratory flow among those who used probiotics. CONCLUSIONS: This pilot study supports the hypothesis that the administration of probiotics as a supplementary therapy for the treatment of children and adolescents with asthma improves the clinical condition of the patients. Further studies are needed to confirm the efficacy of probiotics in asthma treatment.

The use of probiotics as a supplementary therapy in the treatment of patients with asthma: a pilot study and implications

OBJECTIVES: Evaluate the use of probiotics as an additional therapy in the treatment of children and adolescents with asthma in Belo Horizonte, MG-Brazil. METHODS: A pilot longitudinal, experimental and nonrandomized study with 30 patients from six to 17 years old from Belo Horizonte. In the baseline appointment, all patients received beclomethasone, and one group also received a probiotic containing Lactobacillus reuteri (n=14). The patients were reassessed after at least 60 days with the Asthma Control Test, spirometry and self-report of the symptoms they experienced associated with asthma. RESULTS: A predominance of male patients (56.7%) and a mean age of 10.6 years were observed. The groups using probiotics did not differ in terms of sex, age or atopy. In the longitudinal evaluation, an increase in the Asthma Control Test scores and a reduction in the number of symptoms were observed in the probiotic group. There was an increase in the peak expiratory flow among those who used probiotics. CONCLUSIONS: This pilot study supports the hypothesis that the administration of probiotics as a supplementary therapy for the treatment of children and adolescents with asthma improves the clinical condition of the patients. Further studies are needed to confirm the efficacy of probiotics in asthma treatment.

Comparative Effectiveness and Safety of Monoclonal Antibodies (Bevacizumab, Cetuximab, and Panitumumab) in Combination with Chemotherapy for Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis.

BACKGROUND: The last decade has seen the increasing use of biological medicines in combination with chemotherapy containing 5-fluorouracil/oxaliplatin or irinotecan for the treatment of metastatic colorectal cancer (mCRC). These combinations have resulted in increased progression-free survival (PFS) in patients with mCRC; however, there are remaining concerns over the extent of their effect on overall survival (OS). Published studies to date suggest no major differences between the three currently available monoclonal antibodies (MoAbs); however, there are differences in costs. In addition, there is rising litigation in Brazil in order to access these medicines as they are currently not reimbursed. OBJECTIVE: The aim was to investigate the comparative effectiveness and safety of three MoAbs (bevacizumab, cetuximab and panitumumab) associated with fluoropyrimidine-based chemotherapy regimens and compared to fluoropyrimidine-based chemotherapy alone in patients with mCRC, through an updated systematic review and meta-analysis of concurrent or non-concurrent observational cohort studies, to guide authorities and the judiciary. METHOD: A systematic review and meta-analysis was performed based on cohort studies published in databases up to November 2017. Effectiveness measures included OS, PFS, post-progression survival (PPS), Response Evaluation Criteria In Solid Tumors (RECIST), response rate, metastasectomy and safety. The methodological quality of the studies was also evaluated. RESULTS: A total of 21 observational cohort studies were included. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus no bevacizumab mainly around OS, PFS, PPS and the metastasectomy rate, but not for the disease control rates. However, there was an increase in treatment-related toxicities and concerns with the heterogeneity of the studies. CONCLUSION: The results pointed to an advantage in favor of bevacizumab for OS, PFS, PPS, and metastasectomy. Although this advantage may be considered clinically modest, bevacizumab represents a hope for increased survival and a chance of metastasectomy for patients with mCRC. However, there are serious adverse events associated with its use, especially severe hypertension and gastrointestinal perforation, that need to be considered.