Generic drugs – essential for the sustainability of healthcare systems with numerous strategies to enhance their use

The increasing use of lower-cost multiple sourced medicines (generics) and biosimilars are essential to attain or retain universal healthcare in the face of continual pressure on available resources. Alongside this, reduce patient co-payments and enhance access to medicines in countries with high co-payments where affordability was an issue. Supply-side measures, including aggressive procurement practices and increased transparency in the manufacture and pricing of generics, can appreciably lower the price of generics. Such measures alongside demand-side measures can enhance savings versus originators as well as increase access to standard medicines. However, there needs to be trust in the generics to maximise savings. The same applies to biosimilars. Multiple demand-side measures can also appreciably enhance the preferential prescribing of multiple sourced medicines versus still patented medicines in a class or related class without compromising care. As a result, enhance utilisation at lower costs. Countries can learn from each other when planning or instigating reforms, and this will grow

Challenges and opportunities with routinely collected data on the utilization of cancer medicines. Perspectives from health authority personnel across 18 European countries

Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over cost-effectiveness and increasing expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines. Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national collaboration to improve data collection and inform decision-making. Methods: A mixed methods approach was undertaken through a cross-sectional questionnaire followed-up by a focus group discussion. Participants were selected by purposive sampling to represent stakeholders across different European countries and healthcare settings. Descriptive statistics were used to analyze quantifiable questions, whilst content analysis was employed for open-ended questions. Results: 25 respondents across 18 European countries provided their insights on the types of datasets collecting oncology data, including hospital records, cancer, prescription and medicine registers. The most available is expenditure data whilst data concerning effectiveness, safety and outcomes is less available, and there are concerns with data validity. A major constraint to data collection is the lack of comprehensive registries and limited data on effectiveness, safety and outcomes of new medicines. Data ownership limits data accessibility as well as possibilities for linkage, and data collection is time-consuming, necessitating dedicated staff and better systems to facilitate the process. Cross-national collaboration is challenging but the engagement of multiple stakeholders is a key step to reach common goals through research. Conclusion: This study acts as a starting point for future research on patient-level databases for oncology across Europe. Future recommendations will require continued engagement in research, building on current initiatives and involving multiple stakeholders to establish guidelines and commitments for transparency and data sharing

Initiatives and reforms across Scotland in recent years to improve prescribing; findings and global implications of drug prescriptions

Objective: Global expenditure on medicines is increasing driven by a number of factors. These include the launch of new premium-priced medicines for complex diseases including oncology, rise in non-communicable diseases especially with ageing populations and changes in clinical practice. There are also concerns with the rise in antimicrobial resistance due to inappropriate prescribing of antimicrobials as well as concerns with polypharmacy. Both situations increase morbidity, mortality and costs. We are aware of ongoing activities across Scotland to improve the managed entry of new medicines, including new oncology medicines, improve the prescribing of antimicrobials as well as enhance the prescribing of low-cost multiple sourced medicines and biosimilars without compromising care. In addition, seeking to address concerns with polypharmacy. Consequently, we wanted to document these multiple measures and their outcomes to provide an overview to inform all key stakeholders in Scotland as well as the global community as resource pressures grow. Methods: A narrative review of the literature documenting examples of ongoing national and regional initiatives across Scotland to influence future prescribing and their impact where known across multiple disease areas. Significant findings: The co-ordinated approach to improve the prescribing of new medicines limited the prescribing of dabigatran when first launched with recent research providing guidance on the effectiveness and safety of different direct oral anticoagulants as more are launched. The patient reported outcome measures project and other ongoing research activities, including linking datasets, is progressing under the Cancer Medicines Outcomes Programme in Scotland to improve future care with typically differences in the effectiveness of new cancer medicines in routine care versus clinical trials. The Scottish Antimicrobial Prescribing Group is also active in Scotland instigating multiple measures to improve antimicrobial prescribing. This includes improving the dosing of gentamicin and vancomycin as well as reducing the prescribing of antibiotics for women with urinary tract infections. Multiple activities have also resulted in high International Non-proprietary Name (INN) prescribing in Scotland at between 91.4% to 100% across a range of medicines. In addition, increased the prescribing of low-cost multiple sourced medicines versus patented medicines in a class or related class, as well as biosimilars, leading to considerable savings without compromising care. There have also been initiatives to address concerns with the rising costs of combination inhalers for patients with respiratory diseases as well as areas of polypharmacy with varying success. Conclusion: Multiple and co-ordinated approaches have improved the quality and efficiency of prescribing in Scotland. Additional measures are still needed and we will continue to monitor the situation

Strategies to Improve Antimicrobial Utilization with a Special Focus on Developing Countries

From MDPI via Jisc Publications RouterHistory: accepted 2021-06-02, pub-electronic 2021-06-07Publication status: PublishedAntimicrobial resistance (AMR) is a high priority across countries as it increases morbidity, mortality and costs. Concerns with AMR have resulted in multiple initiatives internationally, nationally and regionally to enhance appropriate antibiotic utilization across sectors to reduce AMR, with the overuse of antibiotics exacerbated by the COVID-19 pandemic. Effectively tackling AMR is crucial for all countries. Principally a narrative review of ongoing activities across sectors was undertaken to improve antimicrobial use and address issues with vaccines including COVID-19. Point prevalence surveys have been successful in hospitals to identify areas for quality improvement programs, principally centering on antimicrobial stewardship programs. These include reducing prolonged antibiotic use to prevent surgical site infections. Multiple activities centering on education have been successful in reducing inappropriate prescribing and dispensing of antimicrobials in ambulatory care for essentially viral infections such as acute respiratory infections. It is imperative to develop new quality indicators for ambulatory care given current concerns, and instigate programs with clear public health messaging to reduce misinformation, essential for pandemics. Regular access to effective treatments is needed to reduce resistance to treatments for HIV, malaria and tuberculosis. Key stakeholder groups can instigate multiple initiatives to reduce AMR. These need to be followed up

Corrigendum to "Utilisation trend of long-acting insulin analogues including biosimilars across Europe: findings and implications"

In the article titled "Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications" [1], the captions of Figures 3 and 4 were incorrect. The corrected captions for Figures 3 and 4 appear below

Breast cancer management in the era of Covid-19; key issues, contemporary strategies, and future implications

During the COVID-19 pandemic, several priority diseases were not getting sufficient attention. Whilst breast cancer is a fatal disease affecting millions worldwide, identification and management of these patients did not initially attract critical attention to minimize the impact of lockdown, post-lockdown, and other measures. Breast cancer patients' conditions may not remain stable without proper care, worsening their prognosis. Proper care includes the timely instigation of surgery, systemic therapy, and psychological support. This includes low- and middle-income countries where there are already concerns with available personnel and medicines to adequately identify and treat these patients. Consequently, there was a need to summarize the current scenario regarding managing breast cancer care during COVID-19 across all countries, including any guidelines developed. We systematically searched three scientific databases and found 76 eligible articles covering the medical strategies of high-income countries versus LMICs. Typically, diagnostic facilities in hospitals were affected at the beginning of the pandemic following the lockdown and other measures. This resulted in more advanced-stage cancers being detected at initial presentation across countries, negatively impacting patient outcomes. Other than increased telemedicine, instigating neo-adjuvant endocrine therapy more often, reducing non-essential visits, and increasing the application of neo-adjuvant chemotherapy to meet the challenges, encouragingly, there was no other significant difference among patients in high-income versus LMICs. Numerous guidelines regarding patient management evolved during the pandemic to address the challenges posed by lockdowns and other measures, which were subsequently adopted by various high-income countries and LMICs to improve patient care. The psychological impact of COVID-19 and associated lockdown measures, especially during the peak of COVID-19 waves, and the subsequent effect on the patient's mental health must also be considered in this high-priority group. We will continue to monitor the situation to provide direction in future pandemics

Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe : Findings and Implications

Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology. Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel. Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups. There are concerns with the availability and use of insulin glargine biosimilars among European countries despite lower costs. This can be addressed

Evidence-based public policy making for medicines across countries; findings and implications for the future

Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Extensive narrative review of published papers and contextualizing the findings to provide future guidance. New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Multiple measures will be needed to attain and retain universal healthcare

Current utilization patterns for long-acting insulin analogues including biosimilars among selected Asian countries and the implications for the future

Introduction: Prevalence rates for diabetes mellitus continue to rise, which, coupled with increasing costs of complications, has appreciably increased expenditure in recent years. Poor glycaemic control including hypoglycaemia enhances complication rates and associated morbidity, mortality and costs. Consequently, this needs to be addressed. Whilst the majority of patients with diabetes have type-2 diabetes, a considerable number of patients with diabetes require insulin to help control their diabetes. Long-acting insulin analogues were developed to reduce hypoglycaemia associated with insulin and help improve adherence, which can be a concern. However, their considerably higher costs have impacted on their funding and use, especially in countries with affordability issues. Biosimilars can help reduce the costs of long-acting insulin analogues thereby increasing available choices. However, the availability and use of long-acting insulin analogues can be affected by limited price reductions versus originators and limited demand-side initiatives to encourage their use. Consequently, we wanted to assess current utilisation rates for long-acting insulin analogues, especially biosimilars, and the rationale for patterns seen, across multiple Asian countries ranging from Japan (high-income) to Pakistan (lower-income) to inform future strategies. Methodology: Multiple approaches including assessing utilization and prices of insulins including biosimilars among six Asian countries and comparing the findings especially with other middle-income countries. Results: Typically, there was increasing use of long-acting insulin analogues among the selected Asian countries. This was especially the case enhanced by biosimilars in Bangladesh, India, and Malaysia reflecting their perceived benefits. However, there was limited use in Pakistan due to issues of affordability similar to a number of African countries. The high use of biosimilars in Bangladesh, India and Malaysia was helped by issues of affordability and local production. The limited use of biosimilars in Japan and Korea reflects limited price reductions and demand-side initiatives similar to a number of European countries. Conclusions: Increasing use of long-acting insulin analogues across countries is welcomed, adding to the range of insulins available, which increasingly includes biosimilars. A number of activities are needed to enhance the use of long-acting insulin analogue biosimilars in Japan, Korea and Pakistan

Strategies to improve antimicrobial utilization with a special focus on developing countries

Antimicrobial resistance (AMR) is a high priority across countries as it increases morbidity, mortality and costs. Concerns with AMR have resulted in multiple initiatives internationally, na-tionally and regionally to enhance appropriate antibiotic utilization across sectors to reduce AMR, with the overuse of antibiotics exacerbated by the COVID-19 pandemic. Effectively tackling AMR is crucial for all countries. Principally a narrative review of ongoing activities across sectors was undertaken to improve antimicrobial use and address issues with vaccines including COVID-19. Point prevalence surveys have been successful in hospitals to identify areas for quality improvement programs, principally centering on antimicrobial stewardship programs. These include reducing prolonged antibiotic use to prevent surgical site infections. Multiple activities centering on education have been successful in reducing inappropriate prescribing and dispensing of antimicrobials in ambulatory care for essentially viral infections such as acute respiratory infections. It is imperative to develop new quality indicators for ambulatory care given current concerns, and instigate programs with clear public health messaging to reduce misinformation, essential for pandemics. Regular access to effective treatments is needed to reduce resistance to treatments for HIV, malaria and tuberculosis. Key stakeholder groups can instigate multiple initiatives to reduce AMR. These need to be followed up