Sales of anti-cancer medicines; China, Indonesia, Kazakhstan, Malaysia, Philippines and Thailand.

OBJECTIVE: To assess sales of anti-cancer medicines in the 2017 World Health Organization's WHO Model list of essential medicines in China, Indonesia, Kazakhstan, Malaysia, Philippines and Thailand from 2007 (2008 for Kazakhstan and Malaysia) to 2017. METHODS: We extracted sales volume data for 39 anti-cancer medicines from the IQVIA database. We divided the total quantity sold by the reference defined daily dose to estimate the total number of defined daily doses sold, per country per year, for three types of anti-cancer therapies (traditional chemotherapy, targeted therapy and endocrine therapy). We adjusted these data by the number of new cancer cases in each country for each year. FINDINGS: We observed an increase in sales across all types of anti-cancer therapies in all countries. The largest number of defined daily doses of traditional chemotherapy per new cancer case was sold in Thailand; however, the largest relative increase per new cancer case occurred in Indonesia (9.48-fold). The largest absolute and relative increases in sales of defined daily doses of targeted therapies per new cancer case occurred in Kazakhstan. Malaysia sold the largest number of adjusted defined daily doses of endocrine therapies in 2017, while China and Indonesia more than doubled their adjusted sales volumes between 2007 and 2017. CONCLUSION: The use of sales data can fill an important knowledge gap in the use of anti-cancer medicines, particularly during periods of insurance coverage expansion. Combined with other data, sales volume data can help to monitor efforts to improve equitable access to essential medicines.

Time to Entry for New Cancer Medicines: From European Union-Wide Marketing Authorization to Patient Access in Belgium, Estonia, Scotland, and Sweden.

OBJECTIVES: First, to quantify the median time from European Union (EU)-wide approval to first use (launch) for a sample of cancer medicines and number of launches in Belgium, Estonia, Scotland, and Sweden as of June 2015. Second, to assess whether longer times to launch or lack of launches affected medicines with high or low expected additional clinical benefit. Third, to identify possible determinants of the probability of a cancer medicine to be launched. METHODS: Correlation between time to launch and a set of variables hypothesized to affect launch was tested using a complementary log-log model for a sample of 46 cancer medicines that obtained EU-wide marketing authorization between 2000 and 2014. RESULTS: In median, for a sample of 24 cancer medicines that obtained marketing authorization between 2010 and 2014, the expected time from EU-wide marketing authorization to first use of a medicine was shortest in Sweden, 3.1 months, followed by Scotland (9.3 months), Belgium (14.8 months), and Estonia (27.8 months). Median times to launch were longer for the entire sample of 46 cancer medicines that obtained marketing authorization between 2000 and 2014. In the all-country model, medicines with shorter times to submission for reimbursement, local manufacturers headquarter (or local sales representative), and a Food and Drugs Administration priority review or a combination of expedited approval programs and medicines launched in Scotland and Sweden were associated with a higher hazard of launch. Longer times since EU-wide approval initially correlate with an increased hazard but as time further elapses they negatively affect the hazard of launch. CONCLUSIONS: Median times from marketing authorization to first use of cancer medicines were shorter for medicines launched between 2010 and 2014 versus sample-wide (2000-2014). In Estonia, more medicines than in the other countries were not yet launched at the end of the observation period. There was no correlation between Prescrire and European School of Medical Oncology Magnitude of Clinical Benefit Scale ratings of added clinical value and time to launch.

Diabetes in Algeria and challenges for health policy: a literature review of prevalence, cost, management and outcomes of diabetes and its complications.

BACKGROUND: Diabetes has become an increasingly prevalent and severe public health issue in Algeria. This article investigates the prevalence, the cost and the management of this disease. Its first objective is to better understand the burden (both from an epidemiological and economic perspective) and management of diabetes. The second objective is to understand the health policy strategy adopted by Algeria in order to respond to the disease. METHODS: We conducted a literature review of prevalence, costs, management and outcomes of diabetes and its complications. This was complemented by data compilations and results of expert consultations. RESULTS: The epidemiology of diabetes is continually evolving and is becoming more problematic. The national evidence suggests that the prevalence of diabetes in Algeria has increased from 6.8% in 1990 to 12.29% in 2005, but is quite higher among certain groups and areas of the country. This disease affects all population groups, especially 35-70 year olds, who constitute a large segment of the working population. There are very few estimates of the cost of diabetes. These include a 1998 study on the total cost of type 1 diabetes (USD 11.6 million, which, inflated to 2013 value, totals to USD 16.6 million), a study on the cost of complications in 2010 (at 2013 value, ranging from USD 141 for first-year treatment of peripheral vascular disease to USD 30,441 for first-year cost of renal transplantation) and the 2013 IDF estimates of total cost of type 1 and type 2 diabetes (USD 513 million). CONCLUSIONS: As the prevalence of diabetes continues to increase, the financial burden will increasingly weigh heavily on social security resources and the government budget. Future priorities must focus on empowering general practitioners in treating type 2 diabetes, improving screening of diabetes and its complications, tackling the growing obesity epidemic, strengthening health information systems and implementing the national diabetes prevention and control plan.

The economic burden of diabetes in India: a review of the literature.

BACKGROUND: Diabetes and its complications are a major cause of morbidity and mortality in India, and the prevalence of type 2 diabetes is on the rise. This calls for an assessment of the economic burden of the disease. OBJECTIVE: To conduct a critical review of the literature on cost of illness studies of diabetes and its complications in India. METHODS: A comprehensive literature review addressing the study objective was conducted. An extraction table and a scoring system to assess the quality of the studies reviewed were developed. RESULTS: A total of nineteen articles from different regions of India met the study inclusion criteria. The third party payer perspective was the most common study design (17 articles) while fewer articles (n =2) reported on costs from a health system or societal perspective. All the articles included direct costs and only a few (n =4) provided estimates for indirect costs based on income loss for patients and carers. Drug costs proved to be a significant cost component in several studies (n =12). While middle and high-income groups had higher expenditure in absolute terms, costs constituted a higher proportion of income for the poor. The economic burden was highest among urban groups. The overall quality of the studies is low due to a number of methodological weaknesses. The most frequent epidemiological approach employed was the prevalence-based one (n =18) while costs were mainly estimated using a bottom up approach (n =15). CONCLUSION: The body of literature on the costs of diabetes and its complications in India provides a fragmented picture that has mostly concentrated on the direct costs borne by individuals rather than the healthcare system. There is a need to develop a robust methodology to perform methodologically rigorous and transparent cost of illness studies to inform policy decisions.

From fangs to antidotes: A scoping review on snakebite burden, species, and antivenoms in the Eastern Mediterranean Region.

BACKGROUND: Snake bites cause considerable morbidity and mortality worldwide, yet evidence from low- and middle-income countries remains fragmented. This is particularly the case in Eastern Mediterranean Region where available data on snake bites is relatively weak. Without reliable data, it is difficult to make the case for greater visibility and investment to address the snakebite burden in this Region. A scoping review was therefore conducted to summarize evidence on snake bites in countries of the Eastern Mediterranean. METHODOLOGY/PRINCIPAL FINDINGS: The review employed manual and electronic searching methods of four databases plus Google Scholar, ultimately including 196 records from 20 countries published between 2000 and 2023. More than half originated from Iran, Morocco, and Pakistan. Many records lacked information on permanent sequalae, disability, snake species, and types and sources of antivenoms. When identified, offending snakes belonged to 30 species. Use of more than 12 types of antivenoms were described across the Region, and some were not specific to indigenous species. CONCLUSION/SIGNIFICANCE: Despite the relatively large number of publications identified, the data were concentrated in just a few countries in the Region, and there was little or no information available for the remainder. As is the case worldwide, disability associated with snake bites was poorly characterized and quantified across the Region. There is an urgent need for concrete action at national and regional levels to enhance epidemiological surveillance, research, and the collection of clinical, disability and outcomes data to inform policy and public health investment. Greater regional cooperation and collaboration is also crucial for addressing this neglected disease throughout the Region.

Personalizing health care: feasibility and future implications.

Considerable variety in how patients respond to treatments, driven by differences in their geno- and/ or phenotypes, calls for a more tailored approach. This is already happening, and will accelerate with developments in personalized medicine. However, its promise has not always translated into improvements in patient care due to the complexities involved. There are also concerns that advice for tests has been reversed, current tests can be costly, there is fragmentation of funding of care, and companies may seek high prices for new targeted drugs. There is a need to integrate current knowledge from a payer's perspective to provide future guidance. Multiple findings including general considerations; influence of pharmacogenomics on response and toxicity of drug therapies; value of biomarker tests; limitations and costs of tests; and potentially high acquisition costs of new targeted therapies help to give guidance on potential ways forward for all stakeholder groups. Overall, personalized medicine has the potential to revolutionize care. However, current challenges and concerns need to be addressed to enhance its uptake and funding to benefit patients.

Diabetes management in Thailand: a literature review of the burden, costs, and outcomes.

Management of diabetes represents an enormous challenge for health systems at every level of development. The latter are tested for their ability to continuously deliver high quality care to patients from the day they are diagnosed throughout their life. In this study, we review the status of diabetes management in Thailand and try to identify the key challenges the country needs to address to reduce the current (and future) medical and economic burden caused by the disease.We conducted a literature review on the burden, costs, and outcomes of diabetes in Thailand. This information was complemented by personal communication with senior officials in the Thai Ministry of Health.We identified the following priorities for the future management of diabetes in Thailand. First, increasing screening of diabetes in high risk population and promoting annual screening of diabetes complications in all diabetic patients. Second, identifying and addressing factors affecting poor treatment outcomes. Third, policy should specify clear targets and provide and use a monitoring framework to track progress. Fourth, efforts are needed to further improve data availability. Up-to-date data on the medical and economic burden of diabetes representative at the national level and at least the regional level are essential to identify needs and monitor progress towards established targets. Fifth, promotion of a healthy lifestyle for prevention of diabetes through education and quality information delivered to the public.

Challenges in diabetes management in Indonesia: a literature review.

BACKGROUND AND OBJECTIVES: The expanding diabetes epidemic worldwide could have potentially devastating effects on the development of healthcare systems and economies in emerging countries, both in terms of direct health care costs and loss of working time and disability. This study aims to review evidence on the burden, expenditure, complications, treatment, and outcomes of diabetes in Indonesia and its implications on the current health system developments. METHODS: We conducted a comprehensive literature review together with a review of unpublished data from the Ministry of Health and a public health insurer (Askes). Studies presenting evidence on prevalence, incidence, mortality, costs, complications and cost of complications, treatment, and outcomes were included in the analysis. RESULTS: A limited number of international, national and local studies on the burden and cost of diabetes in Indonesia were identified. National survey data suggests that in 2007 the prevalence of diabetes was 5.7%, of which more than 70% of cases were undiagnosed. This estimate hides large intracountry variation. There was very limited data available on direct costs and no data on indirect costs. The most commonly-identified complication was diabetic neuropathy. DISCUSSION: There were a number of limitations in the data retrieved including the paucity of data representative at the national level, lack of a clear reference date, lack of data from primary care, and lack of data from certain regions of the country. CONCLUSIONS: If left unaddressed, the growing prevalence of diabetes in the country will pose a tremendous challenge to the Indonesian healthcare system, particularly in view of the Government's 2010 mandate to achieve universal health coverage by 2014. Essential steps to address this issue would include: placing diabetes and non-communicable diseases high on the Government agenda and creating a national plan; identifying disparities and priority areas for Indonesia; developing a framework for coordinated actions between all relevant stakeholders.

Epidemiology, management, complications and costs associated with type 2 diabetes in Brazil: a comprehensive literature review.

BACKGROUND: With an estimated 74% of all deaths attributable to non-communicable diseases (NCDs) in 2010, NCDs have become a major health priority in Brazil. The objective of the study was to conduct a comprehensive literature review on diabetes in Brazil; specifically: the epidemiology of type 2 diabetes, the availability of national and regional sources of data (particularly in terms of direct and indirect costs) and health policies for the management of diabetes and its complications. METHODS: A literature search was conducted using PubMed to identify articles containing information on diabetes in Brazil. Official documents from the Brazilian government and the World Health Organization, as well as other grey literature and official government websites were also reviewed. RESULTS: From 2006 to 2010, an approximate 20% increase in the prevalence of self-reported diabetes was observed. In 2010, it was estimated that 6.3% of Brazilians aged 18 years or over had diabetes. Diabetes was estimated to be responsible for 278,778 years of potential life lost for every 100,000 people. In 2013, it is estimated that about 7% of patients with diabetes has had one or more of the following complications: diabetic foot ulcers, amputation, kidney disease, and fundus changes. The estimated annual direct cost of diabetes was USD $3.952 billion in 2000; the estimated annual indirect cost was USD $18.6 billion. The two main sources of data on diabetes are the information systems of the Ministry of Health and surveys. In the last few years, the Brazilian Ministry of Health has invested considerably in improving surveillance systems for NCDs as well as implementing specific programmes to improve diagnosis and access to treatment. CONCLUSIONS: Brazil has the capacity to address and respond to NCDs due to the leadership of the Ministry of Health in NCD prevention activities, including an integrated programme currently in place for diabetes. Strengthening the surveillance of NCDs is a national priority along with recognising the urgent need to invest in improving the coverage and quality of mortality data. It is also essential to conduct regular surveys of risk factors on a national scale in order to design effective preventive strategies.

Enhancing the use of geographic information systems for public health planning and decision-making in the WHO Eastern Mediterranean Region.

From distributing healthcare resources equitably to identifying disease outbreaks, most of the information needs of local health system decision-makers have a geographic component (1). Recognizing the value of geographic information systems for public health planning and decision-making, a 2007 resolution by the Regional Committee of the World Health Organization (WHO) Eastern Mediterranean Region (EMR) called upon Member States to develop institutional frameworks, policies, processes, and to provide the infrastructure and resources needed to support health mapping activities in EMR (2).

Expanding Genotype/Phenotype Correlation in 2p11.2-p12 Microdeletion Syndrome.

Chromosomal abnormalities on the short arm of chromosome 2 in the region p11.2 have been associated with developmental delay, intellectual disability, facial anomalies, abnormal ears, skeletal and genital malformations. Here we describe a patient with a de novo interstitial heterozygous microdeletion on the short arm of chromosome 2 in the region p11.2-p12. He presents with facial dysmorphism characterized by a broad and low root of the nose and low-set protruding ears. Clinical examinations during follow-up visits revealed congenital pendular nystagmus, decreased visual acuity and psychomotor development disorder including intellectual disability. The heterozygous 5 Mb-microdeletion was characterized by an array CGH (Comparative Genomic Hybridization) analysis. In the past two decades, nine patients with microdeletions in this region have been identified by array CGH analysis and were reported in the literature. All these patients show psychomotor development disorder and outer and/or inner ear anomalies. In addition, most of the patients have mild to severe intellectual disability and show facial malformations. We reviewed the literature on PubMed and OMIM using the gene/loci names as search terms in an attempt to identify correlations between genes located within the heterozygous microdeletion and the clinical phenotype of the patient, in order to define a recognizable phenotype for the 2p11.2p12 microdeletion syndrome. We discuss additional symptoms that are not systematically present in all patients and contribute to a heterogeneous clinical presentation of this microdeletion syndrome.

Use of Palliative Care Among Commercially Insured Patients With Metastatic Cancer Between 2001 and 2016.

PURPOSE: Early palliative care, concomitant with disease-directed treatments, is recommended for all patients with advanced cancer. This study assesses population-level trends in palliative care use among a large cohort of commercially insured patients with metastatic cancer, applying an expanded definition of palliative care services based on claims data. METHODS: Using nationally representative commercial insurance claims data, we identified patients with metastatic breast, colorectal, lung, bronchus, trachea, ovarian, esophageal, pancreatic, and liver cancers and melanoma between 2001 and 2016. We assessed the annual proportions of these patients who received services specified as, or indicative of, palliative care. Using Cox proportional hazard models, we assessed whether the time from diagnosis of metastatic cancer to first encounter of palliative care differed by demographic characteristics, socioeconomic factors, or region. RESULTS: In 2016, 36% of patients with very poor prognosis cancers received a service specified as, or indicative of, palliative care versus 18% of those with poor prognosis cancers. Being diagnosed in more recent years (2009-2016 v 2001-2008: hazard ratio [HR], 1.8; P < .001); a diagnosis of metastatic esophagus, liver, lung, or pancreatic cancer, or melanoma (v breast cancer, eg, esophagus HR, 1.89; P < .001); a greater number of comorbidities (American Hospital Formulary Service classes > 10 v 0: HR, 1.71; P < .001); and living in the Northeast (HR, 1.43; P < .001) or Midwest (v South: HR, 1.39; P < .001) were the strongest predictors of shorter time from diagnosis to palliative care. CONCLUSION: Use of palliative care among commercially insured patients with advanced cancers has increased since 2001. However, even with an expanded definition of services specified as, or indicative of, palliative care, < 40% of patients with advanced cancers received palliative care in 2016.

Intensity of End-of-Life Care in a Cohort of Commercially Insured Women With Metastatic Breast Cancer in the United States.

PURPOSE: There is limited evidence on the intensity of end-of-life (EOL) care for women < 65 years old, who account for about 40% of breast cancer deaths in the United States. Using established indicators, we estimated the intensity of EOL care among these women. METHODS: We used 2000-2014 claims data from a large US insurer to identify women with metastatic breast cancer who, in the last month of their lives, had more than one hospital admission, emergency department visit, or an intensive care unit (ICU) admission and/or used antineoplastic therapy in the last 14 days of life. Using multivariate logistic regression, we assessed whether intensity of EOL care differed by demographic characteristics, socioeconomic factors, or regions. RESULTS: Adjusted estimates show an increase in EOL ICU admissions between 2000-2003 and 2010-2014 from 14% (95% CI, 10% to 17%) to 23% (95% CI, 20% to 26%) and a small increase in emergency department visits from 10% (95% CI, 7% to 13%) to 12% (95% CI, 9% to 15%), both statistically significant. There was no statistically significant change in the proportions of women experiencing more than one EOL hospitalization (14% in 2010-2014; 95% CI, 11% to 17%) and of those receiving EOL antineoplastic treatment (24% in 2010-2014; 95% CI, 21% to 27%). Living in predominantly mixed, Hispanic, Black, or Asian neighborhoods correlated with more intense care (odds ratio, 1.39; 95% CI, 1.10 to 1.77 for ICU). CONCLUSION: Consistent with findings in the Medicare population, our results suggest an overall increase in the number of ICU admissions at the EOL over time. They also suggest that patients from non-White neighborhoods receive more intense acute care.

What are the volume and budget needs to provide chemotherapy to all children with acute lymphoblastic leukaemia in Thailand? Development and application of an estimation tool.

OBJECTIVE: Insufficient access to anticancer medicines may contribute to the wide survival differences of children with cancers across the globe. We developed a tool to estimate the volume of medicines and budget requirements to provide chemotherapy to children with acute lymphoblastic leukaemia (ALL). DESIGN: Development and application of an estimation tool. SETTING: Paediatric oncology hospital departments in Thailand. PARTICIPANTS: 318 children aged 0-14 years diagnosed with ALL and 215 children with undiagnosed ALL. INTERVENTIONS: Estimates of volume and budget requirements for administering a full course of chemotherapy for ALL and a further course for children who relapse, according to National Treatment Guidelines. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome measures were the volume (mg) and cost (US$) of medicines needed to treat children with ALL. For medicines whose main indication is paediatric ALL (asparaginase and 6-mercaptopurine), we estimated the difference between volume needed and actual sales in 2017 (secondary outcome). RESULTS: Ten anticancer medicines and four chemoprotective agents are needed for the treatment of paediatric ALL according to the Thai treatment guidelines. Of these 14 medicines, 13 are included in the WHO essential medicines list for children. All are available as generics. We estimated that essential chemotherapy and chemoprotective agents to treat all children diagnosed with ALL in Thailand in 2017 would cost US$ 814 952 (US$ 1 365 422 for diagnosed and undiagnosed children), which corresponds to 0.005% (0.008%) of the country's total health expenditure. The volumes of asparaginase and 6-mercaptopurine available on the Thai market in 2017 were more than sufficient (2.3 and 1.5 times the amounts needed, respectively) to treat all children diagnosed with ALL. CONCLUSIONS: Procuring sufficient quantities of essential medicines to treat children with ALL requires relatively modest resources. Medicine cost should not be a major barrier to ALL treatment in similar settings.

Proposal for a regulation on health technology assessment in Europe - opinions of policy makers, payers and academics from the field of HTA.

INTRODUCTION: In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): 'Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU'. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.

Clinical and Financial Implications of Medicine Consumption Patterns at a Leading Referral Hospital in Kenya to Guide Future Planning of Care.

Background: Medicines can constitute up to 70% of total health care budgets in developing countries as well as considerable expenditure in hospitals. Inventory management techniques can assist with managing resources efficiently. In Kenyatta National Hospital (KNH), a leading hospital in Kenya, over 30% of expenditure is currently allocated to medicines, and this needs to be optimally managed. Objective: To investigate drug consumption patterns, their costs and morbidity patterns at KNH in recent years. Methodology: Cross-sectional retrospective record review. Inventory control techniques, ABC (Always, Better, and Control), VEN (Vital, Essential, and Non-essential) and ABC-VEN matrix analyses were used to study drug expenditure patterns. Morbidity data was extracted from the Medical Records. Results: Out of an average of 811 medicine types procured annually (ATC 5), 80% were formulary drugs and 20% were non-formulary. Class A medicines constituted 13.2-14.2% of different medicines procured each year but accounted for an average of 80% of total annual drug expenditure. Class B medicines constituted 15.9-17% of all the drugs procured yearly but accounted for 15% of the annual expenditure, whilst Class C medicines constituted 70% of total medicines procured but only 5% of the total expenditure. Vital and Essential medicines consumed the highest percentage of drug expenditure. ABC-VEN categorization showed that an average of 31% of medicine types consumed an average of 85% of total drug expenditure. Therapeutic category and Morbidity patterns analysis showed a mismatch between drug expenditure and morbidity patterns in over 85% of the categories. Conclusion: Class A medicines are few but consume the largest proportion of hospital drug expenditure. Vital and essential items account for the highest drug expenditure, and need to be carefully managed. ABC-VEN categorization identified medicines where major savings could potentially be made helped by Therapeutic category and Morbidity pattern analysis. There was a high percentage of non-formulary items, which needs to be addressed. Inventory control techniques should be applied routinely to optimize medicine use within available budgets especially in low and middle income countries.

Drug promotional activities in Nigeria: impact on the prescribing patterns and practices of medical practitioners and the implications.

OBJECTIVE: Pharmaceutical companies spend significant amount of resources on promotion influencing the prescribing behavior of physicians. Drug promotion can negatively impact on rational prescribing, which may adversely affect the quality of patient care. However, little is known about these activities in Nigeria as the most populous country in Africa. We therefore aimed to explore the nature of encounters between Nigerian physicians and pharmaceutical sales representatives (PSRs), and how these encounters influence prescribing habits. METHODS: Cross-sectional questionnaire-based study conducted among practicing physicians working in tertiary hospitals in four regions of Nigeria. RESULTS: 176 questionnaires were completed. 154 respondents (87.5%) had medicines promoted to them in the previous three months, with most encounters taking place in outpatients' clinics (60.2%), clinical meetings (46%) and new medicine launches (17.6%). Information about potential adverse effects and drug interactions was provided in 41.5%, and 27.3% of cases, respectively. Food, in the form of lunch or dinner, was the most common form of incentive (70.5%) given to physicians during promotional activities. 61% of physicians felt motivated to prescribe the drug promoted to them, with the quality of information provided being the driving factor. Most physicians (64.8%) would agree to some form of regulation of the relationship between medical doctors and the pharmaceutical industry. CONCLUSION: Interaction between PSRs and physicians is a regular occurrence in Nigeria, influencing prescribing practices. Meals and cheap gifts were the most common items offered to physicians during their encounters with PSRs. The need for some form of regulation by professional organizations and the government was expressed by most respondents to address current concerns.

Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets.

Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases, and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growth in both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated to finance new medicines as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimize the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need.

Determinants of utilisation differences for cancer medicines in Belgium, Scotland and Sweden.

BACKGROUND: Little comparative evidence is available on utilisation of cancer medicines in different countries and its determinants. The aim of this study was to develop a statistical model to test the correlation between utilisation and possible determinants in selected European countries. METHODS: A sample of 31 medicines for cancer treatment that obtained EU-wide marketing authorisation between 2000 and 2012 was selected. Annual data on medicines' utilisation covering the in- and out-patient public sectors were obtained from national authorities between 2008 and 2013. Possible determinants of utilisation were extracted from HTA reports and complemented by contacts with key informants. A longitudinal mixed effect model was fitted to test possible determinants of medicines utilisation in Belgium, Scotland and Sweden. RESULTS: In the all-country model, the number of indications reimbursed positively correlated with increased consumption of medicines [one indication 2.6, 95% CI (1.8-3.6); two indications 2.4, 95% CI (1.4-4.3); three indications 4.9, 95% CI (2.2-10.9); all P < 0.01], years since EU-wide marketing authorisation [1.2, 95% CI (1.02-1.4); p < 0.05], price per DDD [0.9, 95% CI (0.998-0.999), P < 0.01], and Prescrire rating [0.5, 95% CI (0.3-0.9), P < 0.05] after adjusting for time and other covariates. CONCLUSIONS: In this study, the most important correlates of increased utilisation in a sample of cancer medicines introduced in the past 15 years were: medicines coverage and time since marketing authorisation. Prices had a negative effect on consumption in Belgium and Sweden. The positive impact of financial MEAs in Scotland suggests that the latter may remove the regressive effect of list prices on consumption.