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On a near daily basis, medicines make the news. Abstract topics such as international pricing policy or medicines patents, and concrete topics such as medicines shortages are regularly reported on. In this article, we summarise a 40-year-history of medicines policy in the Netherlands. Furthermore, we briefly touch upon future directions in this area.

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This study addresses the productivity of Dutch hospitals since the start of the health systems reform in 2005. We consider DEA based measures, which include efficiency and quality for the complete set of Dutch hospitals and present cross-sectional and longitudinal analysis. In particular, we consider how hospital efficiency has developed. As the reform created an environment of regulated competition, we pay special attention to relative efficiency. Our results suggest that the differences in efficiency among hospitals have become larger. In the years 2009-2010, the number of hospitals identified as (close to) efficient by DEA analysis decreased.

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Health technology assessment already informed Dutch policymaking in the early 1980s. Evidence of health economic evaluations is, however, only systematically used in drug reimbursement decision making. Outpatient drugs with an added therapeutic value and expensive specialist drugs require evidence from an economic evaluation. Due to many exemptions, however, the availability of evidence of health economic evaluations remains rather low. Although the Dutch reimbursement agency suggested a cost-effectiveness threshold range depending on the severity of the disease (i.e., €10,000 - 80,000 per Quality Adjusted Life Year), it was never confirmed nor endorsed by the Ministry of Health. It is highly questionable whether health economic evaluations currently play a role in actual Dutch reimbursement decision making. Although the requirements exist in policy procedures, recent cases show that Dutch policymakers experience great difficulties in putting restrictions on reimbursement based on evidence from health economic evaluations. The near future will show whether the need will increase to base decisions on societal value for money, and whether Dutch policymakers show the courage to take health economic evaluations seriously.

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BACKGROUND: The relatively low budget impact of orphan drugs is often used as an argument in reimbursement decisions. However, overall, the budget impact of orphan drugs can still be substantial. In this study, we assess the uptake and budget impact of orphan drugs in the Netherlands. METHODS: We examined the number of orphan drugs, the number of patients and budget impact of orphan drugs in the Netherlands in the period 2006 to 2012, both for inpatient and outpatient orphan drugs. Budget impact was provided in absolute numbers and relative to total pharmaceutical spending. RESULTS: The number of orphan drugs and patients treated increased substantially over the period studied. Overall, budget impact increased substantially over a period of six years, both in absolute terms (326% increase) as well as relative to total pharmaceutical spending (278% increase). Growth rates decreased over time. In 2012, 17% of available drugs had an individual budget impact of more than €10 million per year. CONCLUSIONS: Individual budget impact of orphan drugs is often limited, although exceptions exist. However, in total, the budget impact of orphan drugs is considerable and has grown substantially over the years. This could potentially influence reimbursement decisions for orphan drugs in the future.

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BACKGROUND: Previous studies of health policies in Iran have not focused exclusively on the drug reimbursement process. OBJECTIVE: The aim of this study was to describe the entire drug reimbursement process and the stakeholders, and discuss issues faced by policymakers. METHODS: Review of documents describing the administrative rules and directives of stakeholders, supplemented by published statistics and interviews with experts and policymakers. RESULTS: Iran has a systematic process for the assessment, appraisal, and judgment of drug reimbursements. The two most important organizations in this process are the Food and Drug Organization, which considers clinical effectiveness, safety, and economic issues, and the Supreme Council of Health Insurance, which considers various criteria, including budget impact and cost-effectiveness. Ultimately, the Iranian Cabinet approves a drug and recommends its use to all health insurance organizations. Reimbursed drugs account for about 53.5% of all available drugs and 77.3% of drug expenditures. Despite its strengths, the system faces various issues, including conflicting stakeholder aims, lengthy decision-making duration, limited access to decision-making details, and rigidity in the assessment process. CONCLUSIONS: The Iranian drug reimbursement system uses decision-making criteria and a structured approach similar to those in other countries. Important shortcomings in the system include out-of-pocket contributions due to lengthy decision making, lack of transparency, and conflicting interests among stakeholders. Iranian policymakers should consider a number of ways to remedy these problems, such as case studies of individual drugs and closer examination of experiences in other countries.

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OBJECTIVE: To investigate the desirability and feasibility of a cyclic reimbursement process to address uncertainty accompanying initial decision making. METHODS: We performed desk research for three expensive outpatient drugs: imatinib, pegfilgrastim, and adalimumab. We analysed the evidence base at the time of decision making (T=0) and May 2011 (T=1). For T=0, public reports of the Dutch reimbursement agency were investigated regarding available clinical and economic evidence, and a systematic review was performed to retrieve additional economic evidence. For T=1, the systematic review was extended till May 2011. RESULTS: The evidence base at T=0 lacked information on clinically relevant outcomes such as mortality, morbidity, and quality of life (5/8 reports), (long-term) adverse events (2/8 reports) and experience in use (1/8 reports). One budget impact analysis and one economic evaluation were available but no pharmacoeconomic dossiers. The systematic review identified 39 cost-utility studies (of 52 economic evaluations) for T=1, characterised by methodological heterogeneity. CONCLUSIONS: Given the considerable uncertainty accompanying initial decision-making, a more cyclic reimbursement process seems feasible to reduce uncertainty regarding the therapeutical and economical value of expensive drugs. A mandatory evidence development requirement seems desirable to sufficiently meet decision makers' needs.

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OBJECTIVE: To investigate the practical feasibility to develop evidence on drug use and cost-effectiveness in oncology practice. PATIENTS AND METHODS: Feasibility was examined using three Dutch case studies. Each case study investigated the degree of appropriate drug use and its incremental cost-effectiveness. Detailed data were retrospectively collected from hospital records. In total, 391, 316 and 139 patients with stage III colon cancer, metastatic colorectal cancer and multiple myeloma were included in 19, 29 and 42 hospitals, respectively. RESULTS: The methods used in the case studies were feasible to develop evidence on some aspects of drug use including types of treatments used, dosages, dose modifications and healthcare costs. Aspects such as baseline patient characteristics, reasons to start or stop a treatment and treatment effects were less feasible because of missing values. Despite difficulties to correct for confounding by indication, it was possible to estimate incremental cost-effectiveness by synthesising evidence in two of the three case studies. CONCLUSION: It is possible to generate evidence about drug use and cost-effectiveness in oncology practice to facilitate informed decision-making by both payers and physicians. This can improve quality of care and enhance the efficient allocation of resources. However, the optimal approach differs between drugs and their indications. Generating high-quality evidence requires active interdisciplinary collaboration. Patient registries can facilitate data collection but cannot resolve all issues. In most circumstances it is inevitable to use data-synthesis to obtain valid incremental cost-effectiveness estimates, but for some indications it will not be feasible to derive a valid and precise estimate.

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When a new medical technology, for example a new drug, is introduced onto the market there should be a discussion of the balance between "uncertainty versus value to society and demand". The new technology is sometimes given the benefit of the doubt due to a lack of information. Follow-up investigation is actually essential but is seldom mandatory and hardly ever spontaneously initiated. Specific measures, based on stimulation or penalization, could reduce the degree of uncertainty concerning the efficacy, safety and efficiency of a new technology. A serious option when a new drug produces disappointing results is to pay the manufacturer less.

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In 2006, over three million new cases of cancer were diagnosed in Europe. This number will increase in the coming years as a result of an aging population and population growth. Advances in the diagnosis and treatment of cancer have resulted in increased survival rates. Simultaneously, increasing costs of screening, diagnosis and the treatment of cancer could threaten the ability to ensure high-quality care and provide access to care for all patients. New genetic tests and biomarkers may help to identify those subtypes of patients that would be most likely to benefit from new cancer drugs. In our opinion, there is still much to gain in cancer diagnosis and treatment but these gains should be worth the costs.

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The expenditures for hospital drugs are continuously increasing, and grow much faster than the global hospital budgets do. This explosive growth is caused mainly by a few so-called 'expensive drugs' of which the oncolytics form the main part. The global budgets should stimulate more effective provision of care ('technical efficiency'), however the room for technical efficiency is decreasing. Hospitals thus have to make impossible choices, so that eventually equal access can no longer be guaranteed. If no other policies are applied, health care goals will no longer be met. This paper tries to map the contours of the current problem and its possible solutions. It is time governments take up their responsibility and take back control.

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