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There is no consensus on which methods to use to estimate an opportunity cost threshold for the efficient allocation of resources. Researchers have attempted to estimate an evidence-based threshold value, but only a few approaches have been considered and any estimate is currently used by policy makers. This study aims at exploring three assumptions normally applied in the threshold estimation: (i) approaches assume that there is always a displacement involving a loss of health; however, empirical studies suggest that one of the first responses of local health care purchasers is to squeeze greater efficiency out of providers; (ii) to be sure about the appropriate threshold it is necessary to know which health services purchasers are giving up to introduce a new treatment; current estimates bypass this lack of information by averaging the effects of changes in expenditure by clinical area; (iii) recent methodologies consider a single health outcome: mortality; however, health outcomes of many clinical areas may not be well reflected in mortality.
We propose data envelopment analysis (DEA) as a methodology that can help to address these issues by considering efficiency to measure opportunity cost per Primary Health Trust (PCT) in England and by including several outcomes in addition to mortality. This is the first time that DEA is tested in this context.
Results suggest that the majority of health locations have the possibility of decreasing their expenditures between 1 percent and 15 percent without affecting outcomes.
Estimation of the threshold should allow for observation of the actual level of inefficiencies as well as an ability to consider the previous capacity of health locations to respond to changes in expenditures. Moreover, it is crucial to select the appropriate set of health outcomes, such that they reflect health system priorities, otherwise, we would be estimating a threshold that does not reflect likely displacement.
Under the Orphan Regulation, the European Medicines Agency (EMA) intended to incentivize the research and development of new treatments for rare and life-threatening conditions. Marketing authorisation of orphan medicinal products (OMPs) by the EMA is only the first step, as medicines are made available to patients when reimbursement or Health Technology Assessment (HTA) decisions are implemented by national health systems. We analyzed the availability and access to OMPs in the United Kingdom (UK), France, Germany, Italy and Spain. We compared the availability, which is the possibility to prescribe a given OMP, to the access, which refers to the full or partial reimbursement by the public health service.
We collected data on launches, HTA decisions, any centralized commissioning and/or reimbursement decision for all the OMPs authorised since 2000 in the UK countries (England, Scotland and Wales), France, Germany, Italy and Spain.
Since the Orphan Regulation inception, the EMA granted marketing authorization to 143 OMPs. These OMPs are most widely accessible in Germany and France. Reimbursement in Germany is immediate after authorization. France and Italy present a delay of 19 months from authorization to reimbursement, which is shorter than in other countries. In England, less than 50 percent of centrally authorised OMPs are routinely funded by the National Health Service (NHS), including one-third of these recommended by the National Institute for Health and Care Excellence (NICE), and those reimbursed via commissioning policies and the Cancer Drugs Fund.
The assessment of degree of access to OMPs across Europe is limited by differences in the national HTA and reimbursement systems and the heterogeneous information made publicly available on their decisions. Nonetheless, our study suggests that the primary purpose to grant equal availability to OMPs to the patients in the Eropean Union via the implementation of the orphan regulation was partially achieved with important variations of access observed across the countries included in our study.
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