With a systematic review of reasons, we identified 39 reasons represented in 243 articles (scientific and grey literature) for and against special status for the reimbursement of OMPs, then categorized them into nine topics. Results4 Reason 93 Self-evident truths of reason 94 The classical view of the truths of reason 96 The empiricist view of the truths of reason 105 The conventionalist view of the truths of reason 110 Some difficulties and strengths of the classical view 114 Reason,experience,and a priori justification 119 5 Testimony 131 The nature of testimony:formal. This study aims to provide a systematic analysis of moral reasons for and against such a special status for the reimbursement of OMPs in publicly funded healthcare systems from a multidisciplinary perspective.
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Despite the higher occurrence of reasons and articles in favour of a special status, there is no clear-cut solution for this ethical challenge. Just for sake of argument, I did try to download a torrent to see of the.Results suggest that OMP reimbursement issues should be assessed and analysed from a multidisciplinary perspective. Conclusion(No, Ive never been with a hooker, but for some reason, torrents make me feel. More articles took the position for a special status of OMPs (n = 97) than those against it (n = 31) and there was a larger number of reasons identified in favour (29 reasons) than against (10 reasons) this special status.
According to the European Commission Regulation , an orphan designation pertains exclusively to OMPs that are “intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the Community” (Article 2.1) or that fulfill the condition that “without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necesary investment” (Article 2.2). The definition of OMPs slightly varies between regulations. Target population, cost-effectiveness, level of evidence or mechanism of action could be meaningfully addressed and implemented in Health Technology Assessments.Orphan medicinal products (OMPs) are highly specialized treatments for very small groups of patients. Thus, the scientific debate should focus less on the question of disease prevalence but rather on how the important variability of different OMPs concerning e.g.
The incentives vary between jurisdictions but often include market exclusivity, tax exemptions, research funding, and free-of-charge research advice. The European Union has followed this attempt with the Orphan Regulation in 1999 (Reg. Because developing drugs for rare diseases had not been lucrative for the pharmaceutical industry, the United States started incentivizing research and development of OMPs with the Orphan Drug Act in 1983.
Drugs are approved for marketing and orphan designation by medical agencies (such as the Federal Drug Administration in the United States and the European Medical Agency in the European Union) based on their efficacy and safety. Still, a US-based empirical study did not find targeted therapies to mainly cause the increase in OMP approvals. However, not all approved OMPs are targeted towards rare diseases: In light of the ongoing research progress in precision medicine, targeted therapies for common diseases might also fall into the definition of orphan drug regulations. Since the implementation of these incentive programs, the number of approved OMPs has been growing exponentially.
Still, the drug has been considered cost-effective with this price tag compared to alternatives if administered early and has been approved for reimbursement in various countries. Recently approved curative OMPs have well exceeded previous pricing standards: onasemnogene abeparvovec, for instance, a gene replacement therapy attempting to cure Spinal Muscular Atrophy with a one-time treatment, costs more than 2 million US$. As prices are often high and negatively correlate with disease prevalence , OMPs are often not cost-effective. This process may include a Health Technology Assessment (HTA), which assesses the value of medical products as supported by clinical evidence and cost-effectiveness analyses.OMPs share the characteristic of aiming to treat small populations with targeted therapies, which leads to higher costs and difficulties in obtaining clinical evidence.
Second, egalitarians represent the cause that everyone is treated equally, but some theorists acknowledge that certain compensation might be required for the disadvantaged to achieve equality. First, utilitarianism intends to maximise overall population-wide well-being and is traditionally a guiding principle for health policy the element of cost-effectiveness in the traditional reimbursement decision criteria is based on this utilitarian principle. Not reimbursing any orphan drugs, however, is equally problematic given the immense need of patients who depend on them.Theories of distributive justice provide some guidance in the ethical challenge of healthcare resource allocation. Special status, in this context, is defined as the application of differential criteria in reimbursement decision-making for OMPs compared to non-OMPs.Because of the growing number of expensive OMPs, their reimbursement through public health insurances is increasingly manifesting itself as a moral dilemma for decision-makers: Basing OMP reimbursement on rules of exception is becoming unsustainable, as financing many expensive OMPs within a publicly funded healthcare system inevitably leads to cuts in other healthcare areas.
They call for policies that emphasize the needs and interests of communities over the interests and needs of individuals. Fourth, communitarians contrast from libertarian positions with their emphasis on community interests. Therefore, supporting the disadvantaged is only recognized when based on voluntary actions of individuals.
The following research questions are addressed: RQ1—What reasons in favour or against the special status for reimbursing OMPs are discussed in the scientific and grey literature? RQ2—What reasons are dominating the scientific discourse? RQ3—What disciplines contribute to this debate and how heterogeneous is the field? RQ4—To what countries and regions worldwide does this debate refer to?A systematic review of reasons was the methodological basis for this study. To our knowledge, there is not yet a systematic review of the ethical considerations regarding OMP reimbursement available to date. In light of the increasing number of high-priced OMP approvals and the unsolved ethical challenges concerning their reimbursement in publicly funded healthcare systems, this study aims to provide a systematic analysis of moral reasons for and against special status for the reimbursement of OMPs in publicly funded healthcare systems from an interdisciplinary perspective. Moreover, because OMP reimbursement points to an ethical challenge without any clear-cut solution, many authors call for public debates to discuss its challenges and subsequent strategies that are legitimated via deliberative democratic processes. It is thought to be a rule of exception and has been implemented in the Australian OMP reimbursement policy.
Search strategyScientific databases were systematically searched for relevant articles. Moral reasons were defined as arguments about what decision, from a moral perspective, ought to be the right one. It aims to synthesize them rather than to assess their adequacy and quality.
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