Department of Gastroenterology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Department of Dermatology, Barts Health NHS Trust, London, UK.
BioDrugs. 2021 Mar;35(2):187-199. doi: 10.1007/s40259-020-00464-5. Epub 2021 Feb 26.
Biologics are now key drugs in the management of immune-mediated inflammatory diseases. However, the increasingly complex biologics environment and growing cost pressures in the UK have led to variability in drug commissioning and inequity of patient access across regions.
Our objectives were to provide consensus recommendations for enhancing the current situation in biologic prescribing in the UK by balancing clinical freedom with equitable distribution of biologics given the limited availability of resources.
A modified Delphi approach was used to reach integrated, cross-specialty consensus among dermatologists, rheumatologists and gastroenterologists practising within the English National Health Service (NHS).
We describe the concepts of clinical freedom and clinical judgement and demonstrate how, together with patient choice, they can be exercised in the context of biologic prescribing in the NHS. We highlight that in England, local variations occur that are at odds with National Institute for Health and Care Excellence (NICE) guidance; these variably limit the degree to which clinicians can exercise clinical freedom and impact on equity of patient access to treatments. We define factors encompassing a drug's value and identify challenges to the measurement and interpretation of this concept, which can raise barriers to the freedom of clinical choice and appropriate prescribing decisions allowing practices of holistic and personalised medicine. Cross-specialty consensus recommendations on ensuring equitable access to biologics in the NHS while protecting appropriate and individualised drug selection for patients are provided. We have also provided strategies for improving physician-commissioner communication to harmonise equity of patient access to biologics across England and improve patient outcomes. Commentary from patient advisory groups indicates that they welcome our exploration that value does not equal cost and agree that there should be an emphasis on shared decision making, which requires the clinician to practice clinical freedom by aligning the patient's needs and preferences with available treatment choices.
This consensus highlights the need to strike a balance between clinical freedom and short-term cost restrictions to support equitable resource distribution within the English NHS. Consideration of these recommendations may help to harmonise local, regional and national services and balance equity of patient access to biologic treatments with excellence in the NHS.
生物制剂现在是治疗免疫介导的炎症性疾病的关键药物。然而，英国日益复杂的生物制剂环境和不断增长的成本压力导致药物的委托使用存在差异，各地的患者获得药物的机会也不平等。
我们的目标是在资源有限的情况下，通过平衡临床自由与生物制剂的公平分配，为改善英国目前的生物制剂处方提供共识建议，以平衡临床自由与生物制剂的公平分配。
采用改良 Delphi 方法，在英国国家医疗服务体系（NHS）内从事皮肤科、风湿病学和胃肠病学工作的皮肤科医生、风湿病学家和胃肠病学家之间达成跨专业共识。
我们描述了临床自由和临床判断的概念，并展示了它们如何与患者选择一起，在 NHS 中的生物制剂处方背景下得到行使。我们强调，在英格兰，存在与国家卫生与临床优化研究所（NICE）指南不一致的地方差异；这些差异不同程度地限制了临床医生行使临床自由的程度，并影响了患者获得治疗的公平性。我们定义了涵盖药物价值的因素，并确定了衡量和解释这一概念的挑战，这可能会阻碍临床选择的自由和适当的处方决策，从而阻碍整体和个性化医疗的实践。提供了在 NHS 中确保生物制剂公平获得的跨专业共识建议，同时保护患者的适当和个体化药物选择。我们还提供了改善医生委托沟通的策略，以协调英格兰各地生物制剂公平获得，并改善患者结局。患者咨询小组的评论表明，他们欢迎我们探索价值不等于成本，并同意应该强调共同决策，这需要临床医生通过将患者的需求和偏好与可用的治疗选择相匹配来行使临床自由。
这项共识强调了在 NHS 中需要在临床自由和短期成本限制之间取得平衡，以支持公平的资源分配。考虑这些建议可能有助于协调当地、地区和国家服务，并平衡 NHS 中生物治疗患者获得的公平性与卓越性。
