REVIEW Ethical dilemmas associated with the introduction of biologic treatments in chronic rhinosinusitis with nasal polyps* Abstract This review considers ethical dilemmas which may present when introducing the use of biologic treatments alongside existing treatments in the management of chronic rhinosinusitis with nasal polyps. Biologic therapies ofer hope to patients with diseases recalcitrant to conventional therapies but are often signifcantly more expensive. Reducing the need for surgery may act as a disincentive for use within surgical specialities, while reimbursement for administration has the potential to encourage inappro- priate use. Any treatment should be used considering the principles of benefcence (ofering the most efective treatment to the patient) and non-malefcence (minimising the risk of harm); the challenges of comparing the diferent available treatment options are considered. Patient autonomy should be involved a process of shared decision making, but when a third-party payor is involved they may seek to place restrictions on access to treatments that limit the choice of both patient and physician. Such decisions are often based on the cost-efectiveness of novel treatments relative to standard of care; published models suggest that at current market prices, biologics are less cost-efective in all groups that standard care. Social justice (fair distribution of limited healthcare resour- ces) therefore may mandate rationing of access. To this end, working as part of professional organisations or research groups, physicians often produce guidelines that help to identify those in greatest need of novel treatments. The challenges in creating and applying these guidelines are also considered. Key words: biologics, chronic rhinosinusitis, ethics, guidelines, treatment Claire Hopkins ENT Department, Guy’s Hospital, London, United Kingdom Rhinology 60: 3, 162 - 168, 2022 https://doi.org/10.4193/Rhin21.477 *Received for publication: December 23, 2021 Accepted: January 16, 2022 162 Introduction The introduction of novel treatments provides an opportunity to treat those in whom there were previous no efective therapies, or to improve outcomes or reduce the risk of adverse events associated with pre-existing treatments. However, at the same time there is a risk that indications for treatment may be exten- ded such that treatment is ofered to those who are unable to derive signifcant beneft, that novel treatments may be ofered by healthcare practitioners less familiar with the disease or who are unable to ofer all therapeutic options. There are also risks that adoption of novel procedures may be fnancially motivated; a recent systematic review has shown a clear dose response re- lationship between prescribing and fnancial payments from the pharmaceutical industry (1) and there is evidence that industry relationships are associated with the adoption of use of balloon sinuplasty (2) . Conversely, loss of revenue may discourage use of non-surgical interventions that may reduce the requirement for surgery, particularly for conditions such as chronic rhinosinusi- tis with nasal polyps (CRSwNP) that are associated with a high revision rate (3) . It is therefore important to consider where such dilemmas may arise in the introduction of biologics and other novel treatments in the management of CRSwNP when develo- ping guidelines to aid decision making. The need to beneft patients (benefcence) while avoiding harm (non-malefcence), respecting patient choice (autonomy) and achieving fair, equitable treatment of limited health-care resources (justice) are the four principles that underpin ethical