Abbreviations
- CRD
chronic respiratory diseases
- CRSwNP
chronic rhinosinusitis with nasal polyps
- ESS
endoscopic sinus surgery
Chronic respiratory diseases (CRDs), including chronic rhinosinusitis with nasal polyps (CRSwNP), affect approximately one‐third of the global population and represent a major source of long‐term morbidity and health expenditure. CRSwNP alone is responsible for an estimated €64 billion annually in Europe, underscoring the scale of its burden on patients and health systems alike [1]. Despite this impact, only 0.1% of the EU4Health budget (2021–2027) is allocated to CRDs [1], highlighting a stark mismatch between disease burden and policy priority. Delayed diagnosis, lack of access to care, limited reimbursement for advanced therapies, and poor coordination between specialties remain pervasive. Addressing these shortcomings demands not only clinical innovation but also honest appraisals of cost‐effectiveness and health equity.
CRSwNP is a complex inflammatory condition associated with high symptom burden, substantial healthcare utilization, and persistent disease recurrence. In recent years, the introduction of targeted biologic therapies has expanded the therapeutic armamentarium, offering novel avenues for disease control. Nonetheless, comparative cost‐effectiveness analyses have consistently favored endoscopic sinus surgery (ESS) over biologics [2, 3]. While these conclusions hold validity in certain contexts, they are often derived from studies conducted in tertiary academic centers with access to high‐volume, expert sinonasal surgeons. This creates a potentially misleading benchmark that fails to represent the variability in global clinical practice and the reality for most patients.
High‐quality ESS, as demonstrated in randomized controlled trials and long‐term observational studies, provides sustained symptom relief and improved quality of life in appropriately selected patients with CRSwNP [4]. However, these outcomes are closely linked to surgical expertise, patient selection, and perioperative care. Cost‐effectiveness models built on data from such ideal conditions risk overestimating the global efficiency of surgery as a treatment modality. In practice, many patients are treated in settings with dissimilar conditions. Consequently, real‐world outcomes may diverge significantly from those published in the literature. This disconnect must be acknowledged in health‐policy discourse and cost–benefit evaluations.
Moreover, the current debate often omits the fact that biologics offer standardized, reproducible mechanisms of action not as dependent on procedural skill [4]. Furthermore, the current debate often overlooks the fact that biologics offer standardized and reproducible mechanisms of action that are less dependent on procedural skill [4]. Additionally, the current debate often overlooks the fact that biologics provide standardized, reproducible mechanisms of action that are less dependent on procedural skill [4, 5]. However, not all biologic care is equal. Even when formulations and dosages are identical, disparities in healthcare access, insurance coverage and patient support services can affect patients' ability to obtain, store and administer biologics consistently and correctly. Socioeconomic status, digital literacy and health system infrastructure can markedly affect treatment adherence. For example, self‐injection biologics require education and compliance monitoring, both of which are not equally available across populations [6, 7]. Thus, medication compliance varies significantly across regions and demographic groups, thereby influencing real‐world effectiveness.
In addition, the assumption that biosimilars inherently reduce costs without affecting outcomes must be critically examined. While biosimilars have demonstrated comparable efficacy and cost‐savings in rheumatological and gastroenterological diseases [6, 7], this may not automatically translate to otolaryngological indications. For instance, treatment with biosimilars for rheumatoid arthritis has generally not altered the need for surgical interventions such as joint replacements [6, 7]. A similar dynamic may occur in chronic rhinosinusitis with nasal polyposis (CRSwNP): biologics—whether originator or biosimilar—may still delay but not entirely eliminate the need for surgery in refractory cases. Equivalence in molecular structure does not always equate to equivalence in patient outcomes when environmental and health system variables are considered. Therefore, caution must be exercised when extrapolating the cost–benefit of biosimilars across distinct diseases without longitudinal, indication‐specific data.
For patients with comorbid asthma, aspirin‐exacerbated respiratory disease, or contraindications to surgery, biologics can provide targeted immunologic control with relatively predictable safety profiles [5, 8]. The current high cost of biologics undeniably limits access and tips economic models in favor of surgery. Yet this reality is evolving. The anticipated introduction of biosimilars may significantly reduce costs, reshaping the therapeutic landscape. By instance, in rheumatoid arthritis and inflammatory bowel disease biosimilars have already achieved significant cost reductions, increasing patient access and shifting treatment patterns [6, 7]. Similar trends in otolaryngology are plausible and would necessitate a reassessment of long‐term cost‐effectiveness models in CRSwNP.
Furthermore, the value of early intervention must be reconsidered through the lens of health economics. Delayed diagnosis and protracted treatment algorithms impose cumulative direct and indirect costs—loss of productivity, repeated antibiotic courses, emergency visits, absenteeism, and decreased quality of life. The longer inflammation persists unchecked, the greater the likelihood of irreversible mucosal remodeling, reduced response to therapy, and progression to systemic disease, particularly in patients with type 2 inflammation [5, 8]. Studies have shown that delays in initiating effective therapy are associated with worse symptom trajectories and increased societal costs. In this context, both biologics and surgery must be viewed not merely as treatment endpoints but as strategic interventions in a time‐sensitive disease process.
Prevention, timely recognition, and individualized treatment are more cost‐effective than iterative, fragmented care. Clinicians, payers, and policy makers must jointly recognize that the efficiency of any treatment cannot be uncoupled from the infrastructure and context in which it is delivered. While ESS remains an essential and often cost‐effective component of CRSwNP management [4], its comparative advantage should not be generalized from high‐performing centers to under‐resourced settings. Similarly, the current cost of biologics, while a barrier, is not immutable. A dynamic pricing landscape, coupled with real‐world outcome data, should guide the development of future treatment algorithms that are both clinically equitable and economically sustainable.
Ultimately, equitable care for patients with CRSwNP requires an honest appraisal of systemic limitations. The comparison of biologics and surgery must evolve beyond theoretical models and reflect the nuanced realities of global healthcare delivery. Future studies should incorporate multicenter, international data that capture the full spectrum of care environments. Until then, caution should be exercised in drawing conclusions from economically favorable, yet structurally exceptional, surgical data.
Author Contributions
All authors have made substantial contributions to the conception and design of the work, contributed to the interpretation of data, drafted the work, and revised it substantially. They have also approved the version submitted and have agreed both to take personal responsibility for their own contributions and to ensure that questions concerning the accuracy or integrity of any part of the work are appropriately investigated, resolved, and the resolution documented in the literature.
Ethics Statement
The authors have nothing to report.
Conflicts of Interest
Diego M. Conti: Serves as Academic Manager at the European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA) and as Review Editor at Frontiers in Allergy, Rhinology Section. The remaining authors declare no conflicts of interest.
Acknowledgments
The authors have nothing to report.
Data Availability Statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
