Biologicals and Endoscopic Sinus Surgery for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps: An Economic Perspective

Abstract

Chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) is a chronic disease with a high prevalence and high disease burden, and the lack of a cure. The socioeconomic burden of the disease is substantial and has been disproportionally increasing over past decades. Treatment is aimed at attaining disease control. Traditionally, topical corticosteroids, endoscopic sinus surgery, and oral corticosteroids are used to treat CRSwNP. The advent of biologics has revolutionized CRSwNP treatment, but these drugs are expensive. From an economic standpoint, it is worth debating whether biologics should be employed in patients with severe uncontrolled CRSwNP who fail to attain disease control with current therapies. This clinical commentary review provides an overview of the socioeconomic burden of chronic rhinosinusitis and treatment modalities, compares endoscopic sinus surgery versus biologics for severe CRSwNP, discusses management recommendations, and highlights future needs in this field. New ways to reduce costs of biologic treatments need to be explored to attain cost-effectiveness and provide patients who have severe CRSwNP with adequate treatment. Chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) is a chronic disease with a high prevalence and high disease burden, and the lack of a cure. The socioeconomic burden of the disease is substantial and has been disproportionally increasing over past decades. Treatment is aimed at attaining disease control. Traditionally, topical corticosteroids, endoscopic sinus surgery, and oral corticosteroids are used to treat CRSwNP. The advent of biologics has revolutionized CRSwNP treatment, but these drugs are expensive. From an economic standpoint, it is worth debating whether biologics should be employed in patients with severe uncontrolled CRSwNP who fail to attain disease control with current therapies. This clinical commentary review provides an overview of the socioeconomic burden of chronic rhinosinusitis and treatment modalities, compares endoscopic sinus surgery versus biologics for severe CRSwNP, discusses management recommendations, and highlights future needs in this field. New ways to reduce costs of biologic treatments need to be explored to attain cost-effectiveness and provide patients who have severe CRSwNP with adequate treatment. IntroductionChronic rhinosinusitis (CRS) is a chronic disease of the nose and paranasal sinuses affecting 4% to 11% of the population.1Fokkens W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. Reitsma S. et al.European Position Paper on Rhinosinusitis and Nasal Polyps 2020.Rhinology. 2020; 58: 1-464Google Scholar The diagnostic construct of CRS requires the presence of symptoms lasting at least 12 weeks (nasal obstruction and/or rhinorrhea, combined with a loss of smell, facial pain or pressure, or both) and observable abnormalities such as edema, pus, or nasal polyps (nasal endoscopy) or sinus opacification (imaging). By definition, this means that CRS is an umbrella term covering a wide range of pathologies. In past decades, CRS was divided based on the presence of nasal polyps, giving either CRS with nasal polyps (CRSwNP) or CRS without nasal polyps.In the latest update of the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS2020) a classification system is proposed based on a few characteristics: primary versus secondary, localized or unilateral versus diffuse or bilateral, and endotype dominance. In most western societies, CRSwNP is classified as primary, diffuse type 2 CRS, because the underlying mechanism reveals type 2 inflammation (high levels of eosinophils, IL-4, IL-5, and IL-13, and IgE). The absence of these biomarkers (non-type 2 CRS) usually predicts relatively favorable outcomes compared with type 2 CRS. Clinical characteristics of primary diffuse-type 2 CRS include a high prevalence of olfactory dysfunction, good but short-lived responses to oral corticosteroids (OCS), and the presence of comorbidities such as asthma, aspirin or nonsteroidal anti-inflammatory drug–exacerbated respiratory disease (AERD/N-ERD), and eosinophilic otitis media.1Fokkens W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. Reitsma S. et al.European Position Paper on Rhinosinusitis and Nasal Polyps 2020.Rhinology. 2020; 58: 1-464Google Scholar,2Kowalski M.L. Agache I. Bavbek S. Bakirtas A. Blanca M. Bochenek G. et al.Diagnosis and management of NSAID-exacerbated respiratory disease (N-ERD)-a EAACI position paper.Allergy. 2019; 74: 28-39Crossref PubMed Scopus (173) Google Scholar There is currently no cure for CRS. As such, treatment is aimed at attaining disease control.This clinical commentary review focuses on the economic perspective of the treatment of severe, uncontrolled CRSwNP (ie, severe primary, diffuse type 2 CRS) by either surgery or biologicals. The impact of the disease on patients and on society are described, as well as current treatment options. Then, the health economics of disease and treatments are discussed, resulting in management recommendations and identification of future needs.Treatment Modalities in CRSIn patients with CRS, the barrier function of the nasal mucosa is compromised. An inflammatory response is elicited, which for unknown reasons has a self-perpetuating tendency. Diseased mucosa will give rise to tissue remodeling, such as the formation of nasal polyps. Current treatment for CRS aims to reduce this inflammation and support mucosal barrier function. The cornerstone treatment is the local application of nasal corticosteroids as a spray, drops, or rinse, or via other delivery devices.1Fokkens W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. Reitsma S. et al.European Position Paper on Rhinosinusitis and Nasal Polyps 2020.Rhinology. 2020; 58: 1-464Google Scholar However, the presence of bulky nasal polyps can limit the exposure of the nasal mucosa to these drugs and impair treatment efficacy. This is why after an unsuccessful trial of nasal corticosteroids, endoscopic sinus surgery (ESS) is often employed. In this way, a chief aim of ESS is to remove diseased mucosa, nasal polyps, and bony septations to open the paranasal sinuses functionally so that topical treatment is able to reach the sinus mucosa after surgery.Other, nonsurgical treatment options are the use of courses of OCS or long-term courses of antibiotics (eg, macrolides). The former is limited by potentially damaging adverse effects, especially when long-term tapered courses are needed to attain disease control.3Hox V. Lourijsen E. Jordens A. Aasbjerg K. Agache I. Alobid I. et al.Benefits and harm of systemic steroids for short- and long-term use in rhinitis and rhinosinusitis: an EAACI position paper.Clin Transl Allergy. 2020; 10: 1Crossref PubMed Scopus (67) Google Scholar The added value of the latter seems limited, especially in type 2 CRS.1Fokkens W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. Reitsma S. et al.European Position Paper on Rhinosinusitis and Nasal Polyps 2020.Rhinology. 2020; 58: 1-464Google ScholarNone of these treatment strategies provides a cure. The best they can provide is a certain level of disease control. The concept of disease control is based on the burden of disease (problems, impact on quality of life [QoL]) weighed against the risk [need for potentially harmful treatments] and the amount of effort (time, medication, and costs) that it takes to attain that level of control. There are various definitions for control of CRS, each with its own merits and disadvantages.1Fokkens W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. Reitsma S. et al.European Position Paper on Rhinosinusitis and Nasal Polyps 2020.Rhinology. 2020; 58: 1-464Google Scholar,4Bachert C. Han J.K. Wagenmann M. Hosemann W. Lee S.E. Backer V. et al.EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: definitions and management.J Allergy Clin Immunol. 2021; 147: 29-36Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar Still, there is consensus that uncontrolled CRS is defined by the presence of bothersome symptoms despite repetitive ESS, OCS, or both. The European Position Paper on Rhinosinusitis and Nasal Polyps guidelines introduced a standardized approach to CRS disease control in 2012, which was refined in the 2020 edition (Figure 1).A number of traits and comorbidities are associated with poor outcomes of CRS treatment and should be targeted by treating physicians whenever possible. These include exposure to smoke and occupational irritants,5Dietz de Loos D.A.E. Ronsmans S. Cornet M.E. Hellings P.W. Hox V. Fokkens W.J. et al.Occupational exposure influences control of disease in patients with chronic rhinosinusitis.Rhinology. 2021; 59: 380-386Crossref PubMed Scopus (5) Google Scholar and especially in primary diffuse type 2 CRS, the presence of late-onset asthma and AERD/N-ERD. Treatment options in AERD/N-ERD patients include aspirin therapy after desensitization and antileukotrienes (mainly for asthma),2Kowalski M.L. Agache I. Bavbek S. Bakirtas A. Blanca M. Bochenek G. et al.Diagnosis and management of NSAID-exacerbated respiratory disease (N-ERD)-a EAACI position paper.Allergy. 2019; 74: 28-39Crossref PubMed Scopus (173) Google Scholar,6van der Lans Fokkens W.J. Reitsma S. options for chronic rhinosinusitis in Allergy. 2021; Google A. et consensus on and rhinosinusitis Allergy 2021; PubMed Scopus Google E. et of aspirin desensitization by oral aspirin therapy in patients with respiratory a the Rhinosinusitis and Allergy of the of Allergy Clin Immunol. 2021; 147: Full Text Full Text PDF PubMed Scopus Google of aspirin desensitization and aspirin therapy in respiratory Allergy Clin Immunol. 2021; Full Text Full Text PDF PubMed Scopus Google Scholar but despite CRS in AERD/N-ERD is often This patients and physicians often need to for of ESS or Hopkins C. The burden of anti-inflammatory respiratory disease the perspective a of the 2020; 58: Google is as a treatment in the of has for CRS. 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Aasbjerg K. Agache I. Alobid I. et al.Benefits and harm of systemic steroids for short- and long-term use in rhinitis and rhinosinusitis: an EAACI position paper.Clin Transl Allergy. 2020; 10: 1Crossref PubMed Scopus (67) Google C. Han J.K. M. Hellings P.W. Lee S.E. et and of in patients with severe chronic rhinosinusitis with nasal polyps and 2019; Full Text Full Text PDF PubMed Scopus Google M. A. S. systemic corticosteroids in the and 2020; PubMed Scopus Google Scholar and for patients with asthma, the in of asthma and In it to that patients in the biologic treatment to treatment or the the costs of biologic treatment to be to of patients with CRSwNP are to be at risk for disease after and for of surgery, with asthma and with C. Lund V. surgery treatment in chronic rhinosinusitis with nasal 2021; 59: Google S. et surgery in chronic rhinosinusitis with nasal of risk Allergy 2020; 10: PubMed Scopus Google Scholar In such current of will and biologics et M. E. 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Backer V. et al.EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: definitions and management.J Allergy Clin Immunol. 2021; 147: 29-36Abstract Full Text Full Text PDF PubMed Scopus (69) Google C. S. S. et on the use of for chronic rhinosinusitis with nasal 2021; Scopus Google et for use of biologics in management of chronic rhinosinusitis with nasal a of Allergy 2020; 10: PubMed Scopus Google Scholar There is that the in asthma and the of a a approach to severe uncontrolled CRSwNP patients in treatment are is to and with a and/or is especially because asthma and CRSwNP a of uncontrolled disease on the of symptoms and of disease despite treatment, whether it is surgery or systemic corticosteroids, there is whether surgery is an W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. Reitsma S. et al.European Position Paper on Rhinosinusitis and Nasal Polyps 2020.Rhinology. 2020; 58: 1-464Google Scholar,4Bachert C. Han J.K. Wagenmann M. Hosemann W. Lee S.E. Backer V. et al.EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: definitions and management.J Allergy Clin Immunol. 2021; 147: 29-36Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar (Figure can be by nasal or and/or for symptoms as nasal and as well as of a 2 and 2 inflammation is for currently biologics to be so the presence of asthma and/or AERD/N-ERD is an in to systemic such as and An of sinus inflammation on can be an C. S. S. et on the use of for chronic rhinosinusitis with nasal 2021; Scopus Google for biologic treatment for chronic rhinosinusitis with nasal polyps to the European Position Paper on Rhinosinusitis and Nasal with Fokkens et W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. 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Backer V. et al.EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: definitions and management.J Allergy Clin Immunol. 2021; 147: 29-36Abstract Full Text Full Text PDF PubMed Scopus (69) Google need to patients who these drugs is in of the a on a biologic is of the for is proposed on the of the and in the can be at each with in or of a to in and European for and in Allergy and However, the response on a to a response for patients without associated comorbidities such as (Figure In either to to and of surgery or The guidelines whether the is of an level to the because this for biologic treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) to the European Position Paper on Rhinosinusitis and Nasal with Fokkens et W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. 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Reitsma S. high of for chronic rhinosinusitis with nasal Scopus Google Scholar to the and the use of biologic therapy should be and that in will be to be as for most this was in a in which was 2 weeks to weeks over 12 This costs by at least a of R. Fokkens W.J. G. Reitsma S. high of for chronic rhinosinusitis with nasal Scopus Google Scholar approach that have is the use of biologics as medication, in the as a of no have been on the clinical or cost-effectiveness of such an The is for the combined use of surgery and this to after surgery, biologic As such, the of the former be the costs of the latter be In ESS with at least a is can this surgery is and with the of R. Fokkens W.J. G. Reitsma S. high of for chronic rhinosinusitis with nasal Scopus Google traits such as asthma and especially AERD/N-ERD for biologic treatment, because options for AERD/N-ERD in long-term disease der Lans Fokkens W.J. Reitsma S. options for chronic rhinosinusitis in Allergy. 2021; Google Scholar the underlying type 2 CRS will to the of biomarkers that can treatment outcomes for ESS and chronic rhinosinusitis by 2021; 59: Scholar This for either as a treatment have been to disease control in a severe type 2 CRS in a by and future application and in CRS treatment strategies on is to include and costs in because have on associated comorbidities such as asthma and AERD/N-ERD. on the limited biologic treatment in CRSwNP is in its current application and costs to New should be aimed at a of ESS with the cost-effectiveness of ESS and biologics in of treatment and ways to reduce the costs of This will in an in the cost-effectiveness for especially for severe, uncontrolled CRS. IntroductionChronic rhinosinusitis (CRS) is a chronic disease of the nose and paranasal sinuses affecting 4% to 11% of the population.1Fokkens W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. Reitsma S. et al.European Position Paper on Rhinosinusitis and Nasal Polyps 2020.Rhinology. 2020; 58: 1-464Google Scholar The diagnostic construct of CRS requires the presence of symptoms lasting at least 12 weeks (nasal obstruction and/or rhinorrhea, combined with a loss of smell, facial pain or pressure, or both) and observable abnormalities such as edema, pus, or nasal polyps (nasal endoscopy) or sinus opacification (imaging). By definition, this means that CRS is an umbrella term covering a wide range of pathologies. In past decades, CRS was divided based on the presence of nasal polyps, giving either CRS with nasal polyps (CRSwNP) or CRS without nasal polyps.In the latest update of the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS2020) a classification system is proposed based on a few characteristics: primary versus secondary, localized or unilateral versus diffuse or bilateral, and endotype dominance. In most western societies, CRSwNP is classified as primary, diffuse type 2 CRS, because the underlying mechanism reveals type 2 inflammation (high levels of eosinophils, IL-4, IL-5, and IL-13, and IgE). The absence of these biomarkers (non-type 2 CRS) usually predicts relatively favorable outcomes compared with type 2 CRS. Clinical characteristics of primary diffuse-type 2 CRS include a high prevalence of olfactory dysfunction, good but short-lived responses to oral corticosteroids (OCS), and the presence of comorbidities such as asthma, aspirin or nonsteroidal anti-inflammatory drug–exacerbated respiratory disease (AERD/N-ERD), and eosinophilic otitis media.1Fokkens W.J. Lund V.J. Hopkins C. Hellings P.W. Kern R. Reitsma S. et al.European Position Paper on Rhinosinusitis and Nasal Polyps 2020.Rhinology. 2020; 58: 1-464Google Scholar,2Kowalski M.L. Agache I. Bavbek S. Bakirtas A. Blanca M. Bochenek G. et al.Diagnosis and management of NSAID-exacerbated respiratory disease (N-ERD)-a EAACI position paper.Allergy. 2019; 74: 28-39Crossref PubMed Scopus (173) Google Scholar There is currently no cure for CRS. As such, treatment is aimed at attaining disease control.This clinical commentary review focuses on the economic perspective of the treatment of severe, uncontrolled CRSwNP (ie, severe primary, diffuse type 2 CRS) by either surgery or biologicals. The impact of the disease on patients and on society are described, as well as current treatment options. Then, the health economics of disease and treatments are discussed, resulting in management recommendations and identification of future

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