A Critical Look at the Efficacy and Costs of Biologic Therapy for Chronic Rhinosinusitis with Nasal Polyposis.

PURPOSE OF REVIEW: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a highly prevalent disease that results in significant healthcare-related costs as well as costs to society with lost productivity and time. Unfortunately, a significant percentage of patients who suffer with this disease will not find relief from current standard of care medications and surgery. With ongoing efforts to understand the pathophysiology of CRSwNP has come the introduction of monoclonal antibodies, or "biologics," targeting specific elements of the inflammatory pathway in CRSwNP. Despite efficacy, these come at significant cost and, to date, no studies on the cost-efficacy of these biologics in CRSwNP have been published. RECENT FINDINGS: Multiple studies have now demonstrated efficacy for biologics in the treatment of CRSwNP as a primary indication. However, the gains in quality of life and objective measures, while consistent, are small and, arguably, the clinical significance is still unclear. In addition, the high cost of these medications may be hard to justify when evaluated in cost-efficacy studies against standard of care therapy in CRSwNP. Furthermore, while the current literature is most robust in showing the benefit of the biologics in asthma, it does not fully support cost-efficacy for biologics. This review evaluates the current literature regarding efficacy of monoclonal antibodies for the treatment of CRSwNP and considers this efficacy in light of the cost implications to individuals and society.

A call for cost-effectiveness analysis for biologic therapies in chronic rhinosinusitis with nasal polyps.

OBJECTIVE: To identify the need for cost-effectiveness analysis of biologic therapies in the treatment of chronic rhinosinusitis (CRS). DATA SOURCES: Clinical trials of monoclonal antibodies (omalizumab, benralizumab, mepolizumab and dupilumab) for nasal polyposis or chronic rhinosinusitis published on PubMed. STUDY SELECTIONS: Clinical trials of biologic therapies in CRS and nasal polyposis. RESULTS: No cost-effectiveness analyses of biologic therapies in CRS have been performed. CONCLUSION: As more clinical trials of biologic therapies for CRS are conducted, there is a need for cost-effectiveness analysis. Future analyses should consider these therapies as part of medical therapeutic options compared with surgery. To increase generalizability, analyses should include samples from allergy and primary care clinics rather than only otolaryngology clinics.

Pharmacoeconomics of Cyclamen europaeum in the management of acute rhinosinusitis.

OBJECTIVES/HYPOTHESIS: To carry out a pharmacoeconomic analysis of Cyclamen europaeum (CE) in the management of acute rhinosinusitis (ARS) in Spain using data from the PROSINUS (PROspective epidemiological study of the diagnosis and treatment of acute rhinoSINUSitis) study. STUDY DESIGN: This was a prospective observational study to compare the effectiveness and cost-effectiveness between therapies including CE versus other therapies in the management of ARS. METHODS: The study was carried out as a secondary analysis of the PROSINUS study, combining healthcare resource use, productivity loses, and health outcomes from the observational study, with costs representative of the Spanish Health System. RESULTS: CE given as monotherapy appears to be more effective (cure rate) than other monotherapies (15.3% higher, P < .05) and combination (10.3% higher, P < .05) therapies. The addition of CE to other single-drug or combination therapies showed a statistically significant improvement in terms of cure rates when adding CE to two-drug combinations (93.9% vs. 76.5%; P < .05) and no significant effect when added to combinations of three or more drugs (81.1% vs. 79.8; nonsignificant). CE-based therapies generally showed lower indirect costs, although only the comparison of CE alone versus other monotherapies, with a net cost savings of €101 per patient, reached statistical significance (€331 vs. €432, P < .05). In addition, CE-based therapies show lower cost per cured patient in all comparisons, except when CE was used in combination with three or more other drugs. CONCLUSIONS: The use of CE (Nasodren) may be associated to better clinical outcomes at no additional cost for the healthcare system with respect to treatments commonly used for ARS in clinical practice.

Strategies for diagnosing and treating suspected acute bacterial sinusitis: a cost-effectiveness analysis.

OBJECTIVE: Symptoms suggestive of acute bacterial sinusitis are common. Available diagnostic and treatment options generate substantial costs with uncertain benefits. We assessed the cost-effectiveness of alternative management strategies to identify the optimal approach. DESIGN: For such patients, we created a Markov model to examine four strategies: 1) no antibiotic treatment; 2) empirical antibiotic treatment; 3) clinical criteria-guided treatment; and 4) radiography-guided treatment. The model simulated a 14-day course of illness, included sinusitis prevalence, antibiotic side effects, sinusitis complications, direct and indirect costs, and symptom severity. Strategies costing less than 50,000 dollars per quality-adjusted life year gained were considered "cost-effective." MEASUREMENTS AND MAIN RESULTS: For mild or moderate disease, basing antibiotic treatment on clinical criteria was cost-effective in clinical settings where sinusitis prevalence is within the range of 15% to 93% or 3% to 63%, respectively. For severe disease, or to prevent sinusitis or antibiotic side effect symptoms, use of clinical criteria was cost-effective in settings with lower prevalence (below 51% or 44%, respectively); empirical antibiotics was cost-effective with higher prevalence. Sinus radiography-guided treatment was never cost-effective for initial treatment. CONCLUSIONS: Use of a simple set of clinical criteria to guide treatment is a cost-effective strategy in most clinical settings. Empirical antibiotics are cost-effective in certain settings; however, their use results in many unnecessary prescriptions. If this resulted in increased antibiotic resistance, costs would substantially rise and efficacy would fall. Newer, expensive antibiotics are of limited value. Additional testing is not cost-effective. Further studies are needed to find an accurate,low-cost diagnostic test for acute bacterial sinusitis.

[Safety and efficacy of OM-85-BV plus amoxicillin/clavulanate in the treatment of subacute sinusitis and the prevention of recurrent infections in children]. / Seguridad y eficacia de OM-85-BV más amoxicilina/clavulanato en el tratamiento de la sinusitis subaguda y prevención de infecciones recurrentes en niños.

A 6-month double-blind, prospective, randomized, placebo-controlled trial was conducted to establish the safety and efficacy of OM-85-BV in the treatment of subacute sinusitis and in the following prevention of the respiratory tract infections in 56 children from 18 months to 9 years of age. In the subacute phase of the sinusitis the patients were given one OM-85-BV capsule (3.5 mg of bacterial extracts) (n = 26) or placebo (n = 30), daily for ten days; additionally both groups took amoxicillin/clavulanate 40/10 mg/kg daily in three divided doses for 21 days. For the following two months the patients took one OM-85-BV capsule or placebo, ten days a month. In the subacute phase the OM-85-BV group of patients improved sooner (5.56 +/- 4.98 vs 10 +/- 8.49 days) and had a shorter convalescence (15.38 +/- 8.91 vs 20.28 +/- 7.17 days). During the six month follow-up the patients in the OM-85-BV group had a lower number of infections (1.56 +/- 0.3 vs 2.22 +/- 0.43) and required a lower number of drug treatments (1.47 +/- 0.32 vs 1.94 +/- 0.42). One patient treated with OM-85-BV presented a mild rash which disappeared three days after the drug discontinuation. We conclude that OM-85-BV is safe at pediatric ages, as well as accelerates the cure and improvement of subacute sinusitis while it lowers the incidence of respiratory infections.