Economic impact analysis of a minimally invasive temperature-controlled radiofrequency device versus nasal surgery for the treatment of nasal airway obstruction in the United States.

OBJECTIVE: To determine the economic impact of a minimally invasive temperature-controlled radiofrequency (TCRF) device for treating nasal airway obstruction (NAO). METHODS: A budget impact model was developed for two scenarios: a reference scenario of functional rhinoplasty surgery with concomitant septoplasty and inferior turbinate reduction (ITR) performed in the hospital outpatient department where TCRF is not an available treatment option and a new scenario consisting of in-office TCRF treatment of the nasal valve and ITR. A payor perspective was adopted with a hypothetical population plan size of one million members. Costs were estimated over a time horizon of 4 years. The eligible population included patients with severe/extreme NAO and nasal valve collapse (NVC) as the primary cause or significant contributor. Data inputs were sourced from targeted literature reviews. Uncertainty within the model structure and input parameters was assessed using one-way sensitivity analysis. RESULTS: The introduction of a TCRF device resulted in population-level cost savings of $20,015,123 and per-responder average cost savings of $3531 through a 4-year time horizon due to lower procedure costs and complication rates of the device relative to the surgical comparator. Results were robust when varying parameter values in sensitivity analyses, with cost savings being most sensitive to the prevalence of NAO and estimated response rates to functional rhinoplasty and TCRF. CONCLUSIONS: In patients with severe/extreme NAO, with NVC as the primary or major contributor, introducing TCRF with ITR as a treatment option demonstrates the potential for significant cost savings over functional rhinoplasty with septoplasty and ITR.

Nasal valve dysfunction is a common cause of nasal airway obstruction (NAO) that has a significant impact on heath and quality of life for affected individuals. Previously, patients were offered temporary measures or a type of surgery called functional rhinoplasty which is a highly complex surgery that can be costly, requires recovery time, and in rare cases, not be successful. Recently, a new minimally invasive treatment alternative for NAO called temperature-controlled radiofrequency (TCRF) that may be performed in a surgery center or a doctor's office has become available. This paper provides the results of budget impact analysis performed to assess whether adding the TCRF procedure in place of surgery as a choice for patients with NAO will result in cost savings to an insurance payer with 1 million covered individuals in the United States over a period of 4 years. Results show that TCRF may result in an average of 9,416 fewer rhinoplasty surgeries, provide an average 4-year cost-savings of $3,531 for every patient that responds to TCRF treatment, and a savings of $20,015,123 over 4 years for the insurance provider. These potential cost savings over 4 years would likely be due to reduced procedure costs and complication rates compared to surgery.

Septoplasty versus non-surgical management for nasal obstruction in adults with a deviated septum: economic evaluation alongside a randomized controlled trial.

BACKGROUND: For years, the benefits of septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of septoplasty remains unknown. METHODS: We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24 months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective. RESULTS: A total of 203 adults were randomly assigned to septoplasty (N = 102) or non-surgical management (N = 101). After 12 months, the mean cost difference between septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI - 0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24 months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI - 0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings. CONCLUSIONS: Depending on the selected perspective, cost-effectiveness threshold, and time horizon, septoplasty has the potential to be cost-effective. Despite considerable uncertainty, septoplasty seems to be cost-effective from a healthcare perspective, after 24 months against a threshold of €20,000 per QALY. From a societal perspective, septoplasty is not yet cost-effective after 24 months, but it comes closer to the cost-effectiveness threshold as time passes by. TRIAL REGISTRATION: Nederlands Trial Register, NTR3868 (https://www.trialregister.nl/trial/3698). Prospectively registered on February 21, 2013.

Cost-effectiveness of Corticosteroid Nasal Spray vs Surgical Therapy in Patients With Severe to Extreme Anatomical Nasal Obstruction.

IMPORTANCE: Health insurance companies commonly require a trial of corticosteroid nasal spray prior to authorizing nasal surgery, even in patients with severe to extreme anatomical nasal obstruction, despite lack of data supporting such medical therapy. OBJECTIVES: To provide a model for the comparative analysis of medical vs surgical treatment for nasal obstruction to help maximize health care benefit per dollar spent and to explore the cost-effectiveness of corticosteroid nasal spray in patients with severe to extreme nasal airway obstruction on Nasal Obstruction Symptom Evaluation (NOSE) scores. DESIGN, SETTING, AND PARTICIPANTS: A cost-efficiency frontier economic evaluation was performed. The economic perspective was that of the health care third-party payer. Effectiveness data were obtained from NOSE score questionnaires in 179 patients. An incremental cost-effectiveness ratio was determined from the cost and efficacy data. Comparative treatment groups were medical therapy with corticosteroid nasal spray vs surgical therapy for nasal airway obstruction. The study was conducted between January 1, 2011, and December 30, 2013. The time horizon included 1, 2, and 5 years. Data analysis was completed June 1, 2015. MAIN OUTCOMES AND MEASURES: The primary outcome was cost per quality-adjusted life-year (QALY). A modified Markov decision tree model was used. Costs were obtained from the Medicare 2015 physician fee schedule, and the mean was determined (owing to geographic disparity) along with wholesale and generic pharmaceutical pricing. RESULTS: Among 100 men and 79 women evaluated (mean [SD] age, 37.9 [12.9] years), surgical repair of severe nasal airway obstruction cost $6537 and produced a total of 1.15 QALYs at 1 year. Medical treatment involved a trial of corticosteroid nasal sprays, which cost $520 and produced a total of 1.03 QALYs. The surgical approach was markedly more effective but at greater short-term cost. In cases of extreme nasal obstruction, medical treatment cost $520.73 with 1.004 QALYs, demonstrating an incremental cost-effectiveness ratio (ICER) of $354 693 per QALY compared with no treatment. Conversely, surgical treatment cost $6536.64 and produced 1.136 QALYs, with an ICER of $45 633 compared with medical therapy. At 5 years, the ICER decreased from $45 634 to $8110 per QALY for surgical treatment of extreme nasal obstruction. The medical treatment ICER decreased from $354 693 per QALY at 1 year to $273 704 per QALY at 5 years. An ICER was performed and demonstrated a cost threshold of $50 554 per QALY for surgical treatment compared with $67 518 per QALY for medical treatment at 1 year for severe nasal obstruction. If the evaluation is extended to 5 years, surgical treatment cost $8984 per QALY compared with $52 571 per QALY for medical treatment. Owing to the improved effectiveness outcomes, greater cost savings per ICER was demonstrated in patients with extreme nasal obstruction. CONCLUSIONS AND RELEVANCE: Surgical treatment for patients with severe to extreme anatomical nasal obstruction demonstrates increased short-term expense but is cost-effective in the long term. These data suggest that treatment with corticosteroid nasal spray in patients with documented severe to extreme anatomical nasal obstruction is unnecessary and results in a delay in treatment. LEVEL OF EVIDENCE: NA.

Effectiveness of septoplasty versus non-surgical management for nasal obstruction due to a deviated nasal septum in adults: study protocol for a randomized controlled trial.

BACKGROUND: Septoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults. Currently the main indication to perform septoplasty is nasal obstruction. However, the effectiveness of septoplasty for nasal obstruction in adults with a deviated nasal septum remains uncertain. Scientific evidence is scarce and inconclusive, and internationally accepted guidelines are lacking. Moreover, there is no consensus on whether or not septoplasty should be combined with concurrent turbinate surgery. The objective of the current ongoing trial is to study the effectiveness of septoplasty (with or without concurrent turbinate surgery) as compared to non-surgical management for nasal obstruction in adults with a deviated nasal septum, both in terms of subjective (health-related quality of life) as well as objective (nasal patency) outcome measures. METHODS/DESIGN: The study is designed as a pragmatic, multicenter, parallel-group, randomized controlled trial. A total of 200 adults will be enrolled with nasal obstruction based on a deviated nasal septum and an indication for septoplasty according to current medical practice in the Netherlands. Participants will be randomized to either septoplasty (with or without concurrent turbinate surgery as originally indicated by the otorhinolaryngologist) or a non-surgical watchful waiting strategy. Follow-up visits will be scheduled at 0, 3, 6, 12, and 24 months. During each follow-up visit, health-related quality of life questionnaires will be administered and measurements of four-phase rhinomanometry and peak nasal inspiratory flow will be performed. Costs will be studied using a patient-based diary. Effects of septoplasty on health-related quality of life (primary outcome) and nasal patency will be calculated as mean differences with 95 % confidence intervals. Subgroup analyses according to gender, age, and severity of the septal deviation will be performed. All analyses will be performed on an intention-to-treat basis. DISCUSSION: With the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for septoplasty. TRIAL REGISTRATION: Nederlands Trial Register/Dutch Trial Registry ( www.trialregister.nl ), trial identifying number: NTR3868 . Registered on 21 February 2013.

Exploring the clinical value and implications of routine pathological examination of septoplasty specimens.

OBJECTIVES/HYPOTHESIS: During septoplasty, otherwise normal cartilage and bone are removed and routinely submitted for pathologic examination. According to the College of American Pathologists, however, the examination of bone and cartilage from septoplasty and rhinoplasty may be left to the pathologist's discretion. We explored the processing of tissues removed during septoplasty, examining the clinical value and implications of current practices. STUDY DESIGN: Retrospective chart review. METHODS: Our database was searched for septoplasty (CPT code 30520) procedures performed specifically for the indication of nasal obstruction. RESULTS: Five hundred sixteen consecutive cases from 15 surgeons spanning a 2-year period were identified. In the majority of cases, septal tissues removed during surgery were submitted to pathology. The majority of cases (>90%) involved septoplasty performed in conjunction with another procedure, most commonly addressing the inferior turbinates. All septal specimens received gross examination by a pathologist, and a smaller fraction were also examined histologically. Gross findings included the qualitative appearance of the specimen and dimensional measurements of bone and cartilage fragments. No abnormalities were identified (by gross or histologic examination) in any of the specimens. Associated costs included specimen handling, storage, and pathology fees. CONCLUSIONS: In our health care system, it is common practice to submit tissues removed during septoplasty for pathologic examination. This study demonstrates that routine evaluation of septal tissues following surgery for obstruction has no clinical value whatsoever, and is associated with direct and indirect costs. Given the current health care climate, this practice should be further scrutinized and reconsidered.