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The Vest® Airway Clearance System Clinical Dossier

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The Vest® Airway Clearance System Clinical Dossier THE VEST ® AIRWAY CLEARANCE SYSTEM Clinical Dossier To Support Medical Policy Review for Expanded Coverage of Neuromuscular Diseases September 2019 The Vest® Airway Clearance System Clinical Dossier Table of Contents EXECUTIVE SUMMARY 3 Clinical benefits 3 1.1 Spinal Muscular Atrophy 3 1.2 Cerebral Palsy 4 1.3 Amyotrophic Lateral Sclerosis 4 1.4 Muscular Dystrophy 4 Economic benefits 5 Conclusion 9 Product description 11 2.1 The Vest® Airway Clearance System 11 2.2 The Monarch® Airway Clearance System 11 Disease description 13 3.1 Introduction 13 3.2 Airway clearance and lung defense mechanism 13 3.3 Respiratory complications in NMD 13 3.4 Clinical and economic implications of respiratory complications and airway clearance therapy in NMD patients 14 Study summaries 15 LIST OF REVIEW ARTICLES 20 REFERENCES 21 2 The Vest® Airway Clearance System Clinical Dossier Executive Summary CLINICAL BENEFITS The safety and efficacy of High Frequency Chest Wall Oscillation (HFCWO) as an airway clearance modality has been demonstrated in numerous studies in patients with neuromuscular diseases including spinal muscular atrophy, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP), multiple sclerosis (MS) and spinal cord injuries. A trend towards fewer hospitalizations, reduced incidence of pneumonia and reduced intravenous antibiotic use for respiratory infections have been shown. A 2010 randomized controlled trial by Yuan et al. compared clinical outcomes, including duration of acute infections, adverse events, polysomnogram results, chest radiograph findings, and body mass index in a group of Neuromuscular Disease (NMD) and CP patients who were treated with standard chest physiotherapy and another group who received HFCWO over five months. There was a trend toward fewer hospitalizations for intravenous antibiotic therapy in the HFCWO group. That group also had higher maximum oxygen saturation. There were no therapy-related adverse events. Notably, a post-study caregiver survey disclosed significantly better adherence to the prescribed thrice-daily therapy in the HFCWO group, with caregivers citing difficulty with the time required and positioning involved to provide traditional chest physiotherapy.16 Landon et al. demonstrated that 15 NMD patients who were prescribed HFCWO for airway clearance, had significantly less hospitalization rates post initiation of HFCWO. The mean hospitalization rate was 0.37 days per therapy month during the year prior to HFCWO initiation. That rate decreased to 0.08 days per therapy month during the HFCWO intervention period (p value < 0.05), representing an 80% reduction in mean hospitalization rate. Therapy was well tolerated, with 90% of respondents considering the therapy comfortable.17 1.1 Spinal Muscular Atrophy Multiple small case reports support the use of HFCWO in critically ill infants and children with Spinal Muscular Atrophy (SMA). In one 5-year-old with SMA II and Acute Respiratory Distress Syndrome (ARDS) following respiratory syncytial virus infection, HFCWO was used as the primary method of airway clearance and was well tolerated when previously, intrapulmonary percussive ventilation (IPV) combined with mechanical insufflation- exsufflation (MI-E) caused episodes of hypoxemia from presumed alveolar de- recruitment.19 Similarly, Chiappeta et al. conducted a six-week study evaluating substitution of HFCWO in place of chest physiotherapy (CPT) in a ten-year-old girl with Type II spinal muscular atrophy. The child had been hospitalized three times in past year for pneumonia, mucus retention, and pulmonary deterioration. She had received percussion and postural drainage therapy daily from her mother for four years. HFCWO 3 The Vest® Airway Clearance System Clinical Dossier was instituted as her primary airway clearance modality for six weeks. After six weeks of HFCWO, the patient showed stronger cough function and significant improvements in 20 FVC (25%), FEV1 (16%), MEF (20%) and NIF (28%). 1.2 Cerebral Palsy Several small case reports support the use of HFCWO in critically ill infants and children with cerebral palsy during acute illnesses. A retrospective outcomes review of 13 children with CP using HFCWO for at least six months prospectively compared with prior six months without the therapy showed significant aggregate reductions in hospitalizations and ER visits; pre-HFCWO documented eight hospitalizations and five ER visits vs. five hospital stays and one ER visit during HFCWO use. Caregivers also reported fewer respiratory illnesses, less antibiotic use and reduced absenteeism. High treatment adherence was also reported.21 1.3 Amyotrophic Lateral Sclerosis Langford et al. demonstrated significantly improved quality of life and high rates of adherence to therapy on 47 ALS patients on HFCWO therapy.22 In a randomized controlled trial involving nine ALS patients, Chaisson et al. evaluated the effectiveness of HFCWO when added to standard of care in preventing pulmonary complication and prolonging time to death in patients concurrently receiving non- invasive ventilatory support. The addition of HFCWO coincided with a longer time to death.23 A retrospective chart review evaluating the effectiveness of HFCWO therapy in 18 patients with ALS demonstrated a reduction in rate of decline of FVC, MIP and PCEF. 92% of the patients reported easier breathing and feeling better after HFCWO therapy. 85% agreed that therapy eased secretion clearance and improved their quality of life.24 In a 12-week multi-center RCT, Lange DJ et al. demonstrated HFCWO patients had significantly less fatigue and breathlessness compared to the control group and 79% reported high rates of satisfaction with HFCWO treatment.4 1.4 Muscular Dystrophy Respiratory disease is a leading cause of morbidity and mortality in patients with muscular dystrophy. Effective airway clearance is critical for patients with Duchenne muscular dystrophy as early intervention to improve airway clearance can prevent hospitalizations and reduce incidence of pneumonias.2 Crescimanno et al. documented a case study of two young boys with Duchenne muscular dystrophy hospitalized with pandemic A H1/N1 influenza who failed to respond to standard care. CT scans showed extensive pulmonary bilateral segmental atelectasis. Following institution of a sequential respiratory therapy protocol that included multiple sessions of HFCWO therapy augmented with mechanically assisted 4 The Vest® Airway Clearance System Clinical Dossier cough maneuvers, both boys showed rapid clinical and radiological improvement and recovered fully. Treatments were well tolerated even by one boy with severe scoliosis.18 Gomez et al. demonstrated effective mobilization of distal airway secretions resulting in significant clinical improvement after initiation of HFCWO therapy in a 16 year old patients with Duchenne muscular dystrophy and profound kyphoscoliosis.31 ECONOMIC BENEFITS Health economic studies evaluating HFCWO therapy have established total medical costs, hospitalizations, and pneumonia claims were less after initiation of HFCWO than before in a broad group of patients with NMD resulting in significant cost savings. The reductions in health-care utilization and claim costs were the result of a proactive airway clearance regimen utilizing HFCWO therapy. These findings lend support to the routine use of HFCWO therapy in the care of patients with NMDs. In 2016, Lechtzin et al. compared health-care claims of 426 patients with NMD receiving The Vest® Airway Clearance System from two large commercial insurance claim databases before and after initiation of HFCWO. The majority of these patients were documented to have muscular dystrophy (150) and Quadriplegia (171).25 • Total medical costs per member per month decreased 18.6% after HFCWO use (p value .002) • In-patient admission costs decreased by 41.7% (p value .001) • Costs related to treatment of pneumonia decreased by 18.1% (p value .02) • Average length of stay decreased from 11.6 days to 9.1 days 5 The Vest® Airway Clearance System Clinical Dossier Figure 1: Healthcare costs before and after prescription of HFCWO. Costs are shown in U.S. dollars. *P,0.05. PMPM = per member per month; RX = prescription. In a 2018 UK based NICE cost effectiveness analysis, assessed the cost-effectiveness of The Vest® Airway Clearance System compared to chest physical therapy for airway clearance in patients with NMD. A decision-analytic Markov model was developed to estimate the cost and effectiveness of each airway clearance strategy over 5- and 10- year time horizons. Costs were estimated from a UK NHS and personal social services perspective. The main input parameters in the model were the rates of incidence of respiratory infection, respiratory-related hospitalization and antibiotic use due to respiratory infections, and the cost of The Vest® System and NHS resource use for treatment of the respiratory infection. The study demonstrates that over 5- and 10-year time horizons, usage of The Vest® System as a primary airway clearance modality results in fewer costs and more quality- adjusted life-years gained per patient. Results also indicate that this intervention has a high probability of being cost-effective (>98%) at willingness-to-pay thresholds £20,000 and £30,000. Results indicate that The Vest® System is a cost-effective strategy, with significant cost savings being made primarily due to a reduction in the number of hospitalizations that treated patients experience and a reduced length of stay in hospital.26 6 The Vest® Airway Clearance
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