Original Title: Analyse af non-invasiv ventilation i hjemmet til behandling af patienter med kronisk obstruktiv lungesygdom

Authors' objectives: The Danish Respiratory Society advocates domiciliary non-invasive ventilation (NIV) for clinically indicated COPD patients, citing specific criteria including persistent respiratory insufficiency (paCO2 >7kPa) with more than two weeks since last acute exacerbation, a history of >3 NIV-requiring exacerbations within the last year, and difficulties weaning from NIV post-exacerbation. However, its adoption varies across Denmark due to uncertainty regarding its clinical and economic impact. The Danish Health Technology Council wished to assess the current evidence on the topic in support of whether to recommend the use of domiciliary non-invasive ventilation for clinically indicated patients with COPD.

Authors' results and conclusions: Clinical effect and safety: Based on the analysis of clinical effectiveness and safety the Expert Committee identifies a statistically significant and clinically relevant difference in effects between domiciliary NIV and standard treatment for the following effect measures: Median time to death, proportion of patients who have died after one year, median time to hospitalization-requiring acute exacerbation, and health-related quality of life. Based on the current evidence base, it is not possible to identify differences in clinical effect and safety between the three indications for use of domiciliary NIV. Overall, the Expert Committee concludes, that domiciliary NIV yields a positive impact on critical clinical outcomes for clinically indicated patients with COPD. Patient perspective: The analysis of the patient material indicates that for most patients the patient-experienced benefits (e.g., improved sleep, increased hope and energy level) of domiciliary NIV outweigh the negative aspects (e.g., mask discomfort, headaches, need for cleaning of the device) associated with the treatment. For most patient domiciliary NIV is not a burden in everyday life once the patients have become familiar with the device. The practical work involved in managing domiciliary NIV is perceived as limited for patients with treatment success, and the majority express that they would be able to manage the treatment independently. The Expert Committee notes that disease progression, comorbidity, and limited understanding of the disease can be barriers for patients to accept domiciliary NIV and adhere to the recommended treatment. Overall, the Expert Committee assesses that there is broad support for the treatment in encounters with patients and relatives in clinical practice. Organizational implications: The analysis reveals an inter- and intraregional variation in how treatment with domiciliary NIV is organised and structured in the Danish regions. The Expert Committee assesses that some variation in the organisation of treatment can be expected, given the diversity of local conditions, but considers that it should be attempted to standardize treatment offerings as much as possible so that patients across the Danish regions have equal opportunities for treatment with domiciliary NIV. The Expert Committee notes that awareness of chronic hypercapnia and domiciliary NIV as a treatment is increasing among colleagues, but there is room for improvement. With broader awareness, it becomes possible to identify patients with chronic hypercapnia earlier and consequently initiate treatment with domiciliary NIV earlier, provided that the clinical indications are met. Health economics: The Expert Committee assesses that domiciliary NIV creates significant value for patients in terms of the accumulation of quality-adjusted life years (QALYs) through higher survival and by avoiding hospitalization-requiring acute exacerbations relative to standard treatment, albeit at higher costs, resulting in an incremental cost-effectiveness ratio of DKK 234,248 per QALY. If costs for the treatment and care of COPD are included, the incremental cost-effectiveness ratio increases to DKK 878,175 per QALY. The budget impact analysis estimates that a positive recommendation for domiciliary NIV for indicated patients with COPD would result in a five-year budget impact of approximately -DKK 37 million. The Expert Committee notes that if regional expenses for COPD treatment are included, the budget impact will be approximately DKK 30 million. The results are affected by uncertainty, particularly pertaining to methodological assumptions for the analyses.

Project Status: Completed

URL for project: https://behandlingsraadet.dk/find-evalueringer-analyser/analyser/2022/non-invasiv-ventilation-i-hjemmet-til-behandling-af-patienter-med-kronisk-obstruktiv-lungesygdom

Year Published: 2024

URL for published report: https://behandlingsraadet-classic.azureedge.net/media/qbqb5oul/recommendation.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Denmark

Organisation Name: The Danish Health Technology Council

Contact Address: Niels Jernes Vej 6a, 9220 Aalborg

Contact Name: Nikolaj Hellmuth Skak

Contact Email: nsp@behandlingsraadet.dk