Cost-Effectiveness Of Roflumilast As Add-On To Triple Inhaled Therapy Versus Triple Inhaled Therapy In Patients With Severe And Very Severe Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis In The Netherlands

OBJECTIVES: To assess the cost-effectiveness of roflumilast (ROF) added to ICS+LABA+LAMA versus ICS+LABA+LAMA alone in Dutch patients with severe (FEV12 moderate or severe COPD exacerbations in the past year. Data used were derived from the REACT phase 3b/4 clinical trial (NCT01329029). METHODS: An Excel-based cohort state transition (Markov) model estimated total costs and outcomes over 40 years from a Dutch societal perspective. The model has three GOLD-based states: severe COPD, very severe COPD, and death. All patients enter in the severe state and there is an irreversible transition from severe to very severe COPD. Background rates of moderate and severe (requiring hospitalizations) exacerbations were estimated with negative binomial regressions adjusting for disease severity and treatment in the trial sub-population treated with ICS+LABA+LAMA. Published health-related quality of life weights were applied to health states and exacerbations to generate quality-adjusted life years (QALYs). List prices for drugs were used. RESULTS: ROF reduced the annual rate of exacerbations (moderate or severe) compared with ICS+LABA+LAMA alone (rate ratio [RR]: 0.87, p=0.0840).The reduction of the severe exacerbation rate (RR: 0.74; p=0.0213) was greater than that of moderate exacerbations (RR: 0.94; p=0.5195). In Dutch patients with severe COPD, chronic bronchitis and >2 moderate or severe COPD exacerbations in the past year, approximate incremental gains for ROF were 0.20 QALYs at €2,846 per patient (probabilistic cost per QALY: €14,135/QALY), with a 99% probability of being cost-effective at a €80,000/QALY threshold. ROF remained cost-effective under several different sensitivity analyses, and had a favourable cost-effectiveness when evaluated in patients with very severe COPD. CONCLUSIONS: ROF as add-on to ICS+LABA+LAMA is cost-effective for patients with severe or very severe COPD and frequent exacerbations in the Netherlands.