Key result
The addition of roflumilast to LABA in patients with severe-to-very severe COPD reduced exacerbations and yielded an incremental cost-effectiveness ratio of £19,505 per QALY gained, with an 82% probability of being cost-effective at a £30,000/QALY threshold.
Why the study?
Is roflumilast added to LABA cost-effective compared to LABA alone in patients with severe-to-very severe COPD associated with chronic bronchitis in the UK?
Is roflumilast added to LABA cost-effective compared to LABA alone in patients with severe-to-very severe COPD associated with chronic bronchitis in the UK?
Effect estimate: ICER £19,505 per QALY gained (95% CI 364-38646)
Adding roflumilast to LABA in severe-to-very severe COPD reduces exacerbations and is cost-effective in the UK setting.
May support roflumilast add-on in UK severe COPD; extends economic modeling but leaves open real-world confirmation.
OBJECTIVE: To estimate the cost-effectiveness of adding a selective phosphodiesterase-4 inhibitor, roflumilast, to a long-acting bronchodilator therapy (LABA) for the treatment of patients with severe-to-very severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis with a history of frequent exacerbations from the UK payer perspective. METHODS: A Markov model was developed to predict the lifetime cost and outcomes [exacerbations rates, life expectancy, and quality-adjusted life years (QALY)] in patients treated with roflumilast, which showed a reduction in the exacerbation rates and lung function improvement in a pooled analysis from two clinical trials, M2-124 and M2-125. Sensitivity analyses were conducted to explore the impact of uncertainties on the cost-effectiveness. RESULTS: The addition of roflumilast to concomitant LABA reduced the number of exacerbations from 15.6 to 12.7 [2.9 (95 % CI 0.88-4.92) exacerbations avoided] and increased QALYs from 5.45 to 5.61 [0.16 (95 % CI 0.02-0.31) QALYs gained], at an incremental cost of £3,197 (95 % CI £2,135-£4,253). Cost in LABA alone and LABA + roflumilast were £16,161 and £19,358 respectively. The incremental cost-effectiveness ratios in the base case were £19,505 (95 % CI £364-£38,646) per quality-adjusted life-year gained and 18,219 (95 % CI £12,697-£49,135) per life-year gained. Sensitivity analyses suggest that among the main determinants of cost-effectiveness are the reduction of exacerbations and the case fatality rate due to hospital-treated exacerbations. Probabilistic sensitivity analysis suggests that the probability of roflumilast being cost-effective is 82 % at willingness-to-pay £30,000 per QALY. CONCLUSIONS: The addition of roflumilast to LABA in the treatment of patients with severe-to-very severe COPD reduces the rate of exacerbations and can be cost-effective in the UK setting.
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Samyshkin et al. (2013) studied Severe-to-very severe COPD associated with chronic bronchitis with a history of frequent exacerbations. Roflumilast add-on to LABA vs. LABA alone was evaluated on Incremental cost-effectiveness ratio (ICER) per QALY gained (ICER £19,505 per QALY gained, 95% CI 364-38646). The addition of roflumilast to LABA in patients with severe-to-very severe COPD reduced exacerbations and yielded an incremental cost-effectiveness ratio of £19,505 per QALY gained, with an 82% probability of being cost-effective at a £30,000/QALY threshold.
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