BUDGETARY IMPACT OF ADDING ROFLUMILAST TO MANAGED CARE FORMULARY IN THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Purpose: The purpose of this study was to develop a budget impact model that assesses the economic impact of adding roflumilast to existing chronic obstructive pulmonary disease (COPD) treatment from the perspective of a managed care organization(MCO).  Roflumilast, a once-daily oral selective phosphodiesterase-4 inhibitor, is a new approved treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and history of exacerbations.

Method: A hypothetical MCO with 1,000,000 members was used in the model. Prevalence of COPD was estimated using age-specific prevalence data from National Institute of Health and US census demographic data. The number of severe/very severe COPD patients with chronic bronchitis was estimated based on relevant prevalence rates from published literature. Exacerbation rate, exacerbation costs and relative risk reduction of exacerbation associated with roflumilast were taken from published literature. Wholesale acquisition cost and daily average consumption were used to calculate daily price. Cost parameters that impact MCO’s budget included price, co-payment/co-insurance, manufacturer rebate, product utilization, exacerbation rate, exacerbation costs, and relative risk reduction of exacerbation. Roflumilast was assumed to be add-on to existing treatments. The model estimates the impact on the pharmacy budget and medical cost offset due to the avoidance of potential COPD exacerbations. The model accommodates a one-year time horizon with no discounting. Sensitivity analyses were performed using the upper and lower limits of the 95% confidence intervals for exacerbation rate, costs of exacerbation and relative risk reduction of exacerbation to estimate the range of potential medical cost offset.

Result: An estimated 9,253 patients had severe/very severe COPD associated with chronic bronchitis. The base-case model, assuming 50% of these patients were treated with roflumilast and 25% co-insurance, resulted in an increase of $0.57 per member per month (PMPM) pharmacy costs and a decrease of $0.75 PMPM medical costs, with a net reduction of $0.18 for PMPM total healthcare costs. Key drivers of medical cost reductions were inpatient hospitalization (-$0.53 PMPM) and outpatient visits (-$0.18 PMPM). Sensitivity analyses showed that the result is most sensitive to the relative risk reduction of exacerbations associated with roflumilast.

Conclusion: Addition of roflumilast to COPD treatment may result in a net savings to a MCO when taking potential medical cost offsets into account.