Quantifying Annual Medical Economic Burden of Patents and Regulatory Exclusivities on Ics/Laba Inhalers Among End-Stage COPD Patients

OBJECTIVES:

In the United States (US), COPD imposes a substantial societal health and economic burden. High prices of inhalers, the mainstay treatment, due to patent protection and limited generic availability, can lead to high out-of-pocket (OOP) costs. This study aims to model one-year economic burden of market exclusivity for inhaled corticosteroids (ICS) combined with long-acting beta2 agonists (LABA) among end-stage COPD patients.

METHODS:

Using data from the published literature, we developed a Markov model to assess the annual costs of end-stage COPD patients with respect to their adherence level and maintenance therapy cost with ICS/LABA inhalers. We based our model on four health states: very severe COPD with no exacerbation; very severe COPD with non-severe exacerbation; very severe COPD with severe exacerbation; and death. To quantify the economic burden, we modeled increased adherence and its impacts on exacerbations associated with lower OOP costs of generic equivalents in the absence of long patent protection.

RESULTS:

The annual medical cost attributable to the branded ICS/LABA inhalers is estimated to be $14,000 per patient, which is 1.7 times greater than the estimated cost attributed to a generic ICS/LABA inhaler. If the generic equivalents are available after lifting patent exclusivities of branded ICS/LABA, this can result in nearly $6000 savings in annual costs for a patient with very severe COPD.

CONCLUSIONS:

This study projects the substantial annual burden of patent protection for an ICS/LABA inhaler on the US healthcare system. Future studies are needed to examine the impact of market exclusivities for other classes of inhalers across all severity stages of COPD patients.