Impact of Reduction in Falls for Patients with PD and nOH: Post Hoc Economic Analyses of Phase 3 Clinical Trial Data on Droxidopa (P1.020)

Objective: To estimate the impact of droxidopa therapy on costs in patients with Parkinson disease (PD) and neurogenic orthostatic hypotension (nOH) while considering the observed reduction in the number of falls and droxidopa drug cost. Background: nOH results from inadequate noradrenergic response to postural change and is a substantial risk factor for falls in PD patients. Droxidopa is a norepinephrine prodrug recently approved to treat symptomatic nOH caused by primary autonomic failure, dopamine β-hydroxylase deficiency, and nondiabetic autonomic neuropathy. Methods: Cost offset due to reduced falls was estimated by retrospective, piggyback design of randomized controlled trial data and published data. PD patients in a phase 3 study underwent double-blind titration up to 2 weeks with droxidopa, then 8-week maintenance (100-600 mg TID) or placebo. Falls were recorded daily. Utilizing probability of falls to be fatal, falls requiring medical care, and costs from a systematic review of falls in people ≥60 years old living in the community, we calculated the average cost/fall/treatment to estimate potential cost reduction of droxidopa therapy vs placebo. Results: Droxidopa over 10 weeks was associated with significantly fewer falls per patient-week vs placebo and fewer fall-related injuries. The estimated average fall cost per patient was $4573 for droxidopa vs $11,813 for placebo (a cost reduction of $7239). The average droxidopa drug cost was $10,108 (2014 prices). Thus, the net cost of droxidopa therapy was $2869. Sensitivity analyses with more conservative cost and fall estimates increased the net costs to $6640 and $7457, respectively. Conclusions: This simple model indicates that the fall reduction observed with droxidopa treatment limits the financial impact of droxidopa to $2869 over 10 weeks. Inclusion of other potential benefits on functioning, quality of life, and associated costs related to negative consequences of fear of falling may further decrease the overall cost. Funding: Lundbeck Disclosure: Dr. Owen has received personal compensation for activities with Lundbeck as an employee. Dr. Francois holds stock and/or stock options in Lundbeck. Dr. Hauser has received personal compensation for activities with Abbott Laboratories, Acadia Pharmaceutical, Acorda Therapeutics, Allergan, Inc., Abbvie, AstraZeneca, Auspex Pharmaceuticals, Biotie Therapeutics Inc., Chelsea Therapeutics, Inc.,Cowen Ther Dr. Kaufman has received personal compensation for activities with Lundbeck and Astra Zeneca as a Scientific Advisory Board member.Dr. Kaufman has received personal compensation in an editorial capacity for Springer. Dr. Kaufman received has received rese Dr. Heritier has received personal compensation for activities with Lundbeck Research USA, Inc. as a consultant. Dr. Hewitt has nothing to disclose. Dr. Rive has received personal compensation for activities with Lundbeck as an employee. Dr. Rowse has received personal compensation for activities with Lundbeck Research USA, Inc. as an employee.