title: Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data.
abstract: OBJECTIVE
  Falls are associated with neurogenic orthostatic hypotension (nOH) and are an economic burden on the US healthcare system. Droxidopa is approved by the US FDA to treat symptomatic nOH. This study estimates the cost-effectiveness of droxidopa vs standard of care from a US payer perspective.
  
  
  METHODS
  A Markov model was used to predict numbers of falls and treatment responses using data from a randomized, double-blind trial of patients with Parkinson's disease and nOH who received optimized droxidopa therapy or placebo for 8 weeks. The severity of falls, utility values, and injury-related costs were derived from published studies. Model outcomes included number of falls, number of quality-adjusted life-years (QALYs), and direct costs. Incremental cost-effectiveness ratios (ICERs) were calculated. Outcomes were extrapolated over 12 months.
  
  
  RESULTS
  Patients receiving droxidopa had fewer falls compared with those receiving standard of care and gained 0.33 QALYs/patient. Estimated droxidopa costs were $30,112, with estimated cost savings resulting from fall avoidance of $14,574 over 12 months. Droxidopa was cost-effective vs standard of care, with ICERs of $47,001/QALY gained, $24,866 per avoided fall with moderate/major injury, and $1559 per avoided fall with no/minor injury. The main drivers were fall probabilities and fear of fall-related inputs.
  
  
  CONCLUSIONS
  A limitation of the current study is the reliance on falls data from a randomized controlled trial where the placebo group served as the proxy for standard of care. Data from a larger patient population, reflecting 'real-life' patient use and/or comparison with other agents used to treat nOH, would have been a useful complement, but these data were not available.
  
  
  CONCLUSIONS
  Using Markov modeling, droxidopa appears to be a cost-effective option compared with standard of care in US clinical practice for the treatment of nOH.
authors.affiliation: a a Lundbeck LLC , Deerfield , IL , USA.
authors.forename: Clément
authors.initials: C
authors.lastname: François
authors.affiliation: b b University of South Florida , Tampa , FL , USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Hauser
authors.affiliation: c c Creativ-Ceutical , Paris , France.
authors.forename: Samuel
authors.initials: S
authors.lastname: Aballéa
authors.affiliation: d d Creativ-Ceutical USA Inc. , Chicago , IL , USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Dorey
authors.affiliation: c c Creativ-Ceutical , Paris , France.
authors.forename: Elizaveta
authors.initials: E
authors.lastname: Kharitonova
authors.affiliation: a a Lundbeck LLC , Deerfield , IL , USA.
authors.forename: L Arthur
authors.initials: LA
authors.lastname: Hewitt
mesh_terms: D000058:Accidental Falls / Q000191:economics; D000368:Aged; D000978:Antiparkinson Agents / Q000191:economics* / Q000627:therapeutic use*; D001794:Blood Pressure; D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D015103:Droxidopa / Q000191:economics* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007024:Hypotension, Orthostatic / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008390:Markov Chains; D010300:Parkinson Disease / Q000150:complications; D019057:Quality-Adjusted Life Years
chemical_list: D000978:Antiparkinson Agents; D015103:Droxidopa
keywords: Cost-effectiveness; Droxidopa; Falls; Neurogenic orthostatic hypotension (nOH); Norepinephrine; Parkinson’s disease; Quality-adjusted life-years (QALYs)