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Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data.
J Med Econ. 2016; 19(5):515-25.JM

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.

LIMITATIONS

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.

CONCLUSION

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+Show Affiliations

a a Lundbeck LLC , Deerfield , IL , USA.b b University of South Florida , Tampa , FL , USA.c c Creativ-Ceutical , Paris , France.d d Creativ-Ceutical USA Inc. , Chicago , IL , USA.c c Creativ-Ceutical , Paris , France.a a Lundbeck LLC , Deerfield , IL , USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26710315

Citation

François, Clément, et al. "Cost-effectiveness of Droxidopa in Patients With Neurogenic Orthostatic Hypotension: Post-hoc Economic Analysis of Phase 3 Clinical Trial Data." Journal of Medical Economics, vol. 19, no. 5, 2016, pp. 515-25.
François C, Hauser RA, Aballéa S, et al. Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data. J Med Econ. 2016;19(5):515-25.
François, C., Hauser, R. A., Aballéa, S., Dorey, J., Kharitonova, E., & Hewitt, L. A. (2016). Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data. Journal of Medical Economics, 19(5), 515-25. https://doi.org/10.3111/13696998.2015.1136827
François C, et al. Cost-effectiveness of Droxidopa in Patients With Neurogenic Orthostatic Hypotension: Post-hoc Economic Analysis of Phase 3 Clinical Trial Data. J Med Econ. 2016;19(5):515-25. PubMed PMID: 26710315.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data. AU - François,Clément, AU - Hauser,Robert A, AU - Aballéa,Samuel, AU - Dorey,Julie, AU - Kharitonova,Elizaveta, AU - Hewitt,L Arthur, Y1 - 2016/01/18/ PY - 2015/12/29/entrez PY - 2015/12/29/pubmed PY - 2017/1/24/medline KW - Cost-effectiveness KW - Droxidopa KW - Falls KW - Neurogenic orthostatic hypotension (nOH) KW - Norepinephrine KW - Parkinson’s disease KW - Quality-adjusted life-years (QALYs) SP - 515 EP - 25 JF - Journal of medical economics JO - J Med Econ VL - 19 IS - 5 N2 - 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. LIMITATIONS: 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. CONCLUSION: 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. SN - 1941-837X UR - https://www.unboundmedicine.com/medline/citation/26710315/Cost_effectiveness_of_droxidopa_in_patients_with_neurogenic_orthostatic_hypotension:_post_hoc_economic_analysis_of_Phase_3_clinical_trial_data_ L2 - https://www.tandfonline.com/doi/full/10.3111/13696998.2015.1136827 DB - PRIME DP - Unbound Medicine ER -