Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data.
Identifieur interne : 000220 ( PubMed/Corpus ); précédent : 000219; suivant : 000221Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data.
Auteurs : Clément François ; Robert A. Hauser ; Samuel Aballéa ; Julie Dorey ; Elizaveta Kharitonova ; L Arthur HewittSource :
- Journal of medical economics [ 1941-837X ] ; 2016.
English descriptors
- KwdEn :
- Accidental Falls (economics), Aged, Antiparkinson Agents (economics), Antiparkinson Agents (therapeutic use), Blood Pressure, Cost-Benefit Analysis, Dose-Response Relationship, Drug, Double-Blind Method, Droxidopa (economics), Droxidopa (therapeutic use), Female, Humans, Hypotension, Orthostatic (drug therapy), Hypotension, Orthostatic (etiology), Male, Markov Chains, Parkinson Disease (complications), Quality-Adjusted Life Years.
- MESH :
- chemical , economics : Antiparkinson Agents, Droxidopa.
- complications : Parkinson Disease.
- drug therapy : Hypotension, Orthostatic.
- economics : Accidental Falls.
- etiology : Hypotension, Orthostatic.
- chemical , therapeutic use : Antiparkinson Agents, Droxidopa.
- Aged, Blood Pressure, Cost-Benefit Analysis, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Markov Chains, Quality-Adjusted Life Years.
Abstract
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.
DOI: 10.3111/13696998.2015.1136827
PubMed: 26710315
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data.</title><author><name sortKey="Francois, Clement" sort="Francois, Clement" uniqKey="Francois C" first="Clément" last="François">Clément François</name><affiliation><nlm:affiliation>a a Lundbeck LLC , Deerfield , IL , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation><nlm:affiliation>b b University of South Florida , Tampa , FL , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Aballea, Samuel" sort="Aballea, Samuel" uniqKey="Aballea S" first="Samuel" last="Aballéa">Samuel Aballéa</name><affiliation><nlm:affiliation>c c Creativ-Ceutical , Paris , France.</nlm:affiliation></affiliation></author><author><name sortKey="Dorey, Julie" sort="Dorey, Julie" uniqKey="Dorey J" first="Julie" last="Dorey">Julie Dorey</name><affiliation><nlm:affiliation>d d Creativ-Ceutical USA Inc. , Chicago , IL , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kharitonova, Elizaveta" sort="Kharitonova, Elizaveta" uniqKey="Kharitonova E" first="Elizaveta" last="Kharitonova">Elizaveta Kharitonova</name><affiliation><nlm:affiliation>c c Creativ-Ceutical , Paris , France.</nlm:affiliation></affiliation></author><author><name sortKey="Hewitt, L Arthur" sort="Hewitt, L Arthur" uniqKey="Hewitt L" first="L Arthur" last="Hewitt">L Arthur Hewitt</name><affiliation><nlm:affiliation>a a Lundbeck LLC , Deerfield , IL , USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26710315</idno><idno type="pmid">26710315</idno><idno type="doi">10.3111/13696998.2015.1136827</idno><idno type="wicri:Area/PubMed/Corpus">000220</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000220</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data.</title><author><name sortKey="Francois, Clement" sort="Francois, Clement" uniqKey="Francois C" first="Clément" last="François">Clément François</name><affiliation><nlm:affiliation>a a Lundbeck LLC , Deerfield , IL , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation><nlm:affiliation>b b University of South Florida , Tampa , FL , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Aballea, Samuel" sort="Aballea, Samuel" uniqKey="Aballea S" first="Samuel" last="Aballéa">Samuel Aballéa</name><affiliation><nlm:affiliation>c c Creativ-Ceutical , Paris , France.</nlm:affiliation></affiliation></author><author><name sortKey="Dorey, Julie" sort="Dorey, Julie" uniqKey="Dorey J" first="Julie" last="Dorey">Julie Dorey</name><affiliation><nlm:affiliation>d d Creativ-Ceutical USA Inc. , Chicago , IL , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kharitonova, Elizaveta" sort="Kharitonova, Elizaveta" uniqKey="Kharitonova E" first="Elizaveta" last="Kharitonova">Elizaveta Kharitonova</name><affiliation><nlm:affiliation>c c Creativ-Ceutical , Paris , France.</nlm:affiliation></affiliation></author><author><name sortKey="Hewitt, L Arthur" sort="Hewitt, L Arthur" uniqKey="Hewitt L" first="L Arthur" last="Hewitt">L Arthur Hewitt</name><affiliation><nlm:affiliation>a a Lundbeck LLC , Deerfield , IL , USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of medical economics</title><idno type="eISSN">1941-837X</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Accidental Falls (economics)</term><term>Aged</term><term>Antiparkinson Agents (economics)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Blood Pressure</term><term>Cost-Benefit Analysis</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Droxidopa (economics)</term><term>Droxidopa (therapeutic use)</term><term>Female</term><term>Humans</term><term>Hypotension, Orthostatic (drug therapy)</term><term>Hypotension, Orthostatic (etiology)</term><term>Male</term><term>Markov Chains</term><term>Parkinson Disease (complications)</term><term>Quality-Adjusted Life Years</term></keywords><keywords scheme="MESH" type="chemical" qualifier="economics" xml:lang="en"><term>Antiparkinson Agents</term><term>Droxidopa</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hypotension, Orthostatic</term></keywords><keywords scheme="MESH" qualifier="economics" xml:lang="en"><term>Accidental Falls</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Hypotension, Orthostatic</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Droxidopa</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Blood Pressure</term><term>Cost-Benefit Analysis</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Markov Chains</term><term>Quality-Adjusted Life Years</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26710315</PMID><DateCreated><Year>2016</Year><Month>04</Month><Day>20</Day></DateCreated><DateCompleted><Year>2017</Year><Month>01</Month><Day>23</Day></DateCompleted><DateRevised><Year>2017</Year><Month>01</Month><Day>23</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1941-837X</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><Issue>5</Issue><PubDate><Year>2016</Year></PubDate></JournalIssue><Title>Journal of medical economics</Title><ISOAbbreviation>J Med Econ</ISOAbbreviation></Journal><ArticleTitle>Cost-effectiveness of droxidopa in patients with neurogenic orthostatic hypotension: post-hoc economic analysis of Phase 3 clinical trial data.</ArticleTitle><Pagination><MedlinePgn>515-25</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3111/13696998.2015.1136827</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="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.</AbstractText><AbstractText Label="METHODS" NlmCategory="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.</AbstractText><AbstractText Label="RESULTS" NlmCategory="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.</AbstractText><AbstractText Label="LIMITATIONS" NlmCategory="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.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>François</LastName><ForeName>Clément</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>a a Lundbeck LLC , Deerfield , IL , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>b b University of South Florida , Tampa , FL , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aballéa</LastName><ForeName>Samuel</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>c c Creativ-Ceutical , Paris , France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dorey</LastName><ForeName>Julie</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>d d Creativ-Ceutical USA Inc. , Chicago , IL , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kharitonova</LastName><ForeName>Elizaveta</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>c c Creativ-Ceutical , Paris , France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hewitt</LastName><ForeName>L Arthur</ForeName><Initials>LA</Initials><AffiliationInfo><Affiliation>a a Lundbeck LLC , Deerfield , IL , USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>01</Month><Day>18</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Med Econ</MedlineTA><NlmUniqueID>9892255</NlmUniqueID><ISSNLinking>1369-6998</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>J7A92W69L7</RegistryNumber><NameOfSubstance UI="D015103">Droxidopa</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000058" MajorTopicYN="N">Accidental Falls</DescriptorName><QualifierName UI="Q000191" MajorTopicYN="N">economics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000978" MajorTopicYN="N">Antiparkinson Agents</DescriptorName><QualifierName UI="Q000191" MajorTopicYN="Y">economics</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001794" MajorTopicYN="N">Blood Pressure</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003362" MajorTopicYN="N">Cost-Benefit Analysis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004305" MajorTopicYN="N">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015103" MajorTopicYN="N">Droxidopa</DescriptorName><QualifierName UI="Q000191" MajorTopicYN="Y">economics</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007024" MajorTopicYN="N">Hypotension, Orthostatic</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008390" MajorTopicYN="N">Markov Chains</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010300" MajorTopicYN="N">Parkinson Disease</DescriptorName><QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019057" MajorTopicYN="N">Quality-Adjusted Life Years</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Cost-effectiveness</Keyword><Keyword MajorTopicYN="N">Droxidopa</Keyword><Keyword MajorTopicYN="N">Falls</Keyword><Keyword MajorTopicYN="N">Neurogenic orthostatic hypotension (nOH)</Keyword><Keyword MajorTopicYN="N">Norepinephrine</Keyword><Keyword MajorTopicYN="N">Parkinson’s disease</Keyword><Keyword MajorTopicYN="N">Quality-adjusted life-years (QALYs)</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>12</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>12</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>1</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26710315</ArticleId><ArticleId IdType="doi">10.3111/13696998.2015.1136827</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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