Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations
Health technology assessment (HTA) plays an important role in reimbursement decision-making in many countries, but recommendations vary widely throughout jurisdictions, even for the same drug. This variation may be due to differences in the weighing of evidence or differences in the processes or pro...
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| Veröffentlicht in: | Value in health 2020-01, Vol.23 (1), p.10-16 |
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| creator | Vreman, Rick A. Mantel-Teeuwisse, Aukje K. Hövels, Anke M. Leufkens, Hubert G.M. Goettsch, Wim G. |
| description | Health technology assessment (HTA) plays an important role in reimbursement decision-making in many countries, but recommendations vary widely throughout jurisdictions, even for the same drug. This variation may be due to differences in the weighing of evidence or differences in the processes or procedures, which are known as HTA practices.
To provide insight into the effects of differences in practices on interpretation of intercountry differences in HTA recommendations for conditionally approved drugs.
HTA recommendations for conditionally approved drugs (N = 27) up until June 2017 from England/Wales, France, Germany, the Netherlands, and Scotland were included. Recommendations and practice characteristics were extracted from these five jurisdictions and this data was validated. The effect of nonsubmissions, resubmissions, and reassessments; cost-effectiveness assessments; and price negotiations on changes in the percentage of negative recommendations and the interpretation of intercountry differences in HTA outcomes were analyzed using Fisher exact tests.
The inclusion of cost-effectiveness assessments led to significant increases in the proportion of negative recommendations in England/Wales (from 4% to 50%, P |
| doi_str_mv | 10.1016/j.jval.2019.07.017 |
| format | Article |
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To provide insight into the effects of differences in practices on interpretation of intercountry differences in HTA recommendations for conditionally approved drugs.
HTA recommendations for conditionally approved drugs (N = 27) up until June 2017 from England/Wales, France, Germany, the Netherlands, and Scotland were included. Recommendations and practice characteristics were extracted from these five jurisdictions and this data was validated. The effect of nonsubmissions, resubmissions, and reassessments; cost-effectiveness assessments; and price negotiations on changes in the percentage of negative recommendations and the interpretation of intercountry differences in HTA outcomes were analyzed using Fisher exact tests.
The inclusion of cost-effectiveness assessments led to significant increases in the proportion of negative recommendations in England/Wales (from 4% to 50%, P<.01) and Scotland (from 21% to 71%, P<.01). The subsequent inclusion of price negotiations led to significant reductions in the proportion of negative recommendations in England/Wales (from 50% to 14%, P<.01), France (from 31% to 3%, P=.012), and Germany (from 34% to 0%, P<.01). Results indicated that the inclusion of nonsubmissions and resubmissions might affect Scottish negative HTA recommendations (from 7% to 21%), but this effect was not significant. No significant effects were observed in the Netherlands, possibly owing to sample size.
Variations in HTA practices between international jurisdictions can have a substantial and significant impact on conclusions about recommendations by HTA bodies, as exemplified in this cohort of conditionally approved products. Studies comparing international HTA recommendations should carefully consider possible practice variations between jurisdictions.
•Health technology assessment (HTA) plays an important role in reimbursement decision-making.•HTA recommendations vary widely throughout Europe, even for the same drug.•Factors may be associated with variations and can be categorized into factors related to value assessment and factors related to practice variations.•Appropriately considering differences in practices can change conclusions on international HTA recommendation comparisons.•The inclusion of cost-effectiveness assessments and price negotiations significantly altered conclusions within the European jurisdictions for the products in this study. The ability of nonsubmissions and resubmissions/reassessments played a minor role.•When comparing HTA recommendations between jurisdictions, the possible presence of practice related differences should be taken into account.•Multivariable models that try to predict HTA outcomes should appropriately consider practice differences between countries and within countries (e.g., different types of drugs have different processes).</description><identifier>ISSN: 1098-3015</identifier><identifier>EISSN: 1524-4733</identifier><identifier>DOI: 10.1016/j.jval.2019.07.017</identifier><identifier>PMID: 31952664</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>conditional marketing authorization ; Cost analysis ; cost-effectiveness assessment ; Decision making ; differences ; evidence ; Health technology assessment ; Jurisdiction ; Medical technology ; Negotiation ; practice ; procedure ; process ; Public health ; regulation ; reimbursement ; relative-effectiveness assessment ; Technology assessment ; Variation ; Weighing</subject><ispartof>Value in health, 2020-01, Vol.23 (1), p.10-16</ispartof><rights>2019 ISPOR–The Professional Society for Health Economics and Outcomes Research</rights><rights>Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Science Ltd. Jan 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c498t-ca93288256aa1498b4d7f6f61972f919c76944b69746cdef5007efd475610c623</citedby><cites>FETCH-LOGICAL-c498t-ca93288256aa1498b4d7f6f61972f919c76944b69746cdef5007efd475610c623</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jval.2019.07.017$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,30999,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31952664$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vreman, Rick A.</creatorcontrib><creatorcontrib>Mantel-Teeuwisse, Aukje K.</creatorcontrib><creatorcontrib>Hövels, Anke M.</creatorcontrib><creatorcontrib>Leufkens, Hubert G.M.</creatorcontrib><creatorcontrib>Goettsch, Wim G.</creatorcontrib><title>Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations</title><title>Value in health</title><addtitle>Value Health</addtitle><description>Health technology assessment (HTA) plays an important role in reimbursement decision-making in many countries, but recommendations vary widely throughout jurisdictions, even for the same drug. This variation may be due to differences in the weighing of evidence or differences in the processes or procedures, which are known as HTA practices.
To provide insight into the effects of differences in practices on interpretation of intercountry differences in HTA recommendations for conditionally approved drugs.
HTA recommendations for conditionally approved drugs (N = 27) up until June 2017 from England/Wales, France, Germany, the Netherlands, and Scotland were included. Recommendations and practice characteristics were extracted from these five jurisdictions and this data was validated. The effect of nonsubmissions, resubmissions, and reassessments; cost-effectiveness assessments; and price negotiations on changes in the percentage of negative recommendations and the interpretation of intercountry differences in HTA outcomes were analyzed using Fisher exact tests.
The inclusion of cost-effectiveness assessments led to significant increases in the proportion of negative recommendations in England/Wales (from 4% to 50%, P<.01) and Scotland (from 21% to 71%, P<.01). The subsequent inclusion of price negotiations led to significant reductions in the proportion of negative recommendations in England/Wales (from 50% to 14%, P<.01), France (from 31% to 3%, P=.012), and Germany (from 34% to 0%, P<.01). Results indicated that the inclusion of nonsubmissions and resubmissions might affect Scottish negative HTA recommendations (from 7% to 21%), but this effect was not significant. No significant effects were observed in the Netherlands, possibly owing to sample size.
Variations in HTA practices between international jurisdictions can have a substantial and significant impact on conclusions about recommendations by HTA bodies, as exemplified in this cohort of conditionally approved products. Studies comparing international HTA recommendations should carefully consider possible practice variations between jurisdictions.
•Health technology assessment (HTA) plays an important role in reimbursement decision-making.•HTA recommendations vary widely throughout Europe, even for the same drug.•Factors may be associated with variations and can be categorized into factors related to value assessment and factors related to practice variations.•Appropriately considering differences in practices can change conclusions on international HTA recommendation comparisons.•The inclusion of cost-effectiveness assessments and price negotiations significantly altered conclusions within the European jurisdictions for the products in this study. The ability of nonsubmissions and resubmissions/reassessments played a minor role.•When comparing HTA recommendations between jurisdictions, the possible presence of practice related differences should be taken into account.•Multivariable models that try to predict HTA outcomes should appropriately consider practice differences between countries and within countries (e.g., different types of drugs have different processes).</description><subject>conditional marketing authorization</subject><subject>Cost analysis</subject><subject>cost-effectiveness assessment</subject><subject>Decision making</subject><subject>differences</subject><subject>evidence</subject><subject>Health technology assessment</subject><subject>Jurisdiction</subject><subject>Medical technology</subject><subject>Negotiation</subject><subject>practice</subject><subject>procedure</subject><subject>process</subject><subject>Public health</subject><subject>regulation</subject><subject>reimbursement</subject><subject>relative-effectiveness assessment</subject><subject>Technology assessment</subject><subject>Variation</subject><subject>Weighing</subject><issn>1098-3015</issn><issn>1524-4733</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>7QJ</sourceid><recordid>eNp9kU1v1DAQhi0EoqXwBzggS1y4JNiOP2LEZVX6AaoEqhaultcZdx0l8dZOKu2_x9stHDhw8mj8vKPRPAi9paSmhMqPfd0_2KFmhOqaqJpQ9QydUsF4xVXTPC810W3VECpO0Kuce0KIbJh4iU4aqgWTkp-i_ZfgPSSYHGQcJnwNdpi3eA1uO8Uh3u3xKmfIeYRpxrfg4liqzs4hThmvxjjd4YslxR3YCX9bUshdcI-fn_B6C_g2DoCjxz-SLW0H-JdN4Zh-jV54O2R48_SeoZ-XF-vz6-rm-9XX89VN5bhu58pZ3bC2ZUJaS0tnwzvlpZdUK-Y11U5JzflGasWl68ALQhT4jishKXGSNWfow3HuLsX7BfJsxpAdDIOdIC7ZsIZTSVrxiL7_B-3jkqayXaFEQ8rxWl4odqRcijkn8GaXwmjT3lBiDmJMbw5izEGMIcoUMSX07mn0shmh-xv5Y6IAn48AlFs8BEgmu3DQ0oUEbjZdDP-b_xvia58a</recordid><startdate>20200101</startdate><enddate>20200101</enddate><creator>Vreman, Rick A.</creator><creator>Mantel-Teeuwisse, Aukje K.</creator><creator>Hövels, Anke M.</creator><creator>Leufkens, Hubert G.M.</creator><creator>Goettsch, Wim G.</creator><general>Elsevier Inc</general><general>Elsevier Science Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QJ</scope><scope>7X8</scope></search><sort><creationdate>20200101</creationdate><title>Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations</title><author>Vreman, Rick A. ; Mantel-Teeuwisse, Aukje K. ; Hövels, Anke M. ; Leufkens, Hubert G.M. ; Goettsch, Wim G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c498t-ca93288256aa1498b4d7f6f61972f919c76944b69746cdef5007efd475610c623</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>conditional marketing authorization</topic><topic>Cost analysis</topic><topic>cost-effectiveness assessment</topic><topic>Decision making</topic><topic>differences</topic><topic>evidence</topic><topic>Health technology assessment</topic><topic>Jurisdiction</topic><topic>Medical technology</topic><topic>Negotiation</topic><topic>practice</topic><topic>procedure</topic><topic>process</topic><topic>Public health</topic><topic>regulation</topic><topic>reimbursement</topic><topic>relative-effectiveness assessment</topic><topic>Technology assessment</topic><topic>Variation</topic><topic>Weighing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vreman, Rick A.</creatorcontrib><creatorcontrib>Mantel-Teeuwisse, Aukje K.</creatorcontrib><creatorcontrib>Hövels, Anke M.</creatorcontrib><creatorcontrib>Leufkens, Hubert G.M.</creatorcontrib><creatorcontrib>Goettsch, Wim G.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><collection>MEDLINE - Academic</collection><jtitle>Value in health</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vreman, Rick A.</au><au>Mantel-Teeuwisse, Aukje K.</au><au>Hövels, Anke M.</au><au>Leufkens, Hubert G.M.</au><au>Goettsch, Wim G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations</atitle><jtitle>Value in health</jtitle><addtitle>Value Health</addtitle><date>2020-01-01</date><risdate>2020</risdate><volume>23</volume><issue>1</issue><spage>10</spage><epage>16</epage><pages>10-16</pages><issn>1098-3015</issn><eissn>1524-4733</eissn><abstract>Health technology assessment (HTA) plays an important role in reimbursement decision-making in many countries, but recommendations vary widely throughout jurisdictions, even for the same drug. This variation may be due to differences in the weighing of evidence or differences in the processes or procedures, which are known as HTA practices.
To provide insight into the effects of differences in practices on interpretation of intercountry differences in HTA recommendations for conditionally approved drugs.
HTA recommendations for conditionally approved drugs (N = 27) up until June 2017 from England/Wales, France, Germany, the Netherlands, and Scotland were included. Recommendations and practice characteristics were extracted from these five jurisdictions and this data was validated. The effect of nonsubmissions, resubmissions, and reassessments; cost-effectiveness assessments; and price negotiations on changes in the percentage of negative recommendations and the interpretation of intercountry differences in HTA outcomes were analyzed using Fisher exact tests.
The inclusion of cost-effectiveness assessments led to significant increases in the proportion of negative recommendations in England/Wales (from 4% to 50%, P<.01) and Scotland (from 21% to 71%, P<.01). The subsequent inclusion of price negotiations led to significant reductions in the proportion of negative recommendations in England/Wales (from 50% to 14%, P<.01), France (from 31% to 3%, P=.012), and Germany (from 34% to 0%, P<.01). Results indicated that the inclusion of nonsubmissions and resubmissions might affect Scottish negative HTA recommendations (from 7% to 21%), but this effect was not significant. No significant effects were observed in the Netherlands, possibly owing to sample size.
Variations in HTA practices between international jurisdictions can have a substantial and significant impact on conclusions about recommendations by HTA bodies, as exemplified in this cohort of conditionally approved products. Studies comparing international HTA recommendations should carefully consider possible practice variations between jurisdictions.
•Health technology assessment (HTA) plays an important role in reimbursement decision-making.•HTA recommendations vary widely throughout Europe, even for the same drug.•Factors may be associated with variations and can be categorized into factors related to value assessment and factors related to practice variations.•Appropriately considering differences in practices can change conclusions on international HTA recommendation comparisons.•The inclusion of cost-effectiveness assessments and price negotiations significantly altered conclusions within the European jurisdictions for the products in this study. The ability of nonsubmissions and resubmissions/reassessments played a minor role.•When comparing HTA recommendations between jurisdictions, the possible presence of practice related differences should be taken into account.•Multivariable models that try to predict HTA outcomes should appropriately consider practice differences between countries and within countries (e.g., different types of drugs have different processes).</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>31952664</pmid><doi>10.1016/j.jval.2019.07.017</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| source | Elsevier ScienceDirect Journals Complete; Applied Social Sciences Index & Abstracts (ASSIA); EZB-FREE-00999 freely available EZB journals |
| subjects | conditional marketing authorization Cost analysis cost-effectiveness assessment Decision making differences evidence Health technology assessment Jurisdiction Medical technology Negotiation practice procedure process Public health regulation reimbursement relative-effectiveness assessment Technology assessment Variation Weighing |
| title | Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations |
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