Matches in SemOpenAlex for { <https://semopenalex.org/work/W3111458010> ?p ?o ?g. }
Showing items 1 to 75 of
75
with 100 items per page.
- W3111458010 endingPage "S403" @default.
- W3111458010 startingPage "S403" @default.
- W3111458010 abstract "It is unclear if current pricing and reimbursement policies adequately capture the incremental value of individual indications for multi-indication products. This study aims to map the launch sequence of multi-indication products across seven countries and compares indications in terms of quality of clinical evidence, regulatory approval timelines and HTA approval timelines. Twenty-five multi-indication products were identified with FDA approvals of multiple indications between 2009 and 2019. The FDA approval date was taken as a measure of ‘global launch’. Regulatory agency websites, clinicaltrials.gov, and health technology assessment websites in Germany, France, England, Scotland, Canada, the USA and Australia were screened to extract data on marketing authorisations, clinical trial characteristics, and HTA recommendations for all authorised indications. Descriptive statistics and survival analysis were conducted to identify differences between first and subsequent indications in terms of clinical development time, HTA approval time, and quality of clinical evidence. A total of 113 indications were identified across the 25 multi-indication products. The first globally launched indication was more likely to have regulatory approval and receive HTA approval across all settings than subsequent indications (p<0.001). First indications were more likely to have orphan designations (p<0.001), undergo priority review (p<0.001), have phase II, single arm pivotal trial designs (p<0.001), and use surrogate outcomes as a primary endpoint (p<0.001). No significant differences were detected in clinical development time of first vs subsequent indications. Subsequent indications have significantly shorter HTA approval timelines in England, Germany, Canada, and Australia. Given similar clinical development and HTA approval timelines, it is unlikely that manufacturers are systematically delaying the launch of indications to prioritise first launch of a “high value” indication. However manufacturers and payors do not fully align on the value of indication extensions, leading to a greater probability of subsequent indications not launching within individual settings." @default.
- W3111458010 created "2020-12-21" @default.
- W3111458010 creator A5000839870 @default.
- W3111458010 creator A5042397448 @default.
- W3111458010 creator A5042516460 @default.
- W3111458010 creator A5062250544 @default.
- W3111458010 date "2020-12-01" @default.
- W3111458010 modified "2023-09-26" @default.
- W3111458010 title "HTA4 Clinical Development and HTA Approval of MULTI-Indication Oncology Products: Evidence from Germany, France, England, Scotland, the US, Canada, and Australia" @default.
- W3111458010 doi "https://doi.org/10.1016/j.jval.2020.08.034" @default.
- W3111458010 hasPublicationYear "2020" @default.
- W3111458010 type Work @default.
- W3111458010 sameAs 3111458010 @default.
- W3111458010 citedByCount "3" @default.
- W3111458010 countsByYear W31114580102022 @default.
- W3111458010 crossrefType "journal-article" @default.
- W3111458010 hasAuthorship W3111458010A5000839870 @default.
- W3111458010 hasAuthorship W3111458010A5042397448 @default.
- W3111458010 hasAuthorship W3111458010A5042516460 @default.
- W3111458010 hasAuthorship W3111458010A5062250544 @default.
- W3111458010 hasBestOaLocation W31114580101 @default.
- W3111458010 hasConcept C108170787 @default.
- W3111458010 hasConcept C111472728 @default.
- W3111458010 hasConcept C126322002 @default.
- W3111458010 hasConcept C138885662 @default.
- W3111458010 hasConcept C160735492 @default.
- W3111458010 hasConcept C166957645 @default.
- W3111458010 hasConcept C17744445 @default.
- W3111458010 hasConcept C199539241 @default.
- W3111458010 hasConcept C205649164 @default.
- W3111458010 hasConcept C2779703844 @default.
- W3111458010 hasConcept C2780035454 @default.
- W3111458010 hasConcept C2992293740 @default.
- W3111458010 hasConcept C4438859 @default.
- W3111458010 hasConcept C512399662 @default.
- W3111458010 hasConcept C535046627 @default.
- W3111458010 hasConcept C71924100 @default.
- W3111458010 hasConcept C98274493 @default.
- W3111458010 hasConceptScore W3111458010C108170787 @default.
- W3111458010 hasConceptScore W3111458010C111472728 @default.
- W3111458010 hasConceptScore W3111458010C126322002 @default.
- W3111458010 hasConceptScore W3111458010C138885662 @default.
- W3111458010 hasConceptScore W3111458010C160735492 @default.
- W3111458010 hasConceptScore W3111458010C166957645 @default.
- W3111458010 hasConceptScore W3111458010C17744445 @default.
- W3111458010 hasConceptScore W3111458010C199539241 @default.
- W3111458010 hasConceptScore W3111458010C205649164 @default.
- W3111458010 hasConceptScore W3111458010C2779703844 @default.
- W3111458010 hasConceptScore W3111458010C2780035454 @default.
- W3111458010 hasConceptScore W3111458010C2992293740 @default.
- W3111458010 hasConceptScore W3111458010C4438859 @default.
- W3111458010 hasConceptScore W3111458010C512399662 @default.
- W3111458010 hasConceptScore W3111458010C535046627 @default.
- W3111458010 hasConceptScore W3111458010C71924100 @default.
- W3111458010 hasConceptScore W3111458010C98274493 @default.
- W3111458010 hasLocation W31114580101 @default.
- W3111458010 hasOpenAccess W3111458010 @default.
- W3111458010 hasPrimaryLocation W31114580101 @default.
- W3111458010 hasRelatedWork W1993962612 @default.
- W3111458010 hasRelatedWork W2356800349 @default.
- W3111458010 hasRelatedWork W2520496507 @default.
- W3111458010 hasRelatedWork W2800471553 @default.
- W3111458010 hasRelatedWork W2905846344 @default.
- W3111458010 hasRelatedWork W2906461594 @default.
- W3111458010 hasRelatedWork W3111494103 @default.
- W3111458010 hasRelatedWork W4298825552 @default.
- W3111458010 hasRelatedWork W4311333207 @default.
- W3111458010 hasRelatedWork W4311341747 @default.
- W3111458010 hasVolume "23" @default.
- W3111458010 isParatext "false" @default.
- W3111458010 isRetracted "false" @default.
- W3111458010 magId "3111458010" @default.
- W3111458010 workType "article" @default.