Cargando…
Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company
OBJECTIVES: Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model(®) provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an indu...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6521787/ https://www.ncbi.nlm.nih.gov/pubmed/30789111 http://dx.doi.org/10.1017/S0266462318003653 |
_version_ | 1783419031870504960 |
---|---|
author | Ducournau, Pierre Irl, Cornelia Tatt, Iain McCarvil, Mary Gyldmark, Marlene |
author_facet | Ducournau, Pierre Irl, Cornelia Tatt, Iain McCarvil, Mary Gyldmark, Marlene |
author_sort | Ducournau, Pierre |
collection | PubMed |
description | OBJECTIVES: Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model(®) provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an industry perspective and was used by pharmaceutical company Roche to develop a framework for internal assessment of evidence required for market access and coverage/reimbursement (“access evidence”). METHODS: Tools were developed to systematically scope, assess, plan, and summarize access evidence generation. The tools were based mainly on the first four HTA Core Model(®) domains and rolled-out in selected development teams in 2017. Five months after full implementation, the impact of tools was assessed in an internal survey. RESULTS: Systematic access evidence generation started with the Access Evidence Questionnaire, to scope evidence requirements and identify evidence gaps. Findings were summarized in the Access Evidence Metric, which assessed the alignment of available/planned evidence against HTA bodies’ requirements and developed scope mitigation strategies. The Access Evidence Plan was then used to plan and document (additional) evidence generation. Once generated, evidence was summarized in the Access Evidence Dossier. A survey of twenty-seven Roche employees involved in evidence generation showed that the tools made discussions around access strategies and evidence more efficient and transparent. CONCLUSIONS: The HTA Core Model(®) provided a useful framework around which to optimize internal evidence generation and assessment. The benefits of using a standardized HTA approach in industry mirror those expected from implementing the HTA Core Model® in HTA agencies. |
format | Online Article Text |
id | pubmed-6521787 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-65217872019-05-29 Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company Ducournau, Pierre Irl, Cornelia Tatt, Iain McCarvil, Mary Gyldmark, Marlene Int J Technol Assess Health Care Method OBJECTIVES: Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model(®) provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an industry perspective and was used by pharmaceutical company Roche to develop a framework for internal assessment of evidence required for market access and coverage/reimbursement (“access evidence”). METHODS: Tools were developed to systematically scope, assess, plan, and summarize access evidence generation. The tools were based mainly on the first four HTA Core Model(®) domains and rolled-out in selected development teams in 2017. Five months after full implementation, the impact of tools was assessed in an internal survey. RESULTS: Systematic access evidence generation started with the Access Evidence Questionnaire, to scope evidence requirements and identify evidence gaps. Findings were summarized in the Access Evidence Metric, which assessed the alignment of available/planned evidence against HTA bodies’ requirements and developed scope mitigation strategies. The Access Evidence Plan was then used to plan and document (additional) evidence generation. Once generated, evidence was summarized in the Access Evidence Dossier. A survey of twenty-seven Roche employees involved in evidence generation showed that the tools made discussions around access strategies and evidence more efficient and transparent. CONCLUSIONS: The HTA Core Model(®) provided a useful framework around which to optimize internal evidence generation and assessment. The benefits of using a standardized HTA approach in industry mirror those expected from implementing the HTA Core Model® in HTA agencies. Cambridge University Press 2019 /pmc/articles/PMC6521787/ /pubmed/30789111 http://dx.doi.org/10.1017/S0266462318003653 Text en © Cambridge University Press 2019 http://creativecommons.org/licenses/by/4.0/ This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Method Ducournau, Pierre Irl, Cornelia Tatt, Iain McCarvil, Mary Gyldmark, Marlene Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company |
title | Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company |
title_full | Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company |
title_fullStr | Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company |
title_full_unstemmed | Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company |
title_short | Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company |
title_sort | timely, consistent, transparent assessment of market access evidence: implementing tools based on the hta core model® in a pharmaceutical company |
topic | Method |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6521787/ https://www.ncbi.nlm.nih.gov/pubmed/30789111 http://dx.doi.org/10.1017/S0266462318003653 |
work_keys_str_mv | AT ducournaupierre timelyconsistenttransparentassessmentofmarketaccessevidenceimplementingtoolsbasedonthehtacoremodelinapharmaceuticalcompany AT irlcornelia timelyconsistenttransparentassessmentofmarketaccessevidenceimplementingtoolsbasedonthehtacoremodelinapharmaceuticalcompany AT tattiain timelyconsistenttransparentassessmentofmarketaccessevidenceimplementingtoolsbasedonthehtacoremodelinapharmaceuticalcompany AT mccarvilmary timelyconsistenttransparentassessmentofmarketaccessevidenceimplementingtoolsbasedonthehtacoremodelinapharmaceuticalcompany AT gyldmarkmarlene timelyconsistenttransparentassessmentofmarketaccessevidenceimplementingtoolsbasedonthehtacoremodelinapharmaceuticalcompany |