A generalized health economic and outcomes research model for the evaluation of companion diagnostics and targeted therapies

Lee, James A.; Tollefson, Erik; Daly, Matthew; Kielb, Edward

doi:10.1586/erp.13.23

Cited by 10 publications

(8 citation statements)

References 25 publications

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“…Current health economic assessment methodologies consider cost and clinical benefit of drug therapies and diagnostics separately. 17 There are evidential and analytical limitations to the application of traditional health economic modeling methodologies to the evaluation of precision therapeutics. Gaps in evidence exist when patient numbers are restricted, and there may be a lack of comparator data in single arm studies from pivotal trials.…”

Section: Methodology For Economic Evaluationmentioning

confidence: 99%

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The emergence of precision therapeutics

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et al. 2015

Healthc Manage Forum

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In the era of personalized and precision medicine, the approach to healthcare is quickly changing. Genetic and other molecular information are being increasingly demanded by clinicians and expected by patients for prevention, screening, diagnosis, prognosis, health promotion, and treatment of an increasing number of conditions. As a result of these developments, Canadian health leaders must understand and be prepared to lead the necessary changes associated with these disruptive technologies. This article focuses on precision therapeutics but also provides background on the concepts and terminology related to personalized and precision medicine and explores Canadian health leadership and system issues that may pose barriers to their implementation. The article is intended to inspire, educate, and mobilize Canadian health leaders to initiate dialogue around the transformative changes necessary to ready the healthcare system to realize the benefits of precision therapeutics.

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Section: Methodology For Economic Evaluationmentioning

confidence: 99%

“…Current health economic assessment methodologies consider cost and clinical benefit of drug therapies and diagnostics separately. 17…”

Section: Challenges To and Opportunities For Implementation In Canadamentioning

confidence: 99%

The emergence of precision therapeutics

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Racette³

et al. 2015

Healthc Manage Forum

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“…Besides, data collection was carried out by a member of the expert team, limiting bias in the data collection. ERAS programmes have showed to be cost-saving [ 39 , 30 ]. However, resistance to implement ERAS may arise due to competing priorities and pressure in the workplace.…”

Section: Discussionmentioning

confidence: 99%

A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial

et al. 2015

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BackgroundEnhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands.MethodsAll Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary outcome is length of postoperative hospital stay. Additional outcome measures are length of recovery, guideline adherence, and mean implementation costs per patient.DiscussionThis study takes up the challenge to evaluate an efficient strategy for large-scale implementation. Comparing effectiveness and costs of two different approaches, this study will help to define a preferred strategy for nationwide dissemination of best practices.Trial registrationDutch Trial Register NTR4058

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“…Les méthodologies actuelles d'évaluatioń economique de la santé sont analysées séparément selon les coûts et les avantages cliniques des traitements pharmacologiques et des diagnostics 17 .…”

Section: La Méthodologie De L'évaluationéconomiqueunclassified

“…Les directives et l’expérience de l’analyse de l’économie de la santé sont trop limitées pour qu’il soit possible de procéder à l’évaluation économique d’un diagnostic compagnon et du traitement qu’il cible. Les méthodologies actuelles d’évaluation économique de la santé sont analysées séparément selon les coûts et les avantages cliniques des traitements pharmacologiques et des diagnostics 17 .…”

Section: Les Défis Et Les Possibilités Liés à La Mise En œUvre Au Canadaunclassified

L’émergence de la thérapeutique de précision

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À l'ère de la médecine personnalisée et de la médecine de précision, l'approche envers les soins est en rapide mutation. Les cliniciens exigent de plus en plus d'information génétique et moléculaire et les patients s'attendent à la fournir pour la prévention, le dépistage, le diagnostic, le pronostic, la promotion de la santé et le traitement d'un nombre croissant de maladies. Les leaders en santé canadiens doivent comprendre les changements nécessaires liés à ces technologies perturbantes et ouvrir la voie. Le présent article s'attarde sur la thérapeutique de précision, mais contient également de l'information générale sur les concepts et la terminologie liés à la médecine personnalisée et à la médecine de précision. Il explore également le leadership en santé canadien et les problèmes liés au système qui peuvent nuire à leur mise en œuvre. L'article vise à inspirer, informer et mobiliser les leaders en santé canadiens à amorcer un dialogue sur les transformations nécessaires pour préparer le système de santé à profiter des bienfaits de la thérapeutique de précision.

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A generalized health economic and outcomes research model for the evaluation of companion diagnostics and targeted therapies

Abstract: While obtaining accurate data on therapy cost and benefits, test performance remains a key challenge in these analyses, the model presents key trade-offs and priorities for research to obtain more accurate clinical and economic information.

Cited by 10 publications

References 25 publications

The emergence of precision therapeutics

The emergence of precision therapeutics

A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial

L’émergence de la thérapeutique de précision

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