What is the budget impact of a new treatment or new health technology arriving on the market?

Dervaux, B.; Fur, C. Le; Dubois, Sophie; Josseran, Anne; Baseilhac, Éric; Baumstark, Luc; Blin, Olivier; Bresse, Xavier; Debroucker, Frédérique; Delaitre, Olivier; Detournay, B.; Diebolt, Vincent; Durand‐Zaleski, Isabelle; Gaudin, Anne-Françoise; Huot, Laure; Jeanblanc, Grégoire; Launois, R; Lévesque, Karine; Lévy-Bachelot, L.

doi:10.1016/j.therap.2016.12.003

Cited by 2 publications

(3 citation statements)

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“…The level of innovation a drug brings to the market is determined by the drug’s improvement of medical benefit or ASMR compared to the current standard of care. The ASMR assigns ratings from I to V, based on the level of improvement; a drug with an ASMR level I, II or III is considered an innovative drug [ 38 , 39 ]. Iordatii et al define innovation as a new therapeutic option to treat a health problem for which there may already be an existing therapeutic arsenal that is targeting a disease, a symptom, or a risk factor.…”

Section: Resultsmentioning

confidence: 99%

“…On average, five to six articles were published each year and of 65 articles, 38 (58%) were published from 2010 to 2015 and 27 (42%) were published from 2016 to 2020. Several articles referred to the US Food and Drug Administration's (FDA) definition of innovation in the USA [21][22][23][24][25][26][27][28][29], the National Institute for Health and Care Excellence's (NICE) including Kennedy's short study for NICE in the UK [30][31][32][33][34][35][36][37] and the Amelioration du service [38][39][40][41][42]. The most common factor considered while defining innovation was therapeutic benefit as a measure of innovativeness across countries.…”

Section: Definitions Of Innovationmentioning

confidence: 99%

“…The level of innovation a drug brings to the market is determined by the drug's improvement of medical benefit or ASMR compared to the current standard of care. The ASMR assigns ratings from I to V, based on the level of improvement; a drug with an ASMR level I, II or III is considered an innovative drug [38,39]. Iordatii Captures benefits provided around market access, and data or patent protection for an innovative product/ therapy, includes incentives provided specifically to innovations for rare diseases (including orphan drugs) and includes incentives provided for innovations targeted towards pediatric populations Priority/fast-track review Captures benefits provided around accelerated regulatory approvals there may already be an existing therapeutic arsenal that is targeting a disease, a symptom, or a risk factor.…”

Section: Definitions Of Innovationmentioning

confidence: 99%

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Assessing Definitions and Incentives Adopted for Innovation for Pharmaceutical Products in Five High-Income Countries: A Systematic Literature Review

et al. 2023

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Background The concept of health care innovation varies across organizations and countries. Harmonizing the definitions of innovation can augment the discovery of new therapies, minimize costs, and streamline drug development and approval processes. A systematic literature review (SLR) was conducted to gather insights surrounding different elements of innovation in the USA, the UK, France, Germany, and Japan. The SLR identified studies that have defined innovation and captured the types of incentives provided to promote innovation. Methods The MEDLINE, Embase, and EconLit databases were searched via the OVID SP platform on October 22, 2020. A secondary desk search literature review was performed to identify additional information of interest in regional languages: French, German, and Japanese. All the relevant literature in English was screened using the Linguamatics natural language processing (NLP) tool, except for articles from EconLit, which were screened manually using structured search strategies. Articles that describe a definition of innovation or refer to a definition of innovation published were included. All full-text articles were reviewed manually, and two reviewers independently screened the full texts for eligibility. Results After screening, 90 articles were considered to meet the SLR objectives. The most common dimension of innovation identified was therapeutic benefit as a measure of innovation, followed by newness and novelty aspects of innovations. Incentives around exclusivities were found to be the most prevalent in the data set, followed by rewards and premiums. Among the different therapy areas, the largest number of innovations was targeted at oncology. Conclusions This SLR highlights the lack of a unified definition of innovation among regulatory authorities and health technology assessment bodies in five countries, and variation in the types of incentives associated with innovation. The targeted countries cover different dimensions of definition and incentives of innovation at varying levels, with a few focused on specific therapy areas. Harmonization and consensus for innovation would be needed across countries because drug development is a global undertaking. This SLR envisages a more holistic approach to evaluation, wherein the value provided to patients and health systems is accounted for. The results of this SLR will help to promote broader discussion among different stakeholders and decision makers across countries to identify gaps in policies and develop sustainable strategies to promote innovation for pharmaceutical products. Supplementary Information The online version contains supplementary material available at 10.1007/s40290-022-00457-5.

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Section: Resultsmentioning

confidence: 99%