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Integrated to the e-health field, digital therapeutics can be defined as "software, combined or not to a device, in the purpose of prevention, treatment or monitoring of a disease, participating actively in a mechanism of action and based on strong clinical evidence". The aim of this work was to assess the level of digital therapeutics clinical validation and to reflect on their business model. A qualitative study has been conducted and different health actors have been interviewed. The semi-guided interviews made have been analysed through a three-level coding. Twenty-two interviews have been analysed and six categories have been identified. The interlocutors highlighted the leading role of digital therapeutics in the follow-up and prevention, supporting the empowerment of patients. However, the absence of consensus in their definition has led to heterogeneity of definition and a difficulty to limit their scope. Furthermore, the conduct of clinical trials, not really suited for digital therapeutics, forced the editors/manufacturers to search for funding for which availability and continuity are uncertain. By raising the issue of clinical efficacy, demonstration of digital therapeutics, this study has led to new perspectives in assessment and business model. We could see in digital therapeutics a new nature of innovation associated with new organisations of our healthcare system and not necessarily by new therapeutics., (Copyright © 2021 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Across global borders and throughout the various sectors of health care, the search for viable methods to pay for value has intensified. Driven by soaring costs and constrained budgets, public and private payers are seeking innovative ways to incentivize providers and product manufacturers to focus on effective outcomes for patients according to key performance indexes. Conditional pricing and performance-based payment for innovative medicines could facilitate access to quasi-monopsonic french market, in a context of financial crisis, loss of reciprocal confidence, and growing aversion for therapeutic and economical uncertainty. However, we consider these new methods of payment should not be termed "risk-sharing agreements", a misleading term despite its common use today. They also should not impact the national list prices of medicines, that is a decisive tool for stabilizing international trade., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Market Access Agreements (MAA) for drugs have emerged in response to the need to control health expenditures, as well as to the uncertainty about the true benefit of a drug. It is possible to group MAA in two types of agreements: financial agreements and outcome-based agreements. MAA is a growing trend and is shifting towards conditional access. However, the willingness to use these contracts and their implementation differ across countries, and some are still resistant to put them in place. The MAA challenges to overcome encompass the complexity of the schemes, the administrative burden and the difficulty of evaluating MAA. It is likely that these agreements might experience further evolution in the future to become a faster pathway for therapeutic innovations, at a fair price., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

In recent decades, the pharmaceutical industry as built a high level of confidence thanks to innovative medicines that improve both duration and quality of life. Some recent scandals have however discredited this industry, now suspected of cheating or bribery. Even the scientific progresses are challenged on the ground of possible conflicts of interests and value uncertainty. This situation is deleterious. Simultaneously the economic crisis exacerbates the payers' expectations in terms of clinical value and value/price ratio. It also stimulates the demand for outcomes in real life. This induces a new economic approach for the market access of highly expensive reimbursable drugs. It consists in paying only for drugs actually proven effective in terms of actual outcomes, with a full or partial refund of the payer in case of failure, according to accurate and simple criteria in so called "performance agreement". Confidence is restored accordingly., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)