Factors impacting the Medical and Diagnostic Device sector in early fall 2022 in France. Health Technology Organizational Impact Evaluation.

These organizational impacts of health technologies are often claimed or mentioned during the assessment of a medicine or a medical technology or procedure. They are also one of the key eligibility criteria to the CEESP health economic assessment. Nevertheless, until now, these effects of a medical technology are still not taken into consideration during HAS assessment. Framing the organizational effect’s suspected multi-dimensional and structural role in healthcare has been expected by most caregivers, service providers and facilities for a long time. HAS strategic project for 2019- 2024 intends to identify, accompany and follow-up on organizational improvements in care, better patient pathways and coordination between healthcare providers.

A framework defining organizational impacts and outcomes used to measure their effects has been published by the HAS in 2019 and is intended to inform the coverage decision. Indeed, a deep understanding of the way that a technology would impact the healthcare is until now, an unmet need. It is gaining more importance with the upcoming RPM coverage envisioned in the PLFSS 2022, the increased increasing focus on Personalized Medicine, connected health applications, decentralized clinical trials, etc.…

The mapping published by HAS makes it possible to structure the way in which the organizational impacts of a health technology can be identified and measured according to the involved stakeholders, through a classification around the following three macro-criteria:

1.??????impacts directly affecting the components of the care process

2.??????impacts affecting the necessary skills and capacities of the stakeholders involved in the implementation of the care process (training, learning)

3.??????impacts on the general population.

For each of these criteria,

1.??????choice of criteria corresponding to the most relevant organizational impacts according to concerned actors

2.??????proposal of indicators making it possible to objectify each retained criteria and to identify the data to be provided

3.????examples of health technologies to help the user clearly identify the scope of the impact studied and its characteristics

The published mapping does not explain by which means organizational impact will be measured by the CNEDIMTS, CT, CEESP commissions or HAS college. It is also too soon to evaluate if and how this assessment is considered in the pricing of the considered technology. This first step towards organizational impact assessment will undoubtably be followed by others, probably leading to a future clear guideline, and integrating this effect in HAS opinions and further.

It is also noteworthy to highlight the fact that HAS mapping methodology is moving closer towards Value Based Healthcare framework.

Can its organizational impact affect positively the value of your medical device?

Deep understanding of the reimbursement regulation, regulatory watch, validation of patient pathways with sectorial and field experts can help transform your device’s organizational impact into value and transform this value into corporate access strategy in Europe and Asia Pacific.

Let Alira Health?support your company in your global access strategy, countries prioritization to reimbursement dossiers submission. Please leave us a message here:?https://alirahealth.com/contact-us/?so we can get into contact with you.?

Ons Ben Dhia,?Charlotte Decaudaveine,?Anjali Ramkeesoon,?Stelina Tsantila,?Panagiotis Stylos,?Jamie Erskine,?Simon Verdonck,?Simon Verdonck,?Albert Canela,?Richard Charter ??

This article is # 2 out of a serie of 3, find others here:

(1)Towards a legal framework for advanced diagnostics in France: https://www.dhirubhai.net/pulse/potential-factors-impacting-medical-diagnostic-device-michel

(3)Remote patients monitoring systems, Télésurveillance 2022: https://www.dhirubhai.net/pulse/potential-factors-impacting-medical-diagnostic-device-michel-1e