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Log into your account. Sign up. Password recovery. Recover your password. Forgot your password? Get help. Create an account. Share on Facebook. Swiss Journeys: A weekend in the Valais — culture, vineyards and thermal baths. Distinction between concepts of disruptive innovation and incremental innovation is included. We cite for example the use of MRI scanner for the diagnostic of stroke [ 11 ]. The French National Authority for Health HAS consider that a new drug is innovative if one or more of the conditions mentioned bellow are fulfilled:.

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Drug that meet a need that is not or not sufficiently covered [ 12 ]. When authorized and marketed, drugs enabling brain clot thrombolysis were considered as innovative [ 11 ]. Medical or surgical procedure is innovative if it meets the four requirements, set out in instruction no.

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Therefore, it shall:. Be examined with a study of risks associated with its use for patients and healthcare professionals;. Show significant clinical benefit allowing to meet medical need, which is insufficiently or not covered;. The use of thrombectomy, which is an endovascular surgery that aim to mechanically remove the blood clot is a good example of innovative surgical procedure [ 11 ].

The emergence of innovative organisational systems is closely associated with the onset of technical medical innovation. The care of Cerebral Vascular Accident is a good example. The creation of neurovascular units NVUs was closely tied up with the diffusion of innovative drugs, medical imaging equipment and surgical procedure previously cited [ 11 ]. The three following committees carry out this mission:.

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Those data are essential to health technology assessment conducted by the committees mentioned above [ 17 ]. Then, safety and efficiency must be evaluated [ 2 ]. The studies carried out are comparative and randomized as far as possible.

Assessment of medical innovations continues with clinical utility, efficiency and medico-economic studies [ 2 ]. Indeed, the introduction and then the use of innovative health technologies are advantageous for patient care, particularly through the improvement of care pathways. That is why researches that contribute to optimize health care performance and to better understand impact of organisational changes, work practices, health policies and regulation tools, are encouraged in parallel to health technologies assessment [ 4 , 18 ].

Figure 1 shows ex ante evaluation process of medical innovations in France [ 2 ]. Some of the most primary missions of the HAS, as national Health Technology Assessment agency, are to periodically assess expected clinical benefit of health products, acts or health services compare with their provided clinical benefit and support decision making related to registration, reimbursement and management by the French National Health Insurance Assurance maladie of products, acts and health services as well as related to specific conditions of care for individuals with long-term condition [ 19 ].

There are 3 levels of ACB substantial, moderate and low. ISP notion considers public health needs, impact on population health, impact on healthcare system organisation and impact on public health programs and policies [ 21 , 22 ]. There are 5 levels of CAV major, substantial, moderate, minor and no improvement. The level is attributes based on comparative efficacy and safety data with regards to available therapies. This assessment should be carried out if major or substantial or moderate CAV is claimed or is attributed and if a significant impact is expected on the Health National Insurance expenditures.

Therefore, this evaluation is exclusively conducted for medical innovations. It is not unusual that HAS give a favorable opinion for the reimbursement of a medical innovation while it remains uncertainties regarding his use. The doubts may be related to long-term safety or efficiency, effectiveness, respect of indications, or may concern a risk of misuse or unjustified expenditures. In such case, the HAS can apply for post-registration studies. They are supported by the company marketing the innovation [ 2 ]. They tend to gather complementary data, in real use conditions, about treated populations, treatment duration, compliance, benefits, impact on other therapeutic strategies or organisation of healthcare [ 22 ].

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Those studies can be associated with restrictive conditions regarding diffusion, in application of section L. This committee is an interministerial body, which is under the joint authority of health, social security and economy ministers [ 25 ]. Price-setting may be subject to an agreement between the company marketing the innovative product and the CEPS [ 25 ]. If the HAS opinion is favorable to innovation reimbursement by the French National Health Insurance, the medical innovation is registered on a list. With regard to drugs, it is a list mentioned in article L. With regard to medical devices, it is a list of products and services qualifying for reimbursement Liste des Produits et Prestations Remboursables — LPPR mentioned in article L.

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Reimbursement rate is correlated with ACB level. We note that for drugs, their purchase and use at hospital are conditional upon their registration on a list for access to Community Pharmacy [ 28 ]. However, when the cost of an innovative drug or medical device is too high for being integrated to the associated GHS, an individual funding in addition to GHS so-called en sus is intended. In this case the CEPS may decide to register an innovative drug or medical device on a specific list established in article L.

Figure 2 shows all French organizations involved in assessment and market process of medical innovations.

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French organisations involved in assessment market-access process of medical innovations. Medical innovations contribute to improve patient health condition, quality and safety of care, and performance of healthcare delivery [ 2 ]. Early and derogatory market access allow for an anticipated provision of innovations for patients, while controlling associated risks as long-term safety, misuse and unjustified expenditures [ 2 ].

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An early diffusion anterior to the evaluation conducted by the HAS is possible according to some conditions for certain innovative drugs. This early diffusion tends to be derogatory and temporary and contains conditions, which include the conduct of clinical and economic trials. Agreement terms are described in article L. With regard to innovative medical devices, if ACB was evaluated as insufficient by the HAS, but that available data show a potential interest of innovation; they can be eligible for innovation pass Forfait innovation , established in article L.

It is a controlled diffusion program conditioned to the conduct of complementary studies, particularly clinical studies or eventually economic ones.

These studies are supported by the industrial. With some exceptions, any innovation which have been enrolled, before the evluation of the HAS, in a Research Program cannot benefit from innovation pass. This diffusion opportunity tends to be derogatory and temporary. Figure 3 resumes market access process and opportunities of early and derogatory diffusion of medical innovations in France [ 2 ]. Market-access process and opportunities of early or derogatory diffusion of medical innovations in France.

From the perspective of national organisations involved in medical innovation assessment and market-access the main challenge is to find balance between access to innovation and affordability. In France, there are many initiatives to support innovation including research programs and early or derogatory diffusion [ 33 ]. However, it appears necessary to improve regulatory mechanisms and in particular to develop specific procedures regarding disruptive innovations [ 7 ]. Medical innovations are likely to lead to changes in medical strategies, care pathways, or even health pathways.

Development of e-health solutions, like telemonitoring for patient with dialysis-stage renal disease or teleexpertise in cancerology, are good examples of innovative organisation that can upset patient care [ 34 , 35 ]. Nevertheless, it is crucial to evaluate impact of changes induced [ 36 ].