As a reminder, only products whose added expected benefit (ASA, for medical devices) or added medical benefit (ASMR, for pharmaceutical products) is major (I), important (II), moderate (III), or minor (IV) can be included on the list “en sus”[1]. By exception, the ASA/ASMR can be absent (V) when the relevant comparators are included on the list “en sus” for the considered indication, as recently reminded by the Conseil d’Etat in the Incyte decision[2].
In a Medtronic decision, the Conseil d’Etat has provided some interesting clarifications on how the ASA criterion is assessed for inclusion on the list “en sus”.
In an assessment dated May 16, 2023, the French National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) evaluated the medical device KYPHON for three indications and assigned the following for two of them (osteoporotic fractures and fractures secondary to a lytic neoplasia):
- ASA IV compared to conventional non-surgical medical treatments (analgesics, corsets, physiotherapy), specifying that non-surgical treatment is the first-line treatment;
- ASA V compared to vertebroplasty and systems for spondyloplasty with an intracorporeal implant, specifying that the surgical approach of vertebral augmentation can be used for certain patients refractory to medical treatment.
The ministers refused to include KYPHON on the list “en sus” for the two aforementioned indications due to its ASA V and the absence of comparators included on the list for these indications.
However, the Conseil d’Etat considered that these elements alone could not justify the ministers’ decision to refuse the inclusion on the list “en sus”.
The judge criticized the ministers for having:
- neither provided information on the place in the therapeutic strategy of the various comparators selected by the CNEDiMTS;
- nor specified whether or not conventional non-surgical medical treatments – for which KYPHON obtained an ASA IV – were part of the same treatment line as this device.
Therefore, the decision to refuse KYPHON’s inclusion on the list “en sus” for the two considered indications was annulled, and the ministers were ordered to reexamine Medtronic’s request within six months.
This case law raises the delicate question of the wording of the ASA/ASMR. Beyond the level of ASA/ASMR, what consequences should be drawn from its wording in the context of a request for inclusion on the list “en sus”? …and for price negotiations?
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[1] For pharmaceutical products, inclusion on the list “en sus” is also subject to the following conditions: (i) the pharmaceutical product is likely to be administered predominantly during hospitalisations, (ii) its medical benefit (SMR) level is major or important, and (iii) there is a ratio of more than 30% between the estimated average treatment cost per hospitalisation and the tariffs of the majority of services in which the pharmaceutical product is likely to be administered (Article R. 162-37-2 of the French Social Security Code).
For medical devices, inclusion on the list “en sus” is also subject to the following conditions: (i) the device is expected to be used predominantly during a hospitalisation, (ii) the expected benefit (SA) of the device is sufficient, (iii) the frequency of use of the device within the expected homogeneous patient groups (GHM) is less than 80%, and (iv) the ratio between the estimated cost of the device per stay and the amount of one of the GHS in which the device is likely to be used is greater than 30% (Information notice from the Ministry of Health on the inclusion of a product or service on the list “en sus”).
[2] Conseil d’Etat, July 17, 2024, Incyte, req. n° 470665.
