Assessment of spinal implants (interbody cage, interspinous process spacer, spacer, lumbosacral support implant)
The aims of reassessing spinal implants are to :
- determine the indications for spinal implants ;
- assess their actual benefit per indication ;
- define their place in therapeutic strategy ;
- characterise the technical specifications which determine the actual benefit, so as to avoid classification mistakes and clarify which devices are covered by the current generic description ;
- propose an updated nomenclature based on the form and composition of devices ;
- estimate their target population ;
- define the level of evidence required for the trials submitted with applications for inclusion under the brand name ;
- define the conditions of use and prescription for inclusion of the products on the list of products and services qualifying for reimbursement (LPPR).
This assessment concerns spinal implants (interbody cage, interspinous process spacer, spacer, lumbosacral support implant) included on the LPPR.
The working method is based on the analysis of databases in the programme for clinical information systems, a critical analysis of data from the scientific literature, the analysis of files submitted by manufacturers and on the expertise of healthcare professionals in a multidisciplinary working group dedicated to this subject.
Manufacturers and paying agencies were consulted during the work.
The CNEDiMTS recommends, depending on the type of implant, either that generic descriptions be distinguished and clearly defined, and technical specifications updated, or that certain types of spinal implants be included under their brand names.
The Committee recommends individual categorisation, for inclusion under a general description, of interbody cages and of reconstruction implants after corporectomy, and the creation of eight generic descriptions based, firstly, on the level treated (cervical and thoracolumbar) and, secondly, on whether or not there is a bone substitute and an integrated fixing system.
The CNEDiMTS decided as follows:
- there is no added clinical value (ACV V) for different types of cage. The CNEDiMTS therefore recommends that all these devices should be included for reimbursement, except for implants made exclusively of a bone substitute, with no reinforcement of the cage.
Interbody cages made of porous tantalum and ceramic will have to comply with the requirements of registration under the brand name (submission of a file allowing a specific assessment).
- there is no added clinical value (ACV V) for different types of reconstruction implants after corporectomy. The CNEDiMTS therefore recommends that all these devices should be included for reimbursement. The committee stresses the fact that after corporectomy the spine is unstable and that reconstruction implants after corporectomy need an effective anchorage system in the form of a decompression system in the implant.
The CNEDiMTS recommends the deletion of generic descriptions for interspinous process spacers and spacers because of the design disparity of the devices funded under these descriptions, the inability to define them or to describe the common indications and common minimum technical specifications. For these devices, inclusion under the brand name is recommended; this involves the submission of a file by the manufacturer concerned for a specific assessment before reimbursement under the LPPR can be considered.
Finally, for the category “lumbosacral support implants”, the committee recommends the reinclusion of the generic description for longitudinal reconstructive implants.
A new nomenclature based on this reassessment is proposed.