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Assessment of elbow joint implants

Assessment report by the CNEDiMTS [national committee for the evaluation of medical devices and health technologies]
Health technology assessment - Posted on Apr 23 2013

OBJECTIVES

The objectives of the re-assessment of bypass implants were to:
   * determine the indications for bypass implants;
   * assess their actual benefit in each indication;
   * define their role in treatment;
   * identify which technical specifications influence their actual benefit, in order to avoid coding errors and clarify which devices should be included under generic descriptions;
   * suggest an updated nomenclature;
   * estimate the target population;
   * define CNEDIMTS’ expectations for studies submitted during applications for inclusion under brand name;
   * define the terms of use and terms of prescribing envisaged for inclusion of products in the LPPR.

METHOD

This assessment concerns the bypass implants included on the list of products and services qualifying for reimbursement (LPPR).

The working method used comprised analysis of the programme for clinical information systems database, a critical review of data from the scientific literature, analysis of the files submitted by manufacturers, and consultation of expert health professionals who met in a multidisciplinary working group dedicated to the topic.

The manufacturers and paying authorities were consulted during the study

ABSTRACT

Depending on the type of implant, CNEDiMTS recommends either separating out and redefining the generic descriptions, with updated technical specifications, or including certain types of bypass implant under brand name.

For inclusion under a generic description, the Committee recommends distinguishing between synthetic bypass implants that do not contain any biological derivatives or tissue and are not manufactured from such derivatives, and synthetic bypass implants impregnated with products of animal origin, not including bioprostheses and reinforced biological tissues. Among implants that do not contain any biological derivatives or tissue and are not manufactured from such derivatives, the Committee recommends distinguishing between composite implants and implants consisting of a single material (polyester or ePTFE) that are not coated with a surface treatment.  Composite implants are made from several materials (polyester, ePTFE, polyurethane) or from one material combined with a surface treatment that contains an inactive substance. For each category defined as above, the committee recommends that two generic descriptions should be created, indicating whether the bypass implant is straight or bi/multifurcated, as these are indicated for different anatomical lesions.

CNEDiMTS argues that there is no added clinical value (ACV V) between different types of bypass implant. CNEDiMTS therefore recommends that all these devices should be included for reimbursement, with the exception of implants coated with a surface treatment containing an active substance. It is recommended that these devices should be included under their brand name, which involves the submission of an application by the manufacturer for a specific assessment before the implant can be included in the LPPR.

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