Authors' objectives: Bone substitutes are used in various disorders as bone fillers. Several specialities are involved in the use of biomaterials in this indication (orthopaedic surgery, neurosurgery, dental surgery, maxillofacial surgery, ENT and cervical surgery, tumour surgery, etc.). The objectives of this work were to assess the bone substitutes in order to: - determine their indications in the diseases concerned; - define their place in therapeutic use; - assess their clinical value for each indication; - characterise the technical specifications which determine their actual benefit (AB), so as to avoid classification errors and clarify which devices are covered by the current generic categories; - define the conditions of prescribing and using products to be included on the LPPR; - put forward an updated nomenclature; - estimate their target population; - define the level of evidence and the assessment criteria required for trials submitted with applications for inclusion under the brand name.

Authors' recommendations: Depending on the characteristics of bone substitutes, the CNEDiMTS recommends either the development of generic categories defined in particular by accurate technical specifications, or inclusion under brand name. When inclusion under a generic category is recommended, the actual benefit is regarded as sufficient. CNEDiMTS differentiates between two major categories of bone substitutes: - synthetic bone substitutes not containing any derivative or tissue of biological origin or not obtained from such derivatives; - bone substitutes obtained from or containing derivatives or non-viable tissues of animal origin. In the absence of data allowing a comparison of the efficacy and advantages of one type compared with the other, CNEDiMTS recommends that all devices complying with the generic categories put forward by the working group, of whatever type, should be included for reimbursement. CNEDiMTS recommends a common indication for all the generic categories defined, i.e.: "use of bone substitute (for filling, reconstruction, fusion), when autologous solutions are inapplicable or insufficient". The recommended nomenclature differentiates between synthetic substitutes and bone substitutes composed of biomaterials of animal origin. The indications for both product categories are nonetheless identical. CNEDiMTS recommends inclusion under brand name for all bone substitutes that do not meet the agreed technical specifications. The company concerned does need to submit a dossier for a specific assessment before the item can be included in the list of products and services qualifying for reimbursement (LPPR). With the available data it is impossible to state categorically that one type of bone substitute is better than another, nor to identify a reference bone substitute from among the same category of biomaterials. The Committee has ruled that there is no improvement in actual benefit (IAB V) between the various generic categories relating to synthetic substitutes and bone substitutes containing derivatives of animal origin. Moreover, CNEDiMTS has defined the criteria for assessing new devices under their brand name if they do not meet the technical specifications of the proposed generic categories: - when the company has no special claims, one high-quality observational study is the minimum requirement, with an assessment criterion appropriate to the claimed indication and a follow-up of 6 to 24 months, depending on the clinical situation concerned; - when the company claims an improvement in actual benefit in comparison with products already listed on the LPPR, at least one comparative clinical study is required. The choice of comparator must be justified. The assessment criterion must be in accordance with the stated claims (e.g.: if osteoinductive power is claimed, the assessment criterion may be faster bone consolidation in cases of fracture or, in dentistry, improved implant survival). The expected minimum follow-up is from 6 to 24 months, depending on the clinical situation concerned.

Project Status: Completed

Year Published: 2013

URL for published report: http://www.has-sante.fr/portail/upload/docs/application/pdf/2013-06/rapport_devaluation_des_substituts_osseux.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: Haute Autorité de Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: has.seap.secretariat@has-sante.fr

Contact Email: has.seap.secretariat@has-sante.fr