title: Relative Added Value: What are the Tools to Evalue it?
abstract: The relative added value of a drug is currently evaluated in France by the Transparency Commission (TC) of the National Health Authority (HAS), by assigning a level of Improvement in Actual Benefit (IAB). IAB is based on two parameters, efficacy and safety of the product, in a defined target population, either as compared to one or more other drugs with similar indications, or within therapeutic strategy. The items used for evaluation, including the level of clinical effect, the relevance of the comparator, the choice of comparison criteria and the methodology used (indirect comparison, non-inferiority studies, etc.), have been reviewed by the working group in Giens with regard to an analysis of the opinion on TC issued between 2004 and 2007 in several therapeutic areas. First of all, this attempt at rationalisation based on the criteria used to assess the relative added value demonstrated the rareness of direct comparative data, and was followed by a discussion on the possible broadening of the evaluation criteria. The group discussed taking into account the Public Health Impact (PHI), which has now been incorporated into the assessment of Actual Benefit (AB). The group believes that PHI seems to be more related to the notion of IAB than to that of AB. Indeed, it is frequently the relative added value of a new drug that produces an impact in public health. Conversely, considering the comparative evaluation criteria of PHI, which are not systematically taken into account in IMSR (such as improvement in the health of the population, meeting a public health need or impact on the healthcare system), PHI could legitimately be included in the assessment of the relative added value of a drug. Other parameters such as compliance or impact on professional practice have been considered. Thus, the notion of relative added value, evaluated at initial registration, could be based on an expected improvement in medical service. The notion of expected medical service leads to the requirement of producing additional data in real life (post-registration studies), which would support the definitive notion of improvement in actual benefit at the time of renewed registration, while taking into account the place occupied by the drug in the therapeutic strategy.
authors.affiliation: Hôtel Dieu, Université Paris-Descartes, Paris, France. Electronic address: claire.le-jeunne@htd.aphp.fr.
authors.forename: Claire Le
authors.initials: CL
authors.lastname: Jeunne
authors.affiliation: Centre Hospitalier Universitaire de Besançon, Besançon, France.
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Woronoff-Lemsi
authors.affiliation: Direction Générale de la Santé, Paris, France.
authors.forename: Nadine
authors.initials: N
authors.lastname: David
authors.affiliation: Laboratoire Roche, Neuilly sur Seine, France.
authors.forename: Rima de
authors.initials: Rd
authors.lastname: Sahb
keywords: Improvement in Actual Benefit (IAB); Transparency Commission; actual benefit; drug; public health impact; relative added value