title: Progression-free survival, overall survival and quality of life: What is their medicoeconomic importance in oncology?
abstract: Medico-economic evaluations estimate, for a given health technology, the added cost and the clinical benefit compared to a reference strategy. The objective here is to analyze the criteria used to measure clinical benefit as the basis for market access and reimbursement decisions for drugs in oncology both in France and in Europe. Prolonged overall survival is the criterion of choice to demonstrate the benefit of an anticancer drug; a survival gain of 2 to 3 months or more would be considered as relevant for a new product versus the comparator. In the absence of survival benefit or mature data on survival, progression-free survival or symptom-free survival and the availability of alternative curative treatments, decrease in drug toxicity and quality of life improvement may be considered. Differences in clinical benefit assessment between regulatory agencies and payers are not specific to France. Case studies show that it is difficult to find a consistency in reimbursement and pricing decisions and to identify factors that may fully explain reimbursement decisions when survival benefit is not demonstrated.
authors.affiliation: Medicines Development and Training (MDT) services et service de dermatologie, hôpital Tenon, 75020 Paris, France.
authors.forename: Mira
authors.initials: M
authors.lastname: Pavlovic
authors.affiliation: Celgene, 75002 Paris, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Garnier
authors.affiliation: Inserm UMRS 1123, hôpital Henri-Mondor, université Paris Est Créteil, AP-HP, 75004 Paris, France; URCEco Île-de-France, hôpital de l'Hôtel-Dieu, 75004 Paris, France. Electronic address: isabelle.durand-zaleski-ext@aphp.fr.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Durand-Zaleski
authors.affiliation: Boehringer-Ingelheim, 51751 Reims, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Bilbault
authors.affiliation: Bristol-Myers Squibb, 92500 Rueil-Malmaison, France.
authors.forename: Anne-Françoise
authors.initials: AF
authors.lastname: Gaudin
authors.affiliation: Hôpital Cochin, AP-HP, université Paris Descartes Sorbonne Paris-Cité, GH Broca Cochin Hôtel-Dieu, 75010 Paris, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Le Jeunne
authors.affiliation: Takeda France, 92977 Paris-La-Défense, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Lalaude
authors.affiliation: HEVA HEOR, 69006 Lyon, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Roze
authors.affiliation: MSD France, 92418 Courbevoie, France.
authors.forename: Rima
authors.initials: R
authors.lastname: de Sahb
authors.affiliation: Hoffmann-La Roche, Global Pricing and Market Access, 4070 Bâle, Switzerland.
authors.forename: Claudine
authors.initials: C
authors.lastname: Sapède
keywords: French Drug Authority (Haute Autorité de santé [HAS]); IQWIG; Incremental cost-effectiveness ratio; Medico-economic evaluation; NICE; Oncology; Progression-free survival; Survival