title: The merry-go-round of approval, pricing and reimbursement of drugs against the Hepatitis C virus infection in Spain.
abstract: Given that drug innovation has been largely away from breakthroughs, arguing that a new drug recently approved and reaching the market is downright effective, safe and affordable is actually parlous. The soaring costs of an increasing number of new drugs (specially for cancer and rare diseases) threaten to supersede societal absorbing capacity, competing with other health and outside health sector resources. Some health systems are not making headways towards solving the current conundrum of keeping path with the state of the art regulatory mechanisms in delivering cost-effective, equitable and affordable treatments. The way pricing and reimbursement decisions have been made in Spain regarding the recent wave of new drugs against the hepatitis C virus could be one case in point. This paper analyses the path of decision-making and the positioning of the relevant actors in this case, that has set a cumbersome precedent (earmarked fund) for the Spanish National Health Service. It also stresses the need for current decision-making mechanisms on approval, pricing, coverage and reimbursement in Spain to move to a transparent regulatory system, avoiding improvisation and incorporating the highest regulatory standards that other countries have in place.
authors.affiliation: CRES University Pompeu Fabra, Servei de Salut de les Illes Balears, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Campillo-Artero
authors.affiliation: ARAID, Health Services and Policy Research Unit, ARiHSP Health Sciences Institute in Aragon (IACS), IIS Aragón, Spain. Electronic address: sgarciaarm.iacs@aragon.es.
authors.forename: Sandra
authors.initials: S
authors.lastname: Garcia-Armesto
authors.affiliation: Health Services and Policy Research Unit, ARiHSP Health Sciences Institute in Aragon (IACS), IIS Aragón, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: Bernal-Delgado
mesh_terms: D003363:Cost Control; D016527:Drug Costs; D006291:Health Policy; D016174:Hepacivirus; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics*; D009313:National Health Programs / Q000191:economics; D013030:Spain
keywords: Budgetary silos; Hepatitis C drugs; High-price pharmaceuticals; Pharmaceuticals’ pricing, coverage, reimbursement; Value-based pricing