The merry-go-round of approval, pricing and reimbursement of drugs against the Hepatitis C virus infection in Spain

- Current architecture of decision-making is unprepared to deal efficiently with high-cost disruptive drugs such as those against HCV.
- Major impairments in facing the situation have been the unscheduled allocation of assessment functions and lack of transparency.
- Vested industry and misinformed public pressure led public debate banning opportunity-costs considerations.
- Improvised financing tools disregarded real budget impact and are posing a threat to the already strained regional budgets.
- The actual delivery of drugs is not efficient and further lessens public trust.

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.