Faster and more efficient access to medicines with better dialogue between Aifa and the regions
From target population estimation to economic impact assessments: the sharing of key information by the agency would reduce the use of personnel involved in regional policies by almost 40% on average
by Claudio Jommi *, Mattia Altini **, Guido Rasi ***
Improving the system of information exchange between the Italian Medicines Agency (Aifa) and the Regions would bring great benefits to the entire pathway of access to medicines. Information can be shared that optimises regional choices, reduces staff workloads in the Regions, frees up resources to be reallocated to other activities, simplifies and accelerates healthcare planning processes, and reduces the time it takes to access and actually make available new therapies.
Themes of confrontation
In particular, a sharing of key information by Aifa, e.g. the estimation of the target population, the identification of comparator drugs and the related economic impact assessments, would lead to an average reduction of almost 40 per cent in the use of personnel involved in regional policies, which currently averages more than 20 'full-time equivalent' professionals.
A more structured interaction between Aifa and the Regions in the Horizon Scanning phase would have a significant effect on the management time of regional policies. The data emerged from a study - the results of which were presented at a national conference - conducted by Claudio Jommi and Riccardo Novaro of the Department of Pharmaceutical Sciences at the University of Eastern Piedmont (Upo), in collaboration with Dephaforum and the pharmaceutical services of four Regions: Veneto, Emilia-Romagna, Campania and Puglia.
State of the Art and Prospects
At present, the Regions receive the price and reimbursement (P&R) information of a drug after the publication of the relevant determination in the Official Gazette. The data of the P&R Dossier, re-evaluated within the activity of the Offices and the Scientific-Economic Commission of Aifa, are not shared. The Regions therefore proceed to autonomously retrieve this information in order to carry out their own access governance actions.
With the study, we took stock of the current set-up of regional policies, which information sources are used and how the regions interface with stakeholders. We also took stock of how long it takes to manage these policies and the resources used at the regional level, noting the decision-making time from the inclusion of drugs in the regional formularies, to the eventual identification of the centres of supply, to the awarding of the supply, which were found to be highly variable and tended to be lower in the absence of regional formularies and in the presence of a more structured Horizon Scanning activity at the regional level.
