Market access management by pharmaceutical companies in a complex environment: The Italian case study

Market access for pharmaceuticals has become a key issue in the Italian National Health Service, for at least three reasons: (i) market access delays are very high in Italy compared to other countries; (ii) drug policy is mostly driven by cost-containment both at national and regional/local levels; (iii) pharmaceutical policies have been decentralised, thus creating a very fragmented environment. These issues highlight the importance of market access and account management both at the national and the regional/local levels. The organization of market access by pharmaceutical companies in a complex environment, such as the Italian one, has never been investigated in the literature so far. Hence, this research contributes to fill the gap, surveying the industry's perceptions and reactions on a wide range of dimensions concerning market access. More specifically, this paper aims at answering the following research questions: how is market access defined and organised? In which phases of the product life-cycle do companies invest more in market access? Which are the perceived most appropriate tools for market access? Which are the perceived main obstacles to market access? How is the market access performance evaluated? The research question has been investigated through a structured questionnaire, which has been subject to a validation process. Responders were selected according to size (sales) in order to include firms that are more likely to introduce structural changes and to create sub-units. Overall, 43 companies accounting for a cumulated 80% market share (retail + hospitals) were involved. The questionnaire was sent to the General director/Chief executive, who selected the key informant(s). Results show that (i) market access is mostly associated with public affairs and pricing and reimbursement functions; only those companies, whose responder has associated market access with a commercial activity, invest more on actions aimed at fostering market penetration; (ii) market access benefits from tools that (a) increase the knowledge of the relevant target and (b) give evidence of the drug's value (economic evaluation and Health Technology Assessment) or its financial sustainability (budget impact analysis) and (iii) access to regional markets seems to be the most critical issue, thus confirming access problems deriving from decentralisation.