OBJECTIVES: Although patient access schemes (PAS) have historically been implemented for high-cost oncology drugs, recent schemes for chronic diseases like rheumatoid arthritis (RA) have been seen in the UK. This study tries to understand how the shift in PAS from being accepted by payers only for short-term oncology drugs to those for chronic diseases like RA in the UK will influence the situation in Italy, where PAS are known to be widespread. METHODS: This study used qualitative telephone interviews to analyse trends in the UK (n=7) and Italy (n=7). Interviews were conducted in tertiary hospitals as well as local, regional and national level reimbursement authorities involving financial and clinical stakeholders, and key individuals in the implementation of the scheme. Importance of a number of variables affecting new PAS was ranked. RESULTS: Budget-holders in both markets were seen to be sceptical about the impact on long-term budgets due to the move towards PAS for chronic conditions.  Of the 14 stakeholders interviewed, 9 said that such schemes in chronic conditions might help companies access markets with lesser clinical evidence on the basis of the class-effect of the drugs and the risk-sharing nature of the schemes. Monitoring of the outcomes on implementation was thought to be crucial. CONCLUSIONS: In Italy, increase in PAS for chronic diseases will help drug companies bring drugs to the market earlier. On the other hand, the payers will see this as an increased burden on their budgets as it will mean funding longer term treatment. Also, due to recent issues with monitoring of outcomes in PAS in the UK, their future needs re-consideration. This move of PAS towards chronic conditions is expected to increase the impact that post-marketing monitoring will have on market access for expensive ‘me-too’ drugs in the EU.