Table 1 RSA and related policies in the UK, Italy, Australia, and South Korea

main policy for improving access to new drugs

 policy name

risk sharing arrangements (RSA)

patient access schemes (PAS)

managed entry agreement (MEA)

managed entry schemes (MES)

 responsible department/agency

Health Insurance Review and Assessment Service (HIRA)

National Institute for Health and Care Excellence (NICE)

Agenzia Italiana del Farmaco (AIFA)

Pharmaceutical Benefits Scheme (PBS)

 year of introduction

2013

2007

2006

2003 (2011^a)

 target drugs to be applied

∙ cancer drugs or orphan drugs

∙ no alternative treatments or drugs

∙ used in serious, life-threatening condition

no limitation

no limitation

no limitation

 types of risk sharing

∙ CTC and money back guarantee

∙ expenditure cap

∙ refund

∙ utilization cap or fixed cost per patient

∙ others can be suggested

∙ simple discount scheme

∙ complex scheme

∙ payment by result (PbR)

∙ risk sharing (RS)

∙ cost sharing (CS)

∙ capping

∙ special pricing arrangement (SPA)

∙ risk sharing arrangement (RSA)

related policies

 policy name

exemption of economic evaluation (EEE)

cancer drugs fund (CDF)

life-saving drugs program (LSDP)

 year of introduction

2014

2011

1995

 target drugs to be applied

∙ used in serious, life-threatening condition and no alternative intervention

∙ the number of patients is too small to generate evidence

∙ reimbursed in at least three of the seven countries^b

cancer drugs

for life threatening and rare diseases