Objectives: In response to greater health budget restrictions and the rise in costly new treatments, manufacturers and payers have increasing interest in performancebased risk-sharing arrangements (PBRSAs) that address uncertainty and accelerate access to medicines. Our objectives were to review guidelines for PBRSA implementation and the use of PBRSAs in the UK, Italy, and the Netherlands. MethOds: A non-systematic review was undertaken using PubMed to identify guidance on PBRSA implementation. Appropriate governmental and agency websites in the UK, Italy, and the Netherlands were also reviewed to identify PBRSA examples. Key considerations for PBRSA implementation and its historical application in the UK, Italy and the Netherlands were evaluated. Results: Several key considerations for PBRSA implementation were identified from published guidelines. The approach to PBRSA implementation varies between countries with regards to: evidence collection, governance, reporting, and evaluation. While PBRSAs have been applied in the UK, simple cost-sharing arrangements are now encouraged due to difficulties with the implementation and evaluation of PBRSAs. In Italy, AIFA makes extensive use of online monitoring registries to inform their PBRSAs. However, there is no established process for implementation. Currently, in the Netherlands all inpatient drugs with a budget impact > € 0.6 million and an unacceptable level of uncertainty can be granted access via coverage with evidence development arrangements. Both national and international registry data are used in the re-evaluation of reimbursement decisions. cOnclusiOns: The approach to PBRSA implementation varied across the three countries reviewed, although the objectives for their use were similar across the analysed countries. Manufacturers need to consider country-specific factors for implementation and key PBRSA considerations identified via our research offer guidance for applying PBRSAs in these markets.Objectives: Risk Share Agreements (RSAs) are defined as agreements between a payer and a manufacturer where the price level is related to the actual future performance of the product. In the last years RSAs were introduced and applied in various jurisdictions. MethOds: RSAs in Australia, Canada, Italy, Spain, UK and the US were systematically searched for. They were clustered into the type of RSA per country and compared to each other. Results: In Australia the main RSA types were annual sales caps, indication-wide caps, label caps, price-volume agreements, comparator rebates. The details of deeds of agreements/RSAs are generally not publicly available. In Canada the final formulary inclusion decisions are made by each province separately where confidential contracting with direct discounts are preferred. In Italy different contracting mechanisms evolved to payments-by-results in the last years with the AIFA patient registry supporting the implementation of RSAs. Even though payment-by-results was the main type of RSA, cost sharing, cost ceiling, risk sharing and com...

Professor of medicine whose famous report on inequality and health fell foul of the Thatcher government Sir Douglas Black was one of medicine's most important and well loved individuals. His many achievements included a professorship of medicine in Manchester, research on salt and water balance, persuading the profession in the 1940s and 1950s that the NHS was a good thing, and the presidency of the Royal College of Physicians. But he is best known for his 1980 Black report, which spelt out the social inequalities in health and proposed ways of reducing them. In 1977 the then Labour government's health secretary, David Ennals, chaired an expert committee investigating why the NHS had apparently failed to reduce social inequalities in health, and he commissioned Black to write a report. The result was published-or, rather, suppressed-in 1980, when the Conservatives had come to power. The Black report was not to Mrs Thatcher's liking and was never printed; instead, 260 photocopies were distributed in a half hearted fashion on Bank Holiday Monday. However, the report had a huge impact on political thought in the United Kingdom and overseas. It led to an assessment by the Office for Economic CoOperation and Development and the World Health Organization of health inequalities in 13 countries-though not on UK government policy. Penguin Books later published a shorter version of the report. Black provided convincing figures that showed what many suspected-that the poorest had the highest rates of ill health and death. He argued that these rates could not be explained solely by income, education, mobility, or lifestyle, but were also caused by a lack of a coordinated policy that would ensure uniform delivery of services. He recommended health goals, tax changes, benefit increases, and restrictions on the sale and advertising of tobacco. Patrick Jenkin, the social services secretary, estimated with a shudder that Black's proposals-which he hinted were little short of outrageouswould cost an unthinkable £2bn a year. Thin, gentle mannered, poker faced, and self effacing, Black was deeply moral, always serious, and frequently extremely funny. His after dinner speeches were received with rapt attention, as to miss a moment of that soft Scottish voice was to miss a joke. He