Setting up an outcomes guarantee for pharmaceuticals: new approach to risk sharing in primary care

To obtain maximum health benefits from a drug it is necessary to follow the pharmaceutical company's recommendations for use. However, variations in clinical prescribing practice and patient compliance mean that drugs are not always used under optimum conditions. One way of achieving maximum benefit could be to set up an “outcomes guarantee,” in which a pharmaceutical company and prescribing stakeholders (such as health authorities and primary care or hospital trusts) agree on the outcomes that they would expect from a drug in a given indication. If the drug fails to fulfil expectations, the pharmaceutical company refunds the health service for the cost of the drug. This encourages the pharmaceutical company to promote responsible prescribing and ensures that healthcare resources are not wasted on ineffective treatments. The National Institute for Clinical Excellence's shared risk policy for interferon beta in multiple sclerosis, and the subsequent commentary, has raised awareness of the potential for such schemes.1^–5

In 1999, North Staffordshire Health Authority, Parke-Davis (now Pfizer), and Keele University entered a pilot collaboration to provide an outcomes guarantee for statins in lowering blood cholesterol concentrations. The health authority had identified cardiovascular disease as a local priority6 and was looking for ways to disseminate best practice without making excessive demands on itself or its general practitioners. The project enabled the health authority to work openly with a pharmaceutical company to achieve common goals and to share the risks of disseminating good clinical practice. In this article, we describe how the project, which was launched in 2000, was set up.