Guide to better understanding of "the fourth hurdle" - the NICE

A special issue of Adis PharmacoEconomics devoted to helping drugmakers better understand the requirements behind the so-called "fourth hurdle" - demonstrating a drug's reasonable cost effectiveness, has been published by Wolters Kluwer. The issue focuses on the elements essential to gain approval for cost-effectiveness in drug and technology submissions to the UK's National Institute for Health and Clinical Excellence (NICE), the vanguard for assessment (excluding Scotland).

For a drug to be reimbursed by the National Health Service, it first must receive a license and then a reasonable cost-effectiveness rating from the NICE. An approval from the agency not only makes a drug available on the NHS, it can help it succeed globally, as NICE standards are often recognized as a benchmark by others. After extensive consultation with health experts from both inside and outside the organization, the NICE recently updated many of the methods that manufacturers must follow when submitting an application, known as the Reference Case, the report notes.

"The special issue of PharmacoEconomics looks at much of the key thinking and debate that underpinned the latest guidance," said editor Christopher Carswell, "It is essential reading for anyone who plans to submit a technology or drug to [the] NICE for approval and wants to understand the thinking that went into creating the current guidelines," he added.