BRIDGEWATER, New Jersey, September 10 /PRNewswire/ --

- Original Briefing Papers Used by NICE to Shape Its New Cost-Effectiveness Guidelines Offer Unique and Timely Insight for Honing Manufacturer Submissions

Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry, today published a special issue of Adis PharmacoEconomics devoted to helping drug makers better understand the requirements behind the so-called "fourth hurdle" -- demonstrating a drug's reasonable cost effectiveness. The issue focuses on the elements essential to gain approval for cost-effectiveness in drug and technology submissions to the United Kingdom's National Institute for Health and Clinical Excellence (NICE), the vanguard of health technology assessment.

For a drug to be reimbursed by the U.K.'s National Health Service (NHS), it first must receive a license and then a reasonable cost-effectiveness rating from NICE. An approval from NICE not only makes a drug available on the U.K. 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, NICE recently updated many of the methods that manufacturers must follow when submitting an application, known as the Reference Case.

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

According to Carswell, the impetus to create a special issue devoted to overcoming the "fourth hurdle" came from current PharmacoEconomics subscribers who suggested that the best way to ensure against a submission's failure was to better understand NICE's priorities and the factors that led to an update of the guidelines. Many submissions do not pass simply because the applicant failed to account for NICE's fundamental requirements and methods or left out key supporting evidence.

Includes Original NICE Briefing Papers

The current issue offers insight that is instrumental in understanding the minimum requirements necessary to ensure a submission passes. Included is the first-time publication in a peer-reviewed journal of the original briefing papers commissioned by NICE to help guide its decision making. The issue paints a not-so-subtle picture of where changes may be headed in the near future which can help pharma R&D teams craft trials to ensure that the right data are being collected.

The special issue also looks at why NICE is unwilling to consider costs other than those falling within the NHS and Personal Social Services budgets and provides insight on how to deal with evidence uncertainty. It also examines using mixed treatment comparisons as a way to synthesize evidence and addresses industry concerns about the level and use of a cost-effectiveness threshold. NICE's opinion on the updated guidance is included as well.

According to Carswell, the issue is of particular interest to health economists; health outcomes researchers and executives at drug manufacturers; pharma R&D executives; and Contract Research Organizations.

The benchmark journal on the applications of pharmacoeconomics and quality-of-life assessment, PharmacoEconomics is an invaluable source of applied original research and educational material for the healthcare decision maker. The journal is dedicated to the clear communication of complex pharmacoeconomic issues related to patient care and drug utilization.

For more information about Wolters Kluwer Health's Adis PharmacoEconomics journal or any of the highly valued, peer-reviewed Adis publications visit To purchase the NICE issue at a special one-off rate contact Bhavna Tailor at or call +44-(0)1829-771155. For more about Wolters Kluwer Health, visit

About Wolters Kluwer Health

Wolters Kluwer Health (Conshohocken, PA), a division of Wolters Kluwer, is a leading provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry. Major brands include traditional publishers of medical and drug reference tools and textbooks, such as Lippincott Williams & Wilkins and Facts & Comparisons(R); electronic information providers, such as Ovid, Medi-Span(R) and ProVation(R); and pharmaceutical information providers such as Adis International and Source(R). Wolters Kluwer Health has annual revenues (2007) of US$1,044 million (euros 761 million) and employs approximately 2,700 employees globally. For more information, visit

Contact: Tom Kivett Kivett & Company Communications New York, USA +1-212-727-2935 Web site:

Tom Kivett of Kivett & Company Communications for Wolters Kluwer Health +1-212-727-2935, NOTE TO EDITORS: For a free copy of the September PharmacoEconomics or to set an interview with Chris Carswell, please contact Tom Kivett at +1-212-727-2935 or email at