PharmacoEconomics Publishes Special 'Fourth Hurdle' Issue Related to U.K.'s National Institute for Health and Clinical Excellence (NICE)

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

    BRIDGEWATER, N.J., Sept. 10 /CNW/ -- 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 $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


For further information:

For further information: Tom Kivett of Kivett & Company Communications
for Wolters Kluwer Health +1-212-727-2935,

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