DRW Monthly
March 2009
Issue No. 28

UK's National Institute for Health and Clinical Excellence to Accelerate Drug Appraisal Process

The United Kingdom's (UK) Health Minister, Lord Ara Darzi and the National Institute for Health and Clinical Excellence (NICE) announced a four-pronged action plan this month to expedite patient access to cost effective new drugs. The plan also aims to ensure that the UK's National Health Service (NHS) bodies make more transparent and reliable decisions on funding new treatments in the absence of existing NICE guidelines. NICE is a UK-based independent organization responsible for providing national guidance on the promotion of good health and the prevention and treatment of poor health. The organization has developed this action plan in response to growing criticism over the past few years for its role in the time lag between new drug therapies becoming commercially available and patient access to them.

Key measures of the NICE/NHS plan include:

• a public consultation on a new and faster system for referring drugs for NICE appraisal to help the institute issue more timely guidance;
  
• an additional appraisal committee to be established to ensure that NICE has the capacity it needs to assess new drugs and treatments more promptly;
  
• an NHS guidance document to be prepared featuring good practice on how Primary Care Trusts (PCTs) should handle decisions on new drugs when NICE guidelines do not yet exist; and
  
• an investment to be made in "horizon scanning" to identify new potential drugs earlier for appraisal.(1)
  

NICE prepares four forms of guidance: technology appraisal guidance (to address the use of specific health interventions, pharmaceuticals, devices and treatments within the NHS), clinical guidelines, safety and efficacy of interventional procedures guideline and public health guidance. The recently released publication, Topic Selection Process for Technology Appraisals: A Consultation Document, was prepared by NICE in partnership with the UK's Department of Health. This document builds on changes made in the selection of cancer topics identified in the December 2007 Cancer Reform Strategy publication.(2) Its primary goal is to streamline the identification and referral of topics to NICE specifically for technology appraisals. NICE and DOH are seeking public comments until May 22nd on how to improve the timeliness with which technology appraisal topics are referred to NICE, how to increase the transparency of the selection process, how to ensure that NICE's stakeholders have an opportunities to provide input on selecting appraisal topics, and how to remove at least three months from the processing time for non-cancer appraisal topics to become aligned with cancer appraisals.(3)

In addition to accelerating NHS patient access to new treatments, it is hoped that this plan will provide industry with a clearer definition of the concept of "value" while appraising health technology innovations. The issues to be addressed center on how NICE accounts for innovation when establishing the value of new health technologies, whether some forms of value should be considered more important than others, and finally, what constitutes good value for money. (4) NICE and DOH expect to complete the consultation process in July 2009.

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