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The Pharmaceutical Journal
Vol 268 No 7185 p197-203
16 February 2002

Related websites
NICE website (www.nice.org.uk)
NICE appeals process consultation document (PDF* 285K)

NICE launches transparent consultation process

The National Institute for Clinical Excellence has published its first appraisal consultation document under a new open process for reaching recommendations on the use of new treatments.

The process, outlined by NICE at the end of 2000 (PJ, 25 November 2000, p774), entails the publication of preliminary recommendations, which were previously treated as confidential. NICE decided to become more transparent in the light of frequent leaking of confidential reports before final determinations were made.

The first treatment to be considered under the new system is pegylated liposomal doxorubicin hydrochloride (PLDH, Caelyx) — used to treat advanced ovarian cancer.

NICE's provisional recommendation is that PLDH is one option for the second-line (or subsequent) treatment of women with advanced ovarian cancer that is initially resistant or refractory to first-line platinum-based combination therapy or has become resistant after successive courses.

Members of the public and health professionals can comment on the draft recommendation via the NICE website (www.nice.org.uk). After the consultation period, which closes on 1 March, the appraisal committee will meet again on 7 March to produce a final appraisal determination which will be circulated to stakeholders so that they can decide whether or not they wish to appeal. The decision will be published on the NICE website.

NICE consults on appeals process NICE is reviewing the procedure by which interested parties can appeal against its final guidance documents. It is suggesting that the right of appeal should be extended to NHS organisations such as health authorities and primary care trusts and that appeal hearings should be held in public.

Appeal panels should be able to recommend changes to the wording of NICE guidance documents, but not to substitute their interpretation of the evidence for that of the appraisal committee, NICE says.

Copies of the consultation document are available on the NICE website (PDF* 285K). Comments are invited by 3 May 2002.

* PDF files on PJ Online require Acrobat Reader 4 or later.