NICE to initiate fast-track drug approvals process

Government/NHS related news

The National Institute for Clinical Excellence (NICE) is to launch a new, rapid process for assessing drugs and other treatments.

The Single Technology Appraisal (STA) process will sit alongside the global standard process and will initially be used to produce faster guidance on life-saving drugs which have already been licensed and on new medicines close to when they first become available.

Under the new process the institute will issue faster guidance by asking for a single submission of evidence from the drug's manufacturer, carrying out an independent assessment of this evidence more quickly and speed up the move to the final (appeal) stage of the process where the draft recommendations are in line with the licence. The first guidance formulated in such a way is expected in June 2006.

Andrew Dillon, chief executive of NICE said: "We are aware of the need for timely advice on the use of new medicines, particularly for life-threatening conditions such as cancer. The proposals we have set out mean NICE can deal with the current backlog much quicker than planned and that we will be able to issue guidance to the NHS rapidly in the future, once a drug is licensed."

NICE is starting the process immediately and will begin working on Roche's non-Hodgkin's lymphoma therapy MabThera (rituximab), Ortho Biotech's Velcade (bortezomib) for the treatment of multiple myeloma, Bristol-Myers Squibb's Taxol (paclitaxel) and Sanofi-Aventis' Taxotere (docetaxel).

Roche's breast cancer drug Herceptin (trastuzumab) will also be in the first draft of drugs to be fast tracked and is considered to be the catalyst for the move after patient lobbying.

Schering AG's Fludara (fludarabine) for first-line lymphocytic leukaemia, and Ely Lilly's advanced/metastatic breast cancer treatment Gemzar (gemcitabine) are set to proceed with the STA process early next year.

Others drugs that could follow, also next year, include: OSI/ Genentech's Tarceva (erlotinib) for non-small cell lung cancer; SuperGen's Orathecin (rubitecan) for pancreatic cancer, Pfizer's Campto (irinotecan) in adjuvant advanced colorectal cancer, Ely Lilly's Alimta (pemetrexed) for non-small cell lung cancer; MSD's (Merck Sharp & Dohme) Erbitux (cetuximab) for locally advanced recurrent metastatic head and neck cancer, Abbott Laboratories' Xinlay (atrasentan) for hormone-refractory prostate cancer; and Schering-Plough/ MSD's Ezetrol (ezetimibe) for the treatment of hypercholesterolaemia.

In addition to the STA process NICE is consulting on proposals to speed up its current system for carrying out appraisals of more than one drug (the Multiple Technology Appraisal (MTA) process), which will continue to look at groups of drugs that are already on the market in order to compare them to one another.

© Adfero Ltd

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