The UK government has started a new, fast track appraisal system at the National Institute for Health and Clinical Excellence, aimed at shortening the delay between approval of the drug and its availability under the National Health Service.
NICE, which provides guidance on the treatments to be provided under the NHS in England and Wales, had already been asked to fast track a review of Roche’s breast cancer drug Herceptin (trastuzumab) amid growing pressure from patient campaigners [[06/10/05a]].
It will now also accelerate its appraisals of four other treatments, namely Sanofi-Aventis’ Taxotere (docetaxel), Bristol-Myers Squibb’s Taxol (paclitaxel), Roche’s non-Hodgkin’s lymphoma therapy MabThera (rituximab) and Ortho Biotech’s Velcade (bortezomib) for the treatment of multiple myeloma.
The fast-track system – known as a Single Technology Appraisal – will be used to produce faster guidance on life-saving drugs that are already licensed, as well as new products close to when they first become available, according to NICE. The system is intended to overcome problems with access to medicines, which can occur when hospitals and primary care trusts refuse to provide new medicines before NICE delivers its verdict on them, even though they have been expressly instructed not to deny treatment on cost grounds.
In effect, the new system cuts out some portions of the current appraisal system, and means that the process starts when a drug is submitted, not approved for marketing. The agency will ask for a single submission of evidence from the drug’s manufacturer will move quickly to the final (appeal) stage of the process where the draft recommendations are in line with the product’s license. The first guidance developed in this way is expected next June.
A further nine products which have already been referred to the NICE are eligible for consideration under the STA process. Of these, Eli Lilly’s advanced/metastatic breast cancer treatment Gemzar (gemcitabine) and Schering AG’s Fludara (fludarabine) for first-line lymphocytic leukaemia, are set to proceed early next year.
The other seven, which could also start the new process early in 2006, are:
- OSI/ Genentech’s Tarceva (erlotinib) for non-small cell lung cancer; SuperGen’s Orathecin (rubitecan) for pancreatic cancer – subject to licensing;
- Pfizer’s Campto (irinotecan) in adjuvant advanced colorectal cancer – subject to licensing;
- Lilly’s Alimta (pemetrexed) for non-small cell lung cancer;
- Merck KGaA’s Erbitux (cetuximab) for locally advanced recurrent metastatic head and neck cancer – subject to licensing;
- Abbott Laboratories’ Xinlay (atrasentan) for hormone-refractory prostate cancer – subject to licensing; and
- Schering-Plough/Merck & Co’s Ezetrol (ezetimibe) for the treatment of hypercholesterolaemia.
The STA will operate alongside existing NICE appraisal systems and be subject to a consultation process over the next three months. Also, the NICE says it is consulting on proposals to speed up its system for appraising more than one drug – the Multiple Technology Appraisal process – which looks at groups of products already on the market to compare them with each other.
