By Richard Woodman
LONDON (Reuters Health) – Britain's National Institute for Clinical Excellence (NICE) has recommended Schering-Plough's Caelyx for the second-line treatment of advanced ovarian cancer.
In a preliminary assessment published on its Web site, NICE said that the liposomal formulation of doxorubicin was no less effective than topotecan (GlaxoSmithKline's Hycamtin) and, at £10,000 per person, was £2,600 cheaper.
Taking these factors into account, as well as its ease of administration and side-effect profile, Caelyx was the "drug of choice for many, but not all, patients with advanced ovarian cancer for whom first-line chemotherapy has failed."
NICE estimates 2,000 women a year in England and Wales currently receive topotecan at a cost to the National Health Service of £25 million. It says that this will rise to £26.5 million if all these women are first treated with Caelyx and if 500 of them are later given topotecan.
It is the first time that the cost effectiveness watchdog has published preliminary recommendations before issuing final guidance. Normally, recommendations have been leaked to the press, causing such embarrassment that NICE has launched inquiries in vain attempts to identify those responsible.
In a statement explaining the change, NICE said that it wanted to "increase the transparency of the decision-making process."
It said that "appraisal consultation documents" (ACD) would now replace the previously confidential system of "provisional appraisal decisions."
Alongside each ACD, the Institute would now publish an assessment of the clinical and cost effectiveness of the drug under review. Stakeholders would have four weeks to comment before NICE produced its final appraisal determination.
Andrew Dillon, chief executive of NICE said, "This open consultation process will allow all those affected by our work a greater opportunity to engage with the development of the guidance for the NHS, and will assist stakeholders in obtaining the views of those whom they represent."