UK's NICE Rejects Lilly's Alimta in Mesothelioma

LONDON JUN 26, 2006 (Agence de Presse Medicale for Reuters Health) - UK cost-effectiveness watchdog, NICE, has rejected Eli Lilly's Alimta (pemetrexed) for treating mesothelioma, the local arm of the U.S. company said on Monday.

In a statement timed to tie in with the anticipated announcement of the rejection by NICE, Lilly UK said: "NICE has recommended a ban on people with an asbestos-induced cancer, mesothelioma, receiving the only licensed medicine for the disease."

Although NICE refused to supply the data on its draft guidance to APM ahead of today's announcement, Lilly said the body had rejected the drug on the grounds of cost-effectiveness and the decision would come into full-force in October -- from when the drug would no longer be funded by the National Health Service (NHS).

Dr. Joanna Nakielny, Medical Director of Lilly UK said: "This is a major blow for patients with mesothelioma many of whom were unwittingly exposed to asbestos in their working lives. Lilly will be formally appealing NICE's decision."

Lilly will appeal on three fronts, arguing that evidence provided by the company was not properly taken into account, NICE's summaries of clinical effectiveness and cost-effectiveness are not representative of the evidence available, and the recommendations are neither sound nor a suitable basis for guidance to the NHS.

SURVIVAL INCREASE PROVEN

In a briefing note the company said in combination with cisplatin, Alimta offered a proven survival increase of 23% to 40% compared to cisplatin alone.

It also said the cost to the NHS would not be high with only 600 patients in the UK at present being eligible for treatment and the incidence of the disease set to peak within a decade.

A full course - six cycles - of Alimta/cisplatin therapy costs around 8,000 pounds (11,700 euros), Lilly added.

The company said most patients (87%) respond within four cycles allowing an option to reduce the cost of treatment by stopping it in the case of patients who have not responded within 12 weeks.

"An increased survival and reduced cost would lead to a lower cost threshold. The incremental cost per life year (which emphasises the importance of survival) is only just over 30,000 pounds (44,000 euros) for the appropriate fitness levels for treatment."

NICE ENCOURAGING USE OF UNLICENSED MEDICINES

Lilly also argued that by banning Alimta physicians will turn other (unnamed) medicines that, even if not proven for use in the disease are not expressly forbidden.

"Lilly believes that NICE is effectively recommending medicines for the treatment of mesothelioma which they have not assessed and are currently unlicensed for this use.

"Lilly therefore believes that by not recommending pemetrexed, NICE has failed to give adequate weight to the fact that there is no real evidence in support of use of the other therapies currently used to treat mesothelioma patients in England and Wales.

"In particular the safety profile of unlicensed medicines in this cancer has not been evaluated to regulatory standards."

The charity Cancerbackup also criticised NICE's decision, pointing out that yet again a therapy available in Scotland (although Scotland may later adopt final NICE guidance) was being denied to patients in England and Wales.

Joanne Rule, Cancerbackup's Chief Executive, said: "It is unacceptable that if you live in Scotland you can have this treatment, but if you live across the border you can't.

"This cancer can be very difficult to treat and pemetrexed is widely used as an effective treatment in Scotland and the private sector, helping to control symptoms and giving vital extra months of life."

Source: Reuters Health Information