September 25, 2008
Hype Over New Cancer Drug May Give False Hope to Women
By Martin Eatock
A new drug called Lapatinib was recently hailed a "big step forward" for women suffering from advanced breast cancer. Consultant medical oncologist at the Belfast City Hospital, Dr Martin Eatock, argues that its true impact could be limited
Lapatinib, used in combination with the chemotherapy drug capecitabine, was recently licensed for the treatment of Her-2 positive advanced breast cancer, an aggressive form of the disease which affects around a quarter of those women diagnosed. It has been licensed for the treatment of women whose disease has progressed despite previous treatment with other chemotherapy drugs, including Herceptin.
The trial, on which this licensing decision was made, demonstrated that the combination of lapatinib and capecitabine resulted in a response rate of 24% among those taking part in the trial, compared to 14% for capecitabine alone, and an average improvement of eight weeks.
This has not yet resulted in a survival advantage. I would therefore question whether this is truly a "big step" forward. In fact, in a disease, which now has a survival often measured in years, this can at best be described as a modest benefit. I do not, however, write to belittle the potential that this drug has, the results of further clinical trials in patients who have travelled a shorter distance in their cancer journey are currently awaited.
The use of this drug in the NHS has to be considered in relation to other new drugs. Following the introduction of Herceptin for the treatment of early Her-2 positive breast cancer, a system to advise the Regional Medical Services Group (a local commissioning group for specialised healthcare) on the prioritisation of drugs for funding within the NHS here was put in place under the auspices of the Northern Ireland Cancer Network (NiCan).
In the last three years, 15 business cases for new drugs in the treatment of cancer have been considered and 11 of these funded, representing an uplift in the budget for cancer drugs in Northern Ireland from Pounds 12m to Pounds 18m. No business case has yet been received by NiCan for the use of lapatinib in advanced breast cancer.
Despite the success of this programme, the needs of cancer patients have to be considered in relation to the the wider needs of other patients in the NHS. The only way cancer drugs may be compared with drugs for the treatment of heart disease or psychiatric illness is to compare their cost effectiveness.
The National Institute for Clinical and Health Excellence (Nice) has sought to do this over the last nine years in England and Wales. Northern Ireland has been subject to Nice guidance since July 2006. Cost effectiveness of a new agent is assessed by looking at the cost per 'quality-adjusted life-year' gained, a system which gives each treatment a score for the benefit it gives in quality and length of life.
The cost per quality-adjusted life-year gained for lapatinib is estimated to be around Pounds 80,000 and it is therefore unlikely that this will be deemed to be cost effective by Nice, particularly as other new drugs for cancer treatment such as bevacizumab for colorectal cancer with a similar cost effectiveness ratio have not been approved.
Media coverage of the potential benefits of lapatinib is likely to lead to distress for a number of women with breast cancer who will now feel that they are being denied a very effective treatment. Examination of the facts, however, highlight the limited benefit of this drug and would lead to a better informed discussion of the issues around funding of new drugs.
As a cancer physician, I want the best care for all patients with cancer, however this is not necessarily represented by having access to every new drug immediately it is licensed.
Instead, best care reflects the need for the adequate resourcing of cancer services throughout the province to allow equitable access to high quality care, including adequate access to clinical trials examining the true impact of new agents for cancer treatment.
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