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Sam Lister, Health Correspondent of The Times, says that other women will have to wait for Herceptin, or pay for it privately, after today's High Court ruling that Swindon PCT was justified in refusing the drug to breast cancer patient Ann Marie Rogers
Where does today's ruling leave other women diagnosed with the HER-2 form of breast cancer who think they would benefit from Herceptin?
Women identified as suitable for Herceptin - around a fifth of breast cancer sufferers - will have to continue their wait for the drug, unless they can afford to pay for it.
Today's ruling means that it will remain a decision for individual primary care trusts as to whether they provide funding for Herceptin for their patients. Many do not, pointing out that the drug is not yet licensed for early stage breast cancer and has not been given "gold standard" approval for the NHS by the National Institute for Health and Clinical Excellence (NICE).
When will Herceptin be licensed in Britain for use to prevent recurrence of breast cancer? Will this improve access?
Herceptin is currently licensed for use in women with advanced breast cancer, where the disease has spread. Research shows that it may also benefit women in the early stages of cancer. Roche, Herceptin's manufacturer, has yet to submit an application to European licensing authorities for its use in these circumstances. It is expected to do so in the near future, and the licensing process is likely to take some months.
Access to Herceptin in Britain will however only improve significantly once the NICE, which assesses all new treatments, recommends the drug as NHS best practice.
How long will that take? Is there a chance that NICE will refuse to recommend Herceptin in these cases?
NICE has said it will fast-track assessment of Herceptin for early stage use, after a restructuring of its review process prompted by concerns about patients being subjected to unnecessary waits for potentially life-saving drugs. This new system will likely see the drug recommended within six months of it being given a licence. However concerns do remain about the drug, which has been linked to heart problems, and some experts advise caution.
Do other European countries with similar health systems to Britain supply Herceptin in these cases?
Yes. In many other countries, Herceptin is already being made available for early-stage breast cancer without a licence. In Germany, France, Spain, the Netherlands, Slovenia, the US and four provinces in Canada, Herceptin is being prescribed before being licensed.
Why does Herceptin cost so much? £20,000 a year seems an awful lot.
It is a monoclonal antibody - a biological formulation rather than a simple chemical compound - which makes it more expensive to make. It is also in patent, which prevents cheap copies from being produced.
One cancer specialist gave warning today that Herceptin was the first of a generation of new drugs that are going to revolutionise care, but cost an absolute fortune. What are these new drugs, what do they offer, and how are we going to pay for them?
More biological drug treatments will come with much higher price tags. More people will also be on medication as the population continues to age.
Expensive cancer drugs of the future include Avastin and Erbitux, for colorectal cancer, which cost as a combined course around £17,500 per annum but are not currently widely prescribed.
Such treatments, used commonly, will be beyond the coffers of the NHS. Some experts suggest that introducing more insurance-based policies into health care will be the only way to begin to address the problem.
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