Sam Lister, Health Correspondent of The Times, explains why today's appeal court ruling is good news for breast cancer sufferers

What is Herceptin, who can benefit from it and why is it so expensive?

Herceptin (also known as trastuzumab) is one of a new class of cancer drugs known as monoclonal antibodies which are designed to interact with a single cancer-related mechanism in the body. Herceptin targets the HER-2 protein, which can fuel the growth of breast tumours.

The drug is suited to around 20 per cent of breast cancer sufferers who have tumours with a particular genetic make-up (known as HER-2 positive).

It remains very expensive (a course costs £20,000 a year) because it is a state-of-the-art treatment. It is also a biological therapy, rather than a chemical, which can be more complicated to develop and produce.

Why has obtaining Herceptin for treating early stage breast cancer been a postcode lottery so far?

Herceptin is currently licensed for use in women with advanced breast cancer, where the disease has spread within the breast or to another organ.

Research has suggested that it could also benefit women in the early stages of the disease, but it is not currently licensed for use in this group of patients. Some health trusts do however provide it if they feel they can afford it, and it is recommend by a patient's doctor. Others, such as Swindon PCT, have decided against this policy, because of concerns over efficacy and safety as it has yet to be licensed, or because of cost.

What has the Appeal Court said in its ruling today on Herceptin?

The Court of Appeal ruled that the policy of Swindon PCT, which was taken to court by a patient who had been denied the treatment, was "irrational and unlawful". It agreed that as the patient, Ann Marie Rogers, had undisputed clinical need and the treatment had been advised by her doctor, it was "arbitrary in the extreme to say…'you can't have this drug'", as her lawyers argued. The judges said that they could not order the PCT to fund Herceptin treatment for Ms Rogers, but it must "reconsider its policy and formulate a lawful policy".

Does this make it any clearer who is going to be allowed to get Herceptin in the future?

The ruling would suggest that any patient who is recommended Herceptin by her doctor should be able to receive the drug. It will not open the floodgates for any breast cancer sufferer to have Herceptin, however, as only some tumours are suitable for the treatment.

One possible scenario is that the PCT will review its policy and find lawful reasons not to provide the drug to anyone, such as the statutory requirement for every trust to stay within its budget. But it is more likely that women will now find it easier to get Herceptin.

Presumably once the European Medicines Agency (EMEA) has licensed Herceptin and the National Institute of Clinical Excellence has appraised it, there will no longer be any excuse for trusts to refuse to prescribe it. But how long will that take?

Possibly by the end of the summer. Roche, the manufacturer of Herceptin, submitted a licensing application to the EMEA for use of the drug in early stage breast cancer in February. The National Institute for Health and Clinical Excellence (NICE) has agreed to fast-track the review of the drug, and said today that it aimed to report back by the end of July.

Is Ann Marie Rogers right to say that this ruling is the best possible verdict for her?

Yes, because the PCT has agreed to continue funding her treatment (it had previously agreed to provide the drug until a court decision was reached). However if it introduces a "lawful" policy that does not require it to provide patients with Herceptin, then Ms Rogers will only receive the drug for a further 21 days after that decision is taken. As a landmark victory for an individual over a health trust, however, the ruling in favour of Ms Rogers is an important step forward for "patient power".

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