British woman loses Herceptin court battle

Feb 16 2006

A mother of three in the UK suffering from the early-stage of an aggressive form of breast cancer, has lost her high court battle to force her health authority to pay for the potentially life-saving drug Herceptin.

Herceptin is one of a new generation of targeted therapies which attack only cancer cells and are tolerated much better than traditional chemotherapy.

The drug is already used for advanced cancer and other women in the same situation as 54 year old Ms Rogers have been given the drug.

Campaigners are now calling for clarity on who should have access to the drug.

The conflict of opinions has risen because the drug is yet to be licensed or approved by medical authorities for use in women with early stage breast cancer, meaning the decision over who gets the drug is left to individual primary care trusts.

The High Court ruled that Swindon Primary Care Trust in Wiltshire, was within its rights to refuse Rogers the expensive drug treatment as it was not in their policy to do so other than in exceptional cases.

Herceptin costs about 20,000 pounds a year.

High court judge Justice Bean said the court's function was not to comment on the policy but rather to say whether the decision was lawful under British law.

Cancer charities say the decision reinforces the inequalities in accessing Herceptin that patients are suffering and the postcode lottery that continues while a licensing decision is pending.

The drug which promises to save the lives of 1,000 women has already been licensed for women with advanced stage breast cancer, but authorities say in order to ensure its safety and benefits are proven, the standard licensing process must be followed.

They say concerns Herceptin could increase the risk of heart failure, demands more research.

However studies have found the drug can halve the risk of a woman's cancer returning, if she carries the HER2 gene.

British Health Secretary Patricia Hewitt has said that PCTs should not refuse Herceptin treatment on the basis of cost.

Roger's case is the first to reach the High Court over Herceptin and could set a precedent for patients seeking access to the drug on the National Health Service.

She has been receiving the drug since last year when another High Court judge considered she had an "arguable case" and supported her challenge to the Trust who were ordered to provide the drug for Rogers pending the hearing.

Many in the medical profession believe a decision in favour of Mrs Rogers would have had huge implications for decisions on drugs for other conditions and say other groups equally as needy do not have the lobbying power of the breast cancer groups.

They say if people power determines who is prescribed drugs, equity in access to medicines could be sacrificed.

They also say the licensing and regulatory processes are there to ensure that new drugs are both safe and effective as well as to protect patients.

The National Institute for Health and Clinical Excellence (NICE), which advises on the cost-effectiveness of drugs for the NHS, says it will fast-track its appraisal of Herceptin, once that license has been given, all patients will then have equal access to the drug regardless of where they live.