The new and expensive breast cancer drug Herceptin will be made available on the NHS to any woman who can benefit from it, the health secretary announced yesterday.
The announcement by Patricia Hewitt follows the victory of Barbara Clark, the 49-year-old nurse who persuaded her local health authority to pay for her to have the £20,000-a-year drug and threatened to go to the European court of human rights if they did not.
At the moment the drug has not undergone any independent scrutiny. It is only licensed for the treatment of advanced breast cancer, and it has not been assessed by the National Institute for Clinical Excellence (Nice), which is charged with assessing whether drugs are value for money. Cancer charities and campaigners such as Mrs Clark have been piling pressure on the government to allow women to have Herceptin on the NHS once they have had surgery and chemotherapy to get rid of their tumour.
Ms Hewitt said yesterday that all women should be tested to see if their tumours are susceptible to the drug - about 5,000 of the 35,000 diagnosed each year. If so, they will get Herceptin once it has been licensed. "Herceptin has the potential to save many women's lives and I want to see it in widespread use on the NHS," Ms Hewitt said in a statement.
Speaking from her home in Bridgwater, Somerset, Mrs Clark welcomed the government's decision. "This is absolutely fantastic news," she said.
But one critic, professor of medicines policy Joe Collier, yesterday accused the government of putting pressure on the drug licencing body and of bypassing Nice. "It is unacceptable that the minister should be pressurising the licencing authority or dictating to Nice about the proper use of medicines. What they should certainly do is make sure the decision by Nice is very fast. That would be reasonable. But this is a dangerous precedent and Patricia Hewitt should back off," he said.
The government's "cancer tsar", Professor Mike Richards will meet the medical directors of the cancer networks today to ensure they set up facilities immediately for testing women's tumours for the HER2 proteins that indicate they are susceptible to Herceptin. The charity CancerBacup says only half of all women are currently tested.
The health secretary anticipates that the drug will get its licence within nine to 12 months, but the manufacturer, Roche, has not yet put in an application for it. Roche says it will put in its dossier to the European Medicines Evaluation Agency in February next year. The decision is expected next July at the earliest.
About 1,000 lives could be saved each year, the government estimates from the trial data published by Roche, at an annual cost of £100m.
Cancer charities were delighted with the decision, but made it clear they did not even want to wait for the licence. "We are... concerned... that Herceptin will not be available for women with early breast cancer until 2006," said Joanne Rule, chief executive of CancerBacup. "The Department of Health must urgently consider making it available to all women who can benefit."