The much-vaunted breast cancer drug Herceptin is expected to be made available on the NHS to all women with the early stage of disease who need it, following draft approval today from two government advisory bodies.
Cancer charities expressed delight and relief that the months of campaigning are at an end. Herceptin is suitable for only 20% of women suffering from a first breast cancer, but those cancers tend to be aggressive. Ever since the manufacturer announced what were interpreted as spectacular results just over a year ago, many women have been demanding the drug from the NHS, and in some cases have been refused. One woman, Ann Marie Rogers, pursued her case against Swindon primary care trust to the court of appeal and won it in April.
Because of the furore, the National Institute of Clinical Excellence has made its decision on the cost-effectiveness of the drug in record time - two weeks from the licence being granted. Its draft guidance - which is unlikely to be challenged - recommends that Herceptin be used in all women with the particular sort of early stage breast cancer called HER2 positive.
Herceptin does carry risks for women with a history of heart problems, however, and Nice says it must not be given to those. The Scottish Medicines Consortium simultaneously recommended the use of the drug in Scotland.
The draft guidance is expected to be confirmed in a couple of weeks, if there are no appeals against it. Nice rulings are not legally binding, but PCTs will now find it hard to hold out against paying for the drug, which costs around £20,000 a year per person.
"Women with early breast cancer who are HER2 positive will feel immense relief after today's decision to approve Herceptin," said Joanne Rule, Cancerbackup chief executive. "We hope this means that no woman will be forced to fight for treatment to help save her life."
She urged PCTs to authorise payment for the drug immediately and called for the government to set up a fund to help with the cost.
"A year of uncertainty and postcode lottery is at last coming to an end," said Jeremy Hughes, chief executive of Breakthrough Breast Cancer. "Herceptin has highlighted challenges for the NHS in ensuring patients receive new, targeted and effective treatments."
While it welcomed the decision, Cancer Research UK sounded a cautionary note. "We must remember that Herceptin is only suitable in about one in five cases of breast cancer," said Kate Law, head of clinical trials.
"So it's essential not to create a climate of false hope for women, where Herceptin is seen as a miracle cure suitable for everyone with breast cancer."
Nice has been pilloried in the past couple of years for its slow appraisal processes and accused of delaying access to drugs and potentially reducing patients' chances of survival. The speed of its Herceptin decision won praise.
"It's gratifying to see Nice respond so quickly," said Karol Sikora, professor of cancer medicine and honorary consultant oncologist at Imperial College School of Medicine, Hammersmith hospital. "But over the next five years many other high cost cancer drugs will come on the market and it is important that we have robust and rapid decision-making processes in place to deal with these."
Roche, the manufacturer, said the decision was great news for women. In its press statement, the lead investigator in trials of the drug, Ian Smith, head of the breast unit at the Royal Marsden hospital in London, said: "Herceptin is the most important treatment advance ever for women with early stage HER2 positive breast cancer and therefore today's announcement is excellent news for all these women throughout the UK."
Herceptin is one of the first drugs to be targeted at specific types of cancer - in this case those that over-express a protein called HER2 on the surface of the tumour. Women need a test to see if they are among the 20% of breast cancer sufferers whose tumour is HER2 positive. The drug is already licensed and used in late stage breast cancer - where the disease has been treated but returned. In April last year, Roche announced that in women with a first breast cancer, Herceptin halved the chances of a recurrence. This inspired women to demand the drug as a life-saver, even though Roche had not yet applied for a licence in early breast cancer. While Herceptin will postpone return of the disease in some, trial data shows it is not a magic bullet. Studies in the US show 24.6% of women on standard treatment had a recurrence of their cancer after three years, compared with 12.9% of those on Herceptin. Reduction in death rate was small after three years - 8.3% on conventional drug treatment died, compared with 5.7% on Herceptin. But expectations have been high, causing the licensing body and Nice to fast-track approval.
