The following is a statement from the Health secretary Patricia Hewitt on Herceptin.
There is strong, peer-reviewed, published evidence from four independently run trials to suggest that the use of Herceptin to treat HER2 positive early breast cancer could markedly reduce the risk of recurrence.
The best clinical advice suggests that of the 5,000 patients who might be eligible for this treatment, around 20% might be prevented from relapsing. We are therefore working to an estimate that 1,000 lives per year could be saved. That is why we have acted to ensure HER2 testing is available to NHS breast cancer patients across the country and that the NICE assessment of Herceptin, for this group of patients, happens as quickly as possible.
There have been ongoing discussions between NICE and the Department of Health around speeding up the assessment process for new treatments. On 26 September NICE announced they had presented Ministers with their proposals for speeding up the appraisal process.
On 5 October 2005, I announced that I had asked the National Cancer Director, Professor Mike Richards to work with cancer networks to ensure that HER2 testing facilities are put in place throughout the NHS so they are accessible to all women with early breast cancer. I also announced that following a licensing decision on the use of Herceptin for treating patients with early breast cancer, it was to be fast-tracked for use throughout the NHS.
Roche has offered to support individual cancer networks in strengthening HER2 testing arrangements where necessary and is liaising directly with individual cancer networks regarding this.
It is already possible for a clinician to prescribe a drug for an unlicensed indication. The clinician will make this decision after discussion with the patient about the potential risks and taking into account his/her medical history.
However, if the drug is unlicensed, PCTs may also become involved to decide whether to support the clinician's decision and supply the unlicensed drug at NHS expense.
On 25th October 2005, I stated that PCTs should not refuse to fund Herceptin solely on the grounds of its cost. As with the use of other unlicensed drugs, PCTs should take into consideration a whole range of factors before making a decision whether to fund the treatment for women with early stage breast cancer.
In general, Ministers and the Department of Health do not intervene in individual cases - they are rightly, a local matter. However, it is appropriate for Ministers and the Department of Health to clarify policy, which might inform local decision making.
On 8 November 2005, North Stoke PCT issued a statement confirming they would not be funding Herceptin for an individual case. In response to this decision a statement, cleared by me, reiterated that PCTs should not refuse to fund Herceptin solely on the grounds of its cost.
Following a meeting with the patient, North Stoke PCT issued a statement confirming they had decided to fund Herceptin in this individual case, based on "exceptional circumstances".
No one from the Department of Health asked the PCT to change their decision or asked the Strategic Health Authority (SHA) to intervene on the Department's behalf to overturn their decision.