Battle for Herceptin finally over
pharmafile | August 29, 2006 | News story | |
Newbury and Community PCT has lost its appeal against NICE's recommendation for cancer drug Herceptin, finally ending the battle over access to the drug.
After a year of controversy in the UK about access to Herceptin for women with early stage breast cancer, NICE's decision has drawn a line under the arguments and obliges all PCTs to fund treatment where appropriate.
The only remaining avenue for anyone wanting to challenge the decision is to apply for a judicial review in the High Court, which neither Newbury and Community PCT nor any other PCT is understood to be pursuing.
Dr Sarah Rawlings from Breakthrough Breast Cancer said: "We are delighted that NICE has finally published guidance approving Herceptin for women with HER2 positive early stage breast cancer. "We have at last come to the end of a long journey to ensure access to this vital drug for women who could benefit and we hope that today's announcement reassures those PCTs which initially reserved their decision to prescribe the drug until final guidance was issued.
"PCTs now have up to three months to implement this guidance but we would urge them to do so as quickly as possible."
Newbury and Community PCT's appeal had been the last opportunity to block or alter the guidance, but NICE's appeal panel rejected all five of the claims against the decision.
The PCT had challenged NICE's approval of the drug in women with early stage HER2 positive breast cancer on grounds of cost-effectiveness and the number of women eligible to receive the treatment.
The five separate arguments in the appeal included claims that NICE had not specified precisely enough which patients should receive the drug and for how long.
The PCT's first appeal was against the fact that NICE failed to differentiate between patients with a low risk of their breast cancer returning and those with a medium to high risk.
NICE based its decision on data from the HERA trial, which excluded patients with a low risk of their breast cancer returning but its final clinical and cost-effectiveness guidance covers all women with the condition.
Newbury PCT says this means women who are low-risk could receive the drug, despite there being no clinical or cost-effectiveness evidence to suggest they would benefit. It also warned that they would be exposed unnecessarily to the potential cardiac side-effects which are seen in some patients.
But Dr Peter Clark from NICE's appraisal committee said doctors would not prescribe Herceptin to women known to have low risk of recurrence. Furthermore, the drug's licence restricts its use to women with moderate to high risk and this was enough to convince the appeal committee not to rule against the decision.
The appeal panel also dismissed the claim that NICE had failed to take into account the impact of its guidance. The PCT had claimed the need to fund diagnostic testing, as well as Herceptin treatment, would mean other patients would lose out, but the appeal panel said the appraisal had taken full account of the cost–effectiveness of the treatment and its effects on other clinical services.
Joanne Funderburk, board secretary and communications leader of the PCT said it accepted the ruling and welcomed the opportunity to present it case.
"We will continue to put the infrastructure in place to support the full service and those patients currently receiving the treatment will continue to do so," she said.
NICE's chief executive Andrew Dillon, said its assessment of Herceptin showed it to be clinically and cost-effective for women with HER2 positive breast cancer.
He added: "The guidance has been issued rapidly, to ensure consistent use across the NHS and was produced in draft form just two weeks after the licence extension for Herceptin was granted."
NICE's fast-tracking of certain drugs is set to continue, with selected technologies assessed rapidly and close to their licensing date to help speed access to them for patients.
It is now recommended that Herceptin be given at three-weekly intervals for one year or until the disease recurs, whichever is the shortest period, for women with early stage HER2 positive breast cancer.
All England's PCTs now have until the end of November to ensure funding is in place to implement the guidance. It is estimated that between 5,000 and 9,000 women with the disease could benefit from the drug.
