NICE Herceptin appeal decision expected in weeks
pharmafile | July 27, 2006 | News story | |Â Â Â
A final decision from NICE on Roche's breast cancer treatment Herceptin is expected within five weeks, following a PCT appeal against guidance for the drug.
The appeal is the last stage in a highly publicised campaign for access to the drug, which has been at the centre of unrelenting controversy in the UK, with a number of PCTs facing concerted patient campaigns for access.
In June, Herceptin received regulatory approval and a recommendation from NICE for early breast cancer, but the appeal adds further confusion and delay about which women can receive the drug.
Newbury & Community PCT was selected at random as the stakeholder organisation which could appeal against NICE's decision and its objections were held at a public hearing.
The PCT is seeking clarification and guidance on how many HER-2 positive women with early breast cancer should receive the drug and for how long.
Interim associate director of public health, representing the PCT, Dr Jane Wells stressed that the PCT was not saying that women should be denied Herceptin.
She said: "We welcomed the opportunity to ask for clarification on a number of points in the draft guidance. We wanted to make sure that the guidance was as clear and well defined as possible so the PCT could effectively treat patients and fulfil its responsibilities to the local population."
NICE's final appraisal decision recommended Herceptin be given at three weekly intervals for one year or until disease recurrence (whichever is the shortest period) in women with the early stage of HER-2 positive breast cancer.
The PCT wants NICE to take into account the FinHer study, which suggests Herceptin can be taken for nine weeks and still retain its effectiveness. The shorter treatment regime would also reduce the possibility of adverse effects.
In addition, the PCT says it will not be able to carry out cardiac monitoring of women on Herceptin, as recommended by NICE, without it affecting the care of other non-cancer patients with heart conditions, who require regular monitoring.
Chairing the NICE appeal, professor of clinical pharmacology at the University of Leicester David Barnett agreed that evaluating cost effectiveness was a complex situation.
He added: "I think there is room for some flexibility of resources and they have to be addressed at local level."
Despite basing its appeal on the FinHer study, the PCT is well aware only 232 patients were involved in the study and it is gearing up to implement NICE guidance by the original deadline of 1 October of this year.
The appeal will not affect the PCT's current treatment of patients with early HER-2 positive breast cancer.
