NICE: AstraZeneca's Faslodex in breast cancer not 'a good use of resources'
This article was originally published in Scrip
NICE, the health technology appraisal institute for England and Wales, is poised to reject AstraZeneca's Faslodex (fulvestrant) 500mg as an alternative to aromatase inhibitors for treating some women with breast cancer. The institute said there was too much uncertainty over the drug for it to be "a good use of NHS resources".
In preliminary draft guidance issued 22 August, NICE said that it did not recommend the drug as an alternative to aromatase inhibitors for treating oestrogen-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women whose cancer has relapsed on or after adjuvant anti-oestrogen therapy, or whose disease has progressed have disease progression on anti-oestrogen therapy.
AstraZeneca says it is confident about the clinical evidence supporting its oestrogen receptor modulator, which the firm says has an important place in the treatment pathway. The company will be working with NICE to understand what more it needs, said a spokesperson. "This provisional negative NICE recommendation was made despite the clinical evidence demonstrating that fulvestrant is shown to halt the growth of breast cancer for nearly nine months on average," said the company.
The issue for NICE seems to be that although fulvestrant delays time to progression in breast cancer, its impacts on overall survival are less clear, and even the time-to-progression performance is not markedly different from that of aromatase inhibitors. "The committee concluded that it had not been given any conclusive evidence that fulvestrant extends life or delays tumour progression anymore than aromatase inhibitor therapy, which is currently used in the NHS," said Sir Andrew Dillon, NICE's chief executive.
In the final appraisal scope NICE had listed as comparators: low-dose (250mg) fulvestrant administered every four weeks plus loading dose, and aromatase inhibitors (AstraZeneca's Arimidex, anastrozole; Pfizer's aromatase inhibitor Aromasin, exemestane; and Novartis' Femra, letrozole).
AstraZeneca submitted data from the CONFIRM trial which compared Faslodex 500mg with low-dose Faslodex in patients who had either received prior treatment with an anti-oestrogen or an aromatase inhibitor. It also put forward a network meta-analysis, based on eight trials, comparing overall survival and time to progression for Faslodex against the comparators listed in the scope.
The appraisal committee concluded that the 500mg dose offered benefits in terms of increased time to progression over the 250mg doses. But it said that this improvement was only statistically different for patients who had been treated with anti-oestrogen therapy and not for those who had been treated with an aromatase inhibitor. Meanwhile, the network meta-analyses did not show any statistical differences in overall survival between fulvestrant and anastrozole and tetrozole, although there was some statistically significant time-to-progression benefit compared with anastrozole, but not letrozole. Nevertheless, there was uncertainty over the validity of the results owing to the survival models used, according to the committee.
The committee estimated that the most reliable incremental cost-effectiveness ratio for the drug would be £35,000 per quality adjusted life year when compared with anastrozole.
NICE is urging AstraZeneca, patient groups and other consultees to comment on the recommendations so they can contribute to developing the guidance. They have until 13 September to do so. The institute hopes to publish final guidance in January.
The drug is available through England's cancer drugs fund, set up by the UK coalition government to improve the uptake of cancer treatments. It is an interim measure until the new value-based pricing system is up and running.