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Dismay as NICE turns down first-line use of AZ's Faslodex

Says evidence isn’t convincing for use in post-menopausal women

AZ

AstraZeneca's hopes of expanding the use of its breast cancer therapy Faslodex in the UK look rocky after NICE rejected the drug in draft guidance.

The clinical and cost-effectiveness watchdog says the evidence isn't convincing for the use of Faslodex (fulvestrant) in post-menopausal women with oestrogen-receptor-positive, locally advanced or metastatic breast cancer who have not already had treatment with hormonal therapy.

"We can't justify diverting NHS funds from other areas of healthcare in order to fund its use," said Professor Carole Longson, director of NICE's centre for health technology evaluation. Faslodex has an NHS list price of £522.41 for 2x5 ml (250 mg) prefilled syringes, the recommended monthly dose following a 500mg 'loading dose' given two weeks after treatment begins.

The drug - which acts as an oestrogen receptor inhibitor - was approved in this group of breast cancer patients in Europe last month based on the results of the phase III FALCON trial, which showed that the drug was superior to the widely-used aromatase inhibitor anastrozole as a first-line treatment.

The trial, which was reported in The Lancet last November, showed a statistically-significant 20% increase in progression-free survival (PFS) for Faslodex, with patients on the drug having a median PFS of 16.6 months compared to 13.8 months with anastrozole.

NICE acknowledges that the drug "stalls the cancer's growth by around three months compared to aromatase inhibitors" but concludes that "the available evidence did not show that this leads to an increase in overall life expectancy".

It is estimated that of the 32,000 postmenopausal women diagnosed with breast cancer each year in England, around 1,200 would be eligible for treatment with fulvestrant. The draft guidance is now open for comment until 25 September. NICE also turned down Faslodex as a second-line therapy for hormone-receptor-positive patients in 2011.

Baroness Delyth Morgan, chief executive at medical charity Breast Cancer Now, said the verdict was disappointing. "New options for women with this type of breast cancer are long overdue and while fulvestrant’s ultimate survival benefit remains uncertain, it offers a valuable advance in treatment."

She added fulvestrant is in a catch-22 situation; the uncertainty over its survival benefit means it cannot be deemed cost-effective but as a hormone therapy, it also cannot be made available through the Cancer Drugs Fund while further data is collected.

While other drugs such as Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) and Novartis' rival Kisqali (ribociclib) "may yet hold this type of breast cancer at bay even more effectively, but they are currently being appraised by NICE and we cannot assume they will be made routinely available to NHS patients", said Baroness Morgan.

The NICE setback comes just a few days after AZ won FDA approval for Faslodex as a monotherapy in this patient group. The drug has also recently been approved for first-line use in Japan.

Faslodex has been a big earner for AZ for many years, and while it is subject to generic competition in most markets it remains patent-protected in the important US market and brought in sales of $462m in the first half of the year, a decline of 5%.

Last year, AZ entered into a patent settlement with Novartis' generics unit Sandoz that opens the way for generic competition in the US in March 2019, around two years ahead of patent expiry.

Article by
Phil Taylor

4th September 2017

From: Regulatory

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