NICE rejects AstraZeneca’s breast cancer drug
pharmafile | December 14, 2011 | News story | Sales and Marketing | AstraZeneca, Faslodex, NICE
NICE has made its final decision not to recommended AstraZeneca’s breast cancer drug Faslodex, as it says the drug is no better than existing treatments.
The watchdog’s final guidance does not recommend Faslodex (fulvestrant) as an alternative to aromatase inhibitors for postmenopausal women, who have oestrogen-receptor-positive locally advanced or metastatic breast cancer, and have received an anti-oestrogen therapy.
Aromatase inhibitors include Novartis’ Femara (letrozole) and AstraZeneca’s own Arimidex (anastrozole), which are given as low-dose daily tablets.
AstraZeneca says its injectable drug could extend life when compared to using these drugs, but NICE said it found this to be ‘considerably uncertain’.
The watchdog added that while Faslodex has been shown to delay cancer growth, there is no evidence that it is superior to Femara.
This guidance means that NHS doctors should not prescribe the drug as an alternative to aromatase inhibitors for these women, after they have received anti-oestrogen treatment (e.g. tamoxifen).
But the guidance does say that women who are currently receiving Faslodex in this way should be able to continue to do so, until they and their doctors consider it appropriate to stop.
Sir Andrew Dillon, chief executive of NICE, said: “While there is evidence that fulvestrant can delay the growth of breast cancer, our independent advisory committee found that when used according to its marketing authorisation, its effectiveness is uncertain compared to aromatase inhibitors, which are currently the preferred treatment options on the NHS.
“Confidence about the additional benefits new treatments bring is important both for patients and for those who have responsibility for managing the resources available to the NHS.”
NICE currently recommends both Femara and Arimidex for this type of breast cancer. Both drugs are a type of hormone therapy that blocks the production of oestrogen in the body.
Faslodex is an injectable oestrogen antagonist, belonging to a class of agents known as selective oestrogen receptor down-regulators (SERDS).
Cheaper treatments
The current NHS list price of Faslodex is £522.41 for two lots of 5ml (250 mg) prefilled syringes. The recommended dose is 500mg, and is administered every month as two deep intramuscular injections of 250mg.
A further 500mg dose given two weeks later means the first month of treatment costs £1044.82. But aromatase inhibitors are much cheaper: a month’s worth of Femara 2.5mg tablets costs around £90 a month, and a lower dose 1mg form of Arimidex costs about £70.
As Faslodex is considerably more expensive than both drugs and cannot prove superiority, NICE said it could not recommend the drug.
Although NICE has not recommended the drug for regular NHS funding, it can be accessed locally via the government’s Cancer Drugs Fund.
Ben Adams
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