NICE blames Faslodex rejection on uncertainties in AZ data
pharmafile | August 23, 2011 | News story | Sales and Marketing | AstraZeneca, Faslodex, NICE, breast cancer
NICE has not recommended a high-dose form of AstraZeneca’s breast cancer drug Faslodex because of uncertainties over its cost-effectiveness.
In preliminary guidance, NICE said it was minded not to recommend Faslodex (fulvestrant) 500mg as an alternative to aromatase inhibitor therapy in postmenopausal women who have locally advanced or metastatic breast cancer, which is oestrogen-receptor-positive.
Faslodex was originally granted a European licence in 2004 as a 250mg dose, but in January last year this was extended to a higher, 500mg dose, which is what NICE is now assessing.
NICE said that in accordance with the drug’s EMA marketing authorisation, the committee’s provisional recommendation relates to the use of Faslodex 500mg after anti-oestrogen treatments – such as tamoxifen – are no longer controlling the spread of the cancer.
But the cost-effectiveness watchdog said it could not consider the clinical and cost effectiveness of the drug after an aromatase inhibitor – which is what AZ wants – because it is not licenced in the EU for this sub-group of patients.
Current aromatase inhibitors include Pfizer’s Aromasin (exemestane), AstraZeneca’s Arimidex (anastrozole) and Novartis’s Femara (letrozole), all of which are recommended by the Institute for early oestrogen-receptor-positive breast cancer patients that have been through the menopause.
These drugs collectively generated over $3.5 billion last year and are often used a second-line therapy after tamoxifen.
NICE also noted that, although the high-dose form of Faslodex was shown to extend life by at least three months more than patients taking Arimidex and Femara, these data were based on the overall survival results from AZ’s own economic model, which were associated with ‘considerable uncertainty’.
NICE’s chief executive Sir Andrew Dillon said: “After analysing the evidence comparing Faslodex’s clinical effectiveness with aromatase inhibitor therapy, our independent committee found that the estimates of overall survival and time to tumour progression were very uncertain.
“The committee concluded that it had not been given any conclusive evidence that [the drug] extends life or delays tumour progression any more than aromatase inhibitor therapy, which is currently used in the NHS.
“We encourage AstraZeneca, patient organisations and other relevant third parties to comment on this preliminary recommendation during this public consultation period so that they can contribute to the development of this guidance,” Dillon added.
The current NHS list price of the drug is £522.41 for two lots of 5ml (250mg) prefilled syringes.
The first month of treatment costs £1044.82, on account of the additional loading dose but after that, the drug is £522.41 per month.
Comments can be made up until 13 September, with final guidance for the drug expected in January next year.
AstraZeneca wants decision ‘reversed’
In reaction to the news, AstraZeneca said it was committed to working with NICE to explore “all possible solutions” to ensure suitable patients can access Faslodex at a 500mg dose.
Mark Jones, AstraZeneca UK’s marketing company president, said: “AstraZeneca is disappointed that NICE does not recommend Faslodex in its provisional recommendation.
He said AZ was ‘fully confident’ in the benefits that Faslodex can bring to suitable post-menopausal women with oestrogen receptor-positive, advanced breast cancer.
“For these women”, he said, “We would like this initial recommendation to be reversed”.
“We will work closely with NICE through the remainder of the consultation process with the aim of securing a positive final decision and thereby making sure that Faslodex can be made freely available to patients in the NHS,” Jones concluded.
Ben Adams
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