Astellas gets NICE nod
pharmafile | October 18, 2013 | News story | Sales and Marketing | Cancer, NHS, NICE, Xtandi
Astellas Pharma’s new prostate cancer drug Xtandi which has been shown to shrink and kill cancer cells, has been recommended in draft guidance for use on the NHS.
Healthcare cost watchdog NICE has said Xtandi (enzalutamide) can now be used to treat hormone relapsed metastatic prostate cancer – a disease for which relatively few options exist at present.
The charity Prostate Cancer UK welcomed NICE’s green light for the novel, once-daily, inhibitor of the androgen receptor signalling pathway, saying it “could mean extra months of life to countless men”.
But chief executive Owen Sharp said: “We need to see NICE confirm this decision as soon as possible.”
Xtandi, which was developed with Medivation, was approved in Europe earlier this year and is widely tipped by analysts to be a blockbuster, earning $1-2 billion in peak sales in large part because of its proven ability to extend life.
In the Phase III AFFIRM trial, patients taking the drug had a median survival time of 18.4 months – an increase of 4.8 months on those in the placebo arm.
“It is an effective treatment and it also allows patients to be treated at home as it can be taken orally,” said Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
Big competition for the brand will come from J&J’s established Zytiga (abiraterone acetate), which has been on the market since 2011.
Earlier this year Zytiga’s licence was extended in Europe, which means the once-daily pill can now be used to treat metastatic castration-resistant prostate cancer (mCRPC) before chemotherapy.
Xtandi works in a different way to other drugs currently available for treating prostate cancer, and is recommended only if the disease has progressed during or after one docetaxel-containing chemotherapy regimen.
Astellas must also give the NHS an undisclosed discount, agreed in a patient access scheme on the average list price of a course of treatment, which is £25,269.
NICE admits there is ‘some degree of uncertainty’ over the cost per QALY for Xtandi compared with Zytiga – but insists it would remain below £30,000 per QALY gained.
However, Xtandi is more convenient than Zytiga because it can be taken on a full stomach and can help control the cancer longer since, unlike Zytiga, the dose does not have to be reduced to prevent liver toxicity.
Adam Hill
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