There was mixed news for prostate cancer patients in England and Wales this week after cost regulators for the NHS published preliminary guidelines supporting the use of Astellas’ Xtandi but rejecting Janssen’s Zytiga.

NICE is proposing to recommend Xtandi (enzalutamide) for prostate cancer which has spread in people whose first treatment has failed, who have no or mild symptoms, and for whom chemotherapy is not yet clinically indicated.

Its Appraisal Committee concluded that the drug is a well-tolerated treatment that delays chemotherapy, improves survival and is a cost-effective use of NHS resources, offering patients a new option at this stage of the disease.

On the downside, the Institute is barring patients at the same stage in the treatment pathway from access Janssen’s Zytiga (abiraterone).

The Committee agreed that the drug is a well-tolerated treatment that delays chemotherapy, but it was not convinced that the “uncertain evidence” for long-term benefit justified accepting estimates of cost-effectiveness that were significantly above what it would normally consider acceptable.

Zytiga’s incremental cost-effectiveness ratio compared with best supportive care was calculated to be between £35,500 and £59,600, while that for Xtandi came in at £34,500.

The Institute for Cancer Research has welcomed the decision to allow men with prostate cancer access to Xtandi pre-chemo, but chief executive Paul Workman also stressed that it is “a real blow” that NICE is denying men the innovative prostate cancer drug Zytiga in the same setting.

“It is very disappointing that men in England and Wales will not be able to access the treatment - even though in Scotland it has been made available on the NHS. We need to challenge these kinds of inequalities in drug access across the UK,” he said.

High demand for Zytiga

Zytiga is already approved by NICE for routine use after chemotherapy, where it is considered to be cost effective. It is currently available pre-chemo via the Cancer Drugs Fund (CDF), where it is the second most requested medicine, demonstrating the clear demand from patients and clinicians, says Janssen. 

The drugmaker stressed it has proposed a number of different options to the Department of Health, NHS England and NICE, including a reduction in the list price of over 20% and for any patient on the drug to receive it free of charge after 10 months, giving the NHS budgetary certainty in the long term, to no avail.

“There is high demand for abiraterone in England so it is extremely disappointing that yet again patients may not be routinely entitled to earlier access to a treatment on the NHS that can extend survival,” said Mark Hicken, Managing Director, Janssen UK & Ireland. “We disagree with NICE that the evidence we submitted was uncertain.  Our trial, one of the largest and longest in prostate cancer, clearly demonstrates long term survival and quality of life benefits for patients which are also recognised by the clinical community”.

Prostate cancer is the second most common cause of cancer death for men in the UK - in 2015, around 11,350 men are predicted to die from the disease, while every year around 45,000 men are diagnosed at any one time.