NICE looks at Xtandi again

pharmafile | January 28, 2014 | News story | Sales and Marketing Astellas, NHS, NICE, Xtandi 

NICE has announced it is to consult again on its decision to recommend Astellas Pharma’s prostate cancer drug Xtandi after suggesting that it should be available more widely.

In October, NICE’s draft guidance said Xtandi (enzalutamide) should be used to treat hormone relapsed metastatic prostate cancer – a disease for which relatively few options exist at present.

In that guidance, the brand was only recommended for people whose disease has progressed during or after one docetaxel-containing chemotherapy regimen.

However, NICE has now said that limit should be removed, throwing it open to patients who have had ‘any number’ of such treatments.

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But Astellas is ‘disappointed’ and ‘surprised’ that NICE has introduced a restriction which was not in the guidance three months ago: that Xtandi should only be open to patients who have not received abiraterone.

Astellas medical director Alan McDougall called this a “major setback for many prostate cancer patients who would otherwise be eligible for treatment with enzalutamide according to the original draft guidance and licensed indication”. 

“There are few treatments available for patients at this stage of prostate cancer so we are very pleased that we are able to produce draft guidance recommending enzalutamide,” said Carole Longson, director of NICE’s Centre for Health Technology Evaluation.

Xtandi has a different mechanism of action from other anti androgens, blocking the binding of androgens to androgen receptors and the interaction of activated androgen receptors with DNA in the nucleus.

Based on a daily dose and mean treatment length of 8.5 months, the list price of a course of the drug is £25,269, but it will have to be available to the NHS at a lower cost than that under an agreed patient access scheme – the details of which remain undisclosed.

Developed with Medivation, Xtandi was approved in Europe last June and is tipped by analysts to be a blockbuster, earning as much as $2 billion in peak sales.

This figure is predicted, in large part, because of its proven ability to extend life by shrinking and killing cancer cells: 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.

As well as being effective, the oral drug is also convenient, allowing patients to administer it at home – it can also be taken on a full stomach.

Adam Hill

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