16 May 2014
In - Blog

Alexis Wieroniey, Campaigns Manager Alexis Wieroniey, Campaigns Manager

Our guest blogger this week is Alexis Wieroniey, Prostate Cancer UK Campaign Manager, who’s been closely following NICE’s decision whether or not to approve the life-extending drug abiraterone for use before chemotherapy. Here Alexis looks at the some of the issues that are holding up getting this drug into the hands of the men who need it.

Alexis: Earlier this week, we unfortunately learned that the National Institute for Health and Care Excellence (NICE) don’t think they’ll be able to recommend abiraterone – a life-extending prostate cancer drug - for men who are no longer responding to hormone therapy, but haven’t yet had chemotherapy. This could be a huge blow for this group of men. One of the main benefits of abiraterone is that it is less toxic than chemotherapy. It has fewer side effects and has been shown to improve quality of life and give men precious extra months. And, because it’s a tablet, it can be taken in the comfort of a man’s own home, avoiding the need for frequent hospital visits. Importantly, for men who are considered unsuitable for chemotherapy, because they’re too old or frail to cope with the side effects, abiraterone could be one of the few treatments that could give them precious extra time with their families. Not being able to get it could leave them with nowhere else to turn. Back in 2012, we successfully campaigned for abiraterone to be available as an ‘end of life’ drug for men who have already had chemotherapy. Now we think it should be available for men earlier on too because it can delay the need to start chemotherapy or be an alternative for men who aren’t well enough for chemo. And a lot of doctors seem to agree with us. We know this because abiraterone pre-chemotherapy is the second most requested drug on the Cancer Drugs Fund, showing that in England at least this is making its way into standard practice already. So why do NICE say they can’t recommend this drug?

The evidence problem

NICE’s issue is that the evidence supplied by Janssen, the manufacturers of abiraterone, wasn’t good enough to demonstrate either clinical benefit or cost effectiveness. These are both essential criteria for NICE to judge a drug’s suitability for use on the NHS. But Janssen don’t agree with NICE’s assessment of their evidence. One of the main problems in proving the clinical benefit of abiraterone was that the clinical trial was unblinded early., This means that every man on the trial who was originally getting a placebo drug was able to start abiraterone instead. But this happened before the end of the trial. Janssen say this was on the advice of an independent ethical reviewer, because the benefits of abiraterone over placebo were so great that it was no longer ethical to withhold the drug from those men who were only getting the placebo. NICE is saying that, because of this, reliable comparisons can’t be made on the effectiveness of the drug over a placebo, because the two arms of the trial (drug and placebo) were made the same. This affects how the patients are followed up and the significance of the results. NICE says it’s likely that the clinical significance of abiraterone has therefore been over-estimated by Janssen. NICE also raised another issue with the trial. Usually, trials like this for men in the last stages of advanced disease measure overall survival. In other words, how long does a man live if he takes this drug compared to if he doesn’t? This makes it quite straightforward to work out the clinical advantages of the drug. But in this case, Janssen used a different measurement. They measured tumour progression instead. Janssen say that this works just as well as overall survival, but NICE weren’t convinced.

Is cost an issue too?

The other major question is one of cost-effectiveness. Abiraterone is expensive but, if it is classed as an ‘end of life’ drug, NICE can be more flexible over the cost. But NICE says that they can’t consider abiraterone before chemo under their ‘end of life’ criteria. For a drug to be considered an ‘end of life’ drug it needs to be suitable for only a small group of patients (usually under 7,000 people), who are reaching the end of their lives and have a life expectancy of under 24 months. It also needs to extend life by at least three months. NICE say that the use of abiraterone before chemo doesn’t fit this criteria because men on the clinical trial survived for an average of 30 months. Janssen disagree with this too. They say that the standard of care men experienced as part of this clinical trial is greater than that in a normal NHS setting, so in fact, the average survival of men outside of the trial will probably still fall within the ‘end of life’ parameters.

What are we doing – and what can you do?

We don’t think that any of NICE’s objections are big enough to justify withholding abiraterone from men who need it. It’s a drug that’s already making a difference to men in England who can get it via the Cancer Drugs Fund and we want it to make a difference to even more men. We are therefore urging Janssen and NICE to work together and do everything they possibly can to resolve these problems. And while they’re doing that, we want to make it absolutely clear what this drug means to real men, in real life. We’ll be emphasizing this in our response to NICE, and we need your help to do this too. Please find out how you can add your voice to ours by responding to NICE. This is the best chance we have of convincing NICE to change their mind so please take a few minutes to share your views with them. We’ve got until June 5 to make our voice heard – let’s make sure we’re shouting.

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