A bottle of pills

NICE has decided not to recommend sorafenib (Nexavar)

NICE’s decision today not to recommend sorafenib – also known as Nexavar – to the NHS for the treatment of advanced liver cancer, is deeply disappointing for a number of reasons – namely the drug’s cost; the fact that it works; the questions this raises over NICE’s processes; and the effect this has on public perceptions of cancer care.

But before we examine these, we need to clarify the nature of NICE’s latest guidance. Several media reports have suggested that these are preliminary and thus open to consultation – but they’re not.

This is a ‘final decision’ – i.e there will be no further consultation. However, the decision is open to appeal for the next fifteen days, before the final guidance is formally published in a month or so. And NICE have told us that they’ll leave their decision open to review as new evidence emerges.

But with that clarification out the way, let’s return to the decision itself, and why we and others are so disappointed.

Cost

Firstly, this treatment is expensive. Although the drug’s manufacturer (Bayer) have offered the NHS a ‘buy three get one free’ deal, they are unable (or unwilling) to lower the drug’s price to a level that the NICE appraisal committee feels able to accept.

Bayer’s efforts to lower the price to about £3,000 per month still do not bring it within NICE’s limits of what it regards as an acceptable use of taxpayers’ money.

NICE have talked about the other treatments that the NHS could buy for its money. And, to an extent, they have a point.

Effectiveness

But as our chief clinician Professor Peter Johnson pointed out on BBC’s Today programme this morning, sorafenib works.

Most patients with advanced liver cancer can’t be operated on – and surgery is the only treatment that can cure the disease. For people for whom surgery is not a suitable option, there are no alternative treatments – and average survival is about eight months as a result.

Clinical studies have shown that sorafenib can extend people’s lives for an extra four months on average.

And as part of the appraisal process, NICE heard from doctors who have experience of using this drug and who have seen in practice the benefit that it can give.

Transparency

This leads on to a question once again about how NICE makes its decisions.

Is it right that NICE is making recommendations that are at odds with clinical experts? And do we know what sort of priority NICE is giving to these doctor’s opinions, and how they weigh this up against the cost and other evidence available?

To add to this, earlier this year, NICE announced that it was bringing a new series of guidelines to deal with drugs used to extend life in the terminally ill, where there are few other alternatives, which we welcomed at the time.

But although these guidelines were applied in this case, they don’t seem to have solved the problem. It may be that these guidelines aren’t being applied consistently as yet – it’s difficult for us to tell from the information that NICE has given us.

Wider issues

Finally, high-profile decisions not to recommend life-saving extending drugs like this have a corrosive effect upon people’s perception of cancer treatment in this country. As an organisation, NICE makes extremely tricky and often controversial decisions – but very few of its favourable decisions receive as much media attention as its negative ones.

It’s unfortunate that, despite the fact that there’s been so much improvement in cancer care over the last decade, stories over denial of access to expensive cancer drugs continue to dominate the headlines, and give people a poor impression of the quality of cancer care in the UK.

Will Cancer Research UK appeal against the decision?

As we mentioned above, NICE’s decision is open to appeal. But we won’t be appealing.  This is because the appeals process is to allow stakeholders in the consultation process to submit new clinical or economic evidence to NICE’s committee.

Sadly, even though we were stakeholders in the consultation, we have no new evidence to submit – nor can we in any way influence the cost of the drug. We will absolutely support any such appeal where possible, but in this instance, frustratingly, we’re just going to have to hope that a deal can be struck.

Henry