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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

Comments

Matthew Dann January 12, 2010

The government should make this treatment avaliable on a pay per use basis, i.e if a patient needs this treatment and it can help their cause then they either pay for the treatment there and then or have the option of buy now pay later.
If people were able to purchase these drugs personally drugs which could potentially save life’s then why would you not want to make them avaliable?. I believe if someone can afford their treatment then they should be able to do so and claim the monies back from the governemt.
Anyone who is not willing to provide treatment or make treatment avaliable for such a good cause i.e cancer treatment is un humaine and as far as i’m concearned the lowest form of life!!!

Danny Arnoux January 11, 2010

N.I.C.E ? Nasty Institute of hopeless and Cynical Excuses perhaps ?

I lost the most precious, caring and compassionate wife that a man could ever wish for. Because of Cancer, my life will never be the same again and I fully appreciate the true value of human life. To put a price tag on people’s lives, even if it is only extended by a number of precious months is an obscenity. Yes, I apprecaite that the N.H.S isn’t a bottomless pit. However, when it comes to money, I won’t mention the fact that our grubby little Politicians and Bankers make sure that their coffers are full. I’ll bite my tongue and resist the temptation…

Penny January 10, 2010

Just because NICE can’t aford the drug it should not be up to them to decide no-one can use it.
If there are cancer patients out there that can afford to purchase it, they should be given the option.
I know my family would all contribute for anyone of us that needed it. I know this does not help everyone but if the people that can afford it can cover the cost themselves then there is all the more money for the government to help the patients that can’t afford the drug.
After reading FL’s note about his Aunt, there is obviously no question this drug needs to be made available to everyone. There are countless areas where all our Governments waste our money, when it could be put to use elsewhere.
I am very dissapointed with NICE’s decision but not at all surprised. Just another fat cat cock up.

Simon Turner January 10, 2010

I would like to raise a number of points.

1) National Institute of health and Clinical Excellence. I have checked all the dictionary definitions of “excellence” and can find no qualification of cost or price in those definitions. May I suggest that “Excellence” be replaced with the word “Economy”? It would thus reflect the truth. I have never seen the criterion of excellence enter in to any of their decisions.

2) Life is a terminal condition; we are all going to die. Therefore, any medical or surgical intervention is only delaying the inevitable. Have NICE considered the economics of that? I can only hope that they will not.

3) Can we assume that “Liver Cancer” means primary liver carcinoma? A large number of neoplasms metastasise to the liver; notably gut primaries. Can we assume sorafenib is efficacious only for primary liver carcinoma and not for secondaries?

I understand that the NHS does not have a bottomless purse and a National Institute for Clinical Economy is necessary, but I believe in calling a spade a spade. Medical and surgical procedures to prolong life are not a waste of money. Sloppy terms like “liver cancer” may raise false hopes and that is cruel. If the readers of this site can accommodate the word sorafenib, they can certainly grasp the nice difference between primary and secondary tumours.

The Fortean Dentist

Anna January 9, 2010

My mother was on Nexavar. She died in October after taking 2 months of required dose. Her liver did not cope well with the drug and it is possible that she would have been better not taking it. There are also quite nasty side effects like skin itching and sleepiness. I ma not sure that 4 months advantage is an advantage and yes it is expensive. This money may be better spent on BCC for advanced liver cancer patients.

Henry Scowcroft January 9, 2010

Thanks, everyone, for your comments. A couple of you have pointed out an error in the text of the main post, where we referred to ‘life-saving’ drugs in the penultimate section. This should of course have read ‘life-extending’. The post has now been amended. Apologies for the error and the confusion.

Henry

lyn forward January 9, 2010

I lost my darling husband to liver cancer and i think these so called experts who hold peoples lives in there hands should be made to see the pain and suffering these brave people go through .I will never forget nursing my husband along with my children at home knowing there was nothing that could be done for him no hope just so much pain .When some one you haved loved for so long askes to be let to die it cuts like a knife .Please please let lives come before money stop the wars and big pay outs and allow these people to spend a little more time with there loved ones

nasra January 8, 2010

My mum died of liver cancer in 2007, at the time I tried every treatment for my mum. I have only known about the treatment to extend life called Nexavar only today when I saw the artical and comments of people who have been affected by liver cancer. I am angry and annoyed that treatments to extend life could cost so much money. Nobody can buy the price of life, but if their is a treatment that can give families the precious time to be with loved ones then surley companies making these drugs should try and make the treatments much cheaper and avordable. If I could have the chance to have just a few more months with my mum, then I would be so happy, unfortunatley that was not the case. She was ill very ill and at times I felt that maybe for her to pass away would be easier for her. Please allow people to spend more time with loved ones.

John Peter Walsh January 8, 2010

Drug companies have to recover the cost of research and development over the limited span of a patent.They also have to do this via profitability.Research is immensely expensive and the risks of failure,even disgrace,are immense.Patent protection should be extended.
Oncoming drugs will be several orders of magnitude more expensive than any available hitherto.Those first into the arena will be watched,copied and made available later,albeit design and production methods will be strictly guarded.This is quite fair and reasonable.
NICE is financially pre-conditioned and will routinely reject even the most clinically objective findings relative to a new product’s merits.NICE is a straightforward interposed fiscal barrier to pharmaceutical progress,nothing more,nothing less, hypocritically defending the legendary taxpayer- until (s)he,the taxpayer, is stricken with malignant disease…and beyond.Better to pay for a war: – helicopters etc.- than for healing – and definitely not for palliation.

Maureen Burke January 8, 2010

My daughter died of liver cancer age 45years and if she could have had this drug it would have helped .I THINK IT IS DIGUSTING THAT PRICE is more important than saving peoples lives

ACN January 8, 2010

Having said the above, I would like to say that I wholeheartedly agree with Danny Arnoux’s statement “We can find the money to fight wars and yet we count the pennies when it comes to saving live.”.

It is a pitiful shame that the money pit which funds the killing of others appears to be bottomless, while the coin-purse that funds the saving of lives is held so tightly closed.

ACN January 8, 2010

I find it difficult to decide how I feel about this. On the one hand I can see how someone with a terminally ill relative would consider £9000 (or indeed any amount of money) an acceptable price to pay for four more months with their loved one. I know I would in such a situation.

On the other hand, the NHS only have so much money to go around so if they spend this money in order to extend someone’s life for a few months could this be at the expense of equipment which could actually *save* other lives? Incidentally, I think “…high-profile decisions not to recommend life-saving drugs like this…” is misleading in the original article.

It must be a difficult, if not impossible, decision to make. However, the key point is that, as others have mentioned, the fault is not necessarily NICE’s for choosing not to recommend this drug, it is Bayer’s for putting such a high price on the extension of life.

Danny Arnoux January 8, 2010

While these organisations and these powerful (and wealthy) drug companies are wrangling over costs and their grubby little financial deals, let us not forget that there are people affected by this awful Cancer who are dying.

My wife died of Cancer (Breast Cancer and secondary Liver Cancer) last month and was given all the drugs and care that were rightly due to her. I cannot criticise the NHS as they did everything possible for Kathleen. However, I have the greatest contempt when it comes to these drug companies and I also the irony is not lost on me concerning the naming of “NICE”

Hope you guys never get Cancer. If you do, I suspect that you might suddenly change your outlook ?

We can find the money to fight wars and yet we count the pennies when it comes to saving live. Life is precious. You cannot put a price on it. Wake up, it’s time to smell the coffee…

Carolyn January 8, 2010

It’s all well and good having an association of so called experts who decide on the best way to spend tax revenue when it comes to health but where does that prudence go when it comes to bailing out greedy bankers etc and the tax pounds needing to be ploughed into a bottomless pit? It seems that exceptions can always be made when it suits. In my opinion, it is our tax money and we should have a say in how this is spent and when it comes to health – well, let’s say that extending a patient’s life even minimally is still worth more than a banker’s bonus. Where have the basic principles of humanity gone??

BT January 8, 2010

I think NICE should pay up and allow these poor souls that little extra bit of time with their families. After all, we are only here once and should be helped to make the most of our time here, if that is what we want. I agree with Bob too – What IS the point in putting all that time and effort into developing drugs that nobody can afford!

Bob January 8, 2010

What is the point in developing a drug that will help to cure people that no one can afford?

These companies should be ashamed of themselves offering hope then taking it away again. Bit like the taxman really……

FL December 18, 2009

As an American with an aunt who has liver cancer, I’ve been following developments on the disease and was really disappointed about this news.

Here are a few things that haven’t been reported:

1. In the original clinical trial for Nexavar, patient life was extended by about six months (far more than the “few weeks” NICE cited). But that’s for patients who died during the trial time.

Moreover, the trial was conducted with patients with advanced liver cancer. For patients with non-advanced liver cancer, the results have been even better.

My aunt was in that trial, and she is STILL ALIVE. More than THREE YEARS later! At first the side effects were unbearable, but they’re bearable now after her body got used to the drug. My aunt has a good quality of life and became a grandmother a few months ago.

Because the drug is so effective, she also doesn’t require costly care like full time nurse assistance or hospital stays.

2. I am utterly ashamed that the US doesn’t have a universal health option for everyone, but in this case, I would rather be a liver cancer patient in the US, assuming I’m over 65 which is true for most liver cancer patients, because Nexavar is covered under Medicare, the US universal health plan for people over 65.

Here’s the way it works with Medicare: Medicare negotiated a rate with Bayer that, strangely, was less than what the NHS was offered. Medicare pays for 80% of the cost, and the patient pays for the remaining 20%. The patient is also responsible for $4400 of their usual 20% responsibility. After that, Medicare pays for its 80%.

This still makes it a very expensive drug, but Bayer offers a discount based on your income. My aunt is roughly average income, and she qualified for the discount. I think that if you’re below average, you can get it almost free.

It’s still an enormous financial toll on families, about $1000 a month without the discount, but it’s better than having no option at all. And like I said, if you’re low income, you can get it almost free from Bayer.

3. Drug costs almost always decrease as the drug has been out longer.

4. Nexavar has been proven effective not only for liver cancer but also kidney cancer, and studies have just been released showing it’s effective for some breast cancer types too. You’re not only denying liver cancer patients, but patients of other cancers.

I have no financial interest in Bayer and am not always trusting of pharmaceutical companies, having been screwed over before. (I was prescribed an expensive drug that was approved based on false data.) But in this case, I’ve seen how much patients can benefit from Nexavar.

CMC December 15, 2009

Bayer could have set the price so that sorafenib became cost effective by NICE standards if they had wanted to. I would speculate that they chose not to because to do so would have had a detrimental effect on the prices which could be achieved for sorafenib in other countries.
Either that, or they chanced a higher price and hoped NICE would recommend it even though it exceeded the cost per QALY threshold. If that was their strategy it clearly was not successful.

GHR November 22, 2009

Perhaps my question was too personal, and for that I apologise.

PL Hayes November 21, 2009

GHR, your question is… well I think it’s probably against the rules to say what I think about it here so I’ll just ask you another one instead: What allocation of resources would you say is acceptable if, for example, you have £9000 which you can either spend on 4 months of extra life for 1 liver cancer patient or 3 months extra each for 1 liver cancer patient and 2 brain cancer patients?

GHR November 21, 2009

“an extra four months” for £9,000 sounds like very good value to me…..
PL Hayes what price would you say is acceptable to spend another day with your loved you?

PL Hayes November 20, 2009

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

Is that (relatively – and to alternatives, not placebo) impressive? I have to say it doesn’t sound very “life-saving” for the price to me.

peter c November 19, 2009

I can see no evidence in this article that NICE were wrong not to recommend the use of this drug. There is a vague feeling that they must have arrived at the wrong conclusion because it is not the one that the writer wanted.

“But although these guidelines were applied in this case, they don’t seem to have solved the problem.”

This kind of observation is rather too much like that which we see from the CAM supporters, who would have us reject evidence for what we feel about a subject.

Simon K November 19, 2009

Henry, you say that Bayer are “unable (or unwilling) to lower the drug’s price to a level that the NICE appraisal committee feels able to accept”. What’s your opinion of this?

I’m half sensing from this, and from your last line – “we’re just going to have to hope that a deal can be struck” – that you suspect this to be brinkmanship. Is it likely that faced with the prospect of NICE rejecting sorafenib completely, Bayer might reduce the price at the last minute?