Last week NICE issued a press release to say that it has terminated its review of avastin as a first line treatment for metastatic breast cancer (also for lung I think.) It says it has done this because the manufacturers (Roche in Europe …linked to Genentec in USA) refused to submit evidence. The manaufacturers say they decided not to submit evidence because they knew it would not meet NICE’s complex cost effectiveness criteria. So stalemate and this decision has huge implications for those who might benefit from avastin.
I am personally very torn on avastin cause I know cost effectiveness aside that the trial results are very mixed…particularly lack of evidence about overall survival…indeed in USA some patients groups are annoyed that the FDA did approve avastin’s use on lesser evidence than is usually required for cancer drugs.
Again, personally, I think it is dreadful to watch cancer patients mortgaging houses, running their own personal fund raising campaigns for a drug which may actually not help very much. On the other hand it may be that for some people avastin will imporove progression free survival and possibly overall survival. (I have seen arguments from other patient groups in US that this may be the case for triple negative brast cancer for example…and I have triple neg. bc and am nearly out of standard treatment options…so I know how easy it is to think that avastin might be my wonder drug…though my head is doubtful.)
I note that the rejection is for for first line treatment of metastatic cancer and wonder whether some or all Trusts might pay for use after first line treatment has failed??? I know some insurance companies and some Trusts are already doing this.
I don’t personally understand the complexities of NICE’s cost effectiveness criteria…wish I did…I do know that Roche’s profits are phenomenal and wish we lived in a world where multi national drug companies didn’t dominate cancer research and allocation of drugs to patients. I don’t know the extent to which avastin is being hyped for profit or not, or the extent to which cancer patients are being duped or how muchh oncologists refuse to face the fact that their expertrise is limited…but I think all these things are happening right in front of our noses and it is heartbreaking.
You can read the press release on NICE’s website or follow this link for Reuters report:
uk.reuters.com/article/allBreakingNews/idUKL2645842120080626
Jane
Jane - thanks for posting this - how shocking is this game of cat and mouse between Roche and NICE. Given the co-payment and EU issues this is all getting very messy and I think it will take some form of legal action to drive the situation to a solution. I am lucky - getting my avastin privately - but at some point PPP will say no more - what happens then?
Geraldine
At the end of the day, it is only the “cost effectiveness” business that is controlling the situation. As Jane suggests, understanding the criteria is almost impossible - and almost looks like a means of copping out of agreeing that expensive drugs can benefit individuals.
I have never quite understood why NICE has to put everyone through all these hoops. The drugs have been tested and accepted in the USA and in Europe, there must be extensive reports that both places used to approve them, so why go through it all again? Perhaps petitions to both parties from interested potential users should be started.
Ironic that this news comes on the heels of the NHS reforms, which include the speeding up of NICE procedures…
Jenny
Avastin is certainly controversial in the USA. First FDA turned down approval (last December), then approved in March but against some of the patitent reps. Many insurance schemes in US won’t fund. Don’t know about situation in Europe.
Also would love info on avastin’s use as second or third line drug…not just as first line.
So difficult to have a really informed debate on this subject…
And is anyone else, like me, interested in the lack of evidence for avastin’s benefits in overall survival or quality of life??
Jane
Hi Jane
the way I read this on another website (and I think it mght have been CNN) is that Roche pulled it as they felt they were likely to be turned down by NICE, and they did not want to risk the pricing of the drug in Europe - other European countries would use a turn down as a negotiating point.
Like you i am very torn by this. I feel its almost certain my cancer spread through the blood and through blood vessel formulation so I would like a shot at avastin, but it doesn’t really look fully proven. Then we see people here who are doing well on it when they don’t have any immediate other options - where is the truth? For me - It looks like my onc was right that he could probably do better for me with taxotere as a first line treatment, but does that mean I should never have it?
Phoebe, you are 100% right that its about cost effectiveness. Nice takes a value for a year of life of reasonable quality and then calculates whether the drugs will deliver that on average. Who are they to tell me what a year of my life is worth?? So they add nothing on safety. What I really dont understand is why it takes so long.
Wish I had some answers - but it looks like avastin will not become widely available in this country and the insurance schemes will eventually use thiis as well.
cathy
The evidence behind avastin is less than thrilling. Doctors can use it more easily because it is already approved for one disease, but so far it has really proved itself as a breast cancer drug. Since NICE bases its decisions on extension of life and there is no statistically significant improvement of survival found yet for avastin, it would falter whatever cost effectiveness figure NICE used for months of life added. It should also be mentioned that in a few patients avastin has had deadly side effects. I could find no record of any closed clinical trials on avastin for triple negative patients, so it is unlikely that NICE will have the necessary data any time soon and many of the trials are for first-line treatment.
Let’s hope that something else comes along and sooner rather than later.
Hi Christine
Really appreciate your sensible comments…they very much support my own hunches. (but I think you missed out the word ‘not’ in your second sentence!)
best wishes
Jane
Hi Jane Christin and Cathy
I am not as articulate as you all are and I get easily muddled but I just feel this is really sad news. How will we ever really know how good a drug is unless it is readily available to all that need it. There is little information about the success of this drug because people arent telling us how well(or not) they are doing on it.
I am still here and I put it down to avastin but I could be wrong I am due another scan on 28th July so will let you all know if it is still working for me.
I have been invited to Houses of Commons re the co-payment issue and will try and make a sensible contribution.
Its just so sad at the moment with all the premature deaths of young women with this truly horrible disease. Some how something has to be done to improve the current situation.
Love Debsxxx
Debs,
thats great that you have been invited to the house of commons and you know we are 100% behind you. I heard you on the radio and you are very articulate…co-payment for me is not just about avastin and should not be limited to that, its about basic human rights under horrendous pressure…tell us when you go!!
Cathy
Thanks Cathy it is on 17th July I have to be back for treatment on 18th so fingers crossed we can sort out transport.
Debsxxx
Hi Debs - good luck in the House of Commons. I think the government is getting in a real mess with co-payment, EU law etc. I agree with you though oncologist (and others) should be able to prescribe the best drugs for the disease they are treating. What is annoying is that we are so slow compared to other parts of the world. As I said before though I think co-payment will mean Nice will delay approvals of drugs (is this what’s happening with avastin? I don’t know) but I hold out hope around the EU issue.
Geraldine
Hi everyone,
Debs, thank you for bringing the whole copayment nonsense to everyone’s attention. When herceptin came out and my doctor was sure I needed it I had to wait a long time to get it because it wasn’t just a matter of coming up with the money for the drugs. The private hospital wanted £60,000/year to administer a drug that cost £25,000/year. In the end Healthcare at Home came to the rescue, but it was a long process and my oncologist’s management wasn’t as good as it was when I was seeing him under the NHS. It was a good thing that the cancer didn’t come back during the delay. Somehow I managed to get back into the NHS when herceptin became available there.
I am not so sure about avastin, but am willing to admit that it if it works in triple negatives this group is so small relatively that a broader trial might not pick it up. I notice that they seem to be mixing avastin with other chemos in triple negative trials.
I did a bit of a trawl through clinicaltrials.gov yesterday seeing if there were any options there and what struck me was the lack of good clinical trials in the UK. The phase I or phase II clinical trials with the best risk/benefit ratios tend to be those that take existing cancer drugs and try them out in other cancers. There are some other existing cancer drugs that are being tested elsewhere against triple negative cancer (ixempra, centuximab, sutent), but the only trial that seemed relevant for a heavily pretreated triple negative MBC patient in the UK and with your type of spread was a Pfizer trial on an experimental drug. Now, perhaps it will turn out to be a great drug, but experimental drug trials are by nature more risky.
Hi Christine and Geraldine,
the whole thing is a minefield and I will most probably be dragged out and sent to the tower but so what, the alternative is to die quickly and quietly. Just not my style.
I t makes me really cross that they think we wake up one day and think “oh what about co payment, yes lets do that” It happens because they are holding drugs back and that is a disgrace and they should not be allowed to get away with it.
Any way sorry to get on my high horse, I just want them to realize too many women are dying too soon.
Love Debsxxx
Hi Debs,
You’re every bit as articulate as the rest of us…more so than me…cause you’re doing stuff in the media and care passionately about it…good on you! I’m an armchair cancer commentator.
But I disagree with you in some ways. I think the present position on co payments is quite wrong…though I think changing that policy alone will just move the goalposts around so that people who have no hope of ever paying for private drugs feel even more unfairly treated…as they would be if people were paying for an effective drug denied to them.
There is a real issue about why in the UK, a wealthy country, cancer survival statistics are lagging so much behind other equivalent countries in Euopre such as France…and I think the answer why is very complicated and yes in part is to do with availability of drugs. Example: taxotere as a standard treatment for some primary breast cancer came much later to UK than other Eurpean counties…after trials had shown its benefits.
As I’ve said before I have my doubts on avastin…because of the lack of evidence on overall survival. And I say that knowing that many triple negative women in US believe that avastin is doing something for their cancer…and I just don’t know whether the big trials are masking info. on triple negatives or not.
Yes far far too many women are dying of breast cancer, and I wish that research was more focused on real breakthroughs rather than tiny and not very meaningful incremental half improvements, which may turn out to not be improvements at all.
I am privileged to have private insurance which might pay for avastin. My current onc isn’t keen on it, but I’m sure I can find an onc who would say give it a whirl…but for me, and this is something very personal, I am in any case weighing up the benefits of what further treatments I have left against the quality of life they will give me. I probably won’t die quietly but I may indeed choose to die a bit more quickly…though we never ever really know the consequnences of our treatment decisions. Hard stuff.
I don’'t believe NICE has delayed avastin approval because of the co payments issue…its because NICE and Roche are playing ‘cat and mouse’ and because the evidence on its usefulness is just not conclusive…wish as we might that it were.
Jane
Jane
yes I agree with you, I told you I wasnt as articulate as you and I meant it. I can talk but I cant type!
I have never been as ill with this disease as I was FebMarch this year and I was almost saying enough is enough. Very slowly my condition is improving and I just feel while the media is showing an interest I have to try and get all our points of view across to them. They do try to shut me up at times and there never seems to be enough time to cover everything. I was very surprised when I got the invite this week, poor Ian my hubby is being dragged along to London bless hes doing it but I know he wishes I was more like him and didnt ask as many questions. I just hope things will change and drugs will come through faster. I am in the every day is a bonus so if I can make them change their minds it will be worth it.
Thanks Jane and I wish you all the best with your treatment.
Love Debsxxx
I think I can type better than I can talk these days!
Here’s to every day being a bonus for us all as long as possible. Have a good time in the House of Commons.
Jane x
This week I asked my onc about the Avastin debacle and he reckons NICE will quickly review the situation if more evidence is forthcoming from Roche.
Jeny
Yes that is what NICE says in the press release. The problem really is around the lack of poverall survival data without which NICE can’t make its cost effectiveness calculations (I think.)
Jane
I just wish that avastin were better. An article today in the New York Times was rather downbeat:
nytimes.com/2008/07/06/health/06avastin.html?oref=login