At the moment, the American Academy of Neurology are having their 2013 meeting. They have had various new DMDs and their results put before them, none of which are available in the UK yet. Alemtuzumab (campath), which, if used as an induction therapy or in early RRMS, may prevent the transition to SPMS; BG12, an oral DMD, with excellent results but opposed by a competitor in the market, one of whose grounds is ‘there are plenty of efffective DMDs on the market already’; cladribine, a very effective DMD, whose oral method of delivery of the drug was withdrawn by Merck Sorono, but could be administered IV, and is cheap but is not worth the big pharmaceutical companies taking through clinical trials as it is out of patent and they would make no money at it. I realise that most RRMSers are on the mildly effective injectibles, but why isn’t the MS Soc making more of a fuss about the future of MS treatment. There are more effective treatments around the corner but if no one makes asks when and why not now, then a lot of neurologist will deal out the same old, same old
As far as I know…
BG-12, now called Tecfidera (where DO they come up with these names?!), will probably be approved in the UK quite shortly. Alemtuzumab is going through the approval process in the UK too so it shouldn’t be too long before we know about that one as well.
Cladribine may be effective, but it wasn’t rejected purely on cost grounds - it was mainly due to safety concerns, according to the various government agencies.
Any neuro worth his or her salt will know all about the up and coming drugs, but they can only prescribe what NICE approves. NICE only approves what it calculates to be cost effective. It also only considers what is presented for approval, e.g. until Biogen seek approval for Tysabri to be a first line DMD for all RRMSers, it can’t be approved for it, and the drug companies tend to only seek approval for things that they think they might get (because they have the data to back it up that is to NICE’s stringent standards).
The MSS take every opportunity they can to influence NICE to the benefit of MSers (I know because I’ve been involved). I’m not sure what else they are able to do. If you have any ideas, I’m sure they would love to hear them.
Ooh id love to be offered that oral one. Dreading doing them injections scardy cat with needles. X
Hopefully BG12 will be licensed soon in both the US and Europe, although Teva, the makers of Copaxone, petitioned the FDA in January this year not to grant BG12 a licence without more safety information as, according to them, there are plenty of safe and effective DMDs on the market already. Then it will be up to NICE to decide whether the price is justifiable re cost/benefit, which might lead to a lot of horse trading between the pharmaceutical company and NICE before the drug becomes available.
Similarly alemtuzumab, which hopefully should be licensed later this year. Again this will have to go before NICE. All the data show that it is most effective in early RRMS. I hope that it will be allowed as a first line therapy, but it may be that you’ll have to fail on one of the other DMDs before you can get it. It will also depend on its price. The drug company Sanofi has withdrawn it from the market at the moment (it is used in much larger doses to treat leukaemia), although it will be given to named cancer patients. This means that neurologists can no longer prescribe it even off licence to MSers. Some people think this could be a cynical ploy to prevent neurologists stock piling it at the cheaper price, as it will undoubtedly come in at a much higher price as an MS drug.
Oral cladribine (a few tablets every year) was withdrawn for licensing approval by the drug company when the FDA and EMA raised safety concerns and wanted more data. The development programme was not big enough to satisfy the regulators wish without a further phase 3 trial, which would take years and cost a lot of money, eating into the patent that Merck/Serono has. This may have been one of the reasons why the developers dropped it. The CLARITY extension trial has just been published as to its efficacy/safety.
Novartis have petitioned the FDA and EMA in January this year for tysabri to be used as a first line therapy for certain MSers.
One of the things that the MS Soc could possible do is to get NICE to take into account the long term costs of disability if you can’t get early effective DMDs ie more hospitalizations, theneed for mobility aids, more drugs, possible loss of employment, therefore, loss of taxes and the need for benefit payments etc. I don’t think NICE do this at present.
BG12 or Tecfidera as it is now called is due for FDA approval at the end of March so fingers crossed. There is also another oral on the market called Aubagio which I am currently taking. It was approved here in Australia in November last year but was knocked back for subsidy as Gilenya was listed on the PBS (our NICE equivalent) already so I am getting it for free through the drug companies Product Familiarisation Program. Hopefully it will be made available in the UK soon. It is not as effective as BG12 having an efficacy equivalent to the current injectable DMDs of about 30% reduction in relapses but I am happy to take it until BG12 is released.
I was on Cladribine, the other oral that has been mentioned, but it was withdrawn as it only has a proven safety margin for two years treatment and after that the risk of cancer increases dramatically. Even taking it for 2 years increases the cancer risk by 4% and the further risk was not seen as worth it and as the therapeutic timeframe was so short it wasn’t seen as a worthwhile option to continue marketing it.
There are more and more options in the pipeline and more effective treatments coming out all the time. We are living in a very exciting time for MS treatment. I can only imagine how bleak it must have been 20 years ago to be diagnosed and to know there was nothing available at all to treat the disease with.
Can you believe it, oral DMDs are like buses. BG12 and teriflunomide (aubagio), both orals,got the ok today from the European regulators. Now it’s upto NICE to decide if and when they can be used
My money would be on Aubagio getting a no unless there are substantial savings over the injectables, but BG-12 getting a yes. Could easily be wrong though! Kx
Sorry, I have been googling and googling trying to verify this and can’t find anything that shows that BG12 has been approved by the EU and it is certainly still waiting for FDA approval, expected by the end of March. Aubagio has got FDA approval and is approved for use by some other jurisdictions such as Australia but again I can’t find supporting evidence that has been approved by the European regulators.
Can you post some links please? If BG12 really has been approved I really want to know!
LOL Posted the above then wandered over to my email in box and lo and behold there it was from Barts blog
Happy Happy Day
Time for me to contact my neuro…
I just read the blogg that you posted. Ty for posting it.
Can you tell me plz, what kind of relapsing remitting MS will it be given too?
Is it to come under the usual ‘unless your dying MS’ you can’t have it stipulations again
Or is this a general med that wil be prescribed for ALL RR MS patients?
I’m asking as I am currently not allowed anything cos I don’t tick all the boxes at moment you see, However, I am struggling often with the fatigue and no one will help me or give me anything to help yet
Really feel let down big time with the medics since I got this MS m’larky I can tell you!!!
I’m afraid I can’t really answer your question, Anna. I know that the neuros are hoping that BG12 will be allowed as a first line treatment as it is so effective and easy to take. Also as Aubagio has the same effectiveness as the existing injectable DMDs there would be no conceivable reason to withhold it for more severe MS.
However these decisions are made not by the drug companies or by the approving bodies but by NICE in your case or by the PBS in my case in Australia. Aubagio was not given approval for subsidised funding here in Australia, although it is available here, as it was seen as less effective than Gilenya (another oral) that has been given subsidy status so it was deemed finacially non-viable from a Government expenditure point of view here in Australia. I am only on it because I get it free from the drug company.
Now that it has approval staus it will have to go through the NICE process before it will actually be available for people to actually be able to take it and tbh I don’t know how that works over there. Hopefully a more knowledgeable UK person will be a long soon to help you out…
I must admit I find it very odd that over in the UK you don’t seem to get DMDs as soon as you are diagnosed Here in Australia as soon as you have had either your second relapse or there is evidence of any change on MRI you are straight on a DMD. Indeed many people are prescribed a DMD at the very first sign of MS when it is still officiaaly what is called CIS or Clinically Isolated Syndrome. That is, only one neurological event and evidence of at least one lesion but without a full MS diagnosis in the belief that by starting DMDs so early in the disease course it can dramatically slow down the conversion to full MS or even prevent it. None of tyhis waiting until the disease is really bad over here… Our neuros seem to work on the prevention is the best strategy whereas yours seem to wait until the damage is already done
I understand your frustration. Hang in there and hopefully there will be good news soon for you
I was put on a DMD very quickly after my diagnosis here in England. I think it depends on your neuro.
As soon as i had a diagnosis i had to choose. It happened so fast for me that i didn’t have time to do any research into the different ones. I was given the names of the DMD’s and told how often they were injected and i picked one at the same appointment.
I’m glad i chose Rebif and i’m glad i started it early. My ms was pretty active at diagnosis so thats probably why i was rushed onto the DMD.
Anna - have you got a diagnosis? I don’t understand why you don’t tick all the boxes for DMD’s. I would be INSISTING they start me on them early on. There is evidence to show the earlier you start on a dmd - the more effective they are in reducing relapses/progression. Sometimes we have to challenge the neuro’s decision to get what we want.
Yes I have been officially diagnosed for approx 18months now. I have the Demyelination on the Brain and have had the MRI to prove this. I am lucky to have apparently had only 1 relapse in all this time but although I have gotten better from the relapse; I do not feel well most days.
It’s generally to do with the fatigue and it is often disabling at times. I have spoken at every appointment with my MS nurses and Neuro but the most I have had off them is Amantadine. Well, I may as well have been taking Smarties for the good that did or should I say didn’t do
I actually had yet another chat with my MS nurse only last week. Yet again I mentioned the fatigue but she basically told me that there was nothing that she could give me for it and it is just a fact of life with having MS. I could have cried in frustration as I often read of the different meds that some ppl take on here allieviating their fatigue and just wonder why can’t I even be allowed to trry them for gosh sake!!!
I don’t think there is anybody in the medics side of things that I can try as they seem to be one team down my end of country and surely if there was anything they could try they would help me instead of sitting idle by?
Ok rant over now lol!!!
thnx for replying hun
BG12 … Is this oral and if its been approved does it mean I could query it when discussing DMDs with the nurses? Or do I have to try injectables first? X
Lisalou, Until NICE agree that it can be prescribed for us in the UK your nurse can’t do anything, and then it may be upto your PCT whether they will fund it. Ithink I would make her aware that you would like it though in the future
What “different meds” have other people been offered for fatigue?
I think you are being a bit harsh on your team, as there are only two, that I know of: one is Amantadine, which you have tried. The other is Modafinil, which some people have reported great success with, but I do not believe it’s available as a new prescription in most areas, because of an EU ruling restricting its use (people were taking it as a ‘lifestyle’ drug, to help with shift work etc.)
So you have probably already tried the ONLY drug officially approved for MS fatigue. I don’t know what you think these mysterious “other drugs” are, that everybody else is on. I’ve certainly never been offered any of them. In fact, I keep being told my fatigue isn’t caused by MS, but by the other drugs I’m already taking for it!
Possible, but unlikely, as it’s on record in my GP’s notes that I was complaining of fatigue before I ever began taking the other stuff (baclofen & painkillers). So I’m confident it’s pretty much always been the MS, and not what I’m taking for symptom relief.
Famprya has made a huge difference to the amount I sleep and how fatigued I feel. This is not labelled as a fatigue drug at all but as a walking drug, but if you look at how it works, you can imagine it might help with lots of different MS symptoms. In most places in the country, you have to pay for it yourself - £180 for four weeks supply.