NICE not so NICE and Tecfidera has been not yet accepted in UK!

#MSResearch: Looks like NICE have turned down BG-12. 

I have just got a call from a Reporter saying that NICE have rejected approval of Tecfidera pending more paper work.

Fear not it is a "Minded No" which probably means a yes after a bit of paperwork (price?) adjustment

You can read the NICE report here


This will no doubt will be be disappointing news for many MSers, who were hoping for more choice with a new oral medication.  The issue of price is a major part of this. I am sure that ProfG will follow up on this post when he gets the information. 

Tecfidera has had problems in Europe. The first issue was self (company)-inflicted because they would not develop it in Europe until their patent protection was confirmed.

Now it is NICE's turn to put the boot in.

Is their (NICE's) concern efficacy or safety? Not really although there are some side-effect issuses and comments were made on the influence on susbtained progression. However the thing that seems to concern NICE is making sure the Price is right. 

Were they (Biogen-Idec) asking too much, obviously because that is always the way. We know the parent compound is cheap as chips to make...but I have heard a suggested price from a number of Grapevines, which may of course be wrong, which is in line with current treatments approved by NICE.  Biogen did not do its sums as NICE seem to want them.
This posturing serves to give NICE a justification for its existence, god forbid a cheap drug comes around..what would they do then..but cheap drug..what's the chance of that:-). However, the position of first reject and then have a "to and fro" for a couple of months more does not help the UK MSer get choice.

We can already predict what will happen with Alemtuzumab/Lemtrada when it gets NICEd. Then there is also a question of whether it will get a first (according to the EMA) or second-line, or first line for highly active MSers, licence or a Third Line License (in the bin according to the FDA) to complicate this even further.

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