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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    • A minded no is part of the review process by NICE. virtually no drug gets approval at the first round of review. A minded no basically means that more clarifications are required to support the health economic case for the particular drug. I beleive both Teriflunomide and Fingolimod both had minded no's from NICE at the first round of appraisal. Both of these DMTs are now approved for NHS reimbursement. Usually means about a 6 month delay until NICE submits its final FAD recomemdation. Therefore fully expect BG12 to be NICE approved later this year

    • If it was up to you, you would eagerly give anything to anyone… with other people's money of course.

      Live your myth in drugs, gentlemen.

    • Yes but Europe does not pay for the drug, UK Plc does.

      They are going through the price negotiation process which always occurs, it will be approved but this delays that date, to the joys of the competitors already selling drugs

  • I'm on Tecfidera in the US – they're charging my insurance $64,800/year for the drug. While I hope NICE can talk them down, I hope they do approve it for you soon.

  • My son has been on Tecfidera for last 9 months while he has been studying in US at UCSB is there any way he can get Tecfidera in England when he returns next month ?

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