Have you
heard that NICE plans to assess all 4 emerging MS DMTs in one go; instead of a
single technology appraisal (STA) for each drug there will be a multiple technology
appraisal (MTA)?
heard that NICE plans to assess all 4 emerging MS DMTs in one go; instead of a
single technology appraisal (STA) for each drug there will be a multiple technology
appraisal (MTA)?
The drugs
concerned are teriflunomide, BG12, laquinimod and alemtuzumab.
concerned are teriflunomide, BG12, laquinimod and alemtuzumab.
Is this
good or bad news? This will depend on whether you are keen to get access to
these drugs sooner than later.
good or bad news? This will depend on whether you are keen to get access to
these drugs sooner than later.
According
to NICE the STA process is much shorter than the MTA process; an MTA takes ~50
weeks from official invitation to participate to publication of the FAD,
compared to ~34 weeks for the average STA – a 4 month delay.
to NICE the STA process is much shorter than the MTA process; an MTA takes ~50
weeks from official invitation to participate to publication of the FAD,
compared to ~34 weeks for the average STA – a 4 month delay.
The Officeof Health Economics (OHE) found that MTAs take on average 1.97 years compared
to 0.96 years for STAs – a 12 month delay.
to 0.96 years for STAs – a 12 month delay.
Are you
prepared to wait an extra year to access these therapies?
prepared to wait an extra year to access these therapies?
These
figures don’t include the potential delays that may result at the European
Medicine Agency level in relation to the licensing of the products.
figures don’t include the potential delays that may result at the European
Medicine Agency level in relation to the licensing of the products.
All in all
this is not good news for MSers wanting to access to these oral therapies or alemtuzumab.
this is not good news for MSers wanting to access to these oral therapies or alemtuzumab.
I can see
why NICE are doing this; STAs will create a lot more work. I also hope that
this process does not disadvantage any of the more effective products?
why NICE are doing this; STAs will create a lot more work. I also hope that
this process does not disadvantage any of the more effective products?
What do you think?
The products are all at different stages with the EMA- laquinimod has completed its validation process:teriflunomide is due to be reported on in early 2013: BG12 was put forward for consideration in the first quarter of this year: alemtuzumab was only put forward to the EMA in June this year, so how can NICE deal with them all together? Presumably NICE will either have to look at the producs before they all have EMA approval, or wait until they've all received it, which is invidious when there is such an unmet MS need
The extra 4 months are not good, but won't a combined assessment give a better set of guidelines for when to use what?
Depends on whose statistics you believe- NICE says it will be 4 months longer, but in any event would be concluded within a year; the Office of Health Economics say it will be 12 months longer and be concluded within 2 years.
Re: "invidious"Invidious is a very good adjective. I have always suspected that one of the covert roles of NICE is to delay access to new treatments. This would certainly do that.