Lizzy,
Sorry if this post was confusing. Hopefully this is helpful.
The situation in UK decision is really 2 fold. 1) They really do believe that the MO has played a significant role in the incredible Reduce-It results. They just don't know by how much.
They are using this to some degree as a bargaining chip but after hearing all 3 calls, it is more than a bargaining chip. They truly they have drunk from Nessan's MO cup as most of the world.
Secondly, how much has the MO affected results. The British also realize that over time, many patients will stop taking the medication.
For this they have extrapolated that if someone stops taking the medication, how long before the benefits of the medicine no longer help. They have set up models where once you've taken it and stopped it will give you benefit for the rest of your life (think about for instance of the polio vaccine, etc), or maybe it just gives you 5 years benefit, 10 years benefit or 20 years benefit. In the Reduce-It study, 40% of the individuals in the active arm quit taking their medication by the end of the study but the results for this subgroup which was followed over 6 total years still showed those who stopped taking V stayed in the low risk of MACE benefits. Maybe the benefits end at 10 years?, maybe 20 years but we know at least for 5 years. Doing such a model is flawed in the fact that these models are basically saying that at the end of 10 years then everyone will have stopped taking V and there will no longer be any benefit. On the flip side, it just makes sense that if I stop taking V after 5 years that the benefits of the drug aren't going to last for an infinite amount of years as some types of vaccinations may do. I realize that there needs to be some type of setting though to figure cost analysis for a person.
So Amarin and the UK government are arguing against which model to use also. NICE has put basically a ceiling on the top dollar they will pay for a person to gain 1 QALY and that price is $20000UK.
Of course UK does not want to use the infinite model since it will mean they pay a higher price for V and Amarin doesn't want to stay with the 10 year model if they are also going to ding them if 20K is the maximum they are willing to spend for 1 QALY. However, the infinite model is what NICE generally useS on most of their approvals. Realize however how vast a population will be using V compared to most other approved medications however.
If MO is truly by 7% as they attested at their last review decision then it doesn't make sense for them to cover Vaskepa through the governments insurance system figuring a 10 year duration to loss of effect because it will cost them over 34,000 British pounds for every quality adjusted life year.
The chart is set up in 2 columns. The vertical column is based on what percentage you think MO affected the RI results. Amarin has conceded to 1.5% even though they do not believe this is truly the measure but are willing to compromise. We don't know what was discussed with the committee members behind closed doors today but before they were at 7%. After today's discussion, I am certain this has come down but I do not know by how much. My take is that they are now in the 3% region. The horizontal column is based on whether you think the duration of V never stops, or stops at 5 years, or at 10 years. Using the new prices Amarin has negotiated with NICE since the last review, they said that at 1.5% MO effect and at never stopping it would cost almost exactly 20,000 BP to gain one QALY.
NICE also has an evidence review group which looks at the information which the asking company has submitted to verify accuracy. The Evidence Review Group (ERG) has placed their model at 10 years duration and no mineral oil effect and said that it would cost about $21,000BP to gain 1 QALY with the new price offered by Amarin.
Using the new price and sticking at 7% and 10 years (which model was used in the denial about a month ago, it would still cost 31,000BP.
I hope this helps and sorry for my lack of putting it in clearer terms.
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