Thank you TOSCA,
The recommendations came out much more negative than I anticipated. I thought it would be closer to our last AdCom where all the discussion had a negative lean (which it certainly did listening to the NICE committee meeting) but in the end common sense prevails. Doesn't look like that has happened.
I see that the public also can participate in this process and that their comments will be considered:
"• The appraisal committee will meet again to consider the evidence, this appraisal consultation document and comments from the consultees.
• At that meeting, the committee will also consider comments made by people who are not consultees.
• After considering these comments, the committee will prepare the final appraisal document.
• Subject to any appeal by consultees, the final appraisal document may be used as the basis for NICE's guidance on using icosapent ethyl in the NHS in England."
I hope to comment before the 22 February deadline. I am a neophyte compared to many here on understanding the MOA of IE but will do my best with some examples shared by Bhatt, Mason, etc. If others feel so inclined to comment, I would encourage you to also voice the importance of people in the UK having access to Vazkepa. I wish I was as altruistic as many here and only concerned about the welfare of those at risk but unfortunately I am not always as selfless as I should be. I am looking at this more as a loss of well into the 9 figure revenue stream if we lose the UK and set a precedent going forward with our EU countries.
It is clear IMO that if approved that it will be used in the primary care setting for those in the secondary subgroup only (over 45 and established cardiovascular disease).
"However the committee noted that the company’s own ICER for the primary
prevention subgroup was much higher than what NICE normally considers
an acceptable use of NHS resources. It therefore concluded that the
primary prevention subgroup was very unlikely to be cost effective in any additional analyses. It also recalled that it was appropriate to consider each clinically distinct subgroup separately (see section 3.5). Therefore, it would be appropriate for the company to only provide additional analyses and information for the secondary prevention subgroup. The committee concluded that given the uncertainty and the company’s base case ICERs, icosapent ethyl could not be recommended for any of the populations considered."
This trend has to stop.
