Quick summation from the NICE Review on January 11, 2022. This is not exhaustive but very general. I've reached out to a member of the board to post the slides if he isn't too busy.
About 13 public observers
53 total on call which included experts, 2 company reps from AMRN, Committee Members, ERG members
Gary McVeigh-Expert Witness specializing in Omega 3’s. Worked for 25 yrs with diabetic patients and management. His overall attitude was very negative toward Vascepa. He’s very doubtful that Reduce-It results are accurate and whether V actually decreases heart disease substantially.
No conflicts of interest from the NICE members but several of the Patient/Clinical Experts did receive deep pockets from big pharma in other projects etc. If I remember correctly. Nothing from Amarin
Chairman Subhash Pokhrel
Expert Witness-Riyaz Patel-Younger doctor who believes that there is much uncertainty on what to really believe. He would love to see if further studies could be done. He believes that MO may or may not have played a factor. Basically he was riding the line of not enough info. Maybe it works but he isn’t so sold that the MO may not have clouded the results.
Expert Witness-Pete Winocour- Physician who runs diabetes services for over 25 years in lipid related services. Older gentleman who seems to have a lot of common sense. He was basically saying that there is some uncertainty but the trial overall appears to be accurate and beneficial even if MO played a very small effect of 3% or so. He seemed to be a much more reasonable in his approach and was on AMRN side to move forward with it being a part of the CV medications for those in UK.
ERG made a large amount of submissions to AMRN in Dec 2021 and haven’t had time for complete responses yet on several of the questions which AMRN had answered.
Presentation from Patient Perspective:
Unfortunately the options for lipid lowering options is limited
6.4M people in England living with CVD
Estimated 25-35% of people on statins who have elevated trigs
In England 1 in 4 deaths caused by CVD
In 2020 137,152 people died from CVD in England
Pharmaceutical Interventions-Statins are the backbone. Fibrates prescribed for some but another treatment option is helpful
75% of people stop taking lipid lowering therapies after 2 years
Expert for patient care said that No more barriers should be introduced that delay risk reduction.
Heart UK says that IE should be used in Primary Risk Group. Very positive in adding IE
Discussed may not be suitable in Pregnant or Breast Feeding individuals
Clinical Expert Perspective:
Expect most benefit in the secondary prevention group
If recommended, would need to implement a full fasting lipid profile which isn’t always done with patients generally
Expect it to be used in both the primary and secondary care
Benefit in practice may be less than trial group
Some GP’s are overwhelmed by CVD guidance and pushback about value of managing lipids
Many people will not be discovered needing this since at the 3 month visit the fasting lipid profile is not done so many will not get on IE.
Rob Forsyth-
Anticipated list price is 173 british pounds (bp) per 120 capsules which would be 2,106.28 bp per year (not sure how this number was determined since a little more than 173X12). No patient access scheme (would be a primary care medication)???
Major issue with Health Economic Analysis whether the treatment wanes with time or is it linear with time. (This was a major discussion point throughout the discussion. This goes back to what KM said at the JP Morgan Investor Conference. He said a price is guaranteed for the first X years and then it will always go down over time in EU negotiations over the years. This is UK’s way of trying to show that over time, it will not live up to AMRN’s claims with ICER so that they can offer a lower price for the meds at the start of launch with it only going further lower over the years IMO.)
Discussion over MO came up and was reiterated over and over again
The committee could not get off of the triglyceride band wagon. They kept focusing on other studies which failed in lowering trigs to the same level that Reduce-It did but that it did not show any decrease in CV risk. There was very minimal discussion that there may be other physiologic, cellular mechanisms beyond lowering trigs which have benefited the 25% reduction in CVD.
Is the waning at 10 years where V doesn’t benefit the patients any more, is it 20 years? What is the appropriate model. This is extremely important because it effects the overall cost/person for the medication.
Our (AMRN) reps were Hakim and Sabine
"Currently where are you up to on responses to the ERG questions?"
Response: "We have returned all questions in the appropropriate time in the time lines given."
When Chairperson asks the ERG rep why the charts have not been updated for review her comment is that she just got back from vacation and hasn’t had a chance to completely review AMRN’s responses in full yet. (Unbelievable).
She said that they have made great progress and still may be acting for time to treatment validation and cross validation??
It is clear that the UK is not up to date about trigs, their role in CVD and finally one of the experts cleared them that Niacins will not lower CVD but are to be used in hypertrig cases to decrease pancreatitis.
At 5 years, AMRN found that about 34.5% of patients are no longer taking IE in the Reduce-It study
Treatment waning is modeled as lack of medication effectively working over time (not those who may have chosen to no longer take it).
They do not figure drop out rate in this model but do look at it in another model.
Basically the fight is between AMRN saying $22,000 BP/QALY and ERG saying $88,000 BP/QALY
It ended with Gary McVeigh saying that maybe V should not even be approved for use in UK and that the multiple studies except for Reduce-IT does not jive that Omega 3’s are beneficial for CVD and they may be wasting money and making a mistake to make it part of primary care treatment.
At this time the chairperson thanked everyone and everyone was dismissed from the call except the NICE committee which would be discussing it further and making a recommendation.
My own personal opinion is that it will be approved in UK for part of the primary care group. The extent of the Primary patient group or Secondary patient group I do not know. Hopefully both. I do believe that big pharma was after it again and that they are working hard to diminish AMRN’s effects and ability to sell V in UK. I believe that the price for QALY will be favorable for us but not the 22,000. I believe that since we have several EU Medical Organizations recommending V that this will work to our advantage on this passing in an overall favorable way for us even though it will be a compromised agreement. Just my thoughts.
