Amarin Corp Plc (AMRN)

[sts66]

Don't know if this has been posted here already - 2nd review of V by UK's NICE again says no insurance coverage for V because of the MO bullshit - UK is one of the top 3 EU countries for potential V sales - AMRN is going to lose a huge % of future EU revs:

https://www.nice.org.uk/guidance/gid-ta10736/documents/129-2

A clinical expert commented that it was difficult to quantify the
potential negative effects of mineral oil and there was significant
uncertainty. As such, they could not state whether the 7% or 13%
scenario was more plausible.

Considering the ongoing debate in the clinical community about mineral
oil placebos, and the range of reductions in treatment effect reported in
the literature, the committee concluded it would be appropriate to consider
scenarios estimating a reduction in treatment effect from 3% to 10%,
based on the discussion in the EPAR. The committee considered the
scenario using around 7% in its preferred analysis because it was near
the middle of the range and aligned with Doi et al.

Because of the uncertainty an acceptable ICER is below £20,000 per
QALY gained

The company’s new base-case ICER for icosapent ethyl compared with a stable dose of statins with or without ezetimibe was £19,848 per QALY gained for the secondary prevention group. The ERG’s base case included a 10-year treatment
reduction after discontinuation effect and its base-case ICER was £22,609
per QALY gained. The committee preferred the scenario with a 10-year
treatment effect reduction after discontinuation and the treatment effect of
icosapent ethyl was reduced by 7%. This resulted in a committee-
preferred ICER of £34,067 per QALY gained.

Conclusion

Icosapent ethyl is not recommended for reducing the risk of
cardiovascular events in people with elevated triglycerides
3.23 The committee noted uncertainty in the clinical effectiveness evidence for
icosapent ethyl because of the mineral oil placebo in the REDUCE-IT trial
(see section 3.9). It also noted concerns about the generalisability of the
trial results to the NHS in England (see sections 3.6 and 3.7). It was
concerned about the company’s modelling approach (see section 3.122),
including how the treatment effect after discontinuation was modelled
(section 3.155) and the composite outcome (see section 3.133). The committee recalled its preferred ICER was higher than what NICE
normally considers a cost-effective use of NHS resources. Therefore, the
committee concluded that icosapent ethyl is not recommended for
reducing the risk of cardiovascular events in people with elevated
triglycerides

.