Amarin Corp Plc (AMRN)

[lettruthringout]

Yes, your one-year guesstimate seems reasonable.

I'd say maybe a little less. Amarin likely submitted "evidence submission" by April 15 (60 days from "invitation)

Evidence submission from the company

3.2.6 NICE invites the company to provide an evidence submission using a detailed submission template. The deadline for receipt of the evidence submission is 60 calendar days from invitation. After receiving this NICE sends it to the ERG for review.

3.2.7 The information needed for the evidence submission is derived from the approach NICE uses to evaluate the clinical and cost effectiveness of health technologies. This approach is outlined in NICE's guide to the methods of technology appraisal.

3.2.8 For fast track appraisals the evidence must be submitted in templates; the standard submission template or, if it is a cost-comparison case, in the cost-comparison template.

3.2.9 During the 60-day submission preparation stage there will be at least 1 opportunity for the company to discuss key issues with NICE and, if needed, the ERG. NICE will ask the company to provide an update on their submission before the meeting. This engagement will also allow companies to discuss potential regulatory developments during the appraisal and the potential inclusion and handling of commercial arrangement proposals. During the 60-day submission preparation stage companies can request additional engagement with NICE. Engagement will depend on availability of the NICE team at the time of request.

I haven't seen anything on whether Amarin applied for fast-track approval by NICE, but they may meet the criteria and should have considered.

2.4.31 A technology can be considered for the fast track appraisal process if:

The company's base-case incremental cost-effectiveness ratio (ICER) is less than £10,000 per quality-adjusted life year (QALY) gained.

It is likely that the most plausible ICER is less than £20,000 per QALY gained, and it is highly unlikely that it is greater than £30,000 per QALY gained.

2.4.32 Judgements about the technology's suitability for the fast track appraisal process, considering the criteria outlined in section 2.4.31, will be based on:

the robustness of the clinical-effectiveness evidence and its generalisability to the population under consideration

the consistency of the submission with the scope of the appraisal

the consistency of approach to modelling with models accepted in previous appraisals in the same, or similar indications

the size of the population

the budget impact of implementing the technology

the uncertainties in the evidence and

the consequences of decision error.