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Re: TOSCA post# 368709

Friday, 02/04/2022 4:35:59 AM

Friday, February 04, 2022 4:35:59 AM

Post# of 426290
UGH! And the hits keep coming....

Conclusion

Comment on section: Icosapent ethyl is not recommended for reducing the risk of cardiovascular events in people with elevated triglyceridesIcosapent ethyl is not recommended for reducing the risk of cardiovascular events in people with elevated triglycerides

Comment on subsection: 3.21
3.21 The committee noted uncertainty in the clinical effectiveness evidence for icosapent ethyl because of the mineral oil placebo (see section 3.8). It also noted concerns about the generalisability of the trial results to the NHS in England (see section 3.6). It was concerned about the company's modelling approach (see section 3.10), including how the treatment effect after discontinuation was modelled (see section 3.13) and the composite outcome (see section 3.11). The committee noted that the company's updated time to event analysis had not been fully validated by the ERG and requested additional information and analyses. It noted the company's base case results were all above £20,000 per QALY gained. Therefore, the committee concluded that icosapent ethyl is not recommended for reducing the risk of cardiovascular events in people with elevated triglycerides.

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