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1 Recommendations

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1 Recommendations

1.1

Resmetirom alongside diet and exercise should not be used to treat non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with fibrosis stages F2 to F3) in adults.

1.2

This recommendation is not intended to affect treatment with resmetirom that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

What this means in practice

These are NICE's draft recommendations. If these recommendations become final, resmetirom would not be required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because there is not enough evidence to determine whether resmetirom is value for money in this population.

Why the committee made these recommendations

Usual treatment for MASH is diet and exercise. People with MASH typically have multiple cardiometabolic risk factors, including obesity, type 2 diabetes and dyslipidaemia, for which they may also be receiving treatment.

Clinical-trial evidence shows that resmetirom is more likely than placebo to resolve MASH and improve fibrosis. But the main clinical trial is ongoing and there is currently no evidence that resmetirom increases how long people live compared with placebo. There is also currently no evidence that resmetirom reduces the risk of cirrhosis, liver cancer or need for liver transplant compared with placebo. There was uncertainty about whether improvement in liver fibrosis or MASH resolution can accurately predict survival and reductions in advanced liver complications. So there is uncertainty about the long-term treatment effect of resmetirom.

There are also uncertainties in the economic model. For example, treatment eligibility and clinical outcomes were determined using liver biopsy in the trial, but in clinical practice these would be determined using non-invasive tests.

Because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimates for resmetirom. So, it should not be used.