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1 Recommendations

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1 Recommendations

1.1

Teprotumumab should not be used to treat moderate to severe thyroid eye disease in adults.

1.2

This recommendation is not intended to affect treatment with teprotumumab 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

Teprotumumab is not required to be funded in the NHS in England to treat moderate to severe thyroid eye disease. It should not be used routinely in the NHS in England.

This is because there is not enough evidence to determine whether teprotumumab offers benefit in this population.

Why the committee made these recommendations

For this evaluation, the company asked for teprotumumab to be considered only for people with active moderate to severe thyroid eye disease. This does not include everyone who it is licensed for. The committee also concluded that it would only consider teprotumumab as a first-line treatment because this is what the evidence relates to.

Usual treatment for active moderate to severe thyroid eye disease at first line is methylprednisolone with or without mycophenolate.

Clinical trial evidence shows that, compared with placebo, teprotumumab reduces proptosis (bulging eyes) more and reduces diplopia (double vision) in more people.

Teprotumumab has not been directly compared in a clinical trial with methylprednisolone with or without mycophenolate. Indirect comparisons suggest that it is likely to work better than these at improving diplopia and proptosis. But the results are uncertain.

There are also uncertainties in the economic model. This is because the model does not accurately capture the disease course and how it changes with treatment, and because of some simplifying assumptions. Also, the cost-effectiveness estimates are unknown because of the uncertainty in the clinical-effectiveness evidence and modelling. So, teprotumumab should not be used.