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Iptacopan for treating complement 3 glomerulopathy

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1 Recommendations

1.1

Iptacopan should not be used to treat complement 3 glomerulopathy in adults, either:

  • with a renin-angiotensin system (RAS) inhibitor, or

  • alone if a RAS inhibitor is not tolerated or contraindicated.

1.2

This recommendation is not intended to affect treatment with iptacopan 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

Iptacopan is not 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 the available evidence does not suggest that iptacopan is value for money in this population.

Why the committee made these recommendations

There are no licensed treatments for complement 3 glomerulopathy. Usual treatment aims to control the symptoms. Iptacopan aims to treat the condition.

Clinical trial evidence suggests that, compared with placebo, iptacopan reduces the amount of protein in the urine and slows the decline of kidney function. But this is uncertain because the trials were short and included only a small number of people.

There are significant uncertainties in the economic model, including:

  • which evidence should be used

  • the assumptions used

  • whether the model captures all of iptacopan's potential benefits.

Because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimate for iptacopan. Also, all of the cost-effectiveness estimates, from both the company and the external assessment group, are substantially above the range that NICE considers an acceptable use of NHS resources. So, iptacopan should not be used.