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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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1 Recommendations

1.1

Pegcetacoplan should not be used to treat complement 3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis in people 12 years and over.

1.2

This recommendation is not intended to affect treatment with pegcetacoplan 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. For children or young people, this decision should be made jointly by the healthcare professional, the child or young person, and their parents or carers.

What this means in practice

Pegcetacoplan 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 pegcetacoplan is value for money in this population.

Why the committee made these recommendations

Usual treatment aims to control the symptoms of complement 3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis. Pegcetacoplan aims to treat the underlying condition.

Clinical trial evidence shows that pegcetacoplan reduces protein in the urine and slows the decline of kidney function compared with placebo.

There are uncertainties in the economic model, including:

  • how stable disease is defined and used in the model

  • how it includes the costs and benefits of avoiding a kidney transplant.

Because of the uncertainties in the economic model it is not possible to determine the most likely cost-effectiveness estimate for pegcetacoplan. But it is likely to be above the range that NICE considers an acceptable use of NHS resources. So, pegcetacoplan should not be used.