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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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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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Draft guidance consultation

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1 Recommendations

1.1

Catumaxomab should not be used for the intraperitoneal treatment of malignant ascites caused by epithelial cellular adhesion molecule (EpCAM)-positive carcinomas in adults when further systemic anticancer treatment is unsuitable.

1.2

This recommendation is not intended to affect treatment with catumaxomab 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, catumaxomab 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 catumaxomab offers benefit and is value for money in this population.

Why the committee made these recommendations

Usual treatment for malignant ascites (a build of fluid in the abdomen) caused by EpCAM-positive carcinomas is drainage of the ascites through:

  • repeated large-volume paracentesis (LVP) using a temporary catheter, or

  • an indwelling peritoneal catheter (IPC) that can be left in place for prolonged periods to allow ongoing drainage.

Catumaxomab is a treatment that would be delivered into the abdominal cavity (intraperitoneal).

Evidence from a clinical trial suggests that people who have catumaxomab after an initial LVP have longer before needing another LVP than people who have LVP alone. How long people live after having catumaxomab after an LVP compared with LVP alone is uncertain. The clinical evidence is also uncertain because:

  • the trial was done over 20 years ago in a different population and clinical context to current NHS practice 

  • there is no evidence comparing catumaxomab with IPC

  • it is likely that catumaxomab would be delivered using an IPC in the NHS but this was not done in the trial. 

Because of the uncertainties in the clinical evidence, there are uncertainties in the economic model. The model structure is not appropriate for decision making because:

  • it does not accurately capture potential benefits of catumaxomab

  • it does not compare catumaxomab with IPC

  • there is uncertainty about how catumaxomab would be used in the NHS.

Because of the uncertainties in the clinical and economic evidence it is not possible to determine the most likely cost-effectiveness estimates for catumaxomab without further evidence and analyses. So, catumaxomab should not be used.