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    Has all of the relevant evidence been taken into account?
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    Are the summaries of clinical and 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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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1

Erdafitinib is not recommended, within its marketing authorisation, for treating unresectable or metastatic urothelial cancer with susceptible FGFR3 genetic alterations in adults after at least 1 line of treatment for unresectable or metastatic cancer that included a PD‑1 or PD‑L1 inhibitor.

1.2

This recommendation is not intended to affect treatment with erdafitinib 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.

Why the committee made these recommendations

Usual treatment for unresectable or metastatic urothelial cancer with FGFR3 genetic alterations after at least 1 line of treatment that included a PD‑1 or PD‑L1 inhibitor is paclitaxel with or without carboplatin, or best supportive care.

Erdafitinib has not been directly compared in a clinical trial with paclitaxel with or without carboplatin. An indirect comparison suggests that erdafitinib increases how long people have before their cancer gets worse and how long they live compared with paclitaxel with or without carboplatin.

Erdafitinib has not been directly or indirectly compared with best supportive care. This makes the clinical and cost effectiveness of erdafitinib uncertain.

There are also other uncertainties in the economic model, because the:

  • population in the main trial does not reflect people having treatment in NHS clinical practice

  • evidence comparing erdafitinib against paclitaxel with or without carboplatin is uncertain

  • cost of genetic testing has not been modelled accurately

  • estimates of how long people have before their cancer gets worse are not what would be expected.

Because of the uncertainties in the clinical evidence and the economic model, it is not possible to determine the most likely cost-effectiveness estimates for erdafitinib. So, it is not recommended.

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