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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

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

  • Question on Consultation

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

  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?

Draft guidance

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1 Recommendations

1.1

Tisotumab vedotin should not be used to treat recurrent or metastatic cervical cancer that has progressed on or after systemic treatment in adults.

1.2

This recommendation is not intended to affect treatment with tisotumab vedotin 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

Tisotumab vedotin 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 there is not enough evidence to determine whether tisotumab vedotin is value for money in this population.

Why the committee made these recommendations

Usual treatment for metastatic or cervical cancer that has progressed on or after systemic treatment is single-agent chemotherapy.

Clinical trial evidence shows that tisotumab vedotin increases how long people have before their cancer gets worse, and how long they live, compared with the trial investigator's choice of chemotherapy.

There are concerns about the economic model, including:

  • its structure

  • the modelling of how long people have before their condition gets worse and how long they live.

    Because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimates for tisotumab vedotin. So, it should not be used.