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Draft guidance consultation

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1 Recommendations

1.1

Zanidatamab should not be used to treat HER2-positive (defined as immunohistochemistry 3 [IHC3] positive) unresectable locally advanced or metastatic biliary tract cancer in adults after at least 1 line of systemic treatment.

1.2

This recommendation is not intended to affect treatment with zanidatamab 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

Zanidatamab 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 suggest that zanidatamab is value for money in this population.

Why the committee made these recommendations

Usual treatment for HER2-positive (IHC3 positive) unresectable advanced biliary tract cancer after at least 1 line of systemic treatment varies. If further anticancer treatment is suitable, people usually have FOLFOX chemotherapy with active symptom control (ASC). If this is not suitable, people usually have ASC only.

Zanidatamab has not been directly compared in a clinical trial with usual treatment. Indirect comparisons suggest that it is likely to increase how long people have until their condition gets worse and how long people live compared with usual treatment. But, it is uncertain how much extra benefit people would get with zanidatamab.

There are uncertainties in the economic model, particularly about how much zanidatamab may improve health-related quality of life compared with usual treatment.

Because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimates for zanidatamab and more analyses are needed. So, zanidatamab should not be used.