Zanidatamab can be used, within its marketing authorisation, 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. Zanidatamab can only be used if the company provides it according to the commercial arrangement.
Zanidatamab must be funded in the NHS in England for the condition and population in the recommendation, if it is considered the most suitable treatment option. Zanidatamab must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that zanidatamab provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Usual treatment for HER2-positive (IHC3 positive) unresectable advanced biliary tract cancer after at least 1 line of systemic treatment varies. If further 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 FOLFOX or ASC. 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.
When considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, zanidatamab can be used.