1.1 Lenvatinib and sorafenib are recommended as options for treating progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular or Hürthle cell) in adults whose disease does not respond to radioactive iodine, only if:
they have not had a tyrosine kinase inhibitor before or
they have had to stop taking a tyrosine kinase inhibitor within 3 months of starting it because of toxicity (specifically, toxicity that cannot be managed by dose delay or dose modification).
Lenvatinib and sorafenib are recommended only if the companies provide them according to the commercial arrangements.
1.2 This recommendation is not intended to affect treatment with lenvatinib or sorafenib 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 clinician consider it appropriate to stop.
Why the committee made these recommendations
Lenvatinib and sorafenib (tyrosine kinase inhibitors) are the only treatment options for progressive, locally advanced or metastatic differentiated thyroid cancer after surgery and radioactive iodine. For people who cannot have lenvatinib or sorafenib, best supportive care is the only option.
Clinical trial evidence shows that lenvatinib and sorafenib are both effective in delaying disease progression, but there is a higher response rate (that is, more tumours shrink) with lenvatinib and it may delay progression for longer. Clinical expert advice is that this response is associated with an improvement in symptoms, which is valued by patients. Lenvatinib and sorafenib also increase the length of time people live, but it is uncertain by how long.
The cost-effectiveness estimates are higher than what NICE normally considers acceptable, and lenvatinib and sorafenib do not meet NICE's end-of-life criteria. But the treatments do increase length of life and there are no other treatments available for the condition. Also, the cost-effectiveness estimates do not capture the benefits of people having a response to treatment, that is, an improvement in symptoms.
Taking all this into account, lenvatinib and sorafenib are recommended as treatment options for differentiated thyroid cancer after radioactive iodine. However, they are recommended only for people who have not had tyrosine kinase inhibitors before, or who have to stop them early because of tolerability (specifically, toxicity that cannot be managed by dose delay or dose modification). This is because there is not enough clinical evidence and no cost-effectiveness evidence to determine whether the treatments are effective when used sequentially.