Patients with an advanced form thyroid cancer may have to wait three years for NHS access to Eiasai's Lenvima in England, after the drug was left out of the newly launched Cancer Drugs Fund (CDF).
Lenvima (lenvatinib) is not listed on the relaunched CDF and NICE has indicated it will not be able to issue final guidance on the treatment until around June 2018, according to the drugmaker.
The drug was approved in Europe in May 2015 for the treatment of adults with progressive locally advanced or metastatic, differentiated thyroid carcinoma which does not respond to treatment with radioactive iodine (RAI-R), of which there are around 250 cases a year.
People with RAI-R forms of the condition and distant metastases have a median survival of 2.5-3.5 years, and few treatment options are currently available on the NHS in England.
Clinical data show that Lenvima can significantly slow disease progression, with a significant median progression free survival benefit of 18.3 months versus 3.6 months for placebo observed in its pivotal trial.
However, the drug was refused entry to the CDF last year as it was closed to new medicines because of budget constraints, and was not scheduled for assessment by NICE because of its low budget impact, making NHS access very difficult for patients.
Eisai said it knows of at least twenty individual funding requests made by clinicians in England for the use of Lenvima in eligible patients but no patient has yet received the treatment, and it called for "urgent transitional arrangements" to allow access to the drug through the CDF.
"Lenvatinib was developed in the UK and is now manufactured in Hertfordshire in our state of the art facility. With no access to lenvatinib for people with advanced thyroid cancer in the UK for possibly three years, we may be forced to reconsider our future investments here," said Gary Hendler, chairman and chief executive Eisai EMEA.