Eisai is considering taking legal action due to what the company has described as a ‘black hole’ in the provision of rare cancer drugs to UK patients.
Ahead of NICE’s planned publication of a Standard Operating Procedure (SOP) for the new Cancer Drugs Fund (CDF) next week, Eisai has called for an “immediate solution” to what it calls the “inequitable CDF process which discriminates against drugs for rare cancers”.
Its own thyroid cancer therapy Lenvima (lenvatinib) was approved by the European Commission last year, but NICE guidance on the drug is not expected until 2018.
Lenvima is therefore not included in the re-launched CDF and Eisai has requested a special dispensation to be made, which would allow UK patients access to the drug which is manufactured in Hertfordshire.
In a statement, the pharma company said it believes its brand is “caught in limbo because it was not appraised before the CDF closed” earlier this year.
“We believe there is an immediate solution, a transitional arrangement, to allow patients access to a treatment which has been disproportionately delayed by the changes in the CDF process,” says Gary Hendler, chairman and chief executive office, Eisai EMEA.
He added: “Eisai may be forced to consider its level of investment in the UK because it is unacceptable that drugs which are manufactured in England cannot be provided to people in England, without delays of many years.”
As it stands, the new CDF will become a ‘managed access’ fund, with clear entry and exit criteria for drugs. All newly licensed cancer drugs will first be referred to NICE for appraisal.
NICE will then decide whether it should be routinely commissioned or whether it should be considered for funding within the new CDF for a time limited period.
A CDF Investment Group is set be established to manage and oversee the CDF budget, but the clinical and cost effectiveness of limited period funding is as yet uncertain.
The Japanese firm says it is “dismayed and concerned” and is “considering all next steps, including legal action, to remedy what it sees as an unfair and inequitable situation for people with advanced thyroid cancer”.
Lenvima is indicated for the treatment of adults with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (R-RAI).
It has demonstrated 18.3 months progression free survival versus 3.6 months for placebo in RAI-R differentiated thyroid cancer. The cancer forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.