NICE rejects Bayer and Eisai drugs in thyroid cancer

NICE has rejected Bayer's Nexavar and Eisai's Lenvima in thyroid cancer, saying in draft guidance that neither is cost-effective against the disease.
Bayer's drug has been available on the CDF until now, while Lenvima has been awaiting a NICE review for two years.

Both drugs are licensed to treat locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer.

There is a glimmer of hope for both companies, as NICE says both Lenvima and Nexavar are effective in delaying disease progression, and that Lenvima may delay progression the longest.

Lenvima costs around £35,000 per patient for a year's supply, while Nexavar costs almost £47,000 per year per patient.

But cost-effectiveness estimates for both drugs are far above NICE’s usual cut-off, and neither treatment meets criteria allowing for more leeway at the end of a patient's life. The appraisal could now follow a familiar scenario where the companies can tip the balance by offering further price cuts, having both already offered commercially confidential discounts.

NICE said that according to trial data Lenvima extends overall survival to 42.8 months – compared with 34.5 months with patients treated with placebo.

The benefits of Nexavar are less clear, NICE said, because of issues with study design. NICE also noted that side effects were common, with almost all patients treated with the drugs experiencing an adverse event.

[caption id="attachment_16759" align="alignnone" width="134"] Eisai's Gary Hendler,[/caption]

In a statement, Gary Hendler, chief commercial officer, Oncology Business Group, and chairman and chief executive EMEA at Eisai, said NICE’s guidance was “extremely disappointing”.

He noted that the Scottish Medicines Consortium has said it is cost effective, and that last week Wales’s AWSMG also approved funding.

He added: “Thyroid cancer is the fastest accelerating cancer diagnosis in the UK and this aggressive form of thyroid cancer carries a poor prognosis, with 66% of patients dying within five years of diagnosis."

“Eisai believes in the value of providing innovative and effective therapies to cancer patients who need alternatives to the current standard of care and therefore will do everything possible to overturn this negative [decision].”

NICE's decision is in contrast to rulings elsewhere in the UK. Scotland's SMC has approved Nexavar for restricted use in thyroid cancer patients, and granted full approval to Lenvima. Meanwhile in Wales, the AWSMG has also just given the green light to Lenvima.

The chief executive of one thyroid cancer charity made her feelings clear in a tweet.

NICE decides not to approve Sorafenib and Lenvima on the same day that Wales approves Lenvima ,crazy .

— Kate Farnell MBE (@ButterflyThyro) October 20, 2017

Neither drug is suitable for the new-look Cancer Drugs Fund, which gives interim reimbursement for drugs while NICE gathers more cost-effectiveness data.

While NICE said there was scope for manufacturers to present more quality of life data, it was unable to calculate a cost per Quality Adjusted Life Year.