NICE changes stance on Lilly’s breast cancer dug Verzenio

After rejecting Eli Lilly’s Verzenio for breast cancer therapy earlier this year, NICE has relented, recommending the drug for routine NHS use alongside hormonal therapy fulvestrant.

A final appraisal document from the health technology assessment (HTA) agency backs the use of Verzenio (abemaciclib) alongside fulvestrant for the treatment of women with hormone receptor-positive, HER2-negative breast cancer in England and Wales.

The February decision to reject the twice-daily drug was described as a “devastating blow” by patient advocacy group Breast Cancer Now.

The change in NICE’s opinion follows an “improved access scheme” for the drug, which generally means that the manufacturer has agreed an additional discount for the drug – in this case an ex-VAT list price of £2,950 for a 56-count pack of 150mg tablets.

NICE said it also resulted from new economic modelling data submitted by Lilly that backed up the cost-effectiveness of the CDK 4/6 inhibitor for patients with this type of cancer.

“This is welcome news for my patients, many of whom have already benefitted from the extra time this treatment gives them, without the need for chemotherapy,” said Dr Mark Verrill, a consultant medical oncologist at Newcastle upon Tyne Hospitals NHS Foundation Trust.

“We also know from the clinical trial data that abemaciclib extends their life expectancy,” he added.

Patients in England have been able to get access to Verzenio since 2019 via the Cancer Drugs Fund (CDF), which provides interim funding of new treatments while additional data is collected ahead of a decision on routine NHS prescribing. That route is however not available to people in Wales.

The drug has previously been approved for NHS use for previously untreated, hormone-receptor positive, HER2-negative, locally advanced or metastatic breast cancer.

NICE said its appraisal committee had considered the value to patients of having Verzenio as a treatment option, as it is an alternative CDK 4/6 inhibitor to others currently available – Pfizer’s Ibrance (palbociclib) and Novartis’ Kisqali (ribociclib) – and has different side effects.

Despite “uncertainty around the clinical and cost effectiveness estimates,” NICE decided that Verzenio was a cost-effective use of NHS resources.

“The committee also heard from the patient experts that exemestane plus everolimus, the treatment that would normally be used at this stage, was poorly tolerated,” said Meindert Boysen, director of NICE’s Centre for Health and Technology Evaluation.

That means it is used “for only a small number of people because it has similar effects to chemotherapy on quality of life.”

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