The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Eli Lilly’s Verzenios (abemaciclib) with fulvestrant for the treatment of advanced breast cancer patients.

Lilly had been seeking a recommendation within Verzenios’ marketing authorisation, for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in adults who have had endocrine therapy.

NICE has reviewed additional evidence, collected as part of the Cancer Drugs Fund (CDF) managed access agreement for Verzenios plus fulvestrant in these breast cancer patients, to make this appraisal.

Typically, people with hormone receptor-positive, HER2-negative advanced breast cancer receive exemestane plus everolimus after endocrine therapy.

NICE said that there is uncertainty around Verzenios plus fulvestrant treatment because there is no evidence directly comparing this therapy to exemestane plus everolimus.

However, an indirect comparison suggests that people receiving Verzenios plus fulvestrant have longer before their disease progresses and live longer compared to people having exemestane plus everolimus.

NICE added that it is unclear how long people would have treatment for and therefore how much the treatment would cost.

On the cost-effectiveness front, NICE said that because of these uncertainties, estimates vary.

The ‘most likely’ estimates are higher than what NICE usually considers a cost-effective use of NHS resources.

“[The] news that NICE has been provisionally unable to approve Verzenios with fulvestrant for routine use on the NHS following its time on the Cancer Drugs Fund is a devastating blow for thousands of women with incurable secondary breast cancer who could benefit from this innovative treatment in future,” said Delyth Morgan, chief executive at Breast Cancer Now.

“Verzenios with fulvestrant is an example of continued advances in treatment and care for secondary breast cancer and it’s deeply concerning that new patients could be denied the chance to benefit from this progress.

“While treatment will continue for women currently receiving it, NICE, NHS England and Lilly UK must work swiftly together to explore all possible solutions to see this provisional decision reversed, including considering additional discounts. Unless this happens, patients in the future will pay the price of being denied the precious chance this treatment brings to live well for longer,” she added.

The draft recommendation will not affect treatment for those who have already been receiving Verzenios plus fulvestrant via the CDF.

The combination treatment will no longer be available in the CDF for this indication if the final guidance does not recommend Verzenios plus fulvestrant therapy.