NICE rejects Lilly’s breast cancer drug Verzenios

As it stands Eli Lilly’s Verzenios will not be routinely funded on the NHS for breast cancer, as cost-regulators have now issued draft guidelines rejecting the drug.

The preliminary guidelines do not recommend Verzenios (abemaciclib), in combination with an aromatase inhibitor, for some types of breast cancer that has spread.

According to the National Institute for Health and Care Excellence, the drug is as effective as both palbociclib and ribociclib, which NICE already recommends as options for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic breast cancer as initial hormone therapy.

However, "once the patient access schemes are taken into account, abemaciclib is not cost effective relative to the others," it said.

Verzenios, like palbociclib and ribociclib, is a CDK4/6 inhibitor, which work to boost the effect of aromatase inhibitors that block the production of the hormone oestrogen, preventing it from stimulating the growth of some breast cancers.

Around 46,000 women are diagnosed with breast cancer each year in England and Wales, of whom the company estimates approximately 8,000 would be eligible for treatment with Lilly’s drug.

Verzenios was approved in Europe for the treatment of certain metastatic breast cancers earlier this month, based on data from the Phase III MONARCH 2 and 3 trials.

In MONARCH 2, adding Verzenios to AstraZeneca’s Faslodex (fulvestrant) significantly improved progression-free survival compared to Faslodex plus placebo, with figures of 16.4 months versus 9.3 months, respectively.

MONARCH 3 evaluated Verzenios in combination with an AI as initial endocrine-based therapy in postmenopausal women with HR+, HER2- advanced breast cancer who had no prior systemic treatment for advanced disease.

The data show that combining the drug with an AI demonstrated a greater than 28-month median PFS in patients who received initial endocrine-based therapy for metastatic disease (28.2 months vs 14.8 months for placebo/AI).

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