NICE approval for Lilly's Verzenios is “fantastic news for thousands of women”

After being rejected for routine use by the UK's NHS in February, Eli Lilly’s Verzenios (abemaciclib) has now been given the green light by health technology body, NICE.

“Advanced breast cancer is an incurable condition and the aim of treatment is to delay it getting worse and extend survival,” said Meindert Boysen, director of the Centre for Health and Technology Evaluation at NICE (National Institute for Health and Care Excellence).

“The committee heard that CDK4/6 inhibitors like abemaciclib were welcomed by patients because they can delay the time before their cancer gets worse and so delay or avoid the need for chemotherapy.”

CDK4/6 inhibitors like Verzenios block proteins in cancer cells, stopping them from dividing and growing. The drug is already approval on the NHS for previously untreated, hormone-receptor positive, HER2-negative, locally advanced or metastatic breast cancer.

However, Verzenios plus fulvestrant will now be available in England and Wales for the treatment of women with hormone receptor-positive, HER2-negative breast cancer.

Verzenios had previously been available only through the UK’s Cancer Drug Fund, designed to allow patients access to treatments that have not yet been approved for routine NHS prescribing. The drug will now exit the CDF.

The decision was made after hearing patient testimony. Cancer charity, Breast Cancer Now, responded to the NICE consultation following its rejection of Verzenios in its draft guidance and also helped more than 60 women share their experience of treatment.

The NICE decision is “testament to the many women who shared their experiences” said Baroness Delyth Morgan, chief executive of Breast Cancer Now, who welcomed the decision as “fantastic news for thousands of women with hormone receptor positive, HER2 negative incurable secondary breast cancer”. The decision by NICE, she said, is “bringing hope” to women who may now get “precious extra months before their disease progresses”.

NICE stated that the positive recommendation follows an “improved patient access scheme” and further economic modelling data from Lilly. It is widely believed that Lilly cut the price of the drug – previously priced at £2,950 for a packet of 56 150mg-tablets, excluding VAT – to improve its cost-effectiveness.

Clinicians heralded the news. “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 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.”

The key trial for Verzenios was MONARCH 2, which showed the drug in combination with fulvestrant extended the time before a patient’s condition progresses (progression-free survival) by 7.6 months on average compared to fulvestrant alone. Later data suggested the treatment improved overall survival by providing an additional 9.4 months on average compared with fulvestrant.