Lilly Scores New Treatment Option For Verzenios In England
Executive Summary
Health technology assessment body NICE says that Verzenios when used with fulvestrant can be used to treat advanced breast cancer via the Cancer Drugs Fund, giving Eli Lilly the edge in this space for now over rival CDK4/6 manufacturers, Pfizer and Novartis.
Eli Lilly’s CDK4/6 inhibitor Verzenios (abemaciclib) when administered with fulvestrant can now be made available via England’s Cancer Drugs Fund to thousands of women with advanced breast cancer.
The product in combination with fulvestrant becomes the first CDK4/6 inhibitor in the UK to be made available to women who have had prior endocrine treatment for hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body. This is also the first breast cancer treatment to be recommended for use on the new version of the CDF that was launched in July 2016 and which provides interim funding for promising new cancer drugs while further evidence is collected to address clinical uncertainty.
Lilly is the first company to secure a NICE recommendation for this new treatment option for women who have had prior endocrine treatment. The three CDK4/6 inhibitors on the market for breast cancer – Verzenios, Pfizer's Ibrance (palbociclib) and Novartis's Kisqali (ribociclib) – have all previously been approved for routine NHS use in combination with an aromatase inhibitor, for patients with previously-untreated hormone positive, HER2-negative locally-advanced or metastatic breast cancer.
The National Institute for Health and Care Excellence (NICE) made the announcement about the new treatment option using Verzenios this week and released a final appraisal document (FAD) recommending interim use of the combination treatment within the CDF. Pending any appeals against the FAD, final guidance will be published on the NICE website next month.
NICE said the treatment could be an option for up to 4,800 women. It should only be used in patients for whom the most appropriate treatment alternative would be exemestane with everolimus, which, as noted by the charity Breast Cancer Now, is considered by NICE to be the most effective existing treatment following hormone therapy.
Treatment with abemaciclib and fulvestrant (AstraZeneca's Faslodex*) has been shown to slow disease progression and delay the need for chemotherapy, but NICE says there is a lack of evidence around the treatment’s overall survival benefit and cost-effectiveness. As such, the institute is not recommending the treatment for routine commissioning in the NHS in England and has for now recommended that it be funded via the CDF while more data is collected.
NICE will review the guidance when the final analysis of Lilly’s MONARCH 2 study is available; this is expected in February 2020. The HTA body said that “the data collection period is expected to end in December 2021, when enough data has been collected to address the clinical uncertainties” that NICE's committee had highlighted. “The process for exiting the Cancer Drugs Fund will begin at this point and the review of the NICE guidance will start.”
Breast Cancer Now said that the combination therapy's acceptance in the Cancer Drugs Fund was "absolutely fantastic news," but that it would be monitoring the use of the new treatment to check that the everolimus with exemestane option does "not act as a barrier" to its use.
Pfizer and Novartis are also seeking to use their CDK4/6 inhibitors in combination with fulvestrant on the NHS for breast cancer patients who have undergone prior endocrine therapy. NICE is currently preparing guidance for both companies. Novartis's guidance is expected to be published in August, and Pfizer's guidance is expected to be published in December.
Verzenios, known as Verzenio outside the EU, is taken as a twice-daily pill. It normally costs £2,950 for a packet of 56 150mg tablets (excl VAT), but Lilly has agreed a confidential NHS discount under a managed access agreement.
*This article was corrected on 8 May 2019 to state that fulvestrant was AstraZeneca’s Faslodex, and not AstraZeneca's Zoladex.
From the editors of Scrip Regulatory Affairs.