Eli Lilly’s Verzenio just made life incrementally harder for Pfizer’s market-leading Ibrance, thanks to a reimbursement green light in England for the postsurgery treatment of early breast cancer.
Verzenio, also known as Verzenios in Europe, has won backing from England’s drug cost watchdog for routine coverage as a post-surgery treatment for HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.
Unlike the drug’s FDA label, the National Institute for Health and Care Excellence (NICE) doesn’t require that patients test at least 20% on the cellular proliferation index Ki-67 to be eligible for Verzenio. It lists certain pathological tumor involvement criteria such as the number of positive lymph nodes for a patient to be considered high-risk, which matches the patient profile in Verzenio’s phase 3 clinical trial supporting the new use.
By NICE’s estimate, about 4,000 people will be eligible for Verzenio in this early breast cancer adjuvant treatment setting, where the Lilly drug is the only CDK4/6 inhibitor approved.
In the phase 3 monarchE trial, adding Verzenio to traditional endocrine therapy cut the risk of invasive disease recurrence, new cancer development or death by 32%.
Drug appraisers at NICE noted (PDF) that the current invasive disease-free survival analysis is a suitable surrogate for evaluating Verzenio’s coverage here given that it could take up to 10 years to show a “clinically worthwhile” benefit on life extension.
Verzenio’s cost-effectiveness estimates, while uncertain, likely fall within the range that NICE considers an acceptable use of NHS resources, the expert panel concluded.
To win over NICE, Lilly also made a confidential discount from Verzenio’s current list price of 2,950 pounds (about $3,620) per 28-day cycle of 150-mg tablets. Verzenio 150 mg is given twice daily for up to two years in early breast cancer.
Verzenio's ability to prevent tumors from returning means there could be fewer patients up for metastatic disease treatment with CDK4/6 inhibitors. That’s incrementally bad news, mainly for Pfizer’s Ibrance, but also for Novartis’ Kisqali.
Ibrance has already started to lose new patient start share in the U.S. after failing to show an overall survival benefit in phase 3 clinical trials in metastatic disease and after flopping two studies in early-stage cancer. By comparison, with the postsurgery adjuvant nod, Verzenio has been expanding its market share among the three approved CDK4/6 inhibitors.
Novartis is targeting an even broader adjuvant HR-positive, HER2-negative early breast cancer population with the phase 3 Natalee trial. The study, expected to read out next year, tests Kisqali in both high-risk and intermediate-risk patients. By Novartis’ estimate, the intermediate-risk population is three times as large as the high-risk group.