Last October, England’s drug-cost watchdogs dealt Eli Lilly a blow when they decreed that the company’s CDK 4/6 inhibitor to treat breast cancer, Verzenio, wasn't cost-effective. So Lilly dished up a new price break—and now the National Institute for Health and Care Excellence (NICE) is on board.
The problem, initially, was that Lilly couldn’t provide evidence that Verzenio (called Verzenios in Europe) is more effective than its two rivals, Pfizer’s Ibrance and Novartis’ Kisqali, for treating hormone receptor-positive, HER2-negative breast cancer. All three are offered at a list price of £2,950 in the U.K., with each company offering the National Health Service (NHS) a confidential discount. Lilly’s discount wasn’t enough to make Verzenio cost-effective, NICE said at the time.
With a new price break from Lilly, Verzenio is now as good a deal as Ibrance and Kisqali are, NICE ruled. The three drugs “have different side effects, but they all appear to work as well as each other,” NICE said in its guidance document (PDF).
NICE assessed all three CDK inhibitors by determining their costs per quality-adjusted life year gained. One of the challenges the agency faced when reviewing the data on Verzenio was that there’s no data comparing it to its rivals, and survival data is sparse. Lilly had provided phase 3 data showing Verzenio combined with an aromatase inhibitor boosts progression-free survival, but the company does not yet have information on overall survival or whether it can extend patients' lives.
After NICE’s original rejection, a spokesperson for Lilly told FiercePharma the company would work with the agency to try to come to an agreement and that “Lilly prices each of its medicines based on the value they bring to people, healthcare professionals, and payers” based on benefits shown in clinical trials.
NICE’s turnaround will most certainly boost Lilly’s prospects in the crowded CDK field. The drug has three FDA approvals and is conducting several studies in other cancers, including HER-2 positive breast cancer and castration-resistant prostate cancer. But it hasn’t been a completely smooth development path by any means: The drug failed a phase 3 trial in lung cancer last fall.
Lilly is counting on Verzenio to help the company reach its lofty revenue forecast for this year. In December, the company thrilled investors when it released a 2019 revenue estimate of $25.3 billion and $25.8 billion—beating the average estimate of under $25 billion. Lilly also said its sales would grow 6% on average between 2015 and 2020, an improvement over its previous forecast of 5%.
During a meeting with investors, Lilly tagged Verzenio as one of 10 new medicines that’s enjoying better-than-expected volume growth. That has no doubt been driven by the company’s aggressive marketing plan for the drug. Last year, Lilly rolled out a direct-to-consumer ad campaign for Verzenio, which included a TV ad called “Relentless.” It was Lilly’s first DTC campaign in oncology.