Eli Lilly already had a tough marketing task ahead of it when it became the third major player in the market for CDK 4/6 inhibitors to treat breast cancer, behind Pfizer and Novartis. England’s drug-cost watchdogs are making the job even harder.
The country's National Institute for Health and Care Excellence (NICE) made a preliminary determination that Lilly’s drug, Verzenio (called Verzenios in Europe), is not cost-effective to treat hormone receptor-positive, HER2-negative breast cancer. The reason, in a nutshell, is that although Verzenio seems to work just as well as Pfizer’s Ibrance and Novartis’ Kisqali, Lilly didn't make a plausible case that its drug is more cost-effective, NICE said in its appraisal (PDF).
The company does have some time to make an appeal: NICE is taking comments on its recommendation until Nov. 8 and meeting a week later to appraise the drug again.
"Lilly will be taking part in this consultation to try to ensure that Verzenios is available to patients in the U.K.," a Lilly spokeswoman said in a statement emailed to FiercePharma. The company declined to provide pricing details, but "Lilly prices each of its medicines based on the value they bring to people, healthcare professionals, and payers, reflecting the benefit experienced by patients in clinical trials, and the scientific innovation they represent," she said.
Verzenio, Ibrance and Kisqali—all approved in combination with aromatase inhibitors—are offered to England’s National Health Service (NHS) at discounts that haven't been disclosed. NICE took those “patient access schemes” into account in determining the costs of the drugs per quality-adjusted life year (QALY) gained.
Lilly argued that its drug was the cheapest of the three, with the highest QALYs, according to the guidance document. But NICE disagreed, concluding Verzenio has a cost-effectiveness ratio that’s “significantly higher” than £30,000 ($39,100) per QALY.
NICE struggled to determine the cost-effectiveness of Verzenio for a variety of reasons, not the least of which was uncertainty about just how effective the drug is compared with its rivals. Lilly presented phase 3 data that did show Verzenio plus an aromatase inhibitor improves progression-free survival over an aromatase inhibitor alone.
But Lilly hasn’t determined overall survival data from that trial yet, and NICE noted that there’s also no evidence comparing Verzenio with Ibrance and Kisquali. Lilly analyzed 18 studies investigating each of the three drugs with an aromatase inhibitor, but in the end, neither the company nor NICE could find any “real difference in efficacy” among the three drugs, the guidance document said.
Lilly just might be able to turn the decision around, however, judging from some recent experiences for other oncology companies. Roche, for example, tacked a discount onto its drug Tecentriq to snag a NICE approval in lung cancer in April, a full seven months after the agency gave it the thumbs-down. NICE also changed its mind on J&J’s Imbruvica, backing it to treat mantle cell lymphoma after initially turning it down.
Lilly has been working hard to expand the market for Verzenio. The drug has racked up three FDA approvals, including as a solo therapy in breast cancer and as a combo with fulvestrant in women previously treated with hormone therapy. Verzenio missed its endpoint in a phase 3 lung cancer trial, but the company has a variety of ongoing studies in indications ranging from HER2-positive breast cancer to castration-resistant prostate cancer.
Lilly is counting on Verzenio to help raise the profile of its entire oncology portfolio—and to contribute to its 2018 overall revenue goal of $23 billion to $23.5 billion. Cancer drugs are so high a priority for Lilly, in fact, that in August the company promoted R&D veteran Anne White to president of Lilly Oncology.
White brings to the role 25 years of research chops, much of that in oncology—experience she’ll need to guide Verzenio through its challenges, and to nurture Lilly’s other valuable cancer assets, including Cyramza and Lartruvo.