With sales of its breast cancer drug Kisqali lagging, Novartis saw an opening in the U.K. market to gain ground on its competitors. Now that door has swung shut.
In draft guidance published Wednesday, the National Institute for Health and Care Excellence (NICE) chose not to recommend Kisqali (ribociclib) for treatment of women with hormone receptor-positive, HER-2 negative metastatic breast cancer, citing unclear survival data and steep costs.
“Because of the uncertainties in the clinical evidence, and cost-effectiveness estimates that are much higher than NICE normally considers to be an acceptable use of NHS resources, ribociclib with fulvestrant cannot be recommended for routine use in the NHS,” the institute said in a release.
NICE’s decision is a setback for Novartis as it competes for advanced breast cancer sales with Eli Lilly’s Verzenio and Pfizer’s Ibrance, the CDK 4/6 inhibitor market’s top seller by far.
Kisqali, which was approved by the FDA in March 2017, hasn't put up much of a fight against Ibrance, which controlled around $4.1 billion of the worldwide market in 2018 compared with Kisqali’s $235 million share. Verzenio, the third entry to the field, raked in $255 million in 2018.
Data released last June showed that Kisqali, used in tandem with fulvestrant in previously untreated patients, kept disease at bay for a median 20.5 months, compared with just 12.8 months for solo fulvestrant. Investigators estimated that nearly 70% of women in the first-line subgroup still hadn’t seen their disease progress at a median follow-up of 16.5 months.
However, NICE said all of that clinical data didn’t indicate prolonged survival for patients.
Novartis isn’t the only company that has sparred with NICE over breast cancer treatment. In October 2018, the watchdog rebuffed Verzenio, saying it didn't find the drug cost-effective relative to its competitors. But after Lilly offered a significant price cut on top of its confidential discount on England’s NHS, NICE in January overturned its draft guidance and recommended the drug for routine use.
NICE in 2017 backed Kisqali as a treatment for advanced HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor. Despite that nod, Kisqali and its competitors have seen dipping sales in a slowing, crowded market.
Even Ibrance has suffered sales pitfalls, despite holding around 90% of the market. In August, Pfizer COO Albert Bourla told investors on a conference call that stiff competition and a middling market had pushed the company to look for new revenue drivers in the field.
“Right now, the low-hanging fruit has already been harvested and what remains is late adopters,” he said.