Novartis’ Kisqali, trailing Lilly’s Verzenio, nabs limited NICE backing in breast cancer

Kisqali
Novartis' Kisqali has won NICE backing on NHS' Cancer Drug Fund in previously treated HR+/HER- breast cancer. (Novartis)

In breast cancer, Novartis’ Kisqali is trailing closely behind Eli Lilly’s direct competitor Verzenio. Now it's gained even footing with its rival in England, at least where the country's cost-effectiveness watchdogs are concerned.

In a typical change of heart at the National Institute for Health and Care Excellence (NICE), the drug cost watchdog backed Kisqali, in tandem with AstraZeneca’s Faslodex, for previously treated HR+/HER2- breast cancer—after Novartis offered “an improved patient access scheme,” the agency said Wednesday.

Rather than a full nod, Kisqali’s reimbursement on NHS is available only through the Cancer Drugs Fund, which requires a patient’s application. That's the same limitation NICE gave Verzenio in its own recommendation this April.

Ironically, this is one place where Kisquali and Verzenio have managed to beat Pfizer's Ibrance—far and away the leader in this class of CD4/6 inhibitors—to the punch. Ibrance doesn't yet have a NICE decision in second-line breast cancer yet. And Kisqali's positive opinion allows it a chance to gain some ground on the other two.

Ibrance's sales stats show what Kisqali is up against. The Pfizer drug raked in $1.13 billion in sales for the first quarter of 2019 alone. In the same period, Verzenio racked up $109 million, while Kisqali came in last at $91 million despite its beating the Lilly drug to market.

Ibrance's second-line application is still under review, with a decision expected to be finalized in December. All three drugs have NICE approvals for previously untreated patients.

RELATED: ASCO: Novartis' Kisqali posts first-in-class survival win in younger women

NICE's new decision depended on data showing the Kisqali-Faslodex combo could increase the length of time before cancer progresses in people who have had previous endocrine treatment. The duo doesn't yet have data showing it can extend patients’ lives, though, NICE’s appraisal experts pointed out. That makes the drug’s cost-effectiveness too uncertain to grant it routine use on the NHS, they decided.

Kisqali, however, recently became the first to turn up overall survival evidence in newly diagnosed premenopausal women with HR+/HER2- breast cancer.  The combination of Kisqali plus endocrine therapy cut the risk of death by 29% versus endocrine treatment alone, Novartis announced at the American Society of Clinical Oncology annual meeting in June.

Meanwhile, Ibrance had its own glory moment recently. In April, it won an FDA green light to treat males with breast cancer, a small indication that's expected to affect only 2,670 men in 2019. But the approval counts as a landmark because Pfizer largely used real-world evidence to win it, under a new FDA program encouraging drugmakers to pull in that sort of data.

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