NICE says no to Novartis’ Kisqali combo in breast cancer

Novartis’ hopes of a boost for under-performing breast cancer drug Kisqali have been hit by a negative verdict from NICE.

Draft guidance from the cost-effectiveness watchdog has concluded CDK 4/6 inhibitor Kisqali (ribociclib) plus fulvestrant should not be offered routinely on the NHS in England for patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer who have had previous endocrine therapy.

It’s a blow to the company that is likely harder to take because a rival drug in the CDK 4/6 inhibitor class – Eli Lilly’s Verzenio (abemaciclib) – was backed by NICE alongside fulvestrant for this patient group last week, albeit via the Cancer Drugs Fund (CDF).

The draft guidance is subject to a public consultation until 9 May, but says that the decision was made because it is not known whether Kisqali increases the length of time people live, because the final trial results are not available yet.

“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, Kisqali with fulvestrant cannot be recommended for routine use in the NHS,” says the guidance.

“More data may address the uncertainties in the clinical trial evidence but because ribociclib with fulvestrant does not have the plausible potential to be cost-effective at the offered price, it cannot be recommended for use within the Cancer Drugs Fund (CDF),” it adds.

Kisqali, Verzenio as well as Pfizer’s market-leading CDK 4/6 inhibitor Ibrance (palbociclib) are already recommended for first-line use in HR-positive, HER2-negative advanced breast cancer in combination with aromatase inhibitors.

Novartis has struggled to gain traction in the CDK 4/6 inhibitor category, with sales falling from $71m in the third quarter of 2018 to $60m in the last three months of the year.

Ibrance was the first of these drugs to reach the market and has already achieved blockbuster status worldwide, earning around $4bn in 2018, with forecasts of $6bn in 2022 revenues.

That leaves Kisqali and Verzenio jostling for second position, and some analysts says Verzenio has an advantage over Kisqali thanks to its continuous dosing regimen, which means patients don’t have to take treatment holidays to avoid toxicity such as neutropenia.

Early signs are that Lilly’s drug is starting to accelerate even as Kisqali slows down, with fourth quarter revenues reaching $83m in the fourth quarter of 2018.