NICE changes its mind on Novartis’ Kisqali for breast cancer

NICE has backed NHS use of Novartis’ CDK4/6 inhibitor Kisqali alongside fulvestrant for breast cancer patients in England and Wales, three months after rejecting it on cost grounds, via the Cancer Drugs Fund.

The cost-effectiveness watchdog now says Kisqali (ribociclib) can be used with fulvestrant, after endocrine therapy in women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.

NICE said the positive recommendation “follows an improved patient access scheme by the company as part of a commercial arrangement.”

The green light gives Novartis an opportunity to make up ground on its rivals in the CDK4/6 inhibitor category – Pfizer with Ibrance (palbociclib) and Eli Lilly with Verzenios (abemaciclib) – which have been outstripping it in sales terms.

Ibrance was approved for second-line treatment in combination with fulvestrant in HR+/HER2- breast cancer in Scotland last week, but NICE is still deliberating on that indication south of the border and is due to make a decision by the end of the year.

Verzenios meanwhile has been approved in England for previously-treated HR+/HER2- patients, also via the Cancer Drugs Fund (CDF) until Lilly is able to gather more clinical evidence to support its use.

Novartis now has an opportunity to build use of Kisqali in the approximately 5,300 eligible patients per year in England and Wales.

All three drugs are approved by NICE for first-line use in HR+/HER2- breast cancer in combination with an aromatase inhibitor.

First-to-market Ibrance has romped away sales-wise, with sales of $4.1 billion last year. Lilly and Novartis are scrabbling for scraps at the moment, with third-to-market Verzenios bringing in $255 million, overtaking Kisqali which made $235 million.

In April, NICE said that it was unable to recommend Kisqali with fulvestrant due to uncertainties with the clinical and cost-effectiveness estimates, despite data from the MONALEESA-3 trial showing that the combination gave women the possibility of living 5 months longer without their disease worsening, than if receiving fulvestrant alone.

At the time, Baroness Delyth Morgan, chief executive of charities Breast Cancer Care and Breast Cancer Now, said the decision was “deeply disappointing” and denied a “vital additional option 2 to thousands of breast cancer patients.

The regimen “can offer patients precious extra months before their disease gets worse and comes with different side effects to other CDK 4/6 inhibitors which some patients may find more tolerable,” she added.

The green light means that Kisqali is now available “in multiple indications through the NHS which, coupled with the recent ASCO data demonstrating increased survival for pre-menopausal women with HR+/HER2- breast cancer, offers real hope to patients,” said Mari Scheiffele, Novartis Oncology general manager for the UK and Ireland.