Kisqali to be listed November starting three-way competition

Concluded pricing negotiation with NHIS, likely to get listed from November

CDK4/6 inhibitor market competition to expand with Ibrance and Verzenio

The cyclin-dependent kinase 4/6 (CDK4/6) inhibitor market is expanded to a three-way competition.

 

A pharmaceutical industry source reported, Novartis’ hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer treatment Kisqali (ribociclib) has concluded the pricing negotiation with National Health Insurance Service (NHIS).

 

The drug is expected to get listed for reimbursement through a refund type risk sharing agreement (RSA).

 

As a third CDK4/6 inhibitor, Kisqali entered the market the last but its position is not completely negative.

 

The main competition in the market centers the Faslodex (fulvestrant) combination therapy, in which Pfizer’s Ibrance (palbociclib) and Lilly’s Verzenio (abemaciclib) are already in the game with five months gap apart from the point of reimbursement listing.

 

Ibrance and Verzenio were approved in South Korea in August 2016 and May last year, respectively.

 

But considering Kisqali was approved last year October, its gap of reimbursement listing with those two drugs was relatively short.

 

Moreover, Kisqali’s reimbursement standard is looser than the first two drugs.

 

The drug can be prescribed not only to postmenopausal patients who have never had an oophorectomy, but also to premenopausal patients, which would make Kisqali a favorable option.

 

Professor Im Seock-ah of Hemato Oncology Department at Seoul National University Hospital explained, “The MONALEESA-7 study was mainly proposed and led by an Asian researcher, and had 30 percent of Asian patients as registered sample.

 

These findings reflect how Asian region still has a great need for a new treatment option in premenopausal women with breast cancer”.

 

The Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as a first-line treatment in pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer, and confirmed the drug’s effect of significantly extending patient’s overall survival (OS).

 

Specifically, the Kisqali combination group demonstrated median progression-free survival (mPFS) of 23.8 months, whereas endocrine therapy only group had 13 months.

 

In a subset analysis on Asian patients only, the Kisqali combination group’s mPFS was at 24.7 months, which was about 14 months longer than the endocrine therapy only group’s.

 

Also in Phase 3 MONALEESA-3 study, Kisqali confirmed its effect of extending the OS in pre and postmenopausal women.

 

At the point of 42 months, the OS in Kisqali combination group was at 58 percent, and fulvestrant only group was at 46 percent.