2019-05-02| Trials & Approvals

Kisqali Fulvestrant Combo Rejected by NICE for Breast Cancer Treatment in the UK

by GeneOnline
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By GeneOnline staff

The guidance document cites highly uncertain clinical and cost-effectiveness estimates as the reason for not recommending the therapy.

Background and History

Novartis’ Kisqali (ribociclib), is a cyclin-dependent kinase (CDK) inhibitor that restricts cancer progression by targeting the CDK4/6 kinases crucial for cell division. Following a successful phase III trial MONALEESA-3 which showed prolonged progression free survival, last year the drug was FDA approved in combination with the selective estrogen receptor degrader, Faslodex (fulvestrant) for the treatment of postmenopausal women suffering from hormone receptor (HR) positive, human epidermal growth factor receptor (HER2) negative, advanced or metastatic breast cancer. Five months post the FDA approval, the combo therapy also got the thumbs-up from the European Commission (EC) after earning a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Disapproval by NICE

However, the draft guidelines document from the National Institute of Health and Care Excellence (NICE), a non-departmental public body of the Department of Health in the United Kingdom has not recommended this treatment mentioning that “the cost-effectiveness estimates are much higher than the range NICE normally considers an acceptable use of NHS resources”. This is a huge setback for Novartis since a rival treatment involving Eli Lilly’s Verzenio (abemaciclib) and fulvestrant was recommended only a week ago by NICE for patients with the same indication.

Reactions to the news

This is not the first time NICE has rejected key breast cancer drugs for use on the NHS due to high costs. Past causalities include Kadcyla (ado-trastuzumab emtansine) and Perjeta (pertuzumab) and even fulvestrant.

Baroness Delyth Morgan, chief executive at Breast Cancer Now, a charity organization was critical of this verdict by NICE. “It is deeply disappointing that NICE has been unable to approve ribociclib with fulvestrant, which could provide a vital additional option to thousands of patients who have had prior hormone therapy. While a similar treatment is already available, it’s unacceptable that this outcome could unnecessarily limit patient choice and we need all parties to work together to find a solution” she said. She noted that these treatments play a great role in improving and prolonging patient’s lives and urged Novartis, NICE and NHS England to try everything in their power to offer the drug combo therapy to patients at a price the NHS can afford. The guidance is not final and is presently open for comments from consultees, commentators and the public until May 9th.


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