2 Information about ribociclib

Marketing authorisation indication

2.1 Ribociclib (Kisqali, Novartis) is indicated for 'the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.' NICE guidance recommends ribociclib with an aromatase inhibitor as initial endocrine-based therapy. The current appraisal covers only the combination of ribociclib with fulvestrant in people who have already had endocrine therapy.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics.


2.3 The list price for ribociclib is £2,950.00 for a 63‑tablet pack of 200 mg tablets (excluding VAT; British national formulary online, accessed January 2021). The company has a commercial arrangement (simple discount patient access scheme). This makes ribociclib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount. The list price for fulvestrant is £522.41 per 2 × 250 mg/5 ml solution for injection. Fulvestrant is available to the NHS at contract prices negotiated through the Commercial Medicines Unit. These prices are lower than the list prices but are commercial in confidence.

  • National Institute for Health and Care Excellence (NICE)