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New HTA Decisions in England
August 2019
Drug name
KISQALI® (ribociclib)
Decision date
Therapeutic area
Therapeutic sub area
Breast cancer
Recommended with restrictions (CDF)
Ribociclib with fulvestrant is recommended for use within the Cancer Drugs Fund as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in people who have had previous endocrine therapy
Decision Detail
Only if: 1) exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor and 2) the conditions in the managed access agreement for ribociclib with fulvestrant are followed.
Clinical evidence was provided from MONALEESA‑3, a multicentre double-blind randomised placebo-controlled trial comparing ribociclib and fulvestrant with placebo and fulvestrant in adults with hormone receptor-positive, HER2‑negative advanced breast cancer. Results for a subgroup of patients who had previous endocrine therapy were considered relevant to this appraisal but the committee noted concerns that the MONALEESA‑3 trial was not designed to have statistical power to detect treatment effects within subgroups. The committee concluded that ribociclib with fulvestrant increased progression-free survival compared with fulvestrant alone in people who had had previous endocrine therapy, but that the effect on overall survival was currently unknown as data were immature. The results of an indirect comparison of ribociclib and fulvestrant with exemestane and everolimus remain uncertain. The cost-effectiveness estimates are very uncertain. The company's revised base case resulted in an ICER of less than £30,000 per QALY gained. This ICER was presented as commercial in confidence to maintain the confidentiality of the proposed commercial access agreement for ribociclib and the patient access scheme for everolimus. The committee noted that the proposed commercial access agreement for ribociclib is only for this indication, so it could not take this price into account when considering ribociclib with fulvestrant for routine commissioning. The committee also noted that, when the current patient access scheme for ribociclib (which is the offered price for routine commissioning) was used in the cost-effectiveness analyses, the ICERs were all substantially above the range considered to be a cost-effective use of NHS resources. Therefore, ribociclib with fulvestrant cannot be recommended for routine use in the NHS. The committee considered that, based on the cost-effectiveness analyses including the proposed commercial access agreement, there was plausible potential for ribociclib plus fulvestrant to be cost effective compared with exemestane plus everolimus, but more data are needed to resolve the uncertainties. Therefore, ribociclib with fulvestrant is recommended for this population in the Cancer Drugs Fund while these data are collected.