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New HTA Decisions in England
August 2020
Drug name
IBRANCE® (palbociclib)
Decision date
Therapeutic area
Therapeutic sub area
Breast cancer
Recommended with restrictions (CDF)
Palbociclib 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
Palbociclib with fulvestrant is recommended for use within the Cancer Drugs Fund only if: • exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor and; • the conditions in the managed access agreement for palbociclib with fulvestrant are followed.
Clinical evidence was provided by PALOMA‑3, a multicentre double-blind randomised placebo-controlled trial comparing palbociclib and fulvestrant (n=347) with placebo and fulvestrant (n=174) in adults with hormone receptor-positive, HER2‑negative advanced breast cancer. The primary outcome measure of PALOMA‑3 was investigator-assessed progression-free survival (PFS). Treatment with palbociclib plus fulvestrant increased median PFS compared with fulvestrant alone from 4.6 months to 11.2 months (hazard ratio [HR] 0.50; 95% confidence interval [CI] 0.398 to 0.620, p<0.0001). Palbociclib plus fulvestrant resulted in a median 6.9 months gain in overall survival (OS), although this was not statistically significant (median 34.9 months for palbociclib plus fulvestrant compared with 28.0 months for placebo plus fulvestrant [HR 0.81; 95% CI 0.64 to 1.03, p=0.09]). Although 60.2% of the trial population had died at the time of the latest analysis, the committee noted that PALOMA‑3 was not powered to detect a difference in OS and further overall survival trial data were expected. The committee concluded that palbociclib with fulvestrant increased PFS compared with fulvestrant alone, but its effect on OS is currently uncertain. The cost-effectiveness estimates are also very uncertain. The exact incremental cost-effectiveness ratios (ICERs) are commercial in confidence and cannot be reported here. However, because there was a high level of uncertainty in the clinical evidence depending on the approach taken to compare palbociclib plus fulvestrant with everolimus plus exemestane, the committee concluded that palbociclib with fulvestrant could not be recommended for routine commissioning. The committee considered that, based on the cost-effectiveness analyses including the proposed commercial access agreement, palbociclib with fulvestrant has the potential to be cost-effective for the population considered in this appraisal, but more data are needed to resolve the uncertainties in the clinical evidence. Therefore, palbociclib with fulvestrant is recommended for this population in the Cancer Drugs Fund while these data are collected.