1.1 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 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.
1.2 This recommendation is not intended to affect treatment with palbociclib with fulvestrant that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
As agreed during the technical engagement stage, this appraisal focuses on the population who have breast cancer that is resistant to endocrine therapy. This includes people whose disease has progressed up to 12 months after neoadjuvant or adjuvant endocrine therapy or after 1 line of endocrine therapy for advanced disease. The main alternative treatment for this population is everolimus with exemestane.
Clinical trial evidence suggests that, compared with fulvestrant alone, palbociclib with fulvestrant increases the length of time before the disease progresses in people who have had previous endocrine treatment. However, it is uncertain whether people having palbociclib with fulvestrant live longer because the final overall survival data are not yet available. The results of indirect comparisons of palbociclib with fulvestrant and everolimus with exemestane are very uncertain.
The cost-effectiveness estimates are also very uncertain. Most of the plausible estimates are likely to be higher than what NICE normally considers an acceptable use of NHS resources. Therefore, palbociclib with fulvestrant cannot be recommended for routine use in the NHS.
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.