1 Recommendations
1.1 Palbociclib plus fulvestrant is recommended as an option for treating hormone receptor‑positive, HER2‑negative locally advanced or metastatic breast cancer in adults who have had endocrine therapy only if:
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exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and
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the company provides it according to the commercial arrangement.
1.2 If patients and their clinicians consider palbociclib plus fulvestrant and abemaciclib plus fulvestrant or ribociclib plus fulvestrant to be suitable options, use the least expensive treatment. Take account of the monitoring and adverse event costs, dosage, price per dose and commercial arrangements.
Why the committee made these recommendations
This appraisal reviews the evidence for palbociclib plus fulvestrant for hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer after endocrine therapy (NICE technology appraisal guidance TA619). It also reviews new evidence from a clinical trial and data collected from people having treatment through the Cancer Drugs Fund managed access agreement.
Treatment for hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer after endocrine therapy includes exemestane plus everolimus, and the CDK4/6 inhibitors abemaciclib (plus fulvestrant) and ribociclib (plus fulvestrant) if exemestane plus everolimus is the most appropriate alternative. Palbociclib plus fulvestrant is another option that works in a similar way to abemaciclib and ribociclib.
The new evidence collected from people having treatment through the Cancer Drugs Fund shows that palbociclib plus fulvestrant is clinically effective. Additional clinical trial evidence shows that it increases how long people live compared with placebo plus fulvestrant. Indirect comparisons suggest that it has similar clinical effectiveness to abemaciclib plus fulvestrant and ribociclib plus fulvestrant.
A cost comparison suggests palbociclib plus fulvestrant has similar costs to abemaciclib plus fulvestrant and ribociclib plus fulvestrant. So, palbociclib plus fulvestrant is recommended if it is used in the same population as abemaciclib and ribociclib.