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New HTA Decisions in England
December 2019
Drug name
NERLYNX® (neratinib)
Pierre Fabre
Decision date
Therapeutic area
Therapeutic sub area
Breast cancer
Recommended with restrictions
Neratinib is recommended as an option for the extended adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)‑positive early stage breast cancer in adults who completed adjuvant trastuzumab-based therapy less than 1 year ago
Decision Detail
Only if: - trastuzumab is the only HER2‑directed adjuvant treatment they have had, and - if they had neoadjuvant chemotherapy-based regimens, they still had residual invasive disease in the breast or axilla following the neoadjuvant treatment, and - the company provides neratinib according to the commercial arrangement.
The key clinical evidence was provided by ExteNET (n=2,840), a phase 3 randomised controlled trial that compared neratinib treatment with placebo in women with HER2-positive breast cancer who had completed adjuvant trastuzumab treatment within 2 years. The company based its submission on a subgroup of women with early hormone receptor-positive cancer who were less than 1 year from completing adjuvant trastuzumab-based treatment (n=1,334). This subgroup, referred to as the ‘label’ population, is in line with the neratinib marketing authorisation. The committee concluded that neratinib improves invasive disease-free survival compared with placebo in the 'label' population. The cost-effectiveness estimates are uncertain, but within the range NICE normally considers an acceptable use of NHS resources. ICERs were presented as commercial in confidence to maintain the confidentiality of the proposed commercial agreement for neratinib, and therefore cannot be reported. The committee therefore recommended neratinib for hormone receptor-positive, HER2-positive early breast cancer in adults who completed adjuvant trastuzumab-based treatment less than 1 year ago, only if trastuzumab was the only HER2-directed adjuvant treatment they have had, and if their cancer did not have a pathological complete response to neoadjuvant treatment (if they had neoadjuvant chemotherapy-based regimens).