Table 5.

Latest results for neratinib from European Health Technology Assessment (HTA) procedures [56–60]

Country/Institution	Therapeutic indication	HTA evaluation	Source
Germany Joint Federal Committee (G-BA)	Nerlynx® is indicated for the extended adjuvant treatment of adult patients with hormone receptor-positive, HER2 overexpressed/amplified early-stage breast cancer who completed trastuzumab-based adjuvant therapy less than 1 year ago	Added benefit (category: minor; robustness category: hint) compared to the appropriate comparative therapy, i.e. watch and wait	[56]
UK National Institute for Health and Care Excellence (NICE)	“[…] 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 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”	Recommended	[57]
Scotland Scottish Medicines Consortium (SMC)	“Extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than 1 year ago”	Recommended	[58]
Sweden Tandvårds- och läkemedelsförmånsverket, (TLV)	“Indicated for the extended adjuvant treatment of adult patients with hormone receptor positive early-stage HER2 overexpressed/amplified breast cancer who have completed trastuzumab-based adjuvant treatment less than a year ago”	Recommended	[59]
Austria	Nerlynx® is indicated for the extended adjuvant treatment of adult patients with hormone receptor-positive, HER2 overexpressed/amplified early-stage breast cancer who completed trastuzumab-based adjuvant therapy less than 1 year ago	“No Box” Patient-individual request for reimbursement is required, reimbursement can be granted by the insurance-based physician	[60]