Package advice tucatinib (Tukysa®)

The National Health Care Institute has completed its assessment whether tucatinib (Tukysa®) in combination with trastuzumab and capecitabine can be included in the insured package. Tucatinib is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive breast cancer. The reason for this advice was the placing of tucatinib in the lock procedure for expensive medicinal products. The National Health Care Institute advises the Minister of Health, Welfare and Sport to include tucatinib in combination with trastuzumab and capecitabine in the package, provided a price reduction of at least 65% can be achieved.

Registered indication

Tucatinib in combination with trastuzumab and capecitabine is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive breast cancer who have received at least 2 prior anti-HER2 treatment schedules.

Package advice

The National Health Care Institute has concluded that tucatinib in combination with trastuzumab and capecitabine meets the legal criterion of ‘established medical science and medical practice’ for the indication mentioned. It is considered an effective treatment combination that provides a clinically relevant gain in overall survival. However, it is not a cost-effective treatment and it also involves significant additional costs for the health insurance package.

The National Health Care Institute therefore recommends including tucatinib in combination with trastuzumab and capecitabine in the package, provided a price reduction of at least 65% can be achieved.

If tucatinib in combination with trastuzumab and capecitabine is added to the health insurance package, the National Health Care Institute will monitor the use of the combination mentioned. We will inform the Minister about our findings no later than 2025.