Advice on the reassessment of axicabtagene ciloleucel (Yescarta®)
The National Health Care Institute has carried out the reassessment of axicabtagene ciloleucel (Yescarta®). On 1 May 2020, after successful price negotiations with the supplier, the minister of Medical Care authorised axicabtagene ciloleucel (Yescarta®) in the basic health insurance package for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) after two or more lines of systemic therapy. The financial arrangement runs until 1 December 2021. Axi-cel meets established medical science and medical practice after a median follow-up period of 51 months. The price of axi-cel would have to be reduced by at least 5% per cent.
Reassessment
This concerns a reassessment of the advice on axicabtagene ciloleucel (axi-cel) from 2019. On 1 May 2020, the minister of Medical Care authorised axi-cel in the basic health insurance package. The financial arrangement runs until 1 December 2021. In this reassessment, the 3-year survival data of axi-cel (Yescarta®) are used.
Registered indication
Axicabtagene ciloleucel (Yescarta®) is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) after two or more lines of systemic therapy.
The National Health Care Institute's advice
Axi-cel meets established medical science and medical practice after a median follow-up period of 51 months. The budget impact after 3 years is estimated at approximately €44.9 million in the third year. There is a considerable likelihood of the actual budget impact of this therapy exceeding €44.9 million in the future given the anticipated expansion of the indications. The price of axi-cel would have to be reduced by at least 5 per cent.