Package advice for entrectinib and larotrectinib (Rozlytrek® and Vitrakvi®) for the treatment of adult and paediatric patients with solid tumours (cancer) with NTRK gene fusion
The National Health Care Institute has assessed whether the medicinal products entrectinib and larotrectinib (Rozlytrek® and Vitrakvi®) can be reimbursed from the basic health care package. These medicinal products are so-called tumour-agnostic drugs and can be used as monotherapy for the treatment of adults and paediatric patients with solid tumours (cancer) that display a NTRK gene fusion. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to reimburse entrectinib and larotrectinib for the mentioned disorder.
Indication for which reimbursement is requested
Reimbursement is requested for the treatment of adult patients and paediatric patients with solid tumours (cancer) that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Entrectinib and larotrectinib are new, innovative medicinal products (tumour-agnostic). Those are medicinal products used in the treatment of tumours with a certain DNA abnormality. Tumour-agnostic drugs can be used for different types of cancer as long as there is a certain DNA abnormality, regardless of where the tumour is located. This is not the case for the majority of medicinal products, which have been developed to treat tumours depending on the specific organ or tissue where the tumour started.
Conditional inclusion
The medicinal products were considered promising by the medical specialists, but the evaluation framework of the National Health Care Institute was not yet sufficient for tumour-agnostic drugs in 2021. As a result, it was not yet possible to determine whether these products are in line with the established medical science and medical practice (SWP). To give patients access, the two medicinal products have been conditionally included in the basic health care package from 1 October 2021 until 1 January 2025.
Early final review
During the conditional inclusion period, the National Health Care Institute has developed a new evaluation framework for tumour-agnostic drugs. This is the module about the assessment of SWP for tumour-agnostic drugs and for other oncological drugs that have only been studied in single-arm studies. This new module has enabled the National Health Care Institute to assess in an early stage whether entrectinib and larotrectinib meet the established medical science and medical practice and can remain in the basic health care package.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to permanently include entrectinib and larotrectinib (Rozlytrek® and Vitrakvi®) from the conditional inclusion into the basic health care package
How did the advice come about?
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing a package advice. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.