Package advice venetoclax (Venclyxto®)
The National Health Care Institute has completed its assessment whether venetoclax (Venclyxto®) in combination with a hypomethylating agent (HMA) can be included in the insured package. The reason for this advice was the placing of the said medicinal product in the lock procedure for expensive medicinal products. The National Health Care Institute has found that the addition of venetoclax to a hypomethylating agent has a clinically relevant effect on survival. We therefore advise the State Secretary of Health, Welfare and Sport to include venetoclax in the health insurance package, provided that the price negotiations with the marketing authorisation holder result in a lower price that is at least in line with the current price arrangement.
Registered indication
Venetoclax (Venclyxto®) in combination with a hypomethylating agent (HMA) is used for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are not eligible for intensive chemotherapy.
Package advice
The National Health Care Institute advises the State Secretary of Health, Welfare and Sport to include venetoclax in the health insurance package, provided that the price negotiations with the marketing authorisation holder result in a lower price that is at least in line with the current price arrangement. The results are based on an interim analysis and there are uncertainties about the quality of life. These uncertainties have been taken into account in the assessment of the established medical science and medical practice; this is an effective and cost-effective tool. These uncertainties are also part of our advice to negotiate the price. Venetoclax is already being reimbursed for several indications. This supports the argument that at least the price negotiated for previous indications should be matched, or even lower. Lower because a substantial price reduction is fair as it is expected that the reimbursement of previous indications has already largely recouped the investments made.
Finally, the National Health Care Institute urges the physicians' association to investigate the appropriateness of the substance, such as the possibility of shorter treatment and the effectiveness of venetoclax in specific molecular subtypes.