Venetoclax (Venclyxto®) in combination with rituximab for the treatment of chronic lymphocytic leukaemia (CLL)

Zorginstituut Nederland has completed its assessment whether venetoclax (Venclyxto®) in combination with rituximab for the treatment of chronic lymphocytic leukaemia (CLL) who have received at least one previous treatment, can be included in the insured package. Due to its expected high costs the Minister of Health, Welfare and Sport (VWS) has placed venetoclax (Venclyxto®) in the so-called ‘waiting room’ or ‘sluice’ for expensive drugs.
These products can only be accepted into the insured package after the Zorginstituut has advised on their inclusion in the insured package and, where applicable, subject to Ministry negotiations to arrive at a financial arrangement with the supplier.

Criteria for including treatments in the insured package

The Zorginstituut assessed the above-mentioned treatment based on the four package criteria effectiveness, cost-effectiveness, necessity and feasibility. Assessing from the perspective of the basic package which is paid from collective premiums, the Zorginstituut looks at whether new care is better than what is currently available. In doing this we look not only at the degree of certainty that has been achieved, from a scientific perspective and from the perspective of societal support, but also at efficiency aspects. The Zorginstituut was advised by two independent committees: the Scientific Advisory Board (WAR) which examines data on established medical science and medical practice and determines the cost-effectiveness, and the Insured Package Advisory Committee (ACP) which considers the societal assessment. Stakeholders are also consulted during the process.

Zorginstuut's advice

Venetoclax in combination with rituximab complies with the legal criterion ‘established medical science and medical practice’ for the treatment of adult patients with CLL who have received at least one previous treatment. The Zorginstituut advises the Minister, based on the following considerations, to start price negotiations for venetoclax (Venclyxto®):

  • Uncertainty exists about the added value of venetoclax (plus rituximab) in comparison with standard ibrutinib treatment for patients with 17p deletion or TP53 mutation or patients without the said deletion or mutation and with an early relapse.
  • Due to uncertainty about long-term survival, the Zorginstituut concludes that the burden of disease is between 0.67 and 0.76. As the break-even point for the cost-effectiveness reference value is at a burden of disease of 0.7, uncertainty exists about the 80,000 euro/QALY reference value used, which applies to the highest burden of disease. If one assumes a lower burden of disease than 0.7, then treatment with venetoclax is not cost-effective.
  • It is as yet uncertain whether the maximum treatment duration, as cited in the registration text and confirmed by medical professionals, will not be exceeded in practice.
  • The budget impact is high and could increase even further due to uncertainties about the duration of treatment. This could lead to displacement.
  • Venetoclax is already being reimbursed from the basic insurance for the same disorder but in a different line of treatment. Volume is increasing as a result and development costs are being recouped more quickly.

This report is a summary of recommendations by Zorginstituut Nederland. The original text of this excerpt is in Dutch.