Package advice venetoclax (Venclyxto®) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphatic leukaemia (CLL)

Zorginstituut Nederland has completed its assessment whether venetoclax (Venclyxto®) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphatic leukaemia (CLL) can be included in the insured package. Due to its expected high costs the Minister of Medical Care and Sports has placed the treatment in the so-called ‘package lock’ 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.

Zorginstituut Nederland has concluded that venetoclax can be admitted to the basic health care package for the patient groups concerned, but only after successful price negotiations.

Registered indication

Venetoclax (Venclyxto®) in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphatic leukaemia (CLL).

Criteria for including treatments in the insured package

The Zorginstituut assessed venetoclax  based on the four package criteria:

  • effectiveness;
  • cost-effectiveness;
  • necessity;
  • 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;
  • the Insured Package Advisory Committee (ACP) which considers the societal assessment. Stakeholders are also consulted during the process.

Integral package criteria weighting

The Zorginstituut has concluded that venetoclax (Venclyxto®) meets the legal criterion ‘established medical science and medical practice’ for two patient groups that fall within the registered indication:

  • Non-fit patients with CLL not previously treated and mutated IGHV status, without 17p deletion or TP53 mutation;
  • Non-fit patients with CLL not previously treated and unmutated IGHV status, without 17p deletion or TP53 mutation.

Zorginstituut's advice

Venetoclax is an effective medicinal product for the two patient groups. As far as cost-effectiveness is concerned, there are a number of uncertainties. However, it is certain that the new treatment will reduce costs compared to the current standard treatment.

Zorginstituut Nederland recommends that venetoclax be admitted to the basic health care package for the patient groups concerned and that the price is negotiated. Two points are important:

  • There is already a price negotiation process ongoing for the medicinal product ibrutinib, which is partly an alternative to venetoclax in combination with obinutuzumab. This advice on venetoclax in combination with obinutuzumab should therefore also have repercussions for the ongoing negotiations on ibrutinib.
  • Venetoclax is already being reimbursed for several indications. This means that the marketing authorization holder has already been partially compensated for the efforts they have had to make to market the product. This justifies the argument that a lower price can be paid.

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