Ibrutinib (Imbruvica®) for the treatment of Waldenstrom's disease

Zorginstituut Nederland has completed its assessment whether ibrutinib (Imbruvica®) ibrutinib (Imbruvica®) in combination with rituximab, for the indication Waldenstrom macroglobulinemia (WM), can be included in the insured package. Due to its expected high costs the Minister of Medical Care has placed ibrutinib 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. The Zorginstituut advises the Minister of Medical Care not to include ibrutinib in combination with rituximab in the basic package.

Ibrutinib has an orphan drug status. Ibrutinib is only used sporadically in primary care treatment: when patients are not fit enough to undergo treatment with chemoimmunotherapy. Ibrutinib is currently mainly used for recurrent treatment (usually from the second recurrence and after, which is more common in chemoimmunotherapy-refractory patients or in patients not fit enough for chemoimmunotherapy).

Criteria for including treatments in the insured package

The Zorginstituut assessed ibrutinib 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, and the Insured Package Advisory Committee (ACP) which considers the societal assessment. Stakeholders are also consulted during the process.

Zorginstuut's advice

On the basis of the available studies, the conclusion is that the use of this combination does not belong to established medical science and medical practice. This also applies to the very limited room that the Netherlands Association for Haematology sees for the addition of rituximab to ibrutinib, because there is no justification for this application from clinical research. The Zorginstituut therefore advises the Minister of Medical Care not to include ibrutinib in combination with rituximab in the basic package.

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