Avelumab (Bavencio®) in combination with axitinib as a first-line treatment for adult patients with advanced renal cell carcinoma

Zorginstituut Nederland has completed its assessment whether avelumab (Bavencio®) in combination with axitinib can be included in the insured package. This combination is used  as a first-line treatment for adult patients with advanced renal cell carcinoma. 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.

The Zorginstituut advises the Minister not to include avelumab in combination with axitinib in the insured package. One of the reasons is because the professional group of medical experts does not yet have a clear view of the optimal treatment algorithm, due to the arrival of new treatments and the already existing options.

Criteria for including treatments in the insured package

The Zorginstituut assessed avelumab in combination with axitinib 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.

Zorginstituut's advice

Avelumab in combination with axitinib as a first-line treatment for patients with advanced renal cell carcinoma meets the established medical science and medical practice, but there are many uncertainties about the added value of the treatment:

  • The data are not yet sufficient to be able to make a decision about the effect of avelumab in combination with axitinib on overall survival.
  • The added value of avelumab in combination with axitinib in the treatment arsenal is uncertain because it has not been compared to the current standard treatment.
  • There are no indications that the combination of avelumab with axitinib has added value for specific patient groups.
  • Due to the arrival of new treatments and the already existing options, it is still uncertain what the treatment landscape for the mentioned indication will develop.
  • The professional group of medical experts does not yet have a clear view of the optimal treatment algorithm.

The Zorginstituut therefore advises the Minister not to include avelumab in combination with axitinib in the insured package for the indication mentioned above.

Possible reassessment

A reassessment is possible when there is certainty about the effect of avelumab in combination with axitinib on the overall survival gain and the position of this combination within the treatment algorithm for renal cell carcinoma. The Zorginstituut therefore calls on the professional group of medical experts to reconsider their opinion on the place for this combination in the treatment of adult patients with advanced renal cell carcinoma within one year of the availability of new data on overall survival gains. The Zorginstituut would also like to see an answer to the question of what the optimal treatment algorithm is for the indication mentioned.

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