Ipilimumab/nivolumab (Yervoy®/Opdivo®) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma

Zorginstituut Nederland has completed its assessment whether ipilimumab/nivolumab (Yervoy®/Opdivo®) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma, can be included in the insured package. Due to its expected high costs the Minister of Health, Welfare and Sport (VWS) has placed ipilimumab/nivolumab 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 combination 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

Ipilimumab in combination with nivolumab complies with the statutory criterion ‘established medical science and medical practice’ for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma and a Karnofsky score ≥70 (or a comparable test). The Zorginstituut advises the Minister, based on the following considerations, to start price negotiations for the combination ipilimumab/nivolumab:

  • The conclusions on overall survival are based on an interim analysis, which means uncertainty still exists about the added value in the long term compared to the standard treatment.
  • Furthermore, the added value of the combination therapy compared to nivolumab monotherapy is unclear, and as a consequence the possible synergistic effect of the combination therapy is unknown.
  • Various therapies are available for this disease, and new therapies will be developed that will compete with this combination therapy.
  • The cost-effectiveness of the comparative treatment, sunitinib, has never been established. The costs of this comparative treatment are considerable, i.e., €250,000 per patient.

We recommend that, as part of the price negotiations, the Minister makes agreements on collecting additional data in order to identify the group of patients who will benefit most from this combination treatment, and thus promote appropriate use. In addition, the Zorginstituut suggests the Minister might want to re-consider earlier agreements made on the price of nivolumab.

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