Package advice polatuzumab vedotin (Polivy®) in combination with bendamustine and rituximab (Pola-BR) for the treatment of r/r DLBCL

Zorginstituut Nederland has completed its assessment whether polatuzumab vedotin (Polivy®) in combination with bendamustine and rituximab (Pola-BR) can be included in the insured package. The treatment is indicated for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL, a form of lymphoma) who are not eligible for hematopoietic stem cell transplantation (SCT). 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 polatuzumab vedotin can be admitted to the basic health care package for the patient group concerned, but only after successful price negotiations.

Registered indication

Polatuzumab vedotin (Polivy®), in combination with bendamustine and rituximab (Pola-BR) is indicated for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) who are not eligible for hematopoietic stem cell transplantation (SCT). DLBCL is a type of lymphoma. It belongs to the group of non-Hodgkin lymphomas.

Criteria for including treatments in the insured package

The Zorginstituut assessed polatuzumab vedotin 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

The Zorginstituut concludes that the treatment extends life and is not curative, but there is still some uncertainty about the quality of life during the months of life gained. In addition, due to the uncertainty concerning effectiveness and, by extension, cost-effectiveness, it is deemed appropriate to negotiate a price below the reference value.

In addition, there is a lack of long-term data and, in due course, a new ruling should be issued concerning the continuation of the reimbursement for this medicinal product. A pay-for-proof price agreement, stating that a higher price will be paid when more evidence becomes available, may also be an option. If that proves not to be the case, then the negotiation will have to result in an even more competitive price.

Finally, one argument that could be used in price negotiations is that studies are underway into the use of this medicinal product in first-line treatment, which may lead to an increase in patient volume.

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