Durvalumab (Imfinzi®) for the treatment of locally advanced, unresectable, non-small cell lung cancer

Zorginstituut Nederland has completed its assessment of durvalumab (Imfinzi®) as monotherapy for the treatment of locally advanced, unresectable, non-small cell lung cancer (NSCLC). Due to its expected high costs the Minister of Health, Welfare and Sport (VWS) has placed durvalumab 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.

Registration

Durvalumab is an immunotherapy (PD-L1-inhibitor) that aims to improve the immune system's anti-tumour response. It is administered by intravenous infusion. It has the potential of being a curative treatment for a sub-group of patients with a high burden of disease (0.83) for whom no curative treatment is yet available. The current standard treatment of inoperable stage III NSCLC, after concomitant chemotherapy with radiotherapy, is active monitoring until disease progression occurs.

Zorginstituut's advice

The Zorginstituut assessed in particular two aspects in arriving at its advice for the Minister. In connection with the high budget impact and the expectation that this drug will also be used for other indications or earlier treatment lines, which will increase the volumes, the Zorginstituut advised the Minister to negotiate on durvalumab's price. A price-volume agreement seems the logical choice, in view of the realistic chance of an indication extension.
Furthermore, within the framework of improving the appropriate use of durvalumab and similar drugs, the Zorginstituut advises the Minister to carry out further research into PD-L1 expression, or to promote and structurally organise other prognostic tumour markers.

Appropriate use

The NVALT has stated that durvalumab will be included in the guidelines on treating NSCLC, with start criteria in line with those in the phase 3 study that was carried out with this drug. Durvalumab will only be used in centres that fulfil the NVALT's criteria for using immunotherapy.

Evaluation

If durvalumab is accepted into the insured package based on the outcome of price negotiations, the Zorginstituut will actively monitor its use. The Zorginstituut plans to inform the Minister in 2022 about the results of these measurements.

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