OBJECTIVES

The PD-(L)1 landscape has expanded rapidly since their first launch and will continue to do so, with many pipeline trials ongoing. This poster aims to identify HTA trends and the drivers behind them for PD-(L)1s in France, Germany, and the UK over the last 5 years, in order to reveal key insights to support upcoming submissions for new PD-(L)1 products / indications.

METHODS

This study analyzed the HTA outcomes (i.e., TC, G-BA, and NICE) since 2015 for the 6 EMA-approved PD-(L)1s available. Key trends were identified and the drivers behind those trends were evaluated through reviewing product specific HTA commentary.

RESULTS

The influx of PD-(L)1 products and indications in recent years has led to an increase in payer scrutiny, with emerging HTA challenges for the PD-(L)1 class, particularly in France, Germany, and the UK.

In France, a growing number of PD-(L)1 assessments are receiving SMR insufficient (i.e., no reimbursement) or ASMR V (i.e., no added value) from the TC. Furthermore, the TC is more often requesting additional longer-term follow-up data (e.g., 2-year OS) to validate product efficacy and confirm conditional ratings. In Germany, a rise in the number of PD-(L)1s receiving “non-quantifiable” added benefit ratings is observed, likely catalyzed by more frequent orphan indication submissions, as well as a greater perception of data uncertainty from the G-BA. Finally, in the UK, NICE has increasingly relegated PD-(L)1 indications to the Cancer Drugs Fund (i.e., conditional funding), largely citing the high degree of uncertainty in the evidence provided.

CONCLUSIONS

The rapid expansion of the PD-(L)1 landscape, in both the number of new entries and indication expansions, has led to increased payer pressure and HTA challenges. Future entries into the PD-(L)1 class should be prepared for close scrutiny of submitted evidence and the potential risk of class reassessment / renegotiations.