EpcoritamabEpkinly
Treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, who have previously received or are currently unable to receive CAR-T cell therapy, and who are not eligible for stem cell transplantation.
Decision on record
- Meeting Nov 2024 Recommended Relapsed or refractory diffuse large B-cell lymphoma
Access path
- TGA registered · Epkinly
TGA label narrower than the PBS population
- Nov 2024Recommended
vs R-GemOx (rituximab + gemcitabine + oxaliplatin)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of epcoritamab for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The PBAC is satisfied that epcoritamab provides, for some patients, a significant improvement in efficacy over rituximab + gemcitabine + oxaliplatin (R-GemOx), as a proxy for rituximab-based chemoimmunotherapy treatments.PSD · Nov 2024
7.2 The PBAC noted the input from health care professionals, Rare Cancers Australia and Leukaemia Foundation that highlighted the need for more treatment options for relapsed or refractory DLBCL. The PBAC noted the comments from the clinician at the sponsor hearing that, for complex reasons, not all eligible patients for CAR-T cell therapy were accessing such therapy.PSD · Nov 2024
6.58 The submission presented a modelled economic evaluation comparing epcoritamab with R-GemOx (as a proxy for rituximab-based chemoimmunotherapy treatments), for the treatment of patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. The economic evaluation was based on the results of the EPCORE NHL-1 and SCHOLAR-1 studies with additional modelled data.PSD · Nov 2024
Outcomes Quality-adjusted life years; progression-free life years; life years.PSD · Nov 2024
terms of efficacy, and non-inferior but different in terms of safety, compared to R-GemOx (as a proxy for rituximab-based chemoimmunotherapy treatments). Source: Table 1-1, p3 of the submission.PSD · Nov 2024
Abbreviations: CAR, chimeric antigen receptor; DLBCL, diffuse large B-cell lymphoma; R-GemOx, rituximab + gemcitabine + oxaliplatin.PSD · Nov 2024
6.2 The PBAC noted and welcomed the input from health care professionals (2) and organisations (2) via the Consumer Comments facility on the PBS website. The comments from health care professionals working in regional settings described epcoritamab as an effective treatment option for patients in need that can be delivered locally.PSD · Nov 2024
6.91 The submission stated that the sponsor is willing to enter into a risk sharing arrangement based on the financial estimates included in the submission, to address any perceived uncertainty in estimating the overall cost to the PBS. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Nov 2024
Cost-effectiveness
ICER not stated in public summary document; pricing details and economic model marked as redacted in submission
Decision context
PopulationPatients with relapsed or refractory DLBCL after two or more lines of systemic therapy who have previously received or are currently unable to receive CAR-T cell therapy and are not eligible for stem cell transplantation
Risk sharingSpecial pricing arrangements apply; effective prices redacted in the document
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | R-GemOx (rituximab + gemcitabine + oxaliplatin) | — | Single-arm · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| EPCORE NHL-1 | Ph 1, PHASE2 | 666 | Dose-Escalation: Dose Limiting Toxicity (DLT) | active not recruiting |
| EPCORE DLBCL-1 | Ph 3 | 483 | Overall Survival (OS) | active not recruiting |
Consumer voice
Healthcare professionals and patient advocacy organisations provided input highlighting epcoritamab as an effective local treatment option that reduces travel burden, noting manageable side effects requiring staff upskilling, quick subcutaneous administration in outpatient settings, and improved quality of life for patients with relapsed/refractory DLBCL.
The comments from health care professionals working in regional settings described epcoritamab as an effective treatment option for patients in need that can be delivered locally. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients unable to receive or ineligible for CAR-T and stem cell transplantation; TGA label has no such restrictions.