Polatuzumab VedotinPolivy
Treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) in patients with an International Prognostic Index (IPI) score of 3–5, administered in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola+R-CHP).
Decisions on record
- Meeting Mar 2025 Recommended Diffuse large B-cell lymphoma (DLBCL), previously untreated with IPI score 3-5
- Meeting Nov 2022 Not recommended Diffuse large B-cell lymphoma in previously untreated patients
- Meeting Nov 2019 Not recommended Diffuse large B-cell lymphoma (DLBCL)
Access path
- TGA registered · Polivy
TGA label narrower than the PBS population
- Nov 2019Not recommended
vs bendamustine in combination with rituximab (BR)
- Nov 2022Not recommended
Comparator changed: bendamustine in combination with rituximab (BR) → rituximab in…
- ↻ resubmittedMar 2025Recommended · restricted
Comparator changed: rituximab in combination with cyclophosphamide, doxorubicin…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Section 100 (Efficient Funding of Chemotherapy) Authority Required (Telephone/Online) listing of polatuzumab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (Pola+R-CHP) for the treatment of diffuse large B cell lymphoma (DLBCL) in previously untreated patients with an international prognostic index (IPI) score of 3-5.PSD · Mar 2025
The PBAC advised that an ICER range in the order of $15,000 to < $25,000 to $25,000 to < $35,000 per QALY gained (based on the ESC revised base case and with variations in the cost of CAR-T as outlined in paragraph 7.127.11) would be appropriate. As such, the PBAC noted that a price reduction would be required to achieve cost-effectiveness for polatuzumab vedotin.PSD · Mar 2025
The resubmission presented an updated economic evaluation compared to those previously considered at the November 2022 PBAC meeting. In summary, the changes included:PSD · Mar 2025
• Employed a standard parametric survival model rather than a mixture-cure model, refitting survival curves to the new data.PSD · Mar 2025
with superior comparative efficacy and non-inferior comparative safety to R-CHOP. Blue shading indicates data previously seen by the PBAC. Source: Table 1.2, p7 of the resubmission.PSD · Mar 2025
The resubmission described Pola+R-CHP as superior in terms of effectiveness and non- inferior in terms of safety compared to R-CHOP in previously untreated DLBCL patients with an IPI score of 3-5, which was unchanged from the November 2022 submission.PSD · Mar 2025
The PBAC noted and welcomed the input from health care professionals (5) and organisations (4) via the Consumer Comments facility on the PBS website. The comments from health care professionals described Pola+R-CHP as one of the only novel treatment combinations to show a clinically meaningful improvement over R- CHOP and that use of polatuzumab vedotin would bring Australia in line with almost all Western Europe, North America, and much of Asia.PSD · Mar 2025
Input received from Leukaemia Foundation and Lymphoma Australia described how Pola+R-CHP has evidence of improved PFS with Lymphoma Australia highlighting that Pola+R-CHP is recommended in over 18 practice guidelines. The PBAC noted that this advice was supportive of the evidence provided in the submission.PSD · Mar 2025
Cost-effectiveness
ICER values are redacted in the public summary document; specific numeric ICERs are not published.
Decision context
PopulationAdults with previously untreated DLBCL with an International Prognostic Index (IPI) score of 3–5 and WHO ECOG performance status ≤2.
Risk sharingA risk share agreement was proposed with a rebate above proposed utilisation estimates, which assumed a 19% increase in utilisation compared to the November 2022 pre-PBAC response.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended · restricted | Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) | — | RCT · PFS |
| Nov 2022 | Not recommended | rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) | — | RCT · PFS |
| Nov 2019 | Not recommended | bendamustine in combination with rituximab (BR) | — | RCT · Complete Response |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| POLARIX | Ph 3 | 1,000 | Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response… | completed |
Consumer voice
Health care professionals (5) and organisations (4) provided input supporting polatuzumab vedotin combined with R-CHP as a novel treatment option that aligns Australia with international practice, reduces need for subsequent therapies, and addresses high treatment burdens and quality-of-life impacts on patients with relapsed/refractory DLBCL.
Pola+R-CHP as one of the only novel treatment combinations to show a clinically meaningful improvement over R-CHOP and that use of polatuzumab vedotin would bring Australia in line with almost all Western Europe, North America, and much of Asia. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to IPI score 3–5 and ECOG performance status ≤2; TGA label includes all previously untreated DLBCL adults.