国立保健医療科学院 保健医療経済評価研究センター

Center for Outcomes Research and Economic
Evaluation for Health (C2H), National Institute of
Public Health (NIPH)| URL: http://c2h.niph.go.jp

Apr 13th, 2023

[C2H2103] Summary of cost-effectivenessevaluation of polatuzumab vedotin-piiq (POLIVY)

1. Indications
Patients with relapsed or refractory diffuse large B-cell lymphoma
2. Price of the drug
Polatuzumab vedotin-piiq has been reimbursed since May 2021 at JPY 298,825 for
30 mg and JPY 1,364,330 for 140 mg (as of January 2023). The price wascalculated using a similar efficacy comparison method (I), with a usefulness
premium (II) and a 5% premium to promote the development of new drugs andeliminate off-label use. This product was designated as the H1 cost-effectivenessevaluation item.
3. Scope of cost-effectiveness evaluation
This product is indicated for treating patients with relapsed or refractory diffuse
large B-cell lymphoma. The evaluation scope, which was agreed upon during the firstsession of the Expert Committee of Cost-Effectiveness Evaluation (ECCEE), isdescribed below.

Population

Patients with relapsed or refractory
lymphoma receiving;(a) second-line therapy(b) third- or more line therapy

diffuselarge

B-cellComparator

The most cost-effective regimen in salvage chemotherapies,including rituximab.

4. Evaluation of additional benefits
The manufacturer identified salvage chemotherapy and a combination ofbendamustine and rituximab (BR)—the comparator in the GO29365 study—aspotential comparators. Assuming a comparable efficacy, they selected R-ICE as thecomparator, as it is the least expensive option. The manufacturer conducted asystematic review and identified only the GO29365 study as a suitable source toevaluate the additional benefits. This study was a randomized, multicenter, openlabel trial that compared the efficacy and safety of polatuzumab vedotin combinedwith BR in patients with relapsed or refractory diffuse large B-cell lymphoma. The
manufacturer reanalyzed the GO29365 study data for subpopulations (a) and (b) andclaimed additional benefits for overall survival and progression-free survival (PFS).
The GO29365 study showed an imbalance between the polatuzumab vedotin andBR groups in terms of prognostic factors at baseline, potentially favoring thepolatuzumab vedotin group. The academic group expressed concerns but agreed touse it for additional benefit evaluation.
5. Results of the cost-effectiveness analysis
The manufacturer performed a cost-effectiveness analysis using partitioned
survival analysis. Although R-ICE was selected as the comparator chemotherapy,
several clinical parameters were obtained from the GO29365 study.
After modifying the parameters of quality of life (QOL) values and drug prices, theacademic group conducted a cost-effectiveness analysis for populations (a) and (b).
The manufacturer used the QOL values converted from the SF-36 score to the EQ5D, whereas the academic group applied the EQ-5D-3L as a preference-based
measure. To consider age-related reductions in QOL values, the manufacturer applieddifferent QOL values for PFS health status in patients aged over and under 70 years.
However, the academic group determined that progressive disease (PD) status anddetailed age should also be considered for an age-related reduction in QOL values. It
used QOL values for each PFS and PD health status every 10 years. The ECCEE
accepted the following results:
Population

ICER (JPY/QALY)(a)Patients with relapsed or refractory diffuse large B-cell
lymphoma receiving second-line therapy

3,316,899(b)Patients with relapsed or refractory diffuse large B-cell
lymphoma receiving third- or more line therapy

6,629,399