Evidence map›Paper›PMID 38728337›Full record

ArticlePloS one2024

Cost-effectiveness of avelumab first-line maintenance therapy for adult patients with locally advanced or metastatic urothelial carcinoma in France.

Fanny Porte, Anna Granghaud, Jane Chang, Mairead Kearney, Aya Morel, Ingrid Plessala, Hélène Cawston, Julie Roiz, Ying Xiao, Marie-Noelle Solbes and 5 more

Registry-linked trialAbstract read
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02603432 (A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02603432 phase3completednot on this map

A phase 3, multicenter, multinational, randomized, open-label, parallel-arm study of avelumab (msb0010718c) plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial cancer whose disease did not progress after completion of first-line platinum-containing chemotherapy

TypeinterventionalSponsorPfizerRan2016 to 2023Enrolled700ConditionsUrothelial CancerArmsAvelumab, Best Supportive Care, Following the planned interim analysis for this study: Avelumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Fanny PorteHealth Economics Department, Merck Santé S.A.S., Lyon, France.
Anna GranghaudHealth Economics department, Pfizer S.A.S., Paris, France.
Jane ChangHealth Economics department, Pfizer, New York, NY, United States of America.
Mairead KearneyGlobal Value Demonstration, Market Access and Pricing, The Healthcare Business of Merck KGaA, Darmstadt, Germany.
Aya MorelHealth Economics department, Pfizer S.A.S., Paris, France.
Ingrid PlessalaHealth Economics & Market Access (HEMA), Amaris Consulting, Paris, France.ORCID 0009-0000-8993-7569
Hélène CawstonHealth Economics & Market Access (HEMA), Amaris Consulting, Paris, France.
Julie RoizHealth Economics, Evidera, London, United Kingdom.
Ying XiaoHealth Economics, Evidera, London, United Kingdom.
Marie-Noelle SolbesMedical Department, Merck Santé S.A.S., Lyon, France.
Prisca LambertMedical Department, Pfizer S.A.S., Paris, France.
Alain RavaudDepartment of Medical Oncology, Centre Hospitalo-Universitaire de Bordeaux, Bordeaux, France.
Yohann LoriotDepartment of Medical Oncology, Institute Gustave-Roussy, Villejuif, France.
Antoine Thiery-VuilleminDepartment of Medical Oncology, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.
Pierre LévyUniversité Paris-Dauphine, Université-PSL, [LEDA], LEGOS, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated the cost-effectiveness of avelumab first-line (1L) maintenance therapy plus best supportive care (BSC) versus BSC alone for adults with locally advanced or metastatic urothelial carcinoma (la/mUC) that had not progressed following platinum-based chemotherapy in France.

methodsA three-state partitioned survival model was developed to assess the lifetime costs and effects of avelumab plus BSC versus BSC alone. Data from the phase 3 JAVELIN Bladder 100 trial (NCT02603432) were used to inform estimates of clinical and utility values considering a 10-year time horizon and a weekly cycle length. Cost data were estimated from a collective perspective and included treatment acquisition, administration, follow-up, adverse event-related hospitalization, transport, post-progression, and end-of-life costs. Health outcomes were measured in quality-adjusted life-years (QALYs) and life-years gained. Costs and clinical outcomes were discounted at 2.5% per annum. Incremental cost-effectiveness ratios (ICERs) were used to compare cost-effectiveness and willingness to pay in France. Uncertainty was assessed using a range of sensitivity analyses.

resultsAvelumab plus BSC was associated with a gain of 2.49 QALYs and total discounted costs of €136,917; BSC alone was associated with 1.82 QALYs and €39,751. Although avelumab plus BSC was associated with increased acquisition costs compared with BSC alone, offsets of -€20,424 and -€351 were observed for post-progression and end-of-life costs, respectively. The base case analysis ICER was €145,626/QALY. Sensitivity analyses were consistent with the reference case and showed that efficacy parameters (overall survival, time to treatment discontinuation), post-progression time on immunotherapy, and post-progression costs had the largest impact on the ICER.

conclusionsThis analysis demonstrated that avelumab plus BSC is associated with a favorable cost-effectiveness profile for patients with la/mUC who are eligible for 1L maintenance therapy in France.

Indexed as

Antibodies, Monoclonal, HumanizedCost-Benefit AnalysisAdultAgedCarcinoma, Transitional CellFemaleFranceHumansMaintenance ChemotherapyMaleMiddle AgedNeoplasm MetastasisQuality-Adjusted Life YearsUrinary Bladder NeoplasmsUrologic NeoplasmsAntibodies, Monoclonal, Humanizedavelumab

Identifiers

PMID38728337
PMCPMC11086848

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.