PMID- 35556235
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221125
IS  - 2366-1089 (Electronic)
IS  - 2366-1070 (Print)
IS  - 2366-1089 (Linking)
VI  - 10
IP  - 2
DP  - 2022 Dec
TI  - Cost-Effectiveness of PD-L1 Testing in Non-Small Cell Lung Cancer (NSCLC) Using 
      In Vitro Diagnostic (IVD) Versus Laboratory-Developed Test (LDT).
PG  - 391-409
LID - 10.1007/s40487-022-00197-1 [doi]
AB  - INTRODUCTION: Accurate PD-L1 testing for non-small cell lung cancer (NSCLC) 
      maximizes the benefits of immune checkpoint inhibitor (ICI) drugs like 
      pembrolizumab. False negative test results deny ICI treatments to eligible 
      patients, worsening clinical and economic outcomes, while false positives 
      increase costs by using ICI treatments without their benefits. This study 
      evaluates the cost-effectiveness of PD-L1 testing with an in vitro diagnostic 
      (IVD) compared to a laboratory-developed test (LDT) for allocating patients with 
      NSCLC to treatment with either pembrolizumab or chemotherapy using the German 
      healthcare system as a model. METHODS: We developed a decision analytical model 
      to evaluate the cost-effectiveness of PD-L1 testing with a regulatory body 
      approved IVD compared to an LDT from the national German healthcare payer 
      (statutory health insurance system) perspective. Accuracy of PD-L1 testing was 
      based on data from two independent proficiency testing programs. The 1-year model 
      was based on outcomes data from the KEYNOTE-024 clinical trial and treatment 
      patterns reflecting current German practices. RESULTS: IVDs produced accurate 
      PD-L1 testing results in 93% (752/811) of tested cases compared to 73% (492/672) 
      with LDTs. Most misclassifications concerned false negatives, occurring in 21% of 
      LDTs vs 7% of IVDs. Total costs of the IVD group (48,878 euro) were 196 euro higher 
      than the LDT group (48,682 euro). These costs incorporate testing, first- and 
      second-line therapy, managing treatment-related grade 3+ adverse events (AEs), 
      and end-of-life costs for those who died within the year. Total effectiveness 
      (percentage of patients successfully diagnosed and prescribed the correct therapy 
      per German treatment guidelines) was 19 percentage points higher for the IVD 
      group (88%) compared to the LDT group (69%). These differences in costs and 
      effects lead to an incremental cost-effectiveness ratio (ICER) of 1057 euro. 
      CONCLUSION: Compared to LDT technology, on-label IVD use for PD-L1 testing is 
      only slightly more costly and substantially more effective for aligning patients 
      with PD-L1-positive NSCLC with ICI therapy according to German practice 
      guidelines. Given these findings, changes to testing and reimbursement policies 
      may be considered to maximize patient outcomes in NSCLC.
CI  - (c) 2022. The Author(s).
FAU - Hurwitz, Jason T
AU  - Hurwitz JT
AD  - Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, 
      University of Arizona, 1295 N Martin, P.O. Box 210202, Tucson, AZ, 85721-0202, 
      USA.
FAU - Vaffis, Shannon
AU  - Vaffis S
AD  - Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, 
      University of Arizona, 1295 N Martin, P.O. Box 210202, Tucson, AZ, 85721-0202, 
      USA.
FAU - Grizzle, Amy J
AU  - Grizzle AJ
AUID- ORCID: 0000-0003-4485-1459
AD  - Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, 
      University of Arizona, 1295 N Martin, P.O. Box 210202, Tucson, AZ, 85721-0202, 
      USA. grizzle@pharmacy.arizona.edu.
FAU - Nielsen, Soren
AU  - Nielsen S
AD  - NordiQC, Institute of Pathology, Aalborg University Hospital, P.O. Box 561, 9100, 
      Aalborg, Denmark.
FAU - Dodson, Andrew
AU  - Dodson A
AD  - UK National External Quality Assessment Scheme for Immunocytochemistry and 
      In-Situ Hybridisation, 5 Coldbath Square, London, EC1R 5HL, UK.
FAU - Parry, Suzanne
AU  - Parry S
AD  - UK National External Quality Assessment Scheme for Immunocytochemistry and 
      In-Situ Hybridisation, 5 Coldbath Square, London, EC1R 5HL, UK.
LA  - eng
PT  - Journal Article
DEP - 20220513
PL  - New Zealand
TA  - Oncol Ther
JT  - Oncology and therapy
JID - 101677510
PMC - PMC9681966
OTO - NOTNLM
OT  - Advanced NSCLC
OT  - Cost-effectiveness
OT  - Diagnostic
OT  - Germany
OT  - PD-L1
OT  - Pembrolizumab
EDAT- 2022/05/14 06:00
MHDA- 2022/05/14 06:01
PMCR- 2022/05/13
CRDT- 2022/05/13 17:06
PHST- 2022/03/08 00:00 [received]
PHST- 2022/04/20 00:00 [accepted]
PHST- 2022/05/14 06:00 [pubmed]
PHST- 2022/05/14 06:01 [medline]
PHST- 2022/05/13 17:06 [entrez]
PHST- 2022/05/13 00:00 [pmc-release]
AID - 10.1007/s40487-022-00197-1 [pii]
AID - 197 [pii]
AID - 10.1007/s40487-022-00197-1 [doi]
PST - ppublish
SO  - Oncol Ther. 2022 Dec;10(2):391-409. doi: 10.1007/s40487-022-00197-1. Epub 2022 
      May 13.