Cost-Effectiveness of Nadofaragene Firadenovec and Pembrolizumab in Bacillus Calmette-Guérin Immunotherapy Unresponsive Non-Muscle Invasive Bladder Cancer
Copyright © 2023. Published by Elsevier Inc..
OBJECTIVES: Nadofaragene firadenovec is a gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) undergoing Food and Drug Administration review. Pembrolizumab is approved for treating patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS). We evaluated the cost-effectiveness of these treatments compared with a hypothetical therapeutic alternative, at a willingness-to-pay threshold of $150 000 per quality-adjusted life-year (QALY) gained, in CIS and non-CIS BCG-unresponsive NMIBC populations.
METHODS: We developed a Markov cohort simulation model with a 3-month cycle length and lifetime horizon to estimate the total costs, QALYs, and cost per additional QALY from the health sector perspective. Clinical inputs were informed by results of single-arm clinical trials evaluating the treatments, and systematic literature reviews were conducted to obtain other model inputs. Sensitivity analyses were conducted to assess uncertainty in model results.
RESULTS: Nadofaragene firadenovec, at a placeholder price 10% higher than the price of pembrolizumab, had an incremental cost-effectiveness ratio of $263 000 and $145 000 per QALY gained in CIS and non-CIS populations, respectively. Pembrolizumab had an incremental cost-effectiveness ratio of $168 000 per QALY gained for CIS. A 5.4% reduction in pembrolizumab's price would make it cost-effective. The model was sensitive to many inputs, especially to the probabilities of disease progression, initial treatment response and durability, and drug price.
CONCLUSIONS: The cost-effectiveness of nadofaragene firadenovec will depend upon its price. Pembrolizumab, although not cost-effective in our base-case analysis, is an important alternative in this population with an unmet medical need. Comparative trials of these treatments are warranted to better estimate cost-effectiveness.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:26 |
|---|---|
| Enthalten in: |
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research - 26(2023), 6 vom: 15. Juni, Seite 823-832 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Joshi, Mrinmayee [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antineoplastic Agents |
|---|
| Anmerkungen: |
Date Completed 05.06.2023 Date Revised 20.06.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.jval.2022.12.005 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM35041257X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM35041257X | ||
| 003 | DE-627 | ||
| 005 | 20231226044930.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.jval.2022.12.005 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1167.xml |
| 035 | |a (DE-627)NLM35041257X | ||
| 035 | |a (NLM)36529422 | ||
| 035 | |a (PII)S1098-3015(22)04779-9 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Joshi, Mrinmayee |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Cost-Effectiveness of Nadofaragene Firadenovec and Pembrolizumab in Bacillus Calmette-Guérin Immunotherapy Unresponsive Non-Muscle Invasive Bladder Cancer |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 05.06.2023 | ||
| 500 | |a Date Revised 20.06.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023. Published by Elsevier Inc. | ||
| 520 | |a OBJECTIVES: Nadofaragene firadenovec is a gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) undergoing Food and Drug Administration review. Pembrolizumab is approved for treating patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS). We evaluated the cost-effectiveness of these treatments compared with a hypothetical therapeutic alternative, at a willingness-to-pay threshold of $150 000 per quality-adjusted life-year (QALY) gained, in CIS and non-CIS BCG-unresponsive NMIBC populations | ||
| 520 | |a METHODS: We developed a Markov cohort simulation model with a 3-month cycle length and lifetime horizon to estimate the total costs, QALYs, and cost per additional QALY from the health sector perspective. Clinical inputs were informed by results of single-arm clinical trials evaluating the treatments, and systematic literature reviews were conducted to obtain other model inputs. Sensitivity analyses were conducted to assess uncertainty in model results | ||
| 520 | |a RESULTS: Nadofaragene firadenovec, at a placeholder price 10% higher than the price of pembrolizumab, had an incremental cost-effectiveness ratio of $263 000 and $145 000 per QALY gained in CIS and non-CIS populations, respectively. Pembrolizumab had an incremental cost-effectiveness ratio of $168 000 per QALY gained for CIS. A 5.4% reduction in pembrolizumab's price would make it cost-effective. The model was sensitive to many inputs, especially to the probabilities of disease progression, initial treatment response and durability, and drug price | ||
| 520 | |a CONCLUSIONS: The cost-effectiveness of nadofaragene firadenovec will depend upon its price. Pembrolizumab, although not cost-effective in our base-case analysis, is an important alternative in this population with an unmet medical need. Comparative trials of these treatments are warranted to better estimate cost-effectiveness | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Markov model | |
| 650 | 4 | |a bladder cancer | |
| 650 | 4 | |a cost-effectiveness | |
| 650 | 4 | |a nadofaragene firadenovec | |
| 650 | 4 | |a pembrolizumab | |
| 650 | 7 | |a pembrolizumab |2 NLM | |
| 650 | 7 | |a DPT0O3T46P |2 NLM | |
| 650 | 7 | |a BCG Vaccine |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 700 | 1 | |a Atlas, Steven J |e verfasserin |4 aut | |
| 700 | 1 | |a Beinfeld, Molly |e verfasserin |4 aut | |
| 700 | 1 | |a Chapman, Richard H |e verfasserin |4 aut | |
| 700 | 1 | |a Rind, David M |e verfasserin |4 aut | |
| 700 | 1 | |a Pearson, Steven D |e verfasserin |4 aut | |
| 700 | 1 | |a Touchette, Daniel R |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research |d 1998 |g 26(2023), 6 vom: 15. Juni, Seite 823-832 |w (DE-627)NLM115934545 |x 1524-4733 |7 nnns |
| 773 | 1 | 8 | |g volume:26 |g year:2023 |g number:6 |g day:15 |g month:06 |g pages:823-832 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.jval.2022.12.005 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 26 |j 2023 |e 6 |b 15 |c 06 |h 823-832 | ||