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The Comparison of Trial Data-Based and Registry Data-Based Cost-Effectiveness of Infliximab Treatment for Rheumatoid Arthritis in Sweden Using a Modeling Approach

Lekander, Ingrid; Kobelt, Gisela LU ; Svarvar, Patrick; Ljung, Tryggve; van Vollenhoven, Ronald and Borgstrom, Fredrik (2013) In Value in Health 16(2). p.251-258
Abstract
Objective: To evaluate the precision of the predictive cost-effectiveness assessment based on a phase 3 clinical trial with infliximab for the treatment of rheumatoid arthritis in Swedish clinical practice. Methods: Three patient cohorts were identified: the patients included in the infliximab trial (ATTRACT), patients initially treated with infliximab from a Swedish registry (STURE), a subset of these registry patients meeting inclusion criteria for the ATTRACT trial was the third patient cohort; two sets of assumptions in relation to the efficacy data were evaluated: "ATTRACT" (efficacy data over the duration of the trial) and "STURE" (effectiveness data over 10 years). In addition, the impact of including the placebo effect for the... (More)
Objective: To evaluate the precision of the predictive cost-effectiveness assessment based on a phase 3 clinical trial with infliximab for the treatment of rheumatoid arthritis in Swedish clinical practice. Methods: Three patient cohorts were identified: the patients included in the infliximab trial (ATTRACT), patients initially treated with infliximab from a Swedish registry (STURE), a subset of these registry patients meeting inclusion criteria for the ATTRACT trial was the third patient cohort; two sets of assumptions in relation to the efficacy data were evaluated: "ATTRACT" (efficacy data over the duration of the trial) and "STURE" (effectiveness data over 10 years). In addition, the impact of including the placebo effect for the comparator was evaluated as a basis for the calculation of cost-effectiveness by using a modeling approach. A health economic model was utilized to estimate the cost per quality-adjusted life-year (QALY) gained. Results: The results for the three patient cohorts ranged from cost saving to a cost per QALY gained of (sic)2,400 and (sic)24,900 to (sic)26,000 when the ATTRACT and STURE assumptions were used, respectively. Sensitivity analyses indicated that the inclusion of placebo effect had the largest effect on the results, increasing the cost per QALY gained to approximately (sic)50,000 for all patient cohorts. Conclusions: The treatment effect of infliximab measured in clinical trials and clinical practice results in comparable cost-effectiveness ratios, as calculated by using a modeling approach, whereas the assumptions made in relation to the effectiveness data and the chosen comparator have a large impact on the results. This reinforces the value of early modeling studies based on randomized clinical trial data, but assumptions made need to be carefully assessed. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cost-effectiveness analysis, randomized clinical trial, rheumatoid, arthritis
in
Value in Health
volume
16
issue
2
pages
251 - 258
publisher
Wiley-Blackwell
external identifiers
  • wos:000318910400004
  • scopus:84875470097
ISSN
1098-3015
DOI
10.1016/j.jval.2012.11.002
language
English
LU publication?
yes
id
253a6d09-6884-468a-b43b-634633cd459b (old id 3935662)
date added to LUP
2013-08-01 07:42:06
date last changed
2019-07-02 01:02:28
@article{253a6d09-6884-468a-b43b-634633cd459b,
  abstract     = {Objective: To evaluate the precision of the predictive cost-effectiveness assessment based on a phase 3 clinical trial with infliximab for the treatment of rheumatoid arthritis in Swedish clinical practice. Methods: Three patient cohorts were identified: the patients included in the infliximab trial (ATTRACT), patients initially treated with infliximab from a Swedish registry (STURE), a subset of these registry patients meeting inclusion criteria for the ATTRACT trial was the third patient cohort; two sets of assumptions in relation to the efficacy data were evaluated: "ATTRACT" (efficacy data over the duration of the trial) and "STURE" (effectiveness data over 10 years). In addition, the impact of including the placebo effect for the comparator was evaluated as a basis for the calculation of cost-effectiveness by using a modeling approach. A health economic model was utilized to estimate the cost per quality-adjusted life-year (QALY) gained. Results: The results for the three patient cohorts ranged from cost saving to a cost per QALY gained of (sic)2,400 and (sic)24,900 to (sic)26,000 when the ATTRACT and STURE assumptions were used, respectively. Sensitivity analyses indicated that the inclusion of placebo effect had the largest effect on the results, increasing the cost per QALY gained to approximately (sic)50,000 for all patient cohorts. Conclusions: The treatment effect of infliximab measured in clinical trials and clinical practice results in comparable cost-effectiveness ratios, as calculated by using a modeling approach, whereas the assumptions made in relation to the effectiveness data and the chosen comparator have a large impact on the results. This reinforces the value of early modeling studies based on randomized clinical trial data, but assumptions made need to be carefully assessed.},
  author       = {Lekander, Ingrid and Kobelt, Gisela and Svarvar, Patrick and Ljung, Tryggve and van Vollenhoven, Ronald and Borgstrom, Fredrik},
  issn         = {1098-3015},
  keyword      = {cost-effectiveness analysis,randomized clinical trial,rheumatoid,arthritis},
  language     = {eng},
  number       = {2},
  pages        = {251--258},
  publisher    = {Wiley-Blackwell},
  series       = {Value in Health},
  title        = {The Comparison of Trial Data-Based and Registry Data-Based Cost-Effectiveness of Infliximab Treatment for Rheumatoid Arthritis in Sweden Using a Modeling Approach},
  url          = {http://dx.doi.org/10.1016/j.jval.2012.11.002},
  volume       = {16},
  year         = {2013},
}