Cost-effectiveness of drug monitoring of anti-TNF therapy in inflammatory bowel disease and rheumatoid arthritis: a systematic review

Martelli, Laura; Olivera, Pablo; Roblin, Xavier; Attar, Alain; Peyrin–Biroulet, Laurent

doi:10.1007/s00535-016-1266-1

Cited by 70 publications

(44 citation statements)

References 23 publications

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“…The incremental cost-effectiveness gain over the empiric strategy ranged from $500,000 to more than $5 million per quality-adjusted life year gained. Similar results have been reported by the other 3 studies, 38,74,77 with findings showing that the TDM-based strategy of dose deescalation led to cost savings of around 20% per CD patient at 2-year follow-up, and so on. These findings justify the use of TDM to guide efficient decision making and to reduce the overall high cost of IBD biologic therapy.…”

Section: Cost-effectiveness Of Tdmsupporting

confidence: 88%

Therapeutic Drug Monitoring of Biologics for Inflammatory Bowel Disease: An Answer to Optimized Treatment?

Hoseyni

Zhou

2018

The Journal of Clinical Pharma

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Therapeutic drug monitoring (TDM), or the measurement of drug concentrations in blood and antidrug antibodies, for biologic therapies used to treat inflammatory bowel disease (IBD) is an area of growing interest within the IBD community. When there is a definable relationship between drug concentration and clinical effect, blood concentration of biologics (and antidrug antibodies assessment) could be used to predict patient response and to titrate the biologics to maximize therapeutic benefit. This dose individualization has been proven to be more efficacious and cost-effective than empiric dose adjustment and can better guide therapeutic decisions regarding therapy withdrawal or switch. Appropriate implementation and interpretation of drug concentration measurement in TDM are essential to ensure full clinical benefit. Factors that need to be considered include sources of variability, timing of blood sampling, dosing history, analytical performance, immunogenicity, comedications, and clinical status of the patients. Desired target concentrations for biologics used in IBD have not been clearly determined yet. Published concentration thresholds differed widely for a given biologic, indicating a lack of consistent information. Factors other than drug concentration that may contribute to the dose-response variation are largely missing in the current TDM setting. A target range is likely preferable to a single value for TDM of biologics in IBD, and additional prospective research needs to be conducted in order to establish these ranges. Moving forward, TDM may be combined with pharmacodynamic end points and modeling and simulation tools for improved therapeutic benefit in IBD.

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Section: Cost-effectiveness Of Tdmsupporting

confidence: 88%

Therapeutic Drug Monitoring of Biologics for Inflammatory Bowel Disease: An Answer to Optimized Treatment?

Hoseyni

Zhou

2018

The Journal of Clinical Pharma

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“…It has been proposed that therapeutic drug monitoring of TNF antagonists has the potential to be useful for predicting or preventing treatment failure in patients with Crohn's disease, and it may be helpful for deciding therapeutic interventions after primary loss of efficacy, and to make treatment more cost‐effective . Knowledge of specific drug concentration thresholds that correspond with efficacy outcomes, as identified in this analysis, may inform therapeutic drug monitoring and guide decisions in clinical practice.…”

Section: Discussionmentioning

confidence: 97%

Exposure‐response relationship of certolizumab pegol induction and maintenance therapy in patients with Crohn's disease

Casteele

Feagan

Vermeire

et al. 2017

Aliment Pharmacol Ther

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SummaryBackgroundTherapeutic drug monitoring may optimize therapy for Crohn's disease (CD).AimTo use a population pharmacokinetic model that accounts for the time‐varying nature of covariates to simulate certolizumab pegol (CZP) concentrations to evaluate the exposure‐response relationship for CZP in Crohn's disease.MethodsAdults (N = 2157) with Crohn's disease were treated with CZP in nine clinical trials. Simulated CZP concentrations were compared to outcomes at weeks 6 and 26, including Crohn's disease activity index (CDAI) response (decrease from baseline ≥ 100 points), remission (CDAI ≤ 150), C‐reactive protein (CRP) ≤ 5 mg/L, faecal calprotectin (FC) ≤ 250 μg/g, and a composite endpoint of CDAI ≤ 150 and FC ≤ 250 μg/g. Multivariable analyses identified covariates associated with outcomes and receiver operating characteristic analyses determined optimal CZP concentrations.Results CZP concentrations at weeks 2, 4 and 6 were higher in patients with clinical response, remission, CRP ≤ 5 mg/L or FC ≤ 250 μg/g at week 6 than without. In multivariable analyses, higher CZP concentrations at week 6 were associated with the composite outcome at weeks 6 and 26 (P < .001). Although the exposure‐response relationship varied among patients, approximate CZP concentrations of at least 36.1 μg/mL (positive predictive value [PPV] 22.8% and negative predictive value [NPV] 92.7%) and at least 14.8 μg/mL (PPV 28.0% and NPV 90.4%) at weeks 6 and 12 were associated with weeks 6 and 26 outcomes.ConclusionsAn exposure‐response relationship was apparent for CZP in Crohn's disease and achieving higher CZP concentrations may increase the likelihood of attaining efficacy outcomes, but this remains to be evaluated prospectively.

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“…However, the TAXIT and TAI-LORIX trials did not identify any benefit on clinical remission rates, although factors including the high incidence of dose intensification in the TAILORIX clinical care group may explain this [151,152]. Currently, proactive TDM is performed in limited numbers of patients with IBD receiving TNF inhibitors [147] and is not widely recommended unless likely to impact on clinical management, although cost-effectiveness analyses demonstrate its benefits [153]. In addition, the increased affordability of biosimilars relative to biologics could facilitate clinical research incorporating these agents.…”

Section: Pharmacoeconomists' Perspective: Cost Of and Access To Biolomentioning

confidence: 99%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

Self Cite

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Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

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Cost-effectiveness of drug monitoring of anti-TNF therapy in inflammatory bowel disease and rheumatoid arthritis: a systematic review

Cited by 70 publications

References 23 publications

Therapeutic Drug Monitoring of Biologics for Inflammatory Bowel Disease: An Answer to Optimized Treatment?

Therapeutic Drug Monitoring of Biologics for Inflammatory Bowel Disease: An Answer to Optimized Treatment?

Exposure‐response relationship of certolizumab pegol induction and maintenance therapy in patients with Crohn's disease

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

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