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VBCR - October 2016, Vol 5, No 5 - Value Propositions

In This Article




Routine Monitoring of Drug Levels and Antidrug Antibodies Benefits Cost, Improves Treatment Decision-Making

Although monitoring of antidrug antibodies (ADAbs) or serum concentrations of tumor necrosis factor (TNF)-α inhibitors used in the treatment of patients with rheumatoid arthritis (RA) could explain efficacy loss, and help with choosing subsequent medication, such monitoring is not generally done on a routine basis. However, in a recent study, investigators demonstrated the cost benefits of routine monitoring of drug levels and ADAbs in clinical practice, which they reported can, in turn, improve the decision-making process of using TNF-α inhibitors.

Seeking to estimate the likelihood of optimal and nonoptimal treatment decisions based on whether drug trough levels (DLs) and ADAbs are tested in RA, and to model cost-effectiveness of performing routine monitoring of this type, researchers based in Finland gathered drug levels and ADAbs concentration data from 486 and 1137 samples from patients taking adalimumab and infliximab, respectively.

Among samples from patients who were treated with adalimumab and infliximab, DLs were in the target range of 42.0% and 50.4%, and ADAbs were detected in approximately 20.0% and 13.5% of samples, respectively. In patients with low adalimumab or infliximab drug levels, ADAbs were found in 52.3% and 41.3% of samples, respectively. Monitoring data were then merged into probabilities for making optimal treatment decisions.

Over the course of 3 to 6 months, the researchers used a scenario with 100 hypothetical patients to model the economic impact of clinical decision-making. In the model, the combined measurement of DLs and ADAbs was cost-saving compared with the nontesting scenario when the monitoring results affected the treatment decision in ≥2 to 5 of 100 patients (a proportion that is easily exceeded in real-life clinical practice).

According to the authors, ineffective treatment of 5 patients for 3 months or 2.5 patients for 6 months costs approximately €22,065. Thus, they concluded that, when only 2.5 to 5 of 100 patients were treated nonoptimally for 3 to 6 months, routine measurement of drug levels and ADAbs proved to be cost-saving compared with the nontesting scenario.

“Our study indicates that the probability of nonoptimal drug treatment decision is noteworthy among the Finnish patients using infliximab and adalimumab if the data on individual DLs and ADAbs are not available,” the study authors reported. “Even at very low probability of nonoptimal decision, the systematic measurement of DLs and ADAbs seems to be cost-saving.”

Laine J, et al. Biologics. 2016;10:67-73.

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Switching Between Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis

Patients with rheumatoid arthritis (RA) who switched tumor necrosis factor (TNF) inhibitors had higher pretreatment Disease Activity Score 28 (DAS28) rates and higher overall costs compared with those who received the same TNF inhibitor as monotherapy or interrupted therapy, according to the results of a study by Grant W. Cannon, MD, Professor of Medicine, Division of Rheumatology, University of Utah, and Associate Chief of Staff, Academic Affiliations, Veterans Affairs Salt Lake City Health Care System, and colleagues.

Their analysis, through which they sought to assess the clinical outcomes and the drug- and administration-related costs of treating US veterans with RA with TNF inhibitors, compared patients initiating and continuing a single TNF inhibitor with those who later switched to a different TNF inhibitor. Using the Veterans Affairs Rheumatoid Arthritis registry, Dr Cannon and colleagues analyzed the data of 563 patients who initiated treatment with adalim­umab, etanercept, or infliximab between 2003 and 2010. End points included DAS28 scores, and direct drug- and administration-related costs, which were calculated using prices from the Veterans Affairs Pharmacy Benefits Management database.

“Evaluation of treatment patterns and associated costs is important for clinicians to make informed treatment decisions and for payers to manage costs; this evaluation is also important specifically among US veterans with RA because such an assessment has never been conducted in this population,” said Dr Cannon and colleagues in their report.

Of the patients included in the analysis, 262 initiated monotherapy with a TNF inhibitor, 142 restarted their initial therapy with a TNF inhibitor following a gap in their treatment (ie, interrupted therapy) of ≥90 days, and 159 switched to an alternative TNF inhibitor. Results demonstrated that patients who eventually switched therapy had higher DAS28 scores prior to initiating TNF-inhibitor treatment compared with those who received monotherapy or interrupted therapy, and also had the highest mean posttreatment DAS28 scores. Mean annualized costs for drugs and drug administration for the first course of treatment were similar among all patient groups.

“Our findings show that all patients had a similar degree of improvement in disease activity as measured by DAS28 scores whether they were persistent on a single TNF inhibitor agent with and without an interruption of therapy or switched TNF inhibitor agents,” reported Dr Cannon and colleagues. “This work [also] demonstrates that, while the annualized drug costs of the first course of treatment for patients who switched TNF inhibitor therapy were slightly higher than the costs of the first course of treatment in patients who remained on a single TNF inhibitor agent, these cost differences were not statistically significant.”

Cannon GW, et al. Adv Ther. 2016;33:1347-1359.

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Tofacitinib Treatment Demonstrates Cost Benefits in Patients with Rheumatoid Arthritis

In patients with rheumatoid arthritis (RA) who have an inadequate response or intolerance to methotrexate, use of tofacitinib 5 mg twice daily as monotherapy or combination therapy over 2 years was shown to be a lower-cost treatment option than adalimumab, etanercept, certolizumab, and tocilizumab biologic treatment strategies, according to the results of a recent study.

“There is a need for new therapeutic options in RA, since not all patients respond to the currently available treatments (primary nonresponders), or they lose response over time (secondary nonresponders),” said Lindsay Claxton, MMath, Research Consultant, York Health Economics Consortium, University of York, United Kingdom, and co-investigator in a recently published report of the study.

Seeking to compare the costs of treating patients with RA with tofacitinib versus other biologics often prescribed in the United States (eg, adalimumab, etanercept, certolizumab, and tocilizumab), Ms Claxton and colleagues created a model establishing the clinical and economic importance of tofacitinib and key comparator drugs to the healthcare and payer community with a focus on the associated treatment costs of a drug. They also measured the economic impact of monotherapy and combination therapy in patients whose disease responded inadequately to therapy with methotrexate, as well as the economic impact of combination therapy in patients whose disease inadequately responded to a tumor necrosis factor (TNF) inhibitor.

Among other sources, Ms Claxton and colleagues used data from the Rochester Epidemiology Project, and the IMS LifeLink Health Plan Claims Database—the latter of which contained information on 64 million unique patients with Medicaid, Medicare, and commercial insurance between 2007 and 2011—to create a transparent, Excel-based, economic model with a decision-tree approach evaluating costs over a 1- and 2-year time frame. They compared the use of tofacitinib 5 mg twice daily as monotherapy or in combination with methotrexate with similarly labeled biologic therapies; treatment responses were defined by American College of Rheumatology (ACR)20, ACR50, and ACR70 responses.

“The strategies of tofacitinib as a second-line therapy following the failure of methotrexate and as a third-line therapy following the failure of a TNF inhibitor therapy appear to be a cost-saving treatment strategy based upon the assumptions used within the model,” the investigators reported.

“Tofacitinib 5 mg twice a day following MTX [methotrexate] failure is predicted to be a cost-saving treatment option when used either as monotherapy or combination therapy compared with regimens using other bDMARDs [biologic disease-modifying antirheumatic drugs],” they concluded.

Claxton L, et al. J Manag Care Spec Pharm. 2016;22:1088-1102.

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Last modified: November 9, 2016
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