Cost-effectiveness Of Therapeutic Drug Monitoring Research Articles

Therapeutic drug monitoring guided dosing versus standard dosing of alectinib in advanced ALK positive non-small cell lung cancer patients: Study protocol for an international, multicenter phase IV randomized controlled trial (ADAPT ALEC).

Alectinib is first-line therapy in patients with stage IV non-small cell lung carcinoma (NSCLC) and an anaplastic lymphoma kinase (ALK) fusion. A shorter median progression-free survival (mPFS) was observed when alectinib minimum plasma concentrations during steady state (Cmin,SS) were below 435 ng/mL. This may suggest that patients should have an alectinib Cmin,SS ≥ 435 ng/mL for a more favorable outcome. This potential target could be attained by using therapeutic drug monitoring (TDM), i.e. adjusting the dose based on measured plasma trough concentrations. Hypothetically, this will increase mPFS, but this has not yet been evaluated in a randomized controlled trial (RCT). Therefore, the ADAPT ALEC trial is designed, with the primary objective to prolong mPFS in NSCLC patients treated with alectinib by using TDM. ADAPT ALEC is a multicenter, phase IV RCT, in which patients aged ≥ 18 years with advanced ALK positive (+) NSCLC eligible for alectinib in daily care are enrolled. Participants will be randomized (1:1 ratio) into intervention arm A (TDM) or B (control), stratified by brain metastases and prior ALK treatments. Starting dose in both arms is the approved flat fixed dose of alectinib 600 mg taken twice daily with food. In case of alectinib Cmin,SS < 435 ng/mL, arm A will receive increased doses of alectinib till Cmin,SS ≥ 435 ng/mL when considered tolerable. The primary outcome is mPFS, where progressive disease is defined according to RECIST v1.1 or all-cause death and assessed by CT-scans and MRI brain. Secondary endpoints are feasibility and tolerability of TDM, patient and physician adherence, overall response rate, median overall survival, intracranial PFS, quality of life, toxicity, alectinib-M4 concentrations and cost-effectiveness of TDM. Exploratory endpoints are circulating tumor DNA and body composition. The ADAPT ALEC will show whether treatment outcomes of patients with advanced ALK+ NSCLC improve when using TDM-guided dosing of alectinib instead of fixed dosing. The results will provide high quality evidence for deciding whether TDM should be implemented as standard of care and this will have important consequences for the prescribing of alectinib. ClinicalTrials.gov, identifier NCT05525338.

Cost-Effectiveness of Therapeutic Drug Monitoring of Anti-TNF Therapy in Inflammatory Bowel Disease: A Systematic Review.

Infliximab and adalimumab are monoclonal antibodies against tumor necrosis factor (anti-TNF) used to manage inflammatory bowel disease (IBD). Therapeutic Drug Monitoring (TDM) has been proven to prevent immunogenicity, to achieve better long-term clinical results and to save costs in IBD treatment. The aim of this study was to conduct a systematic review on cost-effectiveness analyses of studies that apply TDM of anti-TNF in IBD and to provide a critical analysis of the best scientific knowledge available in the literature. The quality of the included studies was assessed using Consolidated Health Economic Evaluation Reporting Standards (CHEERS). Cost-effectiveness of the TDM strategies was presented as total costs, cost savings, quality-adjusted life-years (QALY) and incremental cost-effectiveness ratio (ICER). Thirteen studies that examined the health economics of TDM of anti-TNF in IBD from 2013 to 2021 were included. Eight of them (61.5%) achieved a score between 17 and 23 on the CHEERS checklist. The comparison between the TDM strategy and an empirical strategy was cost saving. The ICER between reactive TDM and an empirical strategy was dominated (favorable) by reactive TDM, whereas the ICER value for proactive TDM compared to an empirical strategy ranged from EUR 56,845 to 3,901,554. This systematic review demonstrated that a TDM strategy is cost-effective or cost-saving in IBD.

The cost-effectiveness of therapeutic drug monitoring for the prescription drug-based treatment of chronic myeloid leukemia.

BACKGROUND: A recent study demonstrating the use of Therapeutic Drug Monitoring (TDM) in patients with chronic myeloid leukemia (CML) resulted in a higher response rate with imatinib (IM) than demonstrated in second-generation tyrosine kinase inhibitor studies. The cost-effectiveness of TDM combined with IM (IM TDM) in first-line CML treatment has not yet been studied. OBJECTIVES: To determine the cost-effectiveness of IM TDM for the first-line treatment of CML compared to tyrosine kinase inhibitor only treatment. METHODS: A recently published cost-effectiveness model of tyrosine kinase inhibitor-treatment in CML was modified to include IM TDM as a first-line tyrosine kinase inhibitor-based CML treatment option. Efficacy inputs for major molecular response (MMR) rates were taken from previously published studies: IM TDM 65%, dasatinib 52%, nilotinib 53%. Annual tyrosine kinase inhibitor drug prices were derived from the Federal Supply Schedule (FSS) and the average and lowest wholesale acquisition costs (WAC) reported in the Red Book; the annual cost of TDM was $228. Other input costs modeled in the original CML CEA model were updated to 2016 US dollars using the medical service component of the Consumer Price Index. A US payer perspective was used with a 5-year time horizon and a 3.0% discount rate. The model compared first-line IM TDM versus IM alone, nilotinib (NIL) or dasatinib (DAS) in terms of the following outcomes: costs, quality-adjusted life-years (QALYs), and cost-effectiveness (total cost/QALY). Deterministic and probabilistic sensitivity analyses were performed using all key clinical and economic parameters. RESULTS: This study found that IM TDM dominates IM alone with $15,452 to $36,940 in savings and 0.25 higher QALYs. Using FSS, per patient total costs for IM and IM TDM were $270,905 and $233,965, respectively.; Using average WAC, these costs were $461,657 and $446,205, and using lowest WAC, these costs were $366,966 and $350,090. The results comparing first line using of IM TDM to NIL/DAS found that TDM IM had higher QALYs and lower costs (0.08 QALYs lower, and $117,006 to $172,420 savings per patient [varying by price basis]). Thus, in terms of cost-effectiveness, IM TDM dominates NIL/DAS with both lower costs and higher QALYs. CONCLUSIONS: IM TDM is a clinically and economically viable first-line treatment option for CML. DISCLOSURES: This study was funded by Saladax Biomedical. Salamone is an employee of Saladax Biomedical. This study was presented at the IATDMCT Congress, September 2018, Brisbane, Australia.

Cost-Effectiveness of Therapeutic Drug Monitoring-Guided Adalimumab Therapy in Rheumatic Diseases: A Prospective, Pragmatic Trial.

IntroductionTo assess the clinical and cost-effectiveness of therapeutic drug monitoring (TDM) based on serum adalimumab levels compared to standard of care in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. MethodsThis was a non-inferiority, multicentric, non-randomized, pragmatic trial including adult patients diagnosed with moderate-to-severe, clinically stable rheumatic diseases treated with adalimumab. Consecutive patients were assigned 1:2 to the control (CG) or the intervention group (IG), based on the site of inclusion, and followed up for 18 months. Adalimumab serum levels were measured at each study visit and released to the IG only to modify dosing strategy. Data on disease activity, healthcare resource utilization and health-related quality of life (HRQoL) measured through the EQ-5D-5L were collected. Number of persistent and overall flares, time to first flare, days experiencing high disease activity, total direct costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated.ResultsOf the 169 recruited patients, 150 were included in the analysis (52 and 98 patients in the CG and IG, respectively). The primary endpoint was not met as persistent flares were not significantly lower in the IG, although mean (SD) number of flares was numerically lower in the IG (0.67 [0.70] versus 0.90 [0.82], P = 0.073), respectively. Based on EQ-5D-5L utilities, HRQoL was significantly higher in the IG at 3 (P = 0.001) and 6 months (P = 0.035), which overall translated into 0.075 QALYs gained per patient for the IG at month 18. Overall, direct costs were significantly lower for the IG patients (€15,311.59 [4,870.04] versus €17,378.46 [6,556.51], P = 0.030), resulting in the intervention being dominant, leading to increased QALY at a lower overall costConclusionAdalimumab dose tapering based on TDM for rheumatic patients led to an increased quality of life and QALY gain and entailed lower costs, being a more cost-effective alternative than clinically guided management.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-021-00345-5.

The Cost-Effectiveness of Therapeutic Drug Monitoring (TDM) of Generic Imatinib for the Treatment of Chronic Myelogenous Leukemia

INTRODUCTIONA recent clinical study of using therapeutic drug monitoring (TDM) of imatinib mesylate (IM) for the treatment of chronic myelogenous leukemia (CML) found that the cytogenetic response at 12 months was significantly improved with IM TDM (Rousselot, P. et al. Blood 2015 126:133).Given that tyrosine kinase inhibitors (TKI) other than IM had previously shown more rapid molecular responses at standard doses, the improved IM efficacy using TDM provides new clinical information when selecting a CML treatment.A recent cost-effectiveness analysis of TKI for CML found that, when considering the pending loss of patent exclusivity of IM, using IM as a first-line treatment is the most cost-effective treatment option. However, since the loss of patent exclusivity, no studies have considered the cost-effectiveness of IM since the loss of patent exclusivity, nor has the cost-effectiveness of IM TDM been evaluated. OBJECTIVEThe objective of the study was to determine the cost-effectiveness of using generic IM TDM for the first-line treatment of CML. METHODSA peer-reviewed and published TKI cost-effectiveness model in the CML (Padula, WV, et al. JNCI, 2016 Mar 4;108(7)) was modified to include IM TDM as a treatment option. Efficacy inputs for major molecular response (MMR) rates were taken from published clinical studies: IM TDM 65%, dasatinib 52%, nilotinib 53% (Kantarjian H, , et al N Engl J Med. 2010;362:2260-2270; Kantarjian HM, et al. Blood. 2012;119:1123-1129. Larson RA, et al. Leukemia. 2012;26:2197-2203).Using the Federal Supply Schedule and average and lowest wholesale acquisition cost as price bases, alternative estimates were used for drug prices including generic IM. The cost of TDM for IM was added to the IM TDM comparator arm at $228 annually (6 tests at $38 each) over the 5-year time horizon. Other input costs were updated to 2016 U.S. Dollars using the Medical Service index of the Consumer Price Index.A U.S. payer perspective was used with a 5-year time horizon and a 3.0% discount rate. The model compared first-line IM TDM versus first-line IM alone, first-line dasatinib or nilotinib (D/N) in terms of costs, quality-adjusted life-years (QALYs), and cost-effectiveness. Univariate (one-way) and multivariate (two-way) sensitivity analysis was performed on all key clinical and economic parameters. RESULTSThe model found that IM TDM dominates IM alone with $15,452 to $36,940 in savings and 0.25 higher QALYs. Using an FSS price basis, per patient total costs for IM and IM TDM were $270,905 and $233,965, respectively. For WAC average pricing, these costs were $461,657 and $446,205, respectively, and for the lowest WAC pricing, these costs were $366,966 and $350,090, respectively.The results comparing first line using of IM TDM to D/N found that IM TDM had slightly higher QALYs and lower costs (0.08 QALYs, and $117,006 to $172,420 savings per patient [varying by price basis]). Thus, in terms of cost-effectiveness, IM TDM dominates D/N with both lower costs and higher QALYs.The model also found that for each first-line IM TDM patient responding for 5 years $114,577 to $207,564 was saved versus patients receiving first-line D/N. Sensitivity analysis confirmed that the results are robust. CONCLUSIONThe analysis found that IM TDM dominates IM alone and D/N under a wide range of price scenarios. The analysis suggests that IM TDM is both a clinically and economically viable first-line treatment option for CML. DisclosuresSalamone:Saladax Biomedical, Inc: Employment, Equity Ownership. Becker:Saladax Biomedical, Inc.: Consultancy. Padula:Saladax Biomedical, Inc: Research Funding.

PMS68 PROMONITOR FOR THERAPEUTIC DRUG MONITORING IN PATIENTS WITH SEVERE RHEUMATOID ARTHRITIS TREATED WITH ADALIMUMAB IN ENGLAND AND WALES

Adalimumab is used for severe rheumatoid arthritis (RA), but its efficacy is hampered by the presence of low drug levels and anti-drug antibodies (ADAs). Although not currently part of standard National Health Service (NHS) practice, patients who achieve remission may be eligible for supervised dose tapering. This could be done through the use of enzyme-linked immunosorbent assay (ELISA) tests, capable of measuring both drug and ADAs concentrations, alongside conventional clinical assessment. In this study, the economic outcomes of adding therapeutic drug monitoring (TDM) using Promonitor (Grifols–Progenika) assays to standard care in people with severe RA (Disease Activity Score 28>5.1) treated with adalimumab who had either achieved remission or low disease activity were evaluated. A cost-utility analysis based on a decision tree model was informed by a non-randomised trial INGEBIO identified following a systematic review. Since there is a substantial variation in clinical practice for TDM testing, dose-tapering and flare-management strategies in people with RA, and the actual cost of adalimumab to the NHS, incremental cost-effectiveness ratios (ICERs) were estimated for various clinically plausible scenarios and discounts for the list price of adalimumab (Humira®, AbbVie). Costs and resource use were considered from the NHS and Personal Social Services perspective. No discounting was applied to costs and effects due to the short-term time horizon of 18 months. ICERs in all except two scenarios were located in the north-east quadrant of the cost-effectiveness plane and ranged from £4,230 to £164,009 per quality-adjusted life-year gained. When the frequency of testing was one test per year or the cost of phlebotomy appointments to collect trough samples was excluded, the intervention dominated standard care. The cost-effectiveness of TDM with Promonitor for optimizing adalimumab treatment in people with RA is highly uncertain due to data limitations. Thus, future clinical studies are warranted.

Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (the NOR-DRUM study)

BackgroundInfliximab (INX) and other tumour necrosis factor inhibitors (TNFi) have revolutionised the treatment of several immune mediated inflammatory diseases. Still, many patients do not respond sufficiently to therapy or lose efficacy over time. The large interindividual variation in serum drug concentrations on standard doses and the development of anti-drug antibodies are thought to be major reasons for treatment failures. Therapeutic drug monitoring (TDM), an individualised treatment strategy based on systematic assessments of serum drug concentrations, has been proposed as a clinical tool to optimise efficacy of INX treatment. TDM seems reasonable both from a clinical and an economical point of view, but the effectiveness of this treatment strategy has not yet been demonstrated in randomised clinical trials. The NORwegian DRUg Monitoring study (NOR-DRUM) aims to assess the effectiveness of TDM, both with regard to the achievement of remission in patients starting INX treatment (part A) as well as to maintain disease control in patients on INX treatment (part B).MethodsThe NOR-DRUM study is a randomised, open, controlled, parallel-group, comparative, multi-centre, national, superiority, phase IV study with two separate parts, NOR-DRUM A and NOR-DRUM B. Patients with rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, ulcerative colitis, Crohn’s disease and psoriasis are included. In both study parts participants are randomised 1:1 to either TDM of infliximab (intervention group) or to standard treatment with infliximab without knowledge of drug levels or ADAb status (control group). NOR-DRUM A will include 400 patients starting INX therapy. The primary outcome is remission at 30 weeks. In NOR-DRUM B, 450 patients on maintenance treatment with INX will be included. The primary endpoint is occurrence of disease worsening during the 52-week study period.DiscussionAs the first trial to assess the effectiveness, safety and cost-effectiveness of TDM in patients receiving TNFi for a range of immune mediated inflammatory diseases, we hope that the NOR-DRUM study will contribute to the advancement of evidence based personalised treatment with biological medicines.Trial registrationClinicaltrials.gov, NCT03074656. Registered on 090317.

Cost-Effectiveness of Therapeutic Drug Monitoring for Imatinib Administration in Patients with Chronic Myeloid Leukemia

Background: Generic imatinib mesylate (IM) is an effective therapy and is the least costly tyrosine kinase inhibitor (TKI) for patients with chronic myeloid leukemia (CML). Therapeutic drug monitoring (TDM) has the potential to improve the adherence to IM therapy as well as helps oncologists to make an informed decision. This eventually leads a delayed switching to 2ndor 3rdgeneration (2G or 3G) TKIs that dramatically increase the treatment cost. The objective of this study was to determine the short- and lifetime cost-effectiveness of TDM for generic IM administration in patients newly diagnosed with CML.Methods: We built a Markov model to compare CML related healthcare costs, quality adjusted life years (QALY), incremental cost-effectiveness ratio (ICER) and overall survival (OS) between the two monitoring strategies, TDM vs. standard care without TDM (NTDM). Future cost and QALY gained were discounted with an annual rate of 3%. Markov states for chronic phase include normal IM dose (400mg), IM dose escalation (600mg), IM dose reduction (300mg), 2GTKI, 3GTKI. Post TKI phases include accelerate phase, blast phase and post-transplant phase with an assumption that patients need 3GTKI along with a chemotherapy until they receive hematopoietic stem cell transplant. Outcome of this study was an incremental cost effectiveness ratio (ICER). A potential reason for the response or intolerance to IM was informed by a known plasma concentration (Cp) from the TDM arm, that helps a treatment decision between the IM dose change and switching to 2GTKI. In the NTDM arm, response and intolerance rate was influenced by Cp, but clinical decision was blinded from the Cp. The outcomes were calculated over the initial 5 years and accumulated until all patients die. The influence of a changes in generic IM price were tested.Results: Over the initial 5 years, TDM was associated with a drop in the cost (- $6,510) with a trivial decrease in QALY (-0.007) compared to NTDM. The cost-saving continued over the 30 years after the TKI therapy begins. TDM resulted in a lifetime cost increased by $2,358, which was associated with a delayed progress to the post-TKI phases and treatment cost over the extended life years gained. TDM leads an increase in lifetime QALY by 0.149, calculating an ICER of $15,834. When the cost of generic IM further dropped to the 50% of the current whole-sale price, TDM saves the lifetime cost by $11,705. Ten-year survival rates and median OS favored TDM (87.1% and 19.5 years) over NTDM (86.4% and 19 years).Conclusion: TDM has a potential to save the medical expenses for CML care over the first 5 years without influences after the TKI treatment begins. When current generic price maintained, TDM is a cost-effective strategy over a lifetime. Addition drop in the generic IM price could lead a saving in the CML care cost with a gain in the QALY over the lifetime. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

PHS40 - Cost-Effectiveness of Therapeutic Drug Monitoring for Imatinib Administration in Patients with Chronic Myeloid Leukemia

Generic imatinib mesylate (IM) is an effective therapy and is the least costly option for patients with chronic myeloid leukemia (CML). Therapeutic drug monitoring (TDM) has the potential to improve the adherence to IM therapy allowing patients to stay in remission and avoid switching to more toxic and expensive tyrosine kinase inhibitors (TKI). The objective of this study was to determine the cost effectiveness of TDM for generic IM administration in CML patients. We built a Markov model depicting multiple CML states including normal IM dose (400mg), IM dose escalation (600mg), secondary TKI and post TKI phases to calculate an incremental cost effectiveness ratio (ICER) for TDM in reference to non-TDM monitoring . We assumed all patients were followed by molecular monitoring. Transition from normal IM dose to either dose escalation or secondary TKI was determined by the patient response and known plasma concentration (Cp) of IM. The response and Cp were a function of adherence. CML related healthcare costs and quality adjusted life years (QALY) were calculated over a lifetime. Probabilistic sensitivity analyses conditional on multiple levels of generic IM price were performed. TDM was associated with higher cost ($3,344) and an increase in QALY (0.085) compared to non-TDM with an ICER of $39,126 per QALY gained. The ICER was sensitive to the dose-Cp association and the price of IM. TDM achieved a 60% likelihood of being cost-effective at willingness to pay (WTP) threshold $100,000 per QALY gained at the current price. The acceptability at $100,000/QALY increased to 66% when the price of generic IM was reduced by 50%. TDM is likely cost-effective compared to non-TDM. However, the likelihood of acceptance of TDM was less than 70% at the conventional level of the WTP, $100,000 per QALY gained.

Potential cost-effectiveness of therapeutic drug monitoring in patients with resistant hypertension.

Nonadherence to drug therapy poses a significant problem in the treatment of patients with presumed resistant hypertension. It has been shown that therapeutic drug monitoring (TDM) is a useful tool for detecting nonadherence and identifying barriers to treatment adherence, leading to effective blood pressure (BP) control. However, the cost-effectiveness of TDM in the management of resistant hypertension has not been investigated. A Markov model was used to evaluate life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios in resistant hypertension patients receiving either TDM optimized therapy or standard best medical therapy. The model ran from the age of 30 to 100 years or death, using a cycle length of 1 year. Efficacy of TDM was modeled by reducing risk of hypertension-related morbidity and mortality. Cost analyses were performed from a payer's perspective. Deterministic and probabilistic sensitivity analyses were conducted. In the age group of 60-year olds, TDM gained 1.07 QALYs in men and 0.97 QALYs in women at additional costs of €3854 and €3922, respectively. Given a willingness-to-pay threshold of €35,000 per QALY gained, the probability of TDM being cost-effective was 95% or more in all age groups from 30 to 90 years. Results were influenced mostly by the frequency of TDM testing, the rate of nonresponders to TDM, and the magnitude of effect of TDM on BP. Therapeutic drug monitoring presents a potential cost-effective healthcare intervention in patients diagnosed with resistant hypertension. Importantly, this finding is valid for a wide range of patients, independent of sex and age.

Abstract 502: Cost-effectiveness Of Therapeutic Drug Monitoring In Patients With Resistant Hypertension

Background: Non-adherence to anti-hypertensive medications poses a significant problem in the treatment of patients with presumed resistant hypertension (RH). Our recent study has shown that therapeutic drug monitoring (TDM) is a useful tool not only for detecting medication non-adherence but also exploring the barrier to antihypertensive drug therapy, resulting effective BP control. However, the cost effectiveness of TDM in the management of resistant hypertension has not been investigated. Method: A Markov model was used to evaluate life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios in RH patients receiving either TDM optimized therapy or standard best medical therapy (BMT). The model ran from the age of 30 to 100 years or death, using a cycle length of 1 year. Efficacy of TDM was modeled by reducing risk of hypertension-related morbidity and mortality. Results: In the age group of 60-year olds, TDM gained 1.07 QALYs in men and 0.97 QALYs in women at additional costs of є3,854 and є3,922, respectively. Given a willingness-to-pay threshold of є35,000 per QALY gained, the probability of TDM being cost-effective compared to BMT was ≥95% in all age groups from 30 to 90 years. Incremental cost-effectiveness ratios were influenced mostly by the annual frequency of TDM testing, the rate of non-responders to TDM, and the magnitude of effect of TDM on systolic blood pressure (Figure). Conclusion: Therapeutic drug monitoring presents a potential cost-effective health care intervention in patients diagnosed with RH. Importantly, this finding is valid for a wide range of patients, independent of gender and age.

Potential Cost-effectiveness of Therapeutic Drug Monitoring for Depressed Patients Treated With Citalopram

For patients treated with citalopram, it was recently shown that serum concentrations above 50 ng/mL on day 7 of treatment are associated with an improved therapeutic outcome. The aim of this post hoc analysis was to calculate a potential cost-effectiveness of therapeutic drug monitoring (TDM) considering costs for hospitalization, medication, and drug analysis. The study included patients with major depression. Weekly measurements of serum concentrations and assessments of psychopathology were conducted. Fifty-five patients were included in this analysis. For patients with high citalopram serum concentrations (>50 ng/mL), the mean duration of hospitalization was 49 ± 20 days, and it was 72 ± 37 days (P = 0.03) in the group with low drug concentrations (<50 ng/mL). Considering daily costs for hospitalization of 250€,;, the potential savings amounted to 5750€,; per patient for the 23 days. Assuming that 11% of the variation of duration of hospitalization per patient were attributed to the serum concentration of the drug, the resulting savings were 633€,; per patient. Considering the officially listed price of 21€,; per TDM assay, total costs for weekly measurements over a period of 10 weeks of hospitalization were 210€,;. In the groups with high and low serum concentrations, daily costs for citalopram medication were 3.00 ± 0.80€,; and 2.42 ± 0.70€,;, respectively (P = 0.002), and the mean number of comedications was nearly identical, that is, 1.87 ± 1.74 and 1.81 ± 1.86 drugs, respectively (P = 0.919). The data taken together indicate that TDM-guided dosing of citalopram has the potential to be cost effective by reducing the length of hospitalization.

Cost-effectiveness analysis for the use of serum antiepileptic drug level monitoring in children diagnosed with structural-metabolic epilepsy

Treatment with antiepileptic drugs is commonly guided by serum level monitoring. Such monitoring requires expensive laboratory equipment and products. However, well-conducted studies on the cost-effectiveness of therapeutic drug monitoring for antiepileptic drugs are lacking particularly in patients with structural-metabolic epilepsy. The study aims to assess the cost-effectiveness of serum level monitoring services in the management of children with structural-metabolic epilepsy during the first year of diagnosis. A retrospective cost-effectiveness analysis was conducted from the provider perspective. It included patients attended a paediatric neurology clinic. The effectiveness measures used in this analysis were the number of patients that achieved ≥50% reduction in seizure frequency, and the number of patients with 3-month seizure free. Medical records of the patients were reviewed for the required information. Medical chart/billing data obtained from the hospital were collected to estimate the resources used (One Malaysian Ringgit MYR is equivalent to 0.31 USD). The recruited children were followed for one year following their first visit. The average cost effectiveness ratio for the monitored patients (MYR 2735 per patient that achieved a ≥50% reduction in seizure frequency) was lower than that for non-monitored patients (MYR 2921 per patients that achieved a ≥50% reduction in seizure frequency), with incremental cost-effectiveness ratio of MYR 2357 per one additional patient that achieved a ≥50% reduction in seizure frequency. The average cost effectiveness ratios for monitored and non-monitored group were MYR 8279 and MYR 6433 per patient with a 3-month seizure-free period, respectively, with incremental cost-effectiveness ratio of MYR 29,666 per one additional patient with a 3-month seizure-free period. In terms of the effectiveness measures used, serum level monitoring of antiepileptic drugs was found to be cost-effective. However, the incremental cost-effectiveness ratio was found to be sensitive to the cost of management.

Therapeutic drug monitoring in the treatment of HIV-infection.

The use of therapeutic drug monitoring (TDM) in the treatment of HIV-infection is gaining momentum in resource-rich countries. However, data justifying its use is still in short supply. In this manuscript we review the necessary components of TDM before it should be implemented in widespread clinical use. In addition, we provide specific examples of clinical situations where TDM is likely to useful. The overall conclusion of this review is that TDM is a promising therapeutic modality for improving antiretroviral efficacy and reducing toxicity. However, more prospective clinical trials are necessary in order to validate the therapeutic concentrations of antiretroviral drugs suggested by various investigators. In addition, both the clinical utility and cost effectiveness of TDM will need to be demonstrated by well-designed and adequately powered clinical trials in both antiretroviral nai;ve and experienced subjects. At this point in time we consider TDM in the treatment of HIV-infection as experimental with significant promise for the future.

Therapeutic Drug Monitoring Techniques

The clinical utility and cost-effectiveness of therapeutic drug monitoring are well established. This overview summarizes the key concepts of therapeutic drug monitoring and reviews the current methodologies.

Cost-effectiveness of therapeutic drug monitoring.

Cost-effectiveness of therapeutic drug monitoring.