Biologic treatments have enhanced the treatment outcomes of patients with active ankylosing spondylitis (AS). Until recently, TNF-alpha-inhibitors have been the only biologics approved for the treatment of active AS. The objective of this study was to assess the potential financial impact of the first non-TNF-alpha biologic secukinumab (fully human IL-17A-inhibitor) vs adalimumab (TNF-alpha-inhibitor) in the treatment of AS in Finland.
In this model-based budget impact analysis, patients were treated either with secukinumab (150?mg) or adalimumab (40?mg). The number of patients and market share of different biologics were based on national reimbursement registry data. Adalimumab was the most commonly used biologic treatment for AS, and in the base case analysis all adalimumab patients are assumed to switch to secukinumab. Response rates were based on a matching-adjusted indirect comparison between secukinumab and adalimumab. Patients not achieving response were switched to another biologic treatment.
Treating AS patients with secukinumab instead of adalimumab leads to potential savings of 18.2 million euros within a 5-year time period. The total costs within the follow-up time were 59.5 million euros and 77.7 million euros with and without secukinumab, respectively. According to sensitivity analyses, a higher adoption rate of secukinumab corresponds to higher potential savings.
Secukinumab is a cost-saving treatment option compared with adalimumab in the treatment of AS in Finland. More patients could be treated with a biologic by allocating resources more efficiently.
This paper presents data on international differences in use of TNF inhibitors. It is part of a study on burden and cost of RA, access to new therapies and the role of HTA in determining access and cost-effectiveness. United States has the fastest most extensive use of the new drugs, about three times the average in the western European countries and Canada. Eastern and central European countries as well as Australia, South Africa and Turkey lag far behind. However, some smaller European countries, most notably Norway and Sweden have use of the new drugs not far behind the United States. While the income level of the country, and thus the health care expenditures per capita is a major factor for determining use in low and middle income countries, there are still considerable differences among countries with similar high total health care expenditures. Differences in prices are considerable between the US and Europe due to the changes in exchange rates between the US dollar and the Euro, but high and low use is not systematically related to differences in price.
We compared variations among Canadian provinces in rheumatoid arthritis (RA) initiating anti-tumor necrosis factor (TNF) therapy.
Data were obtained from the Optimization of Humira trial (OH) and from the Ontario Biologics Research Initiative (OBRI). Baseline characteristics were compared between regions: Ontario (ON), Quebec (QC), and other provinces (OTH). We compared Ontario OH to OBRI patients who were initiating anti-TNF therapy.
In 300 OH patients, mean age was 54.8 years (13.3). There were 151 (50.3%) ON patients, 57 from QC (19%), and 92 from OTH (30.7%). Regional differences were seen in the number of disease-modifying antirheumatic drugs (DMARD) ever taken (ON: 3.8 ± 1.4, QC: 3.1 ± 1.1, OTH: 3.3 ± 1.4; p
BACKGROUND: Treatment with tumour necrosis factor (TNF)-alpha inhibitors offers promising new opportunities to improve the health-related QOL of patients with rheumatoid arthritis (RA) in Denmark. As of September 2003, two such compounds -- infliximab and etanercept -- were registered for use by patients with RA. These drugs have shown the ability to reduce disease activity and to slow down or halt the development of new joint damage in otherwise treatment-resistant patients with RA. The acquisition cost of the drugs is high, with 1 year of treatment costing euros 9000-12,000 per patient. OBJECTIVE: The aim of this study was to assess the potential impact on the Danish healthcare budget of prescribing infliximab or etanercept to patients with RA. METHOD: Two treatment implementation scenarios were investigated. In the progressive scenario, all patients newly diagnosed with RA were offered TNFalpha inhibitors as the drug of first choice. In the modest scenario, only patients with insufficient disease suppression by conventional therapy with disease-modifying anti-rheumatic drugs (DMARDs) were offered TNFalpha inhibitor therapy. The budget impact analysis, which was part of a Danish health technology assessment of TNFalpha inhibitors, focused on the number of patients offered treatment during a 5-year period and resource use related to drug and staff costs. Simple sensitivity analyses assessed the consequences of changing the drug dosage, the number of patients offered treatment and the rate of treatment cessation. RESULTS: The results suggested that both implementation strategies would impose additional costs per year on the Danish healthcare service, in the range of euros 67-188 million for the progressive scenario and euros 17-49 million for the modest scenario (price level August 2002). These costs represent between half and up to five times the amount currently used on treating patients with RA. CONCLUSION: This analysis suggests that the introduction of TNFalpha inhibitors into the treatment regimen of patients with RA could pose a considerable financial burden on the Danish healthcare system.
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.
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.
The results for the three patient cohorts ranged from cost saving to a cost per QALY gained of €2,400 and €24,900 to €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 €50,000 for all patient cohorts.
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.
The Contingent Ranking Method--a feasible and valid method when eliciting preferences for health care? The objective of the study was to determine the feasibility and validity of the contingent ranking method, when eliciting preferences and measuring willingness to pay for health care. A measurement experiment based on ranking data is reported. Marginal willingness to pay for alleviation of rheumatoid arthritis symptoms that may be the outcome of a treatment with a novel anti-rheumatic agent, cA2 (now called TNF-alpha blockade) was calculated. The estimated marginal willingness to pay value was 650 DKK ($93). With regard to the health status variables and income variable the signs of the coefficients were, as expected, positive. The contingent ranking method is a feasible and valid method for eliciting preferences and determining willingness to pay estimates.
To perform a cost effectiveness analysis of cyclosporine (CyA) in the treatment of rheumatoid arthritis (RA).
Five randomized controlled parallel group clinical trials were selected for metaanalysis. A fixed effects model was used to calculate the treatment effects among the studies. An incremental economic analysis was performed from both a societal perspective and the perspective of Ontario Ministry of Health (MOH). A placebo comparison and 2 head to head comparisons were performed. The total treatment cost was calculated for a typical patient based on a modified intent to treat approach modelled over a one year period.
CyA produced a 25% or greater improvement in tender joint account in 35% of the patients relative to 17% of patients receiving placebo. There was no significant difference in improvement between CyA and azathioprine (Aza) or D-penicillamine (D-Pen). From the perspective of the Ontario MOH, the annual incremental cost of achieving the same level of improvement between CyA and Aza was found to be $1,473, and between CyA and D-Pen, $1,618; the annual incremental cost effectiveness ratio per patient improved of adopting CyA over placebo was $11,547. From a societal perspective, the incremental cost of CyA was $2,886 and $3,731 between Aza and D-Pen, respectively. The annual incremental cost effectiveness ratio against placebo was $20,698.
Given budgetary constraints on provincial drug plans, guidelines identifying patients in whom the cost effectiveness of CyA may be expected to be most favorable need to be explored. When CyA is the last option available to alleviate RA, whether it is "good value for money" depends upon the importance placed on patient improvement by the patients and/or by society, and on the alternative uses of the same scarce resources.
In the climate of rising healthcare expenditures the economic evaluation of new therapies becomes increasingly important in decision-making by health authorities. This article highlights some of the considerations regarding the economic assessment of drug treatments as they relate to rheumatic diseases, with emphasis on new biologic therapies such as tumor necrosis factor inhibitors.
BACKGROUND: Societal decision makers increasingly emphasise their need for evidence based economic analyses to make reimbursement decisions. OBJECTIVE: To analyse the cost utility of adalimumab, on both incremental cost and incremental quality adjusted life years (QALYs), versus traditional disease modifying antirheumatic drugs and the other tumour necrosis factor (TNF) antagonists suitable for submission to the Swedish LFN (Pharmaceutical Benefit Board). METHODS: Swedish unit costs and treatment guidelines from a lifetime perspective were implemented. A mathematical model, incorporating data from seven trials, simulated the experiences of 10 000 hypothetical patients with moderate to severe rheumatoid arthritis (RA). The primary outcome measure-QALYs-was derived from utility values calculated from a relationship between the Health Assessment Questionnaire (HAQ) Disability Index (DI) and Health Utility Index-III (HUI-3) from adalimumab trial results. The model followed the progression of HAQ-DI through a number of treatments in a sequence accounting for mortality, drug and monitoring costs, and other direct costs. RESULTS: When using ACR50 as a response threshold for determining successful treatment, adalimumab plus methotrexate showed the greatest number of QALYs gained (2.3 from one study and 2.1 from the pooled results of two trials). The etanercept plus methotrexate strategy yielded QALY gains similar to the pooled adalimumab results. Except for the infliximab strategy, the costs results were between 35 000 and 42 000, a range normally considered cost effective in other European countries. CONCLUSION: Adalimumab appears to be cost effective for the treatment of moderate to severe RA. The results suggest that adalimumab is at least as cost effective as other TNF antagonists.
To estimate, from a public payer's perspective, the 5-year cost effectiveness of adding leflunomide (LEF) to a sequence of disease-modifying antirheumatic drugs (DMARDs) representative of a typical rheumatoid arthritis (RA) management approach adopted by Canadian rheumatologists.
A DMARD sequence including LEF was compared with one excluding it, using a 5-year simulation model where patients with RA cycle through different treatment regimens. Data were obtained through a systematic literature search (drug withdrawal rates, number and type of adverse events, American College of Rheumatology 20% responder status) and separately conducted surveys (choice of DMARD sequence, management of adverse events). Costs for adverse event management were calculated using the Ontario Schedule of Benefits, and monitoring costs were calculated according to official Canadian product monograph recommendations. Wholesale prices of all drugs were adjusted by the allowable markup and prescription fees. Utilities (as measured by the standard gamble [SG] and rating scale [RS] techniques) were obtained from 482 patients who participated in a 1-year randomized controlled trial that compared LEF, methotrexate, and placebo. Costs and utilities were discounted by 3%. Probabilistic sensitivity analysis was performed.
Adding LEF to a conventional strategy of DMARDs increased the 5-year management costs by $1,231 compared with the strategy without LEF, which results in a cost-effectiveness ratio of $13,096 per additional year of response to treatment, and cost-utility ratios of $54,229 (RS) and $71,988 (SG) per quality-adjusted life-year gained.
Adding LEF as a new option to a conventional sequence of DMARDs extends the time patients may benefit from DMARD therapy at a reasonable cost effectiveness and cost utility. LEF data are limited to clinical trials; data from observational studies would be needed to corroborate these findings.