Access to new therapies in hospitals depends upon both clinical trial evidence and local Pharmacy and Therapeutics (P&T) committee approval. The process of formulary evaluation by P&T committees is not well-understood.
To describe the formulary decision-making process in Canadian hospitals for cardiovascular medications recently made available on the Canadian market.
Postal survey of hospital pharmacy directors in all Canadian hospitals with more than 50 beds. Target drugs included abciximab, enoxaparin, dalteparin, clopidogrel, eptifibatide and tirofiban.
Of 428 surveys mailed, responses were received from 164 P&T committees representing 350 hospitals for an effective response rate of 82%. While physicians make up the largest proportion of committee membership, pharmacists play an influential role. Information most commonly cited as influencing formulary decisions included published clinical trials (97%), regional guidelines (90%), pharmacoeconomic data (84%), decisions at peer hospitals (73%) and local opinion leaders (60%). However, this information was often not required on formulary applications. Approval timelines varied widely for target medications but there were no regional, hospital or P&T committee characteristics that were independent predictors of early formulary application or approval.
There is wide variability in the time taken for Canadian institutions to adopt new cardiovascular therapies, which is not explained by regional, hospital or P&T committee characteristics. Standardization of the formulary application and evaluation processes, including sharing of information amongst institutions, would lead to broader understanding of the applicable issues, more objectivity and improved efficiency.
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.
Adjuvant trastuzumab is widely used in HER2-positive (HER2+) early breast cancer, and despite its cost-effectiveness, it causes substantial costs for health care. The purpose of the study was to develop a tool for estimating the budget impact of new cancer treatments. With this tool, we were able to estimate the budget impact of adjuvant trastuzumab, as well as the probability of staying within a given budget constraint.
The created model-based evaluation tool was used to explore the budget impact of trastuzumab in early breast cancer in a single Finnish hospital district with 250,000 inhabitants. The used model took into account the number of patients, HER2+ prevalence, length and cost of treatment, and the effectiveness of the therapy. Probabilistic sensitivity analysis and alternative case scenarios were performed to ensure the robustness of the results.
Introduction of adjuvant trastuzumab caused substantial costs for a relatively small hospital district. In base-case analysis the 4-year net budget impact was 1.3 million euro. The trastuzumab acquisition costs were partially offset by the reduction in costs associated with the treatment of cancer recurrence and metastatic disease.
Budget impact analyses provide important information about the overall economic impact of new treatments, and thus offer complementary information to cost-effectiveness analyses. Inclusion of treatment outcomes and probabilistic sensitivity analysis provides more realistic estimates of the net budget impact. The length of trastuzumab treatment has a strong effect on the budget impact.
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.
Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. Symptoms include but are not limited to abdominal pain, nausea, emesis, and diarrhea. Anti-TNF-a drugs are increasingly being used in patients with CD who have inadequate response to conventional therapy. However, these medications are quite expensive. The objective of this study is to evaluate the cost-utility of two anti-TNF-a drugs (infliximab, adalimumab) for refractory CD.
A Markov model was used to estimate the costs and QALYs of three treatments (usual care, infliximab, adalimumab) over a 5 year time horizon. After initial treatment, patients achieve remission, achieve treatment response or remain in the drug refractory health state. Patients who achieve remission or treatment response are at risk of relapse each 3 month model cycle. Patients in the drug refractory health state either remain in the health state or have surgery in each cycle. Different costs and utility values were assigned to the various model health states. Model input parameters including initial response rates, relapse rates, utility values were derived from published literature.
Usual care had both the lowest expected costs ($17,017) and QALYs (2.555), while infliximab had both the highest expected costs ($54,084) and QALYs (2.721). The incremental cost per QALY moving from usual care to adalimumab and from adalimumab to infliximab was estimated to be to be $193,305 and $451,165, respectively.
Based on common willingness to pay thresholds, ant-TNF-a drugs would not be perceived as a cost effective treatment for refractory CD.
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.