W. Ken Redekop

The cost effectiveness of Apligraf® treatment of diabetic foot ulcers

AbstractBackground: Diabetic foot ulcers (DFUs) present a treatment challenge and result in a large economic burden, requiring careful evaluation of the clinical efficacy and cost effectiveness of new treatment modalities. DFU clinical trials of the bio-engineered skin substitute Apligraf® (Novartis Pharma AG, Basel, Switzerland) have demonstrated improved clinical efficacy compared with good wound care (GWC) alone. Objective: To determine the economic impact and cost effectiveness of Apligraf® plus GWC compared with GWC alone in the treatment of DFUs. Study perspective: Societal. Methods: A Markov-based simulation model was created to compare the costs and effects of Apligraf® plus GWC to those of GWC alone over a 12-month period. The primary health states were ‘uninfected ulcer’, ‘infected ulcer’, ‘gangrene’, and ‘healed ulcer’. Transition probabilities were based on clinical trial results, while cost estimates were based on estimates of resource utilisation in the Netherlands. The cost-effectiveness outcome measures were the incremental cost per ulcer-free month gained and the incremental cost per amputation avoided. Results: Costs in the first year of treatment were €4656 for Apligraf® plus GWC and €5310 for GWC alone (1999 values). Treatment with Apligraf® led to lower costs since its greater effectiveness offset the added cost of the product. This benefit was realised after 5 months, the crossover point of the two cost curves. Apligraf® use increased the amount of ulcer-free time by by 1.53 months (7.78 vs 6.25) and reduced the risk of amputation (6.3% vs 17.1%). Sensitivity analyses showed that cost parameters (e.g. units of Apligraf® required, cost of treatment practice) and transition probabilities between health states affected the cost results. Conclusions: Treatment with Apligraf® plus GWC resulted in a 12% reduction in costs over the first year of treatment compared with GWC alone. The increased ulcer-free time coupled with a reduced risk of amputation to a large extent offset the initial costs of the product.

Relationships among Self‐Management, Patient Perceptions of Care, and Health Economic Outcomes for Decision‐Making and Clinical Practice in Type 2 Diabetes

OBJECTIVES Type 2 diabetes (T2D) treatment involves complex interactions between biological, psychological, and behavioral factors of care, requiring multifaceted efforts in clinical practice and disease management to reduce health and economic burdens. We aimed to quantify correlations among these factors and characterize their level of inclusion in economic analyses that are part of informed medical decision-making. METHODS A comprehensive, stepwise systematic literature review was performed on published articles dated 1993 to 2008 using medical subject heading and keyword searches in electronic reference libraries. Data were collected using standardized techniques and were analyzed descriptively. RESULTS A total of 97 articles fulfilling all inclusion criteria were reviewed, including 16 on economic models (17% of articles). Most studies were retrospective (41 of 97; 42%) and from managed care perspectives (66%). Oral antidiabetic drugs were a central focus, appearing in 83% of studies. Patient behaviors, particularly medication adherence and persistence in real-world settings, are well researched (n=65) and may influence diabetes outcomes, cardiovascular risk, mortality rates, and treatment-specific resource use (e.g., hospitalizations) and costs (<or=

The cost of treatment of Alzheimer's disease in The Netherlands: a regression-based simulation model.

3400 annually per patient). Nevertheless, they are absent from current economic models. CONCLUSIONS Strong correlations exist between patient behaviors, perspectives of care, health outcomes, and costs in T2D. Enhancing their inclusion in pharmacoeconomic modeling, notably the influence on clinical effectiveness of variation in self-management between treatments, should ultimately lead to more accurate estimates of comparative cost-effectiveness, and thereby improve value-based resource allocation and patient access to appropriate therapy.

The Economic Evaluation of Medical Devices

AbstractObjective: To examine the potential economic impact of treatment of Alzheimer’s disease. Design: Regression-based simulation estimation of the long term costs of Alzheimer’s disease under a number of treatment scenarios. Data from an epidemiological study conducted in Rotterdam, The Netherlands, was used to simulate disease progression. Comparison of the costs and effectiveness experienced by the patients were used to measure the impact of treatment. Patients and intervention: 2 theoretical cohorts of patients with Alzheimer’s disease, one of which receives standard treatment, while the other receives a treatment which slows cognitive decline as measured by the Mini-Mental State Examination (MMSE). Main outcome measures and results: Under one of the scenarios examined, the baseline cost of Alzheimer’s disease was 97 866 euro (EUR; 1996 values) per patient over 10 years’ follow-up; the cost was almost EUR100 000 under all scenarios. Life expectancy following onset was about 4.5 years and MMSE decline was approximately 2 points per year for a typical prevalent (existing) patient and almost twice as much for incident (newly diagnosed) patients (1.82 vs 3.42 points per year, respectively). Slowing the rate of cognitive decline results in a slightly increased life expectancy, with more time being spent at home and less in a nursing home. Total costs (excluding those of therapy) will decrease, but savings will be modest and may well be less than the cost of therapy. Under the same scenario, total savings were EUR1571 per patient which corresponds to an annual break-even cost of just EUR453. Decisions regarding the initiation or termination of therapy will affect both the number of patients treated and the costs and potential savings of treatment. Conclusions: The savings made in treating Alzheimer’s disease will almost certainly be small in comparison with total costs and may well be offset by the cost of the treatment itself. Simulation models can be used to estimate the effect of therapy on the costs of care and can be useful tools in clinical decision-making and allocation of resources. These results show the need for further research into the costs and effects of treatment of Alzheimer’s disease.

Cost Effectiveness of Continuous Terbinafine Compared with Intermittent Itraconazole in the Treatment of Dermatophyte Toenail Onychomycosis: An Analysis Based on Results from the L.I.ON. Study

The economic evaluation of medical technology has evolved as a key element in supporting health budget allocation decisions. Among suppliers of innovation, the medical device industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year. Accordingly, the broad variety of technologies covered by the umbrella term ‘medical devices’ have come under increasing scrutiny regarding their cost effectiveness. In the process, a number of device-specific factors have become apparent, each of which can complicate a thorough economic evaluation and limit its informative value. Some of these factors relate to specific characteristics of device functioning. Examples of such factors include the fact that most technologies require, or form part of, a procedure and that many devices have multiple indications or purposes. Others in turn reflect external conditions and are more general in character, such as the regulatory framework that a medical device manufacturer faces prior to market approval and the structure of the medical device industry. Drawing on the available literature, these complicating factors and their practical implications are discussed and used as a basis to elaborate on the emerging challenges for the economic evaluation of medical devices.

Systematic review of available evidence on 11 high-priced inpatient orphan drugs

AbstractObjective: To compare the costs and effectiveness of 2 oral antifungal treatment regimens in patients with dermatophyte toenail onychomycosis. Design and methods: A cost-effectiveness analysis using a model based on data from the Lamisil versus Itraconazole in Onychomycosis (L.I.ON.) study, a randomised controlled trial comparing continuous terbinafine with intermittent itraconazole. The trial included 4 treatment arms: terbinafine 250 mg/day for 12 or 16 weeks (T12, T16) and itraconazole 400 mg/day for 1 week in every 4 weeks for 12 or 16 weeks (I3, I4). Cost calculations for 6 countries (Finland, Germany, Iceland, Italy, The Netherlands, UK) included costs for medication, physician visits, laboratory tests, management of adverse events and management of relapse. Effectiveness was based on complete cure rates (mycological cure plus 100% toenail clearing). Costs per complete cure were determined and both average and incremental cost-effectiveness ratios were calculated. Perspective: Healthcare system. Main outcome measures and results: In the L.I.ON. study, terbinafine was seen to be more effective than itraconazole (cure rates, 45.8 vs 23.4%). In most comparisons (5 of the 6 countries), the costs of T12 were statistically significantly lower than those of I3 [range: −37 to −173 euros (EUR); 1998 values; 1.172 US dollars = EUR1], indicating that T12 was the dominant strategy (i.e. less expensive and more effective). One exception (Finland) showed an incremental cost-effectiveness ratio of EUR524 per additional cure. In the other 5 countries, T16 and I4 were essentially equal in cost, but the greater effectiveness of T16 (cure rates, 55.1 vs 25.9%) resulted in a situation of extended dominance. Conclusion: From a healthcare system perspective, continuous terbinafine is less costly and more effective than intermittent itraconazole in the treatment of dermatophyte toenail onychomycosis.

Costs and prices of single dental fillings in Europe: a micro‐costing study

BackgroundAttention for Evidence Based Medicine (EBM) is growing, but evidence for orphan drugs is argued to be limited and inferior. This study systematically reviews the available evidence on clinical effectiveness, cost-effectiveness and budget impact for orphan drugs.MethodsA systematic review was performed in PubMed, Embase, NHS EED and HTA databases for 11 inpatient orphan drugs listed on the Dutch policy rule on orphan drugs. For included studies, we determined the type of study and various study characteristics.ResultsA total of 338 studies met all inclusion criteria. Almost all studies (96%) focused on clinical effectiveness of the drug. Of these studies, most studies were case studies (41%) or observational studies (39%). However, for all orphan diseases at least one experimental or quasi-experimental study was found, and a randomized clinical trial was available for 60% of the orphan drugs. Eight studies described the cost-effectiveness of an orphan drug; an equal number described an orphan drug’s budget impact.ConclusionsDespite the often heard claim that RCTs are not feasible for orphan drugs, we found that an RCT was available in 60% of orphan drugs investigated. Cost-effectiveness and budget impact analyses for orphan drugs are seldom published.

Long‐Term Outcomes of Continuous Intrathecal Baclofen Infusion for Treatment of Spasticity: A Prospective Multicenter Follow‐Up Study

Dental fillings represent an established procedure to treat tooth decay. The present paper provides a cost comparison of dental filling procedures across nine European countries. More specifically, the paper aims to estimate the costs and prices (i.e. reimbursement fees) of a single dental filling procedure in an approximately 12-year-old child with a toothache in a lower molar who presents at a dental practice, as described in a case vignette. Both amalgam and composite fillings were examined. Total costs were determined by identifying resource use and unit costs for the following cost components: diagnostic procedures, labour, materials, drugs, and overheads. Altogether, 49 practices provided data for the cost calculations. Mean total costs per country varied considerably, ranging from 8 euros to 156 euros. Labour costs were the most important cost driver in all practices, comprising 58% of total costs. Overhead costs were the second-most important cost component in the majority of countries. Actual cost differences across practices within countries were relatively small. Cost variations between countries were primarily due to differences in unit costs, especially for labour and overheads, and only to a lesser extent to differences in resource use. Finally, cost estimates for a single dental filling procedure based on reimbursement fees led to an underestimation of the total costs by approximately 50%.

The cost effectiveness of tapered versus abrupt discontinuation of oral cyclosporin microemulsion for the treatment of psoriasis.

Long‐term outcomes of 115 patients treated with continuous intrathecal baclofen infusion are reported. A prospective follow‐up study was conducted in eight centers. Patients were followed up over a 12‐month period. The follow‐up scores on the three spasticity scales (Ashworth, spasm, and clonus scales) were significantly lower at every follow‐up visit in comparison to the intake score, except for the clonus scale scores at 12 months. Improvements in health‐related quality of life (EQ‐5D) and functionality (SIP‐68, functional independence measure) were small and nonsignificant. A significant reduction in severity of self‐reported personal problems rating scale was observed. Sixty‐six patients had no adverse events. Types of adverse events reported were wound complications (22%), catheter problems (36%), cerebrospinal fluid leakage (25%), and other complications (17%). Intrathecal baclofen reduces spasticity and severity of patient‐reported problems but its effect on quality of life and functionality is less apparent. Improvements are desired in selection criteria, design of spinal catheters, and outcome scales.

Individualized angiotensin-converting enzyme (ACE)-inhibitor therapy in stable coronary artery disease based on clinical and pharmacogenetic determinants: The PERindopril GENEtic (PERGENE) risk model

AbstractObjective: To assess the cost effectiveness of tapered versus abrupt discontinuation of a microemulsion formulation of cyclosporin in patients with chronic plaque psoriasis. Methods: A cost-effectiveness analysis was performed in parallel with a nonblind, multicentre, international clinical trial of the safety and efficacy of intermittent short courses of cyclosporin. Direct and indirect costs were considered within a 1-year period following randomisation. Patients: Patients with chronic plaque psoriasis inadequately controlled with topical treatment. Study perspective: The studywas conducted froma societal perspective and was performed using data from Canada, Spain, Turkey and the UK. Main outcomes measures: The health outcome used was the total number of systemic therapy-free days (STFDs) over the first year. The mean incremental cost-effectiveness ratio (ICER) was determined by dividing the differences in average cost per patient by the differences in average STFDs per patient. Results: The overall ICER was dominant because tapered discontinuation was associated with both lower costs and improved efficacy in comparison with abrupt discontinuation. Further analyses showed that tapered discontinuation was a cost-effective alternative to abrupt discontinuation therapy, even when a conservative definition for cost effectiveness was adopted. Conclusion: This cost-effectiveness analysis demonstrated that tapering cyclosporin wasmore cost effective than abruptly stopping cyclosporin in patients with chronic plaque psoriasis.