Cost-Effectiveness of Lower Extremity Nerve Decompression Surgery in the Prevention of Ulcers and Amputations: A Markov Analysis.

BACKGROUND: The costs and health effects associated with lower extremity complications in diabetes mellitus are an increasing burden to society. In selected patients, lower extremity nerve decompression is able to reduce symptoms of neuropathy and the concomitant risks of diabetic foot ulcers and amputations. To estimate the health and economic effects of this type of surgery, the cost-effectiveness of this intervention compared to current nonsurgical care was studied. METHODS: To estimate the incremental cost-effectiveness of lower extremity nerve decompression over a 10-year period, a Markov model was developed to simulate the onset and progression of diabetic foot disease in patients with diabetes and neuropathy who underwent lower extremity nerve decompression surgery, compared to a group undergoing current nonsurgical care. Mean survival time, health-related quality of life, presence or risk of lower extremity complications, and in-hospital costs were the outcome measures assessed. Data from the Rotterdam Diabetic Foot Study were used as current care, complemented with information from international studies on the epidemiology of diabetic foot disease, resource use, and costs, to feed the model. RESULTS: Lower extremity nerve decompression surgery resulted in improved life expectancy (88,369.5 life-years versus 86,513.6 life-years), gain of quality-adjusted life-years (67,652.5 versus 64,082.3), and reduced incidence of foot complications compared to current care (490 versus 1087). The incremental cost-effectiveness analysis was -€59,279.6 per quality-adjusted life-year gained, which is below the Dutch critical threshold of less than €80,000 per quality-adjusted life-year. CONCLUSIONS: Decompression surgery of lower extremity nerves improves survival, reduces diabetic foot complications, and is cost saving and cost-effective compared with current care, suggesting considerable socioeconomic benefit for society.

Assessing the epidemiological disease burden and health insurance treatment cost of diabetic polyneuropathy based on health insurance claims data / A diabeteses polyneuropathia okozta epidemiológiai és egészségbiztosítási betegségteher elemzése egészségbiztosítási adatok alapján.

Összefoglaló. Bevezetés: Az idegrendszeri károsodás az egyik leggyakrabban kialakuló komplikáció a cukorbetegek körében, mely az egyénnek és a finanszírozónak is jelentos terhet jelent. Célkituzés: Elemzésünk célja volt a diabeteses polyneuropathia okozta epidemiológiai és egészségbiztosítási betegségteher elemzése. Adatok és módszerek: Az adatok a Nemzeti Egészségbiztosítási Alapkezelo (NEAK) finanszírozási adatbázisából származnak, és a 2018. évet fedik le. Meghatároztuk az éves betegszámokat és a 100 000 lakosra jutó igénybevételi prevalenciát, továbbá az éves egészségbiztosítási kiadásokat korcsoportos és nemenkénti bontásban és ellátási típusonként. A vizsgált kórképet a Betegségek Nemzetközi Osztályozása (10. revízió) szerinti G6320-as kóddal azonosítottuk. Eredmények: A diabeteses polyneuropathia kezelésére a NEAK 6,63 milliárd Ft (24,52 millió USD; 20,78 millió EUR) egészségbiztosítási kiadást fordított 2018-ban. E költségek legnagyobb hányadát a gyógyszerek ártámogatása adta (78,29%). A teljes népességre számolt, 100 000 fore vetített prevalencia 862/100 000 fo volt a férfiak, 981/100 000 fo a nok esetében, együtt 924/100 000 fo a járóbeteg-szakellátásban. A 65-74 évesek jelentek meg a legnagyobb számban az egyes ellátási szinteken. A nemek eloszlása között a legtöbb vizsgált korcsoport tekintetében számottevo különbség nem tapasztalható, 65 év felett azonban már jóval magasabb a nok aránya. Következtetés: A betegség elofordulási gyakorisága a nok esetében 15,6%-kal magasabb. Idosebb korban jelentosen magasabb betegszámot figyeltünk meg. A neuropathiás szövodmények elkerülése érdekében a terápiás kezelésen túl a megelozésre is sokkal nagyobb figyelmet javasolunk fordítani. Orv Hetil. 2021; 162(Suppl 1): 38-45. INTRODUCTION: Neurological complications are the most common type of complications among type 2 diabetes mellitus patients, which put a heavy burden on both individuals and health insurance organizations. OBJECTIVE: The aim of our study was to determine the epidemiological and health insurance disease burden of non-insulin-dependent diabetes with neurological complications. DATA AND METHODS: Data were derived from the financial database of the National Health Insurance Fund Administration (NHIFA) of Hungary for the year 2018. Data analysed included annual patient numbers and prevalence of care utilisation per 100 000 population according to age groups and sex. Patients were identified with the following code of the International Classification of Diseases, 10th revision: G6320. RESULTS: In 2018, NHIFA spent 6.63 billion HUF (24.52 million USD; 20.78 million EUR) on treating diabetic polyneuropathy. Reimbursement of pharmaceuticals was the main cost driver (78.29% of total expenditure). Based on patient numbers in outpatient care, prevalence in 100 000 population was 862 men, 981 women, together 924 people based on outpatient-care utilization. Most patients were aged between 65-74 years in all forms of care. Regarding sex, no significant differences were found among most age groups, however, the ratio of women tends to be higher above 65 years of age. CONCLUSION: Prevalence was found to be by 15.6% higher among women. Significantly higher patient numbers were found in old age. Besides therapeutic interventions, prevention should gain considerably more attention to avoid polyneuropathic complications. Orv Hetil. 2021; 162(Suppl 1): 38-45.

Cost-effectiveness analysis of the Neuropad device as a screening tool for early diabetic peripheral neuropathy.

OBJECTIVE: To carry out a cost-effectiveness analysis of the use of Neuropad as a screening test for diabetic neuropathy together with the standard care tool, the 10-g monofilament, in people with diabetes. RESEARCH DESIGN AND METHODS: A cost-effectiveness analysis using a Markov model was developed to assess the impact on costs and outcomes of using Neuropad as a test for diabetic neuropathy (1) as a complement to the standard test, the 10-g monofilament (Neuropad + monofilament vs. monofilament); and (2) as a substitute for the monofilament (Neuropad vs. monofilament); from the healthcare provider perspective. The time horizon was 3 years. Data on costs and health gains were extracted from the literature. The incremental cost-utility ratio was calculated. Deterministic and probabilistic sensitivity analyses were also performed. RESULTS: Compared with standard care, Neuropad, in combination with the 10-g monofilament tool, is the dominant strategy as it leads to higher health gains and lower costs. In practice, compared with using the monofilament alone, performing both tests would lead to a savings of £1049.26 per patient and 0.044 QALY gain. Results were found to be consistent across the sensitivity analyses. CONCLUSIONS: Using both screening tools (Neuropad + monofilament) is a cost-effective strategy and the dominant alternative, when compared against using the 10-g monofilament alone. The results would be of special relevance in the early detection of diabetic peripheral neuropathy and to ensure the efficient allocation of resources and, thus, the sustainability of healthcare systems.

Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes.

PURPOSE OF REVIEW: Diabetic peripheral neuropathy eventually affects nearly 50% of adults with diabetes during their lifetime and is associated with substantial morbidity including pain, foot ulcers, and lower limb amputation. This review summarizes the epidemiology, risk factors, and management of diabetic peripheral neuropathy and related lower extremity complications. RECENT FINDINGS: The prevalence of peripheral neuropathy is estimated to be between 6 and 51% among adults with diabetes depending on age, duration of diabetes, glucose control, and type 1 versus type 2 diabetes. The clinical manifestations are variable, ranging from asymptomatic to painful neuropathic symptoms. Because of the risk of foot ulcer (25%) and amputation associated with diabetic peripheral neuropathy, aggressive screening and treatment in the form of glycemic control, regular foot exams, and pain management are important. There is an emerging focus on lifestyle interventions including weight loss and physical activity as well. The American Diabetes Association has issued multiple recommendation statements pertaining to diabetic neuropathies and the care of the diabetic foot. Given that approximately 50% of adults with diabetes will be affected by peripheral neuropathy in their lifetime, more diligent screening and management are important to reduce the complications and health care burden associated with the disease.

Clinical and economic burdens experienced by patients with painful diabetic peripheral neuropathy: An observational study using a Japanese claims database.

BACKGROUND: Diabetic peripheral neuropathy (DPN) may often be painful. Despite the high prevalence of painful DPN (pDPN) among patients with diabetes mellitus (DM), understanding of its clinical and economic burden is limited. This study aimed to describe the clinical and economic burdens faced by patients with pDPN in Japan, and compared them with those experienced by patients with DPN but without painful symptoms (non-pDPN). METHODS: This retrospective, observational study used data from a large-scale, hospital-based Japanese claims database collected from April 2008 to June 2015. Comorbidities, clinical departments visited, length of hospital stay, and medical costs for the period of ± 6 months from the diagnosis of pDPN or non-pDPN were described for each group. Glycemic control status was examined for each group for patients with glycated hemoglobin data. RESULTS: The data of 8,740 patients with pDPN (mean age 70.0 years, 53.4% male) and 12,592 patients with non-pDPN (mean age 67.7 years, 55.7% male) were analyzed. Patients with pDPN had more comorbidities than patients with non-pDPN; 48.7% and 30.9% of patients in the respective groups had 20 or more comorbidities. The median length of hospital stay was 5 days longer in patients with pDPN. The median total medical costs were higher in patients with pDPN (\517,762) than in patients with non-pDPN (\359,909). Patients with pDPN spent higher median costs for medications, but the costs for glycemic control drugs were similar in both groups. For 3,372 patients with glycated hemoglobin data, glycemic control was similar between the two groups. CONCLUSION: Patients with pDPN experienced greater clinical and economic burdens than patients with non-pDPN, suggesting that patients who develop pDPN may suffer not only from the complications of DM and pain, but also from other comorbid disorders.

Optimizing adaptive design for Phase 2 dose-finding trials incorporating long-term success and financial considerations: A case study for neuropathic pain.

In this paper, we propose an adaptive randomization design for Phase 2 dose-finding trials to optimize Net Present Value (NPV) for an experimental drug. We replace the traditional fixed sample size design (Patel, et al., 2012) by this new design to see if NPV from the original paper can be improved. Comparison of the proposed design to the previous design is made via simulations using a hypothetical example based on a Diabetic Neuropathic Pain Study.

A model to estimate cost-savings in diabetic foot ulcer prevention efforts.

BACKGROUND: Sustained efforts at preventing diabetic foot ulcers (DFUs) and subsequent leg amputations are sporadic in most health care systems despite the high costs associated with such complications. We sought to estimate effectiveness targets at which cost-savings (i.e. improved health outcomes at decreased total costs) might occur. METHODS: A Markov model with probabilistic sensitivity analyses was used to simulate the five-year survival, incidence of foot complications, and total health care costs in a hypothetical population of 100,000 people with diabetes. Clinical event and cost estimates were obtained from previously-published trials and studies. A population without previous DFU but with 17% neuropathy and 11% peripheral artery disease (PAD) prevalence was assumed. Primary prevention (PP) was defined as reducing initial DFU incidence. RESULTS: PP was more than 90% likely to provide cost-savings when annual prevention costs are less than $50/person and/or annual DFU incidence is reduced by at least 25%. Efforts directed at patients with diabetes who were at moderate or high risk for DFUs were very likely to provide cost-savings if DFU incidence was decreased by at least 10% and/or the cost was less than $150 per person per year. CONCLUSIONS: Low-cost DFU primary prevention efforts producing even small decreases in DFU incidence may provide the best opportunity for cost-savings, especially if focused on patients with neuropathy and/or PAD. Mobile phone-based reminders, self-identification of risk factors (ex. Ipswich touch test), and written brochures may be among such low-cost interventions that should be investigated for cost-savings potential.

A Trial-Based Economic Evaluation Comparing Spinal Cord Stimulation With Best Medical Treatment in Painful Diabetic Peripheral Neuropathy.

The objective was to perform an economic evaluation comparing spinal cord stimulation (SCS) in combination with best medical treatment (BMT) with BMT in painful diabetic peripheral neuropathy patients. Alongside a prospective 2-center randomized controlled trial, involving 36 painful diabetic peripheral neuropathy patients with severe lower limb pain not responding to conventional therapy, an economic evaluation was performed. Incremental cost-effectiveness ratios were based on: 1) societal costs and quality-adjusted life years (QALYs), and 2) direct health care costs and the number of successfully treated patients, respectively, both with a time horizon of 12 months. Bootstrap and secondary analyses were performed to address uncertainty. Total societal cost amounted to €26,539.18 versus €5,313.45 per patient in the SCS and BMT group, respectively. QALYs were .58 versus .36 and the number of successfully treated patients was 55% versus 7% for the SCS and BMT group, respectively. This resulted in incremental cost-effectiveness ratios of €94,159.56 per QALY and €34,518.85 per successfully treated patient, respectively. Bootstrap analyses showed that the probability of SCS being cost-effective ranges from 0 to 46% with willingness to pay threshold values ranging between €20,000 and €80,000 for a QALY. Secondary analyses showed that cost-effectiveness of SCS became more favorable after correcting for baseline cost imbalance between the 2 groups, extending the depreciation period of SCS material to 4 years, and extrapolation of the data up to 4 years. Although SCS was considerably more effective compared with BMT, the substantial initial investment that is required resulted in SCS not being cost-effective in the short term. Cost-effectiveness results were sensitive to baseline cost imbalances between the groups and the depreciation period of the SCS material. PERSPECTIVE: Painful diabetic peripheral neuropathy is a common complication of diabetes mellitus and the humanistic and economic burden is high. This article presents the cost-effectiveness of SCS in patients suffering from painful diabetic peripheral neuropathy from a societal and health care perspective with a time horizon of 12 months.

A study on comparative efficacy and cost effectiveness of Pregabalin and Duloxetine used in diabetic neuropathic pain.

AIM: The study was designed for comparing the efficacy and cost effectiveness of Pregabalin and Duloxetine used in Diabetic Neuropathic Pain. METHODS: The prospective interventional 6 month study was conducted in a diabetic clinic of a 500 bedded tertiary care hospital in South India. The subjects having diagnosed with diabetic neuropathy and not treated with Pregabalin and Duloxetine or any other drugs of its class were selected. The data were collected using NPS and Neuro QoL questionnaires. The cost of both drugs used in the study was calculated as the mean of the price of 3 leading common brands of those drugs. The comparative efficacy was calculated by comparing the mean difference produced by both drugs in NPS and QoL scores. The cost effectiveness were calculated by ICER ratio. RESULTS: The results have shown a significant improvement in the mean difference of NPS and Neuro QoL scores of both Pregabalin (p=<0.001) and Duloxetine (p=<0.001) before and after the therapy, the Duloxetine dominates over Pregabalin in both. The mean cost of Pregabalin for 3 months therapy was found to be INR 668.7 and that for Duloxetine was INR 756. Duloxetine showed a better effect but more expensive. ICER ratio was calculated and found that a cost of INR 61.47 per extra QoL gained by Duloxetine. CONCLUSION: The study have revealed that, both drugs are found to be effective.On conducting cost effective analysis, a significant better improvement in QoL of patients was obtained by Duloxetine with comparatively mild increase in the price.

The Therapeutic Effect of Pancreatic Kininogenase on Treatment of Diabetic Peripheral Neuropathy in Patients with Type 2 Diabetes.

Background: To determine the therapeutic efficacy and cost-effective of pancreatic kininogenase (PKase) on treatment of diabetic peripheral neuropathy (DPN) compared with Prostaglandin E1 (PGE1) in patients with type 2 diabetes. Methods: 104 patients with DPN receiving standard glucose control therapy were randomly assigned into 3 groups: Group-A received PKase treatment, Group-B received PGE1 treatment, and Group-C received only standard glucose control therapy. Michigan neuropathy screening instrument (MNSI) score, neurophysiology examination, and nerve conduction velocity were measured. Results: Standard glucose control therapy significantly reduced hyperglycemia to a similar level in all groups. Questionnaire grading and neurophysiology examination both indicated that no significant difference was found at the end of treatment between Groups -A and -B. Except for the ulnar nerve sensory conduction velocity that was significantly improved in Group-B, the remaining nerve conduction velocity (regardless of sensory or motor nerve conduction velocities) was improved to a similar level in Groups -A and -B. Group-A had significantly reduced questionnaire grading and better improvement in motor nerve conduction velocity of the common peroneal nerve, ulnar nerve, and sensory nerve conduction velocity of the sural nerve as compared with Group-C. However, the medical cost of PKase was only 18.9% of that of PGE1 during one course of treatment. Conclusions: PKase has the similar therapeutic efficacy as PGE1 on treatment of DPN in patients with type 2 diabetes. However, the medical cost of PKase is one fifth of that of PGE1. Thus, PKase is a cost-effective drug for treatment of DPN.

Single- Versus Multiple-Drug Pharmacotherapy in the Management of Diabetic Painful Neuropathy.

This study compared patient characteristics and health care costs between newly treated diabetic painful neuropathy (DPN) patients receiving mono- pharmacotherapy and those receiving combination pharmacotherapy. A retrospective cohort was developed through Inovalon's Medical Outcomes Research for Effectiveness and Economics Registry (MORE2) database. Patients included were ≥18 years on the date of first DPN prescription: tricyclic antidepressant, opioids, duloxetine, gabapentin, pregabalin, or lidocaine. The authors conducted a simple proportional hazards model comparing times to discontinuation, switch, or addon. Multiple logistic regression was used to identify predictors of combination pharmacotherapy. There were 7145 patients on mono-pharmacotherapy and 421 patients on combination pharmacotherapy. Patients receiving combination pharmacotherapy were 130% more likely to discontinue their medications than patients receiving mono-pharmacotherapy. Female patients and those with > 7 comorbidities were more likely to be started with combination pharmacotherapy. Elderly patients were less likely to be started with combination pharmacotherapy. The total cost of care difference between mono- and combination pharmacotherapy was not statistically significant (P = .66); therefore, newly treated DPN patients should add on another medication sooner than 30 days when considering combination pharmacotherapy. All first-line medications have similar efficacy; for this reason, cost should be considered in the treatment decision.

TRENDS IN THE CARE AND OUTCOMES OF MEDICARE BENEFICIARIES WITH TYPE 2 DIABETES, 2002-2011.

OBJECTIVE: To summarize characteristics of Medicare beneficiaries with type 2 diabetes and to describe changing trends in care and outcomes. METHODS: We conducted a retrospective cohort study of a nationally representative 5% sample of fee-for-service Medicare beneficiaries 65 years and older with prevalent type 2 diabetes, between January 1, 2002, and December 31, 2011. The main outcome measures were diabetes-related screening tests, mortality, hospital admissions, dialysis, and lower extremity amputation. RESULTS: The average age of Medicare beneficiaries with diabetes was 76.5 years, 56% were women, and 83% were white. Screening practices in beneficiaries with diabetes improved from 2002 to 2011, with rising rates of foot exams, renal screening, hemoglobin A1c tests, and lipid profile tests. The prevalence of nephropathy and neuropathy increased. Although inpatient admissions declined from 2002 to 2011, diabetes-related emergency department visits increased. Amputation and end-stage renal disease remained static, while 1-year mortality declined over the study period. CONCLUSION: In this medically complex group of patients with high comorbidity, we observed improvements in screening practices and room for further improvement. Although the mortality rate decreased, other outcomes did not improve consistently. Health care resource has changed over time, with decreased hospital admissions and increased emergency department visits. ABBREVIATIONS: CCW = Chronic Conditions Data Warehouse ESRD = end-stage renal disease HbA1c = hemoglobin A1c HEDIS = Healthcare Effectiveness Data and Information Set ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification.

The impact of comorbidities on inpatient Charcot neuroarthropathy cost and utilization.

AIMS: The purpose of this study was to portray the impact of comorbidities on inpatient cost and utilization in Charcot neuroarthropathy (CN) patients. METHODS: Two cohorts, CN and diabetic peripheral neuropathy (DPN), were identified by ICD-9 codes in the California Office for Statewide Health Planning and Development 2009-2012 public patient discharge files. DPN and CN costs and length of stay (LOS) were compared adjusting for the number of chronic conditions. The impact of the Elixhauser comorbidity measures and other comorbidities on costs and LOS in CN subjects was evaluated. RESULTS: CN was associated with 17.2% higher costs and 1.4 days longer LOS compared to DPN alone. Adjusting for 0.71 additional chronic conditions in CN patients accounted for 79.8% of variance and estimated a 13.9% cost difference between cohorts. Subjects averaged 4.5 Elixhauser comorbidities with higher scores corresponding to increased cost, LOS, and inpatient mortality. Other diabetic foot risk factors demonstrated that foot ulcers, foot infections, and osteomyelitis had significantly higher costs. Patients with foot ulcers, osteomyelitis, and depression had significantly increased LOS. CONCLUSIONS: Systemic and local comorbidities significantly impact the cost, utilization, and inpatient mortality in inpatient management of Charcot foot.

Long-term cost-effectiveness of initiating treatment for painful diabetic neuropathy with pregabalin, duloxetine, gabapentin, or desipramine.

Painful diabetic neuropathy (PDN) affects nearly half of patients with diabetes. The objective of this study was to compare the cost-effectiveness of starting patients with PDN on pregabalin (PRE), duloxetine (DUL), gabapentin (GABA), or desipramine (DES) over a 10-year time horizon from the perspective of third-party payers in the United States. A Markov model was used to compare the costs (2013 $US) and effectiveness (quality-adjusted life-years [QALYs]) of first-line PDN treatments in 10,000 patients using microsimulation. Costs and QALYs were discounted at 3% annually. Probabilities and utilities were derived from the published literature. Costs were average wholesale price for drugs and national estimates for office visits and hospitalizations. One-way and probabilistic (PSA) sensitivity analyses were used to examine parameter uncertainty. Starting with PRE was dominated by DUL as DUL cost less and was more effective. Starting with GABA was extendedly dominated by a combination of DES and DUL. DES and DUL cost $23,468 and $25,979, while yielding 3.05 and 3.16 QALYs, respectively. The incremental cost-effectiveness ratio for DUL compared with DES was $22,867/QALY gained. One-way sensitivity analysis showed that the model was most sensitive to the adherence threshold and utility for mild pain. PSA showed that, at a willingness-to-pay (WTP) of $50,000/QALY, DUL was the most cost-effective option in 56.3% of the simulations, DES in 29.2%, GABA in 14.4%, and PRE in 0.1%. Starting with DUL is the most cost-effective option for PDN when WTP is greater than $22,867/QALY. Decision makers may consider starting with DUL for PDN patients.

Short-term cost analysis of complications related to glycated hemoglobin in patients with type 1 diabetes in the Italian setting.

AIMS: The aim of this study is to assess the impact of the diabetes-related complications on costs and to shed light on the potential savings that could be obtained by the National Healthcare System if better glycemic control was to be achieved in the type 1 diabetes population. METHODS: Epidemiologic data were used to distribute diabetes type 1 patients into A1c levels, and the relative risk of diabetes-related complications associated with the level of A1c was extrapolated from published risk curves. The costs associated with all complications in the Italian settings, retrieved from published literature, were used to estimate the economic impact of complications in each A1c level from the NHS perspective and the potential savings that could be obtained should a treatment strategy allow to achieve better metabolic control. RESULTS: The reduction in the number of complications translates into consistent monetary savings compared to current scenario. Within 5 years, €29 and €33 million would be saved if all patients reduced their A1c level by 1 % and within the range 7-8 % (53-64 mmol/mol), respectively. CONCLUSIONS: This work allows focusing on the impact of managing the diabetes-related complications on the overall costs, not yet reported in the literature. It was shown that the potential savings for the National Healthcare Service associated with a more effective glycemic control are substantial.

Duloxetine for the treatment of painful diabetic peripheral neuropathy in Venezuela: economic evaluation.

INTRODUCTION: Painful diabetic peripheral neuropathy affects 40-50% of patients with diabetic neuropathy, leading to impaired quality of life and substantial costs. Duloxetine and pregabalin have evidence-based support, and are formally approved for controlling painful diabetic peripheral neuropathy. METHODS: We used a 12-week decision model for examining painful diabetic peripheral neuropathy first-line therapy with daily doses of duloxetine 60mg or pregabalin 300mg, under the perspective of the Instituto Venezolano de los Seguros Sociales. We gathered model parameters from published literature and expert´s opinion, focusing on the magnitude of pain relief, the presence of adverse events, the possibility of withdrawal owing to intolerable adverse events or due to lack of efficacy, and the quality-adjusted life years expected in each strategy. We analyzed direct medical costs (which are expressed in Bolívares Fuertes, BsF) comprising drug acquisition besides additional care devoted to treatment of adverse events and poor pain relief. We conducted both deterministic and probabilistic sensitivity analyses. RESULTS: Total expected costs per 1000 patients were BsF 1 046 146 (26%) lower with duloxetine than with pregabalin. Most of these savings (91%) corresponds to the difference in the acquisition’s cost of each medication. duloxetine also provided 23 more patients achieving good pain relief and a gain of about two quality-adjusted life years per 1000 treated. Model was robust to plausible changes in main parameters. Duloxetine remained the preferred option in 93.9% of the second-order Monte Carlo simulations. CONCLUSIONS: This study suggests duloxetine dominates (i.e., is more effective and lead to gains in quality-adjusted life years), remaining less costly than pregabalin for treatment of painful diabetic peripheral neuropathy.

INTRODUCCIÓN : La neuropatía diabética periférica dolorosa (NDPD) afecta a 40-50% de los pacientes con neuropatía diabética y se asocia con un deterioro significativo de la calidad de vida y con costos de magnitud considerable. Tanto duloxetina (DUL) como pregabalina (PGB) cuentan con sustento científico basado en evidencias y han sido formalmente aprobados para controlar la NDPD. MÉTODOS: Se utilizó un modelo de decisión a 12 semanas para examinar el tratamiento de primera línea para la neuropatía diabética periférica dolorosa, con dosis diarias de duloxetina 60 mg o con pregabalina 300 mg, bajo la perspectiva del Instituto Venezolano de los Seguros Sociales. Los parámetros del modelo proceden de literatura publicada y opinión de expertos, enfocándose en la magnitud del alivio del dolor, la presencia de eventos adversos, la posibilidad de abandono debido a eventos adversos intolerables o por falta de eficacia y en los años de vida ajustados por calidad esperados con cada estrategia. Se analizaron los costos médicos directos (expresados en bolívares fuertes), integrados por la adquisición de medicamentos, además del cuidado adicional que se origina por el tratamiento de los eventos adversos y como consecuencia de un pobre alivio del dolor. Se llevaron a cabo análisis de sensibilidad de tipo determinístico y probabilístico. RESULTADOS: Los costos totales esperados por cada 1000 pacientes fueron de 1 046 146 bolívares fuertes (26%) más bajos con duloxetina en comparación con la pregabalina. La mayor parte de estos ahorros (91%), corresponde a la diferencia en el costo de adquisición entre ambos medicamentos. La duloxetina también se asoció con ganancias de 23 pacientes que lograron un buen alivio del dolor y de dos años de vida ajustados por calidad por cada 1000 tratados. El modelo se mantuvo robusto ante cambios plausibles en sus parámetros principales. La duloxetina continuó siendo la opción preferida en 93,9% de las simulaciones de Monte Carlo de segundo orden generadas. CONCLUSIONES: El presente estudio sugiere que la duloxetina domina a (es más efectiva, conduce a ganancias en años de vida ajustados por calidad y es menos costosa que) la pregabalina, para el tratamiento de la neuropatía diabética periférica dolorosa.

[The cost of polypharmacy in patients with type 2 diabetes mellitus]. / Costo de la polifarmacia en el paciente con diabetes mellitus tipo 2.

BACKGROUND: Polypharmacy or the concomitant use of three or more medications, may increase the complexity of health care and its costs. AIM: To determine the costs of polypharmacy in patients with Type 2 Diabetes Mellitus in a Mexican population sample. PATIENTS AND METHODS: Analysis of health care costs in 257 patients with Type 2 Diabetes Mellitus from two family care facilities, who had at least five consultations during one year. The cost of professional care by family physicians, pharmacological care and medications were considered to calculate the total expenses. The price of medications and the number of units consumed in one year were used to determine pharmacological expenses. Medications were grouped to determine costs derived from complications and concomitant diseases. Costs were calculated in US dollars (USD). RESULTS: The mean cost derived from family physician fees was USD 82.32 and from pharmacy fees USD 29.37. The mean cost of medications for diabetes treatment was USD 33.31, for the management of complications USD 13.9 and for management of concomitant diseases USD 23.7, rendering a total cost of USD 70.92. Thus, the total annual care cost of a diabetic patient was USD 182.61. CONCLUSIONS: Medications represent less than 50% of total expenses of diabetic patients with polypharmacy.

Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature.

AIMS: Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus. A systematic literature review was conducted to provide an overview of published literature in the last 10-years on the epidemiology, humanistic burden and economic burden of PDPN in Europe. METHODS: A search was performed according to pre-defined strategy and review criteria in Embase, Pubmed, and conference proceedings databases from 2003 till December 2012. In total, 30 publications written in English covering the relevant patient population and topics of interest. RESULTS: European prevalence ranges from 6% to 34% in diabetes mellitus patients. PDPN has a significant humanistic and economic impact. Patients are limited in their general functioning and their ability to sleep and often experience anxiety and depression. Not surprisingly, PDPN is associated with reduced Health-Related-Quality-of-Life (HRQoL). PDPN patients incur high health care costs due to hospitalizations and outpatient visits. In addition, the painful symptoms cause impaired work productivity. Studies suggest both humanistic and economic burden increase with higher pain severity. CONCLUSIONS: The burden from PDPN appears to be higher with increasing pain severity. More severe pain leads to a higher impairment in daily functioning, sleep and HRQoL. Higher pain intensity also leads to increasing healthcare costs and work productivity losses.

Costo de la polifarmacia en el paciente con diabetes mellitus tipo 2 / The cost of polypharmacy in patients with type 2 diabetes mellitus

Background: Polypharmacy or the concomitant use of three or more medications, may increase the complexity of health care and its costs. Aim: To determine the costs of polypharmacy in patients with Type 2 Diabetes Mellitus in a Mexican population sample. Patients and Methods: Analysis of health care costs in 257 patients with Type 2 Diabetes Mellitus from two family care facilities, who had at least five consultations during one year. The cost of professional care by family physicians, pharmacological care and medications were considered to calculate the total expenses. The price of medications and the number of units consumed in one year were used to determine pharmacological expenses. Medications were grouped to determine costs derived from complications and concomitant diseases. Costs were calculated in US dollars (USD). Results: The mean cost derived from family physician fees was USD 82.32 and from pharmacy fees USD 29.37. The mean cost of medications for diabetes treatment was USD 33.31, for the management of complications USD 13.9 and for management of concomitant diseases USD 23.7, rendering a total cost of USD 70.92. Thus, the total annual care cost of a diabetic patient was USD 182.61. Conclusions: Medications represent less than 50% of total expenses of diabetic patients with polypharmacy.