What Was, Is No More: Community Pharmacy Economics.

DISCLOSURES: No funding supported the writing of this article. The author is an employee of AmerisourceBergen and leads its Good Neighbor Pharmacy program, which supports independent community pharmacy customers.

Differential Index-Hospitalization Cost Center Impact of Enhanced Recovery After Surgery Program Implementation.

BACKGROUND: Most hospitals in the United States are reimbursed for colectomy via a bundled payment based on the diagnosis-related group assigned. Enhanced recovery after surgery programs have been shown to improve the value of colorectal surgery, but little is known about the granular financial tradeoffs required at individual hospitals. OBJECTIVE: The purpose of this study is to analyze the index-hospitalization impact on specific cost centers associated with enhanced recovery after surgery implementation for diagnosis-related groups commonly assigned to patients undergoing colon resections. DESIGN: We performed a single-institution retrospective, nonrandomized, preintervention (2013-2014) and postintervention (2015-2017) analysis of hospital costs. SETTING: This study was conducted at an academic medical center. PATIENTS: A total of 1297 patients with diagnosis-related group 330 (colectomy with complications/comorbidities) and 331 (colectomy without complications/comorbidities) were selected. MAIN OUTCOME MEASURES: The primary outcome was total index-hospitalization cost. Secondary outcomes included specific cost center expenses. RESULTS: Total median cost for diagnosis-related group 330 in the pre-enhanced recovery after surgery group was $24,111 ($19,285-$28,658) compared to $21,896 ($17,477-$29,179) in the enhanced recovery after surgery group, p = 0.01. Total median cost for diagnosis-related group 331 in the pre-enhanced recovery after surgery group was $19,268 ($17,286-$21,858) compared to $18,444 ($15,506-$22,847) in the enhanced recovery after surgery group, p = 0.22. When assessing cost changes after enhanced recovery after surgery implementation for diagnosis-related group 330, operating room costs increased (p = 0.90), nursing costs decreased (p = 0.02), anesthesia costs increased (p = 0.20), and pharmacy costs increased (p = 0.08). For diagnosis-related group 331, operating room costs increased (p = 0.001), nursing costs decreased (p < 0.001), anesthesia costs increased (p = 0.03), and pharmacy costs increased (p = 0.001). LIMITATIONS: This is a single-center study with a pre- and postintervention design. CONCLUSIONS: The returns on investment at the hospital level for enhanced recovery after surgery implementations in colorectal surgery result largely from cost savings associated with decreased nursing expenses. These savings likely offset increased spending on operating room supplies, anesthesia, and medications. See Video Abstract at http://links.lww.com/DCR/B204. IMPACTO DE LA IMPLEMENTACIÓN DEL PROTOCOLO DE RECUPERACIÓN MEJORADA DESPUÉS DE CIRUGÍA EN EL COSTO DE LA HOSPITALIZACIÓN ÍNDICE EN CENTROS ESPECÍFICOS: La mayoría de los hospitales en los Estados Unidos son reembolsados por la colectomía a través de un paquete de pago basado en el grupo de diagnóstico asignado. Se ha demostrado que los programas de recuperación después de la cirugía mejoran el valor de la cirugía colorrectal, pero se sabe poco sobre las compensaciones financieras granulares que se requieren en los hospitales individuales.El objetivo de este estudio es analizar el impacto del índice de hospitalización en centros de costos específicos asociados con la implementación de RMDC para grupos relacionados con el diagnóstico comúnmente asignados a pacientes que se someten a resecciones de colon.Realizamos un análisis retrospectivo, no aleatorio, previo (2013-2014) y posterior a la intervención (2015-2017) de los costos hospitalarios de una sola institución.Centro médico académico.Un total de 1. 297 pacientes con diagnóstico relacionado con el grupo 330 (colectomía con complicaciones/comorbilidades) y 331 (colectomía sin complicaciones/comorbilidades).El resultado primario fue el índice total de costos de hospitalización. Los resultados secundarios incluyeron gastos específicos del centro de costos.El costo medio total para el grupo relacionado con el diagnóstico de 330 en el grupo de recuperación pre-mejorada después de la cirugía fue de $24,111 ($19,285- $28,658) en comparación con $21,896 ($17,477- $29,179) en el grupo de recuperación mejorada después de la cirugía, p = 0.01. El costo medio total para DRG 331 en el grupo de recuperación pre-mejorada después de la cirugía fue de $19,268 ($17,286- $21,858) en comparación con $18,444 ($15,506-$22,847) en el grupo de recuperación mejorada después de la cirugía, p = 0.22. Al evaluar los cambios en los costos después de una recuperación mejorada después de la implementación de la cirugía para el grupo 330 relacionado con el diagnóstico, los costos de la sala de operaciones aumentaron (p = 0.90), los costos de enfermería disminuyeron (p = 0.02) los costos de anestesia aumentaron (p = 0.20) y los costos de farmacia aumentaron (p = 0.08). Para el grupo 331 relacionado con el diagnóstico, los costos de la sala de operaciones aumentaron (p = 0.001), los costos de enfermería disminuyeron (p < 0.001) los costos de anestesia aumentaron (p = 0.03) y los costos de farmacia aumentaron (p = 0.001).Este es un estudio de un solo centro con un diseño previo y posterior a la intervención.El retorno de la inversión a nivel hospitalario para una recuperación mejorada después de la implementación de la cirugía en la cirugía colorrectal se debe en gran parte al ahorro de costos asociado con la disminución de los gastos de enfermería. Es probable que estos ahorros compensen el aumento de los gastos en suministros de quirófano, anestesia y medicamentos. Consulte Video Resumen en http://links.lww.com/DCR/B204. (Traducción-Dr. Gonzalo Hagerman).

Pharmaceutical cost analysis of dental diseases: An Indian scenario.

BACKGROUND: Medicines are an integral part of the health system and the accessibility hugely depends on affordability and availability of medicines. Oral health is an integral component of overall well-being but is ironically often one of the most neglected areas of healthcare. There is paucity of data on the pharmaceutical cost components of dental disease, so this study aims to address this lacuna on the pricing of medicines. OBJECTIVE: This research study can be considered a partial economic evaluation that focuses on an estimation of costs associated with medicines used in the treatment of selected oral diseases to suggest policy measures to reduce out-of-pocket expenditure on medicines. METHODS: Using cost analysis research design on the PharmaTrac dataset and cross-comparing it with public procurement rates of the Rajasthan Medical Services Corporation (RMSC) indicates that the pharmaceutical cost of treating caries and periodontitis is approximately three times higher if median retail prices are considered instead of RMSC public procurement costs. RESULTS: Medicine cost of treating a single episode of caries or periodontitis using RMSC medicine rates at all levels of care is approximately 1.9-2.5 times lower than retail prices of the same formulations. CONCLUSION: Our results strongly suggest that centralized public procurement of dental medicines with an efficient monitoring and control can reduce the out-of-pocket expenditure.

Comparative Approaches to Drug Pricing.

The United States relies primarily on market forces to determine prices for drugs, whereas most other industrialized countries use a variety of approaches to determine drug prices. Branded drug companies have patents and market exclusivity periods in most industrialized countries. During this period, pharmaceutical companies are allowed to set their list price as high as they prefer in the United States owing to the absence of government price control mechanisms that exist in other countries. Insured patients often pay a percentage of the list price, and cost sharing creates some pressure to lower the list price. Pharmacy benefit managers negotiate with drug companies for lower prices by offering the drug company favorable formulary placement and fewer utilization controls. However, these approaches appear to be less effective, compared with other countries' approaches to containing branded drug prices, because prices are substantially higher in the United States. Other industrialized countries employ various forms of rate setting and price regulation, such as external reference pricing, therapeutic valuation, and health technology assessment to determine the appropriate price.

The impact of pharmaceutical marketing on market access, treatment coverage, pricing, and social welfare.

Pharmaceutical spending in the United States, Canada, and the EU is growing. Public payers cover a large portion of these costs and have responded by instituting various pricing and access policies to limit their expenditure. One challenge that public payers face is additional demand induced by a manufacturer's marketing effort. We use a game theoretic approach to study the impact of pharmaceutical marketing on six practical pricing and access policies: negotiated pricing, open pricing, controlled pricing, a listing process, a risk-sharing arrangement, and a value-based pricing with risk-sharing arrangement. We find that all non-value-based policies result in either restricted access or suboptimal treatment coverage. We find that marketing is the highest in the first-best setting where all decisions are made by a social planner. We also find that the value-based pricing with risk-sharing arrangement is preferred by the manufacturer and from a societal perspective whereas no policy is universally preferred by a health care payer. A value-based pricing with risk-sharing arrangement always results in zero net monetary benefit for a health care payer. Therefore, considering non-value-based arrangements, we find that a negotiated pricing policy, a controlled pricing policy, or a risk-sharing arrangement may be socially preferred.

How much to invest in glycemic control of a patient with diabetes mellitus type 2? A constant dilemma for the Brazilian Public Health System (SUS)

Diabetes mellitus type 2 (DM2) affects millions of people worldwide and causes several complications for the patient, consuming large sums of financial resources from the health services. This study aims to estimate the financial investment of DM2 treatment for glycemic control of the patient, from the point of view of the municipal Public Health System (SUS). The Delphi technique was used to validate the opinion of a team of judges, specialists in DM2, and health service managers, on the investment necessary for glycemic control of patients with DM2 through the application of questionnaires. In order for the patient to achieve glycated hemoglobin (A1c) < 7%, an investment of US$ 2,419.06 (value/patient/year) is necessary. As the value of A1c increases, investment is reduced. This result reveals the intention to allocate resources for the prevention of DM2 and its complications

A Transparent and Consistent Approach to Assess US Outpatient Drug Costs for Use in Cost-Effectiveness Analyses.

BACKGROUND: Assessment of drug costs for cost-effectiveness analyses (CEAs) in the United States is not straightforward because the prices paid for drugs are not publicly available and differ between payers. CEAs have relied on list prices that do not reflect the rebates and discounts known to be associated with these purchases. OBJECTIVES: To review available cost measures and propose a novel strategy that is transparent, consistent, and applicable to all CEAs taking a US health care sector perspective or a societal payer's perspective. METHODS: We propose using the National Average Drug Acquisition Cost (NADAC), the Veterans Affairs Federal Supply Schedule (VAFSS), and their midpoint as the upper bound, lower bound, and base case, respectively, to estimate net drug prices for various payers. We compare this approach with wholesale acquisition cost (WAC), the most common measure observed in our literature review. The minimum WAC is used to provide the most conservative comparison. RESULTS: Our sample consists of 1436 brand drugs and 1599 generic drugs. On average, the upper bound (NADAC) is 1% and 9.8% lower than the WAC for brand and generic drugs respectively, whereas the lower bound (VAFSS) is 48.3% and 54.2% lower than the WAC. The NADAC is less than the WAC in 89.6% of drug groups. The distributions of these relationships do not show a clear mode and have wide variation. CONCLUSIONS: Our study suggests that the WAC may be an overestimate for the base case because the minimum WAC is higher than the NADAC for most drugs. Our approach balances uncertainty and lack of data for the cost of pharmaceuticals with the need for a transparent and consistent approach for valid CEAs.

Industry Payments to Physician Specialists Who Prescribe Repository Corticotropin.

Importance: Despite great expense and little evidence supporting use over corticosteroids, prescriptions for repository corticotropin (H. P. Acthar Gel; Mallinckrodt Pharmaceuticals) have increased markedly. Aggressive sales tactics and payments from the manufacturer may influence prescribing behavior for this expensive medication. Objective: To characterize industry payments to physician specialists who prescribe corticotropin in the Medicare program. Design, Setting, and Participants: This study was a cross-sectional analysis of Centers for Medicare & Medicaid Services 2015 Part D prescribing data linked to 2015 Open Payments data. Nephrologists, neurologists, and rheumatologists with more than 10 corticotropin prescriptions (frequent prescribers) in 2015 were included. Exposures: Frequency, category, and magnitude of corticotropin-related payments from Mallinckrodt recorded in the Open Payments database. Main Outcomes and Measures: Frequency, category, and magnitude of corticotropin-related payments from Mallinckrodt, as well as corticotropin prescriptions and expenditures for Medicare beneficiaries. Results: Of the 235 included physicians, 65 were nephrologists; 59, neurologists; and 111, rheumatologists. A majority of frequent corticotropin prescribers (207 [88%]) received corticotropin-related payments from Mallinckrodt. The median (range) total payment for 2015 was $189 ($11-$138 321), with the highest payments ranging from $56 549 to $138 321 across the specialties. More than 20% of frequent prescribers received more than $10 000 and the top quartile of recipients received a median (range) of $33 190 ($9934-$138 321) in total payments per prescriber. Payments for compensation for services other than consulting contributed the most to the total amount. Mallinckrodt payments were positively associated with greater Medicare spending on corticotropin (ß = 1.079; 95% CI, 1.044-1.115; P < .001), with every $10 000 in payments associated with a 7.9% increase (approximately $53 000) in Medicare spending on corticotropin. There was no association between corticotropin-related payments and spending on prescriptions for synthetic corticosteroids. Conclusions and Relevance: In this study, most nephrologists, neurologists, and rheumatologists who frequently prescribe corticotropin received corticotropin-related payments from Mallinckrodt. These findings suggest that financial conflicts of interest may be driving use of corticotropin in the Medicare program.

Pharmacoeconomic study comparing carbetocin with oxytocin for the prevention of hemorrhage following cesarean delivery in Lima, Peru.

Postpartum hemorrhage is one of the main causes of maternal death. Oxytocin has traditionally been used to prevent postpartum hemorrhage. AIM: To compare oxytocin with carbetocin, a long-acting analog of oxytocin, for prevention of uterine hemorrhage after cesarean delivery. MATERIALS & METHODS: Clinical data were retrieved from the 2012 Cochrane meta-analysis "Carbetocin for preventing postpartum hemorrhage". A decision tree was constructed. The direct costs were those of medications from the Peruvian official price list (DIGEMID). Costs associated with additional oxytocic drugs, blood transfusions, postpartum hemorrhage kits and hysterectomy were obtained from Hospital Nacional Edgardo Rebagliati Martins. The perspective of the study was that of the payer. The time horizon for calculating quality-adjusted life years (QALYs) was 1 year (2015). RESULTS: Patients who received carbetocin required fewer additional uterotonic agents, had fewer hemorrhages and received fewer blood transfusions. Therefore, the costs associated with these interventions were lower. The incremental cost-effectiveness ratio was S/. 49,918 per QALY gained, which is lower than the threshold we estimated for Peru. CONCLUSION: Carbetocin is more cost-effective than oxytocin for prevention of uterine hemorrhage after cesarean delivery.

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries.

This article discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has been shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation; however, implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the hospital and offpatent outpatient sectors has been proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.

The enigma of value: in search of affordable and accessible health care.

In times of shrinking resources and pharmaceutical breakthrough situations, our value-assessing systems are stretched to their very limits. Assessing value is highly complex. Current value-assessment systems risk neglecting important factors, such as therapy duration, budget impact, or the importance of combination therapies. Especially when dealing with breakthrough therapies within high-prevalence indications, these factors play an important role in health care spending. When it comes to assessing value in Switzerland, the system is innovation and access-friendly; the price level of pharmaceutical products, however, is relatively high in comparison to neighboring countries. The Swiss pricing and reimbursement system can still improve in terms of efficiency and transparency.

Economic evaluation of a randomized controlled trial of pharmacist-supervized patient self-testing of warfarin therapy.

WHAT IS KNOWN AND OBJECTIVE: The increase in numbers of patients requiring oral anti-coagulation testing in outpatient clinics has focused attention on alternative flexible systems of anti-coagulation management. One option is pharmacist led patient self-testing (PST) of international normalised ratio (INR) levels. PST has demonstrated improvements in anti-coagulation control, but its cost-effectiveness is inconclusive. This study reports the first cost-effectiveness evaluation of a randomized controlled trial of an automated direct-to-patient expert system, enabling remote and effective management of patients on oral anti-coagulation therapy. METHODS: We conducted an economic evaluation alongside a randomised controlled trial investigating a pharmacist led PST method. The primary outcome was to determine the cost effectiveness of PST in comparison with usual care (management in a hospital based anti-coagulation clinic). Long term anti-coagulation patients were recruited to a 6 month cross over study between PST and routine care in an anti-coagulation clinic. Economic evaluation was from the healthcare payer perspective. RESULTS AND DISCUSSION: On a per patient basis over a 6 month period, PST resulted in an incremental cost of €59.08 in comparison with routine care. Patients achieved a significantly higher time in therapeutic range (TTR) during the PST arm in comparison with routine care, (72 ± 19.7% vs. 59 ± 13.5%). Overall cost of managing a patient through pharmacist supervised PST for a 6 month period is €226.45. Additional analysis of strategies from a societal perspective indicated that PST was the dominant strategy. WHAT IS NEW AND CONCLUSION: Pharmacist led patient self-testing is a viable method of management. It provides significant increases in anti-coagulation control for a minimal increase in cost.

Parallel imports and a mandatory substitution reform: a kick or a muff for price competition in pharmaceuticals?

What has been the effect of competition from parallel imports on prices of locally sourced on-patent drugs? Did the 2002 Swedish mandatory substitution reform increase this competition? To answer these questions, we carried out difference-in-differences estimation on monthly data for a panel of all locally sourced on-patent prescription drugs sold in Sweden during the 40 months from January 2001 to April 2004. On average, facing competition from parallel imports caused a 15-17% fall in price. While the reform increased the effect of competition from parallel imports, it was only by 0.9%. The reform, however, did increase the effect of therapeutic competition by 1.6%.

Updated cost-of-care estimates for commercially insured patients with multiple sclerosis: retrospective observational analysis of medical and pharmacy claims data.

BACKGROUND: For patients with multiple sclerosis (MS), previous research identified key disease sequelae as important cost drivers and suggested that among users of disease-modifying drugs (DMDs) in 2004, DMDs represented 73% of the total cost of care. More recent studies were limited to incident disease/treatment and/or excluded DMDs from cost estimates. To support contemporary pharmacoeconomic analyses, the present study was conducted to provide updated information about MS-related costs and cost drivers including DMDs. METHODS: For each of 2 years, 2006 and 2011, commercially insured, continuously eligible patients with ≥ 1 medical claim diagnosis of MS were sampled. MS-related charges were based on medical claims with MS diagnosis plus medical/pharmacy claims for DMDs. 2006 charges were adjusted to 2011 $ using the medical care component of the consumer price index (CPI). Subgroups of patients using DMDs (interferon [IFN] beta-1a intramuscular or subcutaneous, IFN beta-1b, glatiramer, natalizumab) in 2011 were identified. By-group differences were tested with bivariate statistics. RESULTS: Mean (standard deviation [SD]) age of 15,902 sample patients in 2011 was 47.6 (11.8) years, 76% female. Mean [SD] MS charges ($26,520 [$38,478] overall) were significantly (P < 0.001) higher for patients with common disease sequelae: malaise/fatigue (n = 2,235; $39,948 [$48,435]), paresthesia (n = 1,566; $33,648 [$45,273]), depression (n = 1,255; $42,831 [$51,693]), and abnormality of gait (n = 1,196; $48,361 [$55,472]). From 2006 to 2011, CPI-adjusted MS charges increased by 60%. Among patients treated with a single DMD in 2011, inpatient care was 6% of charges (range = 4%-8%; P = 0.155); outpatient care was 19% (range = 14%-20% except for natalizumab [29%]; P < 0.001); and DMDs were 75% (range = 67%-81%; P < 0.001). CONCLUSIONS: Common MS sequelae remain important cost drivers. Although MS treatment costs are increasing, the proportion of MS charges due to DMDs in 2011 is similar to that reported in 2004.

Consequences, measurement, and evaluation of the costs associated with adverse drug reactions among hospitalized patients in China.

BACKGROUND: Adverse drug reactions (ADRs) are a leading cause of morbidity in developed countries and represent a substantial burden on health-care resources. Many countries spent 15% to 20% of their hospital budgets to treat drug complications. However, few studies have measured the pharmacoeconomic effects of ADRs on hospitalized patients in China. The study estimates the costs of ADRs as identified from the spontaneous voluntary reports completed from healthcare professionals. To do so, we calculate these costs, determine the sum of Medicare payments and their proportion of total healthcare spending, and evaluate the incidence of ADRs, characteristics of hospitalized ADR patients, and outcomes of ADRs in China. METHODS: This retrospective survey studied patients who experienced ADRs during their hospitalization at a Chinese tertiary-care teaching hospital. The patients were divided into group A and group B according to general ADRs and serious ADRs in Provisions for Adverse Drug Reaction Monitoring and Reporting. The direct costs included treatment fees, inspection fees, laboratory fees, materials fees, bed charges, drug charges, nursing care, meals, and other expenses and the sunk-cost losses were calculated according to the hospital information system (HIS). Indirect costs of ADR treatment were calculated according to the human capital approach. The epidemiological characteristics of ADRs were evaluated. RESULTS: 2739 were diagnosed with ADR during the study period, which translates to an ADR rate of 0.81%. The total socioeconomic loss from 2739 cases of ADR was estimated at ¥817401.69, consisting of direct costs of ¥603252.81 and indirect costs of ¥214148.88. On average, the costs per patient amounted to ¥196.10 in group A, ¥7032.29 in group B. The sum of medicare payment and proportion were ¥219061.13 (65.23%) and ¥105422.02 (39.42%) in group A and B. The ADR incidence in old-age patients was significantly higher than in other age groups (P < 0.0001). The most common drug class associated with ADRs represented antibiotics (957 patients, 34.94%). CONCLUSIONS: The costs of especially severe ADRs could not be ignored, and in this hospital 0.13% of patients were diagnosed with ADRs associated with relatively higher direct costs than who suffered from mild ADRs, largely due to extended hospitalization.

The population-based prescription database IADB.nl: its development, usefulness in outcomes research and challenges.

Research databases with large numbers of prescriptions in observational settings can provide valuable information in addition to the initial randomized controlled trials. This paper reports on the development of prescription database IADB, formerly known as InterAction Database. IADB contains prescriptions from 54 community pharmacies in The Netherlands and covers a population of 500,000 people. Both the age distribution and the prevalence of drugs used are comparable to a large extent with the Dutch population. The representativeness of the population covered is examined by comparing population composition and drug use with data of the whole Dutch population. Enriching IADB with, among others, clinical parameters by linking to other databases is explored. A strong and unique aspect of IADB is the possibility to track patients over time, even when they receive their medication from different pharmacies. The authors conclude IADB is a useful tool for pharmacoepidemiological and pharmacoeconomic outcomes research.

Ginkgo biloba extract EGb 761 in the treatment of dementia: a pharmacoeconomic analysis of the Austrian setting.

OBJECTIVE: We used efficacy data from three clinical trials to investigate the pharmacoeconomic implications of treating noninstitutionalized Austrian dementia patients with a drug based on EGb 761R, a standardized extract from Gingkgo biloba. In a separate analysis, we compared the pharmacoeconomic aspects of achieving treatment success with EGb 761R and cholinesterase inhibitors. METHODS: A fixed-effect model was used to conduct a metaanalysis of activities of daily living data from 1,201 patients diagnosed with dementia and treated with either EGb 761R (240 mg/day) or matched placebo for 22 or 24 weeks under double-blind conditions. From this analysis, the delay in activities of daily living (ADL)-based disease progression was estimated. Current Austrian drug reimbursement prices, physician fees, and federal subsidies for seven stages of home care were applied to calculate overall costs in four scenarios. For the comparison with cholinesterase inhibitors, metaanalysis data pertaining to overall clinical impression as published by the Cochrane Group were compared to corresponding data from our EGb 761R studies. RESULTS AND DISCUSSION: The benefit of treatment with EGb 761R (240 mg/day) corresponds to a delay in ADL deterioration by 22.3 months compared to placebo. Overall net savings with EGb 761R treatment ranged from EUR 3,692 to EUR 29,577, mainly driven by delays in progression towards higher home care subsidies. For one additional therapy success with EGb 761R, EUR 530.88 was required. In a tentative cost comparison, cholinesterase inhibitors required higher expenses to achieve treatment success.

Diffusion of innovations in social interaction systems. An agent-based model for the introduction of new drugs in markets.

The existence of imitative behavior among consumers is a well-known phenomenon in the field of Economics. This behavior is especially common in markets determined by a high degree of innovation, asymmetric information and/or price-inelastic demand, features that exist in the pharmaceutical market. This paper presents evidence of the existence of imitative behavior among primary care physicians in Galicia (Spain) when choosing treatments for their patients. From this and other evidence, we propose a dynamic model for determining the entry of new drugs into the market. To do this, we introduce the structure of the organization of primary health care centers and the presence of groups of doctors who are specially interrelated, as well as the existence of commercial pressure on doctors. For modeling purposes, physicians are treated as spins connected in an exponentially distributed complex network of the Watts-Strogatz type. The proposed model provides an explanation for the differences observed in the patterns of the introduction of technological innovations in different regions. The main cause of these differences is the different structure of relationships among consumers, where the existence of small groups that show a higher degree of coordination over the average is particularly influential. The evidence presented, together with the proposed model, might be useful for the design of optimal strategies for the introduction of new drugs, as well as for planning policies to manage pharmaceutical expenditure.

Reimbursement decisions of the All Wales Medicines Strategy Group: influence of policy and clinical and economic factors.

BACKGROUND: There have been several explorations of factors influencing the reimbursement decisions of the National Institute for Health and Clinical Excellence (NICE) but not of other UK-based health technology assessment (HTA) organizations. OBJECTIVE: This study aimed to explore the factors influencing the recommendations of the All Wales Medicines Strategy Group (AWMSG) on the use of new medicines in Wales. METHODS: Based on public data, logistic regression models were developed to evaluate the influence of cost effectiveness, the quality and quantity of clinical evidence, disease characteristics (including rarity), budget impact, and a range of other factors on the recommendations of AWMSG and its subcommittee, the New Medicines Group (NMG). RESULTS: Multivariate analyses of 47 AWMSG appraisals between 2007-9 correctly predicted 87% of decisions. The results are suggestive of a positive influence on recommendations of the presence of probabilistic sensitivity analyses (PSAs) but, counter-intuitively, a statistically significant negative influence of evidence from high-quality randomized controlled trials (RCTs) [odds ratio 0.059; 95% CI 0.005, 0.699]. This latter observation may be attributed to our strict definition of high quality, which excluded the use of surrogate endpoints. Putative explanatory variables, including cost effectiveness, budget impact, underlying disease characteristics and 'ultra'-orphan drug status were not statistically significant predictors of final AWMSG decisions based on our dataset. Univariate analyses indicate that medicines with negative recommendations had significantly higher incremental cost-effectiveness ratios than those with positive recommendations, consistent with the pursuit of economic efficiency. There is also evidence that AWMSG considers equity issues via an ultra-orphan drugs policy. CONCLUSIONS: Consideration of decision uncertainty via PSA appears to positively influence the reimbursement decisions of AWMSG. The significant negative impact of the presence of high-quality RCTs, and the lack of a significant positive impact of other expected factors, may reflect issues in the plausibility of supporting evidence for medicines that received negative recommendations. Furthermore, it serves to emphasize the difficulties in applying the usual hierarchies of evidence to the HTA process, and in particular to the appraisal of high-cost specialist medicines close to market launch.