Hospital Prices for Physician-Administered Drugs for Patients with Private Insurance.

BACKGROUND: Hospitals can leverage their position between the ultimate buyers and sellers of drugs to retain a substantial share of insurer pharmaceutical expenditures. METHODS: In this study, we used 2020-2021 national Blue Cross Blue Shield claims data regarding patients in the United States who had drug-infusion visits for oncologic conditions, inflammatory conditions, or blood-cell deficiency disorders. Markups of the reimbursement prices were measured in terms of amounts paid by Blue Cross Blue Shield plans to hospitals and physician practices relative to the amounts paid by these providers to drug manufacturers. Acquisition-price reductions in hospital payments to drug manufacturers were measured in terms of discounts under the federal 340B Drug Pricing Program. We estimated the percentage of Blue Cross Blue Shield drug spending that was received by drug manufacturers and the percentage retained by provider organizations. RESULTS: The study included 404,443 patients in the United States who had 4,727,189 drug-infusion visits. The median price markup (defined as the ratio of the reimbursement price to the acquisition price) for hospitals eligible for 340B discounts was 3.08 (interquartile range, 1.87 to 6.38). After adjustment for drug, patient, and geographic factors, price markups at hospitals eligible for 340B discounts were 6.59 times (95% confidence interval [CI], 6.02 to 7.16) as high as those in independent physician practices, and price markups at noneligible hospitals were 4.34 times (95% CI, 3.77 to 4.90) as high as those in physician practices. Hospitals eligible for 340B discounts retained 64.3% of insurer drug expenditures, whereas hospitals not eligible for 340B discounts retained 44.8% and independent physician practices retained 19.1%. CONCLUSIONS: This study showed that hospitals imposed large price markups and retained a substantial share of total insurer spending on physician-administered drugs for patients with private insurance. The effects were especially large for hospitals eligible for discounts under the federal 340B Drug Pricing Program on acquisition costs paid to manufacturers. (Funded by Arnold Ventures and the National Institute for Health Care Management.).

Home intravenous antibiotherapy and the proper use of elastomeric pumps: Systematic review of the literature and proposals for improved use.

Over several decades, the economic situation and consideration of patient quality of life have been responsible for increased outpatient treatment. It is in this context that outpatient antimicrobial treatment (OPAT) has rapidly developed. The availability of elastomeric infusion pumps has permitted prolonged or continuous antibiotic administration by dint of a mechanical device necessitating neither gravity nor a source of electricity. In numerous situations, its utilization optimizes administration of time-dependent antibiotics while freeing the patient from the constraints associated with infusion by gravity, volumetric pump or electrical syringe pump and, more often than not, limiting the number of nurse interventions to one or two a day. That much said, the installation of these pumps, which is not systematically justified, entails markedly increased OPAT costs and is liable to expose the patient to a risk of therapeutic failure or adverse effects due to the instability of the molecules utilized in a non-controlled environment, instability that necessitates close monitoring of their use. More precisely, a prescriber must take into consideration the stability parameters of each molecule (infusion duration, concentration following dilution, nature of the diluent and pump temperature). The objective of this work is to evaluate the different means of utilization of elastomeric infusion pumps in intravenous antibiotic administration outside of hospital. Following a review of the literature, we will present a tool for optimized antibiotic prescription, in a town setting by means of an infusion device.

Parenteral cytotoxic drug wastage at a tertiary hospital in Kuala Lumpur: How much and why?

PURPOSE: To identify the cost and reasons of returned parenteral chemotherapy regimens at a tertiary hospital in Kuala Lumpur, Malaysia. METHODS: Data were retrospectively extracted from all the Chemotherapy Return Forms in 2016, which is a compulsory documentation accompanying each return of parenteral chemotherapy regimen. The following data were extracted: patient's diagnosis, gender, location of treatment (i.e. ward/daycare clinic), start date of chemotherapy regimen, type of cytotoxic drug returned, dose of cytotoxic drug returned, number of cytotoxic drug preparations returned and reason for return as well as whether the returned cytotoxic drug preparations could be re-dispensed. The cost of wastage was calculated based on the cost per mg (or per unit) of the particular returned cytotoxic drug. RESULTS: One hundred and fifty-nine cases of returned chemotherapy regimen comprising of 231 parenteral cytotoxic drug preparations were analysed. The total cost of returned chemotherapy regimen for 2016 was €3632, with €756 (20.8%) worth of chemotherapy regimens returned due to preventable reasons and €2876 (79.2%) worth of chemotherapy regimens returned due to non-preventable reasons. Approximately 50% of cases returned chemotherapy regimen were due to deterioration of patient's clinical condition and another 24.5% of cases of returned chemotherapy regimen were attributed to adverse drug reactions. CONCLUSION: Wastage associated to non-preventable reasons such as adverse drug reactions and preventable causes like refusal of patients can be further reduced by using newer healthcare innovations and establishment of written institutional protocols or standard operating procedures as references for in-charge healthcare personnel when cytotoxic drug-related issues occur. Adoption of cost-saving strategies that have been proven by studies could further improve current cost containment strategies.

Implications of parenteral chemotherapy dose standardisation in a tertiary oncology centre.

BACKGROUND: Dose banding parenteral chemotherapy has the potential to optimise aseptic unit capacity and reduce drug expenditure without compromising the service provided. METHODS: Dose banding tables from NHS England were implemented into the electronic chemotherapy prescribing system. Compliance to the dose bands was analysed and submitted quarterly. Analysis of drug expenditure, drug use and cost per milligram data was also collected. RESULTS: Expenditure on the 17 drugs identified in the 2016/17 dose standardisation CQUIN reduced by approximately £100,000 per month over the CQUIN despite an increase in the number of prescribed doses of these drugs. At the beginning of the year, the percentage of work compounded in house was 60%, which was reduced to 51% of total workload at the end of the year due to outsourcing commonly prescribed doses from commercial pharmaceutical aseptic manufacturers. CONCLUSION: Dose banding parenteral chemotherapy is an efficient cost-saving strategy which also can help to increase the capacity of the aseptic unit.

Impact of the implementation of a nurse-managed outpatient parenteral antibiotic therapy (OPAT) system in Baltimore: a case study demonstrating cost savings and reduction in re-admission rates.

Objectives: Evidence supports the safety and effectiveness of outpatient parenteral antibiotic therapy (OPAT). A registered nurse (RN)-managed multidisciplinary team OPAT model was implemented at our hospital. We evaluated the impact of the new OPAT model on readmissions during OPAT and other core OPAT processes. Methods: All potential OPAT cases from 1 November 2013 to 31 June 2017 discharged from the Johns Hopkins Bayview Medical Center were followed up in a retrospective cohort study. Relevant clinical and patient characteristics were collected for the first OPAT course per patient. The primary outcome was all-cause readmission to any facility part of the Johns Hopkins Health System within 30 days of OPAT discharge. Proportions of OPAT patients readmitted before and after the implementation of the new OPAT model were compared. A log-binomial regression was used to compare the risk of readmission, adjusted for age, sex, race/ethnicity, site of OPAT care, opioid dependence and OPAT treatment duration. Results: Five hundred and seventeen OPAT patients were included in the analysis; 51.1% were discharged after the implementation of the new OPAT model. Readmission rates decreased from 20.2% to 13.3% following the RN-managed OPAT programme (P = 0.04). The results of the adjusted model indicated that nurse management was associated with a 39% reduction in the risk of readmission (adjusted relative risk 0.61; 95% CI 0.41-0.91; P = 0.01). Our financial evaluation estimated that the reduction in readmissions achieved by the RN-managed model saved the hospital $649 416 over 15 months. Conclusions: The RN-managed OPAT programme was associated with a significant reduction in readmissions.

Organization, quality and cost of oncological home-hospitalization: A systematic review.

BACKGROUND: Home-hospitalization might be a patient-centred approach facing the increasing burden of cancer on societies. This systematic review assessed how oncological home-hospitalization has been organized and to what extent its quality and costs were evaluated. RESULTS: Twenty-four papers describing parenteral cancer drug administration to adult patients in their homes were included. Most papers concluded oncological home-hospitalization had no significant effect on patient-reported quality of life (7/8 = 88%), but large majority of patients were satisfied (12/13, 92%) and preferred home treatment (7/8, 88%). No safety risks were associated with home-hospitalization (10/10, 100%). The cost of home-hospitalization was found beneficial in five trials (5/9, 56%); others reported no financial impact (2/9, 22%) or additional costs (2/9, 22%). CONCLUSION: Despite heterogeneity, majority of reported models for oncological home-hospitalization demonstrated that this is a safe, equivalent and acceptable alternative to ambulatory hospital care. More well-designed trials are needed to evaluate its economic impact.

Validation of the burn intervention score in a National Burn Centre.

The Linköping burn score has been used for two decades to calculate the cost to the hospital of each burned patient. Our aim was to validate the Burn Score in a dedicated Burn Centre by analysing the associations with burn-specific factors: percentage of total body surface area burned (TBSA%), cause of injury, patients referred from other (non-specialist) centres, and survival, to find out which of these factors resulted in higher scores. Our second aim was to analyse the variation in scores of each category of care (surveillance, respiration, circulation, wound care, mobilisation, laboratory tests, infusions, and operation). We made a retrospective analysis of all burned patients admitted during the period 2000-15. Multivariable regression models were used to analyse predictive factors for an increased daily burn score, the cumulative burn score (the sum of the daily burn scores for each patient) and the total burn score (total sum of burn scores for the whole group throughout the study period) in addition to sub-analysis of the different categories of care that make up the burn score. We retrieved 22301 daily recordings for inpatients. Mobilisation and care of the wound accounted for more than half of the total burn score during the study. Increased TBSA% and age over 45 years were associated with increased cumulative (model R2 0.43, p<0.001) and daily (model R2 0.61, p<0.001) burn scores. Patients who died had higher daily burn scores, while the cumulative burn score decreased with shorter duration of hospital stay (p<0.001). To our knowledge this is the first long term analysis and validation of a system for scoring burn interventions in patients with burns that explores its association with the factors important for outcome. Calculations of costs are based on the score, and it provides an indicator of the nurses' workload. It also gives important information about the different dimensions of the care provided from thorough investigation of the scores for each category.

Clinical efficacy, cost analysis and patient acceptability of outpatient parenteral antibiotic therapy (OPAT): a decade of Sheffield (UK) OPAT service.

Outpatient parenteral antimicrobial therapy (OPAT) has evolved relatively slowly in the UK. This study describes the OPAT service based in a large UK teaching hospital in Sheffield, and examines the clinical efficacy, patient acceptability and costs saved over a 10-year period. Data on 3812 episodes of OPAT administered between January 2006 and January 2016 were retrieved from a prospectively maintained electronic database. This study compared the real costs of the OPAT service with estimated costs of conventional inpatient care for these patient episodes, and analysed patient feedback questionnaires that were administered randomly between January 2014 and January 2015. A wide range of infections were managed during the 10-year period. Skin and soft tissue infections accounted for 57% of OPAT episodes. The total number of bed-days saved was 49,854. A successful outcome (cure or improvement) was found in 3357 (88%) episodes. Re-admission occurred in 265 (7%) episodes. The rates of healthcare-associated infections were low: 15 intravenous-line-related infections were recorded (0.3 per 1000 OPAT patient-days). Patient acceptance and satisfaction with OPAT were high. OPAT cost 15%, 39%, 40% and 44% of inpatient costs for an infectious diseases unit, national average costs, other departments (non-infectious diseases unit), and the minimum national average costs for each diagnostic category, respectively. This study shows that OPAT is safe, clinically efficacious and acceptable for treating a wide range of infections with high levels of patient satisfaction and substantial cost savings.

Peritonectomy and hyperthermic intraperitoneal chemotherapy: cost analysis and sustainability.

BACKGROUND: Malignancies of the peritoneum remain a challenge in any hospital that accepts to manage them, due not only to difficulties associated with the complexity of the procedures involved but also the costs, which - in Italy and other countries that use a diagnosis-related group (DRG) system - are not adequately reimbursed. MATERIAL AND METHODS: We analyzed data relative to 24 patients operated on between September 2010 and May 2013 with special regard to operating room expenditure, ICU stay, duration of hospitalization, and DRG reimbursement. The total costs per patient included clinical, operating room, procedure, pathology, imaging, ward care, allied healthcare, pharmaceutical, and ICU costs. RESULTS: Postoperative hospital stay, drugs and materials, and operating room occupancy were the main factors affecting the expenditure for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. We had a median hospitalization of 14 days, median ICU stay of 2.4 days, and median operating room occupancy of 585 min. The median expenditure for each case was € 21,744; the median reimbursement by the national health system € 8,375. CONCLUSIONS: In a DRG reimbursement system, the economic effort in the management of patients undergoing peritonectomy procedures may not be counterbalanced by adequate reimbursement. Joint efforts between medical and administration parties are mandatory to develop appropriate treatment protocols and keep down the costs.

Mandatory infectious diseases approval of outpatient parenteral antimicrobial therapy (OPAT): clinical and economic outcomes of averted cases.

OBJECTIVES: The use of outpatient parenteral antimicrobial therapy (OPAT) has been increasing worldwide due to its evident clinical utility; however, there is also concern about overuse and increased risk to patients in terms of antibiotic toxicity and intravenous line-associated complications. At our university-affiliated county teaching hospital with mandatory Infectious Diseases (ID) approval for all OPAT courses, we looked at clinical outcomes and cost savings of patients denied OPAT. METHODS: Electronic medical records of patients denied OPAT were retrospectively reviewed. Demographic, medical, infection-specific and drug-specific data were collected for each patient, including the regimen ultimately recommended by ID in lieu of OPAT. Patients were determined to have clinical cure, probable cure or treatment failure based on resolution or recurrence of infection for up to 1 year after OPAT denial. The amount of money saved in direct OPAT costs in these patients was calculated. RESULTS: Fifty-six patients were denied OPAT during the study period and were discharged with either oral or no additional antibiotics. Clinical cure was documented in 42 patients (75%), probable cure in 7 patients (12.5%) and treatment failure in 7 patients (12.5%). Of the seven treatment failures, only one patient (1.8%) was deemed to be a true failure after thorough chart review. Overall, the estimated OPAT-specific cost saving was $215 424 or $3847 per patient. CONCLUSIONS: Mandatory ID approval of all OPAT courses can decrease healthcare costs while maintaining good clinical outcomes.

Medicamentos Genéricos. Contener el gasto farmacéutico pero con garantías de calidad / Generic drugs: we must cut pharmaceutical spending but undertaking drug quality

La Organización Mundial de la Salud y todas las agencias reguladoras de medicamentos (ARM) están promoviendo la comercialización de medicamentos genéricos con un objetivo fundamental de contención del gasto farmacéutico. Además los medicamentos genéricos son opciones terapéuticas irreemplazables en países que carecen de los medicamentos innovadores. Los medicamentos genéricos son considerados sustitutos coste-eficientes de los medicamentos de marca, y en España suponen alrededor del 20% del total de prescripciones, cifras todavía lejanas con respecto de la utilización de los mismos en Estados Unidos y otros países de la Unión Europea. A pesar del interés económico en el empleo de genéricos, en este artículo revisaremos su interés desde el punto de vista clínico-farmacológico como sustancias que deben cumplir unos requisitos mínimos de calidad para garantizar su eficacia y seguridad en los pacientes. Un medicamento genérico es un fármaco comparable al medicamento innovador o de referencia (o de marca) en la dosis, presentación, vía de administración, cualidad e indicaciones. El medicamento genérico y el de marca tienen que demostrar su equivalencia terapéutica. Con la excepción de los administrados por vía parenteral, dos medicamentos demuestran su equivalencia terapéutica si tras la administración de una dosis molar idéntica, sus efectos en términos de eficacia y seguridad son similares, comprobado exclusivamente por los estudios de bioequivalencia, comparando los parámetros farmacocinéticos y la biodisponibilidad de los productos. Las formulaciones parenterales no tienen que demostrar su bioequivalencia terapéutica ya que ella se considera evidente desde el principio. Tal consideración debería revisarse, especialmente en relación con los medicamentos antiinfecciones parenterales. Conviene mencionar que aunque un medicamento de marca y el correspondiente genérico, tras su aprobación por la correspondiente agencia reguladora, son intercambiables en relación con sus efectos clínicos, pueden variar de forma muy notoria en las características de la presentación y su apariencia. Los consumidores de los medicamentos de marca reciben siempre el mismo producto con las mismas características. Sin embargo, los pacientes que toman fármacos genéricos tienen que asumir que los comprimidos o las cápsulas pueden variar en el tamaño, color y la forma dependiendo del tipo de fabricante que suministra el producto(AU)

The World Health Organization and all drug regulatory agencies (DRA) support the commercialization of generic medicines because they control costs and are irreplaceable therapeutic options in countries lacking the innovator product. Generic drugs are widely considered to be cost-efficient substitutes for brand-name medications. They make up about 20% of the total number of prescriptions in Spain, a figure that is still far from the use of generic drugs in USA and other European countries. Despite economical interest in this issue, in this article we review the interest of generic drugs from a pharmacological and clinical perspective that must undertake drug quality to ensure drug efficacy and safety of the patients. A generic drug (generic drugs, short: generics) is defined as «a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use». Both the reference drug and the generic drug have to demonstrate previously they are therapeutically equivalent. With the exception of parenteral drugs, two products have demonstrated to be therapeutically equivalent if after administration in the same molar dose, their effects with respect to both efficacy and safety are essentially the same, as determined from bioequivalence studies in terms of comparison of appropriate pharmacokinetic parameters and bioavailability. Parenteral formulations, however, are not required to demonstrate therapeutic equivalence because it may be considered self-evident. Such assumptions have never been challenged, but there are reasons to do so for parenteral antimicrobials. It is interesting to highlight that although brand-name drugs and generic drugs are both approved by DRA and may be interchangeable with respect to their clinical effects, they can differ substantially in their appearance. Consumers of brand-name medications receive identical-appearing batches of pills with each refill, whereas consumers of generic drugs must be prepared to receive pills of a different size, color, and shape, depending on which manufacturer is supplying their pharmacies(AU)

[Hyperthermic intraperitoneal chemotherapy in the German DRG system. Analysis of case cost calculations of a maximum care university]. / Hypertherme intraperitoneale Chemotherapie im G-DRG-System. Analyse der Fallkostenkalkulationen eines universitären Maximalversorgers.

BACKGROUND: Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) offers patients with peritoneal cancer of various origins the chance of a relevant increase in life expectancy. These cases are very complex from a medical viewpoint and very expensive from an economical aspect. An analysis of case cost calculations was performed to find out whether this procedure can on average be carried out cost-effectively by a maximum care university. MATERIALS AND METHODS: All cases from 2008 in which HIPEC was carried out were analyzed. The types of main diagnosis, secondary diagnoses, procedures, times from incision to suture and hospital stay were analyzed. On the basis of the case costs the proceeds and marginal returns were calculated from the diagnosis-related groups (DRGs) and additional remuneration when applicable. The causes of positive and negative marginal returns were explained using the InEK cost matrix. RESULTS: In 18 patients there were 9 different main diagnoses and 7 different "main procedures" (from a surgical perspective the most resource intensive procedures) and a total of 10 different DRGs were identified in the grouping algorithm. With an average of 2 operations (range 1-7) per patient the summed incision-to-suture time was 423 min (170-962 min). The patients stayed on average 6.4 days (1.3-17.6 days) in intensive care. The average case cost was 21,072€ (range 8,657-55,904€) and the proceeds 20,474€ (6,333-37,497€). Each case had on average a debit balance of 598€ (range from 11,843€ profit balance to 18,407€ debit balance) with an assumed base rate of 2,786€. The causes for positive or negative marginal profits were mostly operating times, incision-to-suture times and duration of intensive care. CONCLUSIONS: The proceeds showed on average a deficit of only 3% compared to the costs. The operating times must be decreased by optimization particularly of the preoperative approach. Interventions should be carried out in one stage only and the intraoperative connecting and waiting times should be reduced in order to reduce the incision-to-suture times.

Health-related quality of life, treatment satisfaction, and costs associated with intraperitoneal versus subcutaneous insulin administration in type 1 diabetes: a randomized controlled trial.

OBJECTIVE: To investigate the effects of continuous intraperitoneal insulin infusion (CIPII) compared with subcutaneous insulin on health-related quality of life (HRQOL) and treatment satisfaction, and to perform a cost analysis in type 1 diabetes. RESEARCH DESIGN AND METHODS: We used an open-label, prospective, crossover, randomized, 16-month study (N = 24). HRQOL and patient satisfaction were assessed with questionnaires (the 36-item short-form health survey [SF-36], the World Health Organization-Five Well-Being Index [WHO-5], and the Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Direct costs of CIPII and continuous subcutaneous insulin infusion (CSII) were compared. RESULTS: Questionnaire scores were higher with CIPII than with subcutaneous therapy. Yearly direct pump- and procedure-associated costs for CIPII were estimated at 10,910 euroscompared with 4,810 euros for CSII. CONCLUSIONS: Apart from improving glycemic control, CIPII improved HRQOL and treatment satisfaction compared with subcutaneous insulin. Direct pump- and procedure-associated costs are considerably higher for CIPII, however.

A cost analysis of Outpatient Parenteral Antibiotic Therapy (OPAT): an Asian perspective.

The concept of Outpatient Parenteral Antibiotic Therapy (OPAT) is relatively new in Asia. This study compared the actual costs and outcomes of care involving OPAT with conventional inpatient-only care at a university hospital in Singapore. Actual costs were obtained for selected patients enrolled in OPAT after 1 January 2005 and these costs were directly compared with those of age-, gender- and diagnosis-matched patients managed as inpatients only prior to the availability of OPAT in the preceding 12 months. Outcomes of patients were also considered. The OPAT and inpatient-only groups comprised 72 and 93 enrollments, respectively. Mean treatment duration for OPAT patients was 42.5 days versus 19 days for those receiving inpatient-only care (P < 0.001). The mean total treatment cost for OPAT and inpatient-only care was US$12 736 and $12 403, respectively (P = 0.706). Mean cost per day for care including an OPAT episode was US$278 versus $457 per day for inpatient-only care (P < 0.001). There was no difference in outcomes between the two groups. OPAT is a viable alternative to inpatient care as it is safe, effective and results in lower daily costs. The trend to longer treatment courses is worthy of further review.

Experience using peripherally inserted central venous catheters for outpatient parenteral antibiotic therapy in children at a community hospital.

BACKGROUND: Outpatient parenteral antibiotic therapy with peripherally inserted central catheters (PICCs) is safe, clinically effective, and cost effective in pediatric populations cared for at academic and free-standing pediatric hospitals. Our study evaluates the transferability of these findings to a community hospital setting. METHODS: Data were retrospectively collected on PICCs used in children at a community hospital from December 2003 to September 2006. The Fisher exact test and a logistic regression were used for statistical analysis. RESULTS: Thirty-nine PICCs were placed in 34 patients. The total number of catheter days at home was 800 (mean 20.5 +/- 13.9). We demonstrated a 97% success rate in completing therapy at home, with 82.3% completion with a single PICC. Our overall complication rate was 33.3%, consisting of occlusion, accidental displacement, cracks in the catheters, and local irritation. There were no instances of phlebitis or suspected or confirmed catheter infection or sepsis. There were no statistically significant differences in these values compared with reports from major pediatric centers. The cost savings was $1070 per day of home health care when compared with costs of inpatient hospitalization. CONCLUSIONS: We believe that this is the first study to demonstrate the effectiveness of PICC use for outpatient parenteral antibiotic therapy in pediatric patients in a community hospital setting, and demonstrates the ability for this to be done at the standard of care expected at major pediatric centers.

Treatment of invasive fungal infections: stability of voriconazole infusion solutions in PVC bags

Voriconazole is a novel broad-spectrum antifungal drug, employed in the treatment of invasive fungal infections, and represents an alternative to amphotericin B treatment. The manufacturer recommends that any unused reconstituted product should be stored at 2ºC to 8ºC, for no more than 24 h, but no recommendations about i.v. infusion solutions are given. Previous works have reported on the stability of voriconazole in polyolefin bags and just one in 5 percent dextrose polyvinyl chloride (PVC) bags, at a 4 mg.mL-1 concentration. In this work, the stability of voriconazole as an i.v. infusion solution in 0.9 percent sodium chloride and in 5 percent dextrose, in PVC bags, at 0.5 mg.mL-1, stored at 4 ºC and at room temperature, protected from light, was evaluated. These infusion solutions were analyzed for a 21-day period. Chemical stability was evaluated by HPLC assay. Visual inspection was performed and pH of the solutions was measured. No color change or precipitation in the solutions was observed. The drug content remained above 90 percent for 11 days in 0.9 percent sodium chloride and for 9 days in 5 percent dextrose solutions. The i.v. infusion solutions stored at room temperature were not stable. At room temperature, the voriconazole content dropped down to 88.3 and 86.6 percent, in 0.9 percent sodium chloride or 5 percent dextrose solutions, respectively, two days after admixture. Assays performed at the end of the study suggest the sorption of voriconazole by the PVC bags. The results of this study allow cost-effective batch production in the hospital pharmacy.

Capecitabine versus bolus fluorouracil plus leucovorin (folinic acid) as adjuvant chemotherapy for patients with Dukes' C colon cancer : economic evaluation in an Italian NHS setting.

BACKGROUND AND OBJECTIVE: In the recent X-ACT (Xeloda in Adjuvant Colon cancer Therapy) trial, oral capecitabine (Xeloda) demonstrated superior efficacy and an improved safety profile compared with infused fluorouracil + leucovorin (folinic acid) [FU+LV] in patients with Dukes' C colorectal cancer. We used the X-ACT results to determine the cost effectiveness of capecitabine compared with FU+LV from the perspective of the Italian National Health Service (NHS). METHODS: Medical resource use data were collected throughout the treatment period. Unit costs for drug administration, hospitalization, emergency room visits and concomitant medications were obtained using Italian published sources. A health-state transition model was used to estimate the incremental cost-effectiveness ratio per quality-adjusted life-month (QALM) gains in the intent-to-treat population (1004 and 983 patients in the capecitabine and FU+LV arms, respectively). Costs and effectiveness were discounted at 3.5%. Costs were calculated in euros (2005 values). RESULTS: Administration of capecitabine required fewer clinic visits per patient than FU+LV (7.35 vs 28.0, respectively). Mean acquisition costs per patient for capecitabine were higher than for FU+LV (euro 2533 vs euro 231, respectively), but this difference was offset by the difference in mean chemotherapy administration costs per patient for FU+LV (euro 4338, compared with euro 152 for capecitabine). Mean total hospital days and medication costs for treatment-related adverse events were higher for FU+LV than for capecitabine (euro 352 vs euro 78, respectively). The cost of emergency room visits for the treatment of adverse events did not differ between the treatment groups. With respect to the lifetime horizon, compared with FU+LV, capecitabine is projected to increase QALMs by a mean 6.5 months, with overall cost savings of euro 2234 over the treatment period. These findings show that capecitabine is an economically dominant treatment in this setting. CONCLUSIONS: Adjuvant capecitabine for patients with Dukes' C colon cancer has the same activity in terms of outcome when compared with FU+LV but is a lower cost option from the economic perspective of the Italian NHS.