Economic burden of chemotherapy-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck in France: real-world data from the permanent sample of national health insurance beneficiaries.

Aims: Overall survival (OS) of patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) is extremely poor. New therapeutic options emerge but need to establish their economic value. The objective was to describe the direct and related costs of R/M SCCHN in France. Materials and methods: We selected all adult patients treated with chemotherapy for R/M SCCHN between 1 January 2009 and 31 December 2014 from the permanent sample of the French national health insurance database (EGB). Data were analyzed from the index date (first chemotherapy) until patients' death or 31 December 2015. "Treatment period" and "end-of-life" (EoL) (from last chemotherapy until death) were distinguished. Costs included all hospitalizations for SCCHN and ambulatory care. Costs of hospitalized and non-hospitalized adverse events (AEs) were estimated. Results: Among 267 patients identified, 85% were men, 44% had metastases at the index date and the mean age was 62.0 years (±9.9). The most common tumor location was oropharynx (29%) but 39% of patients had multiple locations. Median OS was 9.3 (95% CI: 7.9-11.8) months for the overall population. The average total direct cost per patient was €49,954, broken down into €32,908 (95% CI: 29,525-36,290) for hospitalizations and €17,047 (14,941-19,152) for ambulatory care. Main cost drivers were drug acquisition and administration (€14,538) during the treatment period (209 days on average) and palliative care (€3,750) during the EoL period (125 days). Regarding related costs, around 12% of patients received disability pensions (€1,397 per patient [624-2,171]) and sick leave payments (€1,592 [888-2,297]). "Metabolism and nutrition disorders" and "Infections and infestations" were the most expensive hospitalized AEs (€1,513 and €1,180 per patient, respectively). Febrile neutropenia was the most expensive non-hospitalized AE (€766 per patient). Conclusions: This analysis of real-world data confirms the poor prognosis of patients with R/M SCCHN and provides cost data for future economic evaluations.

Effectiveness and cost of contraception in France (FACET study): a cohort study from the French National Healthcare Insurance Database.

OBJECTIVE: To assess the effectiveness and costs associated with contraceptive methods based on real-world data in France. STUDY DESIGN: A cross-sectional cohort study based on data from a representative sample of the French National Healthcare Insurance Database (Echantillon Généralistes des Bénéficiaires (EGB)) was performed between January 1st 2006 and December 31st 2012. Women aged 15 years or older and users of at least one reimbursed contraceptive method between January 1st 2012 and December 31st 2012 were selected. The outcome of interest was unintended pregnancy, defined as pregnancies occurring after at least one month since the dispensation of a contraceptive method. The mean annual costs of contraceptive methods (in 2012 Euros) were collected in the database from a health system perspective. Costs were expressed for the first year of use, considering the next years of use and taking into account or not the cost of unplanned pregnancies. RESULTS: A population of 48,090 women representative of the 4,664,730 French women with a reimbursed contraceptive method was identified in the EGB in 2012: 68.6% used at least one reimbursed oral contraception (OC), 30.2% used at least one intrauterine devices (IUD) (LGN-IUS 52 mg, 17.6%; copper, 13.1%) and 5.1% used at least one etonogestrel implant. Unplanned pregnancies rates ranged from 0.6% with LNG-IUS 52 mg and 0.8% with the etonogestrel implant to 4.8% with 1st and 2nd generation combined OCs. The mean annual costs of contraception for the first year of use ranged from €145 for 1st-2nd generation combined oral contraceptions (COCs) to €308 for LNG-IUS 52 mg taking into account the next years of use, the etonogestrel implant was associated with the lowest mean annual cost (€88). When costs of unplanned pregnancies were taken into account, the mean annual cost of contraception for the first year of use was lower for progestin-only OC (€251) and copper IUD (€257) compared to etonogestrel implant (€300) and LNG-IUS 52 mg(€323). CONCLUSION: This real-world study suggests that Long-acting reversible contraceptives (LARCs) (i.e. implant and IUDs) should be considered for a broader use to prevent unplanned pregnancies and related abortions in France both from a public health and economic perspective.

Economic impact of ulipristal acetate on surgical procedures for uterine fibroids in France.

OBJECTIVE: To assess the budget impact of using ulipristal acetate (UPA) 5 mg to treat women with uterine fibroids (UF) causing moderate to severe symptoms. DESIGN: We modelled trends in the number of surgical procedures for symptomatic UF, with and without the use of UPA for preoperative or intermittent treatment and assessed the budget impact of UPA use from the French national healthcare insurance system perspective. SETTING: A French national hospital database (PMSI) that records admissions and relative procedures to public and private hospitals. PARTICIPANTS: Women eligible for surgical procedures for uterine fibroids. MAIN OUTCOME MEASURES: Economic impact of UPA treatment. RESULTS: This study based on observational retrospective data shows that the current use of UPA in its preoperative indication was associated with 5645 fewer surgeries from 2013 to 2015. Extrapolation suggests 17 885 fewer surgeries from 2016 to 2019. Overall, preoperative use of UPA results in substantial cost savings for the French national healthcare insurance system, with a cumulated budget impact estimated at €-5 million from 2013 to 2015 and €-13.5 million from 2016 to 2019. In addition, treating women nearing the menopause (≥48 years old) with intermittent treatment from 2017 to 2019 could produce an incremental cost saving of €19 million. CONCLUSIONS: This study shows that the use of UPA in women eligible for surgical procedures for UF is associated with considerable savings for the French national healthcare insurance system in both preoperative and intermittent indications by decreasing the need to perform surgeries.

Management and cost analysis of cancer patients treated with G-CSF: a cohort study based on the French national healthcare insurance database.

OBJECTIVES: To describe the management and costs associated with G-CSF therapy in cancer patients in France. METHODS: This study analyzed a representative random population sample from the French national healthcare insurance database, focusing on 1,612 patients with hematological or solid malignancies who were reimbursed in 2013 or 2014 for at least one G-CSF treatment dispensed in a retail pharmacy. Patient characteristics and treatment costs were analyzed according to the type of cancer. Then the costs and characteristics of patients associated with the use of different G-CSF products were analyzed in the sub-set of breast cancer patients. RESULTS: The most frequent malignancies in the database population were breast cancer (23.3%), hematological malignancies (22.2%), and lung cancer (12.4%). The reimbursed G-CSF was pegfilgrastim in 34.1% of cases, lenograstim in 26.7%, and filgrastim in 17.9%. More than one G-CSF product was reimbursed to 21.3% of patients. The total annual reimbursed health expenses per patient, according to the type of G-CSF, were €27,001, €24,511, and €20,802 for patients treated with filgrastim, lenograstim, and pegfilgrastim, respectively. Ambulatory care accounted for, respectively, 35%, 38%, and 41% of those costs. In patients with breast cancer, ambulatory care cost was €7,915 with filgrastim, €7,750 with lenograstim, and €6,989 with pegfilgrastim, and the respective cost of G-CSF was €1,733, €1,559, and €3,668. CONCLUSION: All available G-CSF products have been shown to be effective in cancer patients, and both daily G-CSFs and pegylated G-CSF are recommended in international guidelines. Nevertheless, this analysis of G-CSF reimbursement indicates that the choice of product can markedly affect the total cost of ambulatory care.

Effectiveness and cost of hepatitis C virus cryoglobulinaemia vasculitis treatment: From interferon-based to direct-acting antivirals era.

BACKGROUND: The net benefits of new hepatitis C virus (HCV) direct-acting antiviral drugs (DAA) in patients with cryoglobulinaemia vasculitis (CryoVas) are unknown. OBJECTIVE: To analyse the effectiveness and cost of all treatments used for HCV-CryoVas in the DAA vs pre-DAA era. METHODS: A chart review of all HCV-CryoVas patients who received antivirals from 1993 to 2016 in a tertiary centre was performed. Treatment effectiveness was analysed for clinical, immunological and virological responses. Cost analyses included anti-HCV treatments, non-antiviral drugs, plasmapheresis, dialysis and hospitalizations. We compared main data in the pre-DAA vs DAA period. RESULTS: About 201 HCV-CryoVas patients were included (women, 53.2%; mean age, 59.2 years; Metavir score F3-F4, 36.7%; genotype 1, 64.2%). Patients in the DAA era (n=27) compared to those in the pre-DAA era (n=174) showed higher rates of clinical (96.3% vs. 78.6%), immunological (89.5% vs. 77.1%), and sustained virological response (75.0% vs. 42.8%). Death rate was 14.8% vs. 24.4% respectively. In the DAA compared to pre-DAA era, mean cost of anti-HCV drugs increased from 11 855 to 57 632 € while mean CryoVas-related cost decreased for both hospitalizations (from 33 510 to 21 347€) and non-antiviral treatments (from 17 347 to 11 397€). CONCLUSION: Improved antiviral efficacy of HCV drugs in the DAA era led to increased clinical and immunological efficacy and a lower death rate. Use of DAAs was associated to higher costs for HCV drugs while costs related to both hospitalizations and non-antiviral treatments decreased.

Ready-to-use pre-filled syringes of atropine for anaesthesia care in French hospitals - a budget impact analysis.

BACKGROUND: Patient safety is improved by the use of labelled, ready-to-use, pre-filled syringes (PFS) when compared to conventional methods of syringe preparation (CMP) of the same product from an ampoule. However, the PFS presentation costs more than the CMP presentation. OBJECTIVE: To estimate the budget impact for French hospitals of switching from atropine in ampoules to atropine PFS for anaesthesia care. METHODS: A model was constructed to simulate the financial consequences of the use of atropine PFS in operating theatres, taking into account wastage and medication errors. The model tested different scenarios and a sensitivity analysis was performed. RESULTS: In a reference scenario, the systematic use of atropine PFS rather than atropine CMP yielded a net one-year budget saving of €5,255,304. Medication errors outweighed other cost factors relating to the use of atropine CMP (€9,425,448). Avoidance of wastage in the case of atropine CMP (prepared and unused) was a major source of savings (€1,167,323). Significant savings were made by means of other scenarios examined. The sensitivity analysis suggests that the results obtained are robust and stable for a range of parameter estimates and assumptions. STUDY LIMITATIONS: The financial model was based on data obtained from the literature and expert opinions. CONCLUSION: The budget impact analysis shows that even though atropine PFS is more expensive than atropine CMP, its use would lead to significant cost savings. Savings would mainly be due to fewer medication errors and their associated consequences and the absence of wastage when atropine syringes are prepared in advance.

Persistence and adherence to single-tablet regimens in HIV treatment: a cohort study from the French National Healthcare Insurance Database.

OBJECTIVES: To compare adherence and persistence (continuous treatment with a prescribed medication) in HIV adult patients who received combination ART (cART) as a once-daily single-tablet regimen (STR) versus other administration schedules. METHODS: A representative random sample of the French National Healthcare Insurance Database was used. Adherence and persistence were compared according to their administration schedules using χ(2) and survival analyses. STRs were marketed in France in 2009 and the study period was selected to allow a sufficient number of patients with an STR and a relevant duration of follow-up. RESULTS: During the period covered (2006-11), 362 HIV-positive adult antiretroviral-naive patients (566 lines of treatments) were selected. The mean rates of adherence were 89.6% for the STR (tenofovir/emtricitabine/efavirenz; n = 76), 86.4% for cART with >1 pill once daily (n = 242) and 77.0% for cART with >1 daily intake (n = 248; P < 0.0001 versus STR). Kaplan-Meier estimations of persistence after 2 years of treatment were 79.1% for the STR, 53.3% for cART with >1 pill once daily and 51.8% for cART with >1 daily intake (P = 0.001; log-rank test). Sensitivity analyses confirmed these results. After excluding treatment sequences showing a switch from tenofovir/emtricitabine plus efavirenz to the similar STR, the rates of persistence were 80.3% for the STR (n = 60), 77.3% for atazanavir-containing cART (n = 96) and 68.3% for darunavir-containing cART (n = 56) at 18 months (global P = 0.006). CONCLUSIONS: These results suggest that persistence is higher in HIV patients treated with an STR compared with other administration schedules. Significant benefit in terms of adherence was observed with the STR in comparison with regimens with >1 daily intake but no difference was observed when comparing with regimens involving >1 pill once daily.

Impact of bariatric surgery on the medical management and costs of obese patients in France: an analysis of a national representative claims database.

BACKGROUND: Bariatric surgery (BS) procedures are increasing but few studies have investigated their influence on medical management and costs in France. METHODS: The "Echantillon Généraliste des Beneficiaires" (EGB) is a 1/97 representative sample (n = 520,000 in 2011) of a national claims database covering about 80 % of the population. Adult patients treated for the first time with BS from January 2007 to December 2009 were identified, and a cohort including 350 patients was constituted with a 2-year follow-up before and after this primary procedure date (T). All items of reimbursed medical consumption and comorbidities over this period were identified. A comparison on the consumed resources and costs of BS was performed over time using multivariate models. RESULTS: The annual per capita reimbursed health expenses evolved from 2633 (±3124) in year (T - 2) to 3557 (±3380) in (T - 1), to 4240 (±3840) in (T + 1) (excluding procedure cost), and to 3755 (±5037) in (T + 2) with differences according to the type of surgery. In 39 % of patients, the evolution of those costs between (T - 2) and (T + 2) decreased by 5 %. In multivariate models, the significant factors were the presence of diabetes or hypertension medications before the procedure. Most items of medical consumption increased over the period pre- and post-procedure and started to decrease in (T + 2). CONCLUSIONS: Although this series contains mostly gastric bandings, which were less likely to affect comorbidities, the workup for preparing BS was probably an opportunity to benefit from a general clinical assessment which has generated extra short-term medical consumption and expenses began decreasing without allowing return on investment.

Cost of managing anemia in end-stage renal disease: the experience of five French dialysis centers.

OBJECTIVE: The aim of this retrospective study was to evaluate the direct cost of anemia treatment in hemodialysis patients and to evidence factors predictive of 1-year cost. METHODS: Retrospective study which included hemodialyzed patients during year 2009 in five centers. Patients were evaluable if they had at least one hemoglobin (Hb) assay per month and were monitored for at least 4 months. Patients were classified in different "annual Hb category" according to their monthly mean Hb [Hb categories: Ideal (10 ≤ Hb ≤ 12 g/dL); High (Hb > 12 g/dL) and Low (Hb < 10 g/dL) if >75% of time in respective category, otherwise classified in the Fluctuating category]. RESULTS: We analyzed 636 patients (male, 59.4%) with a mean age of 67 years who underwent 144 hemodialysis sessions (median number per patient) in 2009. The cost of anemia treatment was largely driven by erythropoiesis-stimulating agents (ESA) (68% of total cost for Low Hb category and approximately 90% for the other Hb categories). Adjusted predictive factors for 1-year direct cost of anemia treatment (p < 0.0001) were dialysis center (2,518-5,617), death (6,091 vs. 4,911), age (4,911 for ≤55 years and 5,378 for 65-75 years), female gender (4,911 vs. 4,398 for male), Low Hb category (13,005 vs. 5,034 for Ideal, 4,911 for Fluctuating and 2,418 for High), serum ferritin level (5,102 for 200-500 µg/mL and 4,646 for ≥500 µg/mL) and duration of dialysis (4,911 if ≤2 years and 2,952 if 4-6 years). LIMITATIONS: Retrospective study, and low number of patients in the Low Hb category. CONCLUSIONS: The main factors that were predictive of 1-year cost of anemia treatment in hemodialysis patients were centers, patients in the Low Hb category, and dialysis duration of less than 2 years.

Incidence and costs of bleeding-related complications in French hospitals following surgery for various diagnoses.

BACKGROUND: Limited information is available on the epidemiology and economics of bleeding during surgery in France. METHOD: The objective of this study was to examine the incidence, costs and length of stay (LOS) of bleeding-related complications during various surgical procedures. RESULTS: Amongst all 88 different surgical DRGs recognised by the French database 24 (totalling 321,657 hospitalisations) yielded WB rates ≥10% (range 10.3-25.3%). The highest DRG rates were for transplantations, cardiac and major orthopaedic surgery, vascular and solid organ surgery. CONCLUSIONS: The present study for France demonstrates a significant increase of hospital LOS and associated costs following post-surgical bleeding, supporting the need for blood conservation strategies.

Diagnosis and management of anaemia and iron deficiency in patients with haematological malignancies or solid tumours in France in 2009-2010: the AnemOnHe study.

OBJECTIVE: To describe the management of anaemia in 2009-2010 in France in patients with haematological malignancies (HM) or solid tumours (ST). METHODS: Retrospective observational study in 57 centres, enrolling adult patients with HM or ST treated for an episode of anaemia (duration of the episode ≥ 3 months occurring in the last 12 months). RESULTS: 220 patients with ST (breast, 18%; lung, 18%) and 56 with HM (lymphoma, 60%) were included (median age, 68 years; female, 53%). Mean haemoglobin level at anaemia diagnosis was 9.3 ± 1.4 g/dL (<8 g/dL for 16%) and 9.8 ± 1.1g/dL (<8 g/dL for 6%) in HM and ST patients, respectively. At least one parameter of iron deficiency (ferritin, transferrin saturation) was assessed in 26% of HM and 19% of ST patients. Treatment of anaemia included erythropoiesis-stimulating agents (ESA) for 98% of HM and 89% of ST patients. Iron was prescribed to 14% (oral, 12%; intravenous, 2%) of HM patients and to 42% (oral, 17%; intravenous, 25%) of ST patients. The rates of blood transfusions were high: 70% in HM and 46% in ST patients; transfusions alone or administrated with ESA were more frequent in patients with Hb <8 g/dL. CONCLUSION: Although recent guidelines recommend evaluating iron deficiency and correcting anaemia by using intravenous iron, our study in cancer patients evidenced that ESA and blood transfusions are still frequently used as the treatment of anaemia in cancer patients. Iron deficiency is insufficiently assessed (only one patient among five) and as a consequence iron deficiency is most likely insufficiently treated.

Economic impact of use of chlorhexidine-impregnated sponge dressing for prevention of central line-associated infections in the United States.

BACKGROUND: The economic impact of adding chlorhexidine gluconate (CHG)-impregnated sponge dressing to standard care (ie, chg-impregnated sponge dressing + skin preparation and transparent film dressing vs skin preparation and transparent film dressing) for the prevention of central-line infections was evaluated. METHODS: Clinical and economic data were obtained from peer-reviewed published studies to populate the decision model. The efficacy of reducing catheter-related bloodstream infection (CR-BSI) incidence with CHG-impregnated sponge dressing came from 2 recent randomized controlled trials. One-way and two-way sensitivity analyses were performed on key clinical and economic parameters. RESULTS: Based on model calculations, a hypothetical 400-bed hospital inserting 3,078 central venous catheters (CVCs) per year is expected to avoid an average of 35 CR-BSIs, 145 local infections, and 281 intensive care unit days annually with the systematic use of CHG-impregnated sponge dressing. Potential hospital net cost savings (mainly because of reduced CR-BSIs with use of the dressing) would be $895,000 annually. Results were robust across a range of values in sensitivity analyses. CONCLUSION: CHG-impregnated sponge dressing is a cost-effective CR-BSI prevention treatment option for patients requiring CVCs. The importance of these results should be considered in the context of federal government and insurance company policies that no longer permit enhanced reimbursement for CR-BSI.

Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma.

BACKGROUND: This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. METHODS: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication. RESULTS: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation. CONCLUSION: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma.

Treatment persistence and cost-effectiveness of latanoprost/latanoprost-timolol, bimatoprost/bimatoprost-timolol, and travoprost/travoprost-timolol in glaucoma: an analysis based on the United Kingdom general practitioner research database.

OBJECTIVE: To compare treatment persistence and costs with 3 glaucoma treatment sequences (first-line/second-line): latanoprost/latanoprost-timolol (LLT), bimatoprost/bimatoprost-timolol (BBT), and travoprost/travoprost-timolol (TTT), derived from the UK General Practitioner Research Database (UK-GPRD). METHODS: Patient records referring to ocular hypertension, topical glaucoma treatment, surgery, or laser therapy were extracted. Patients prescribed LLT, BBT, or TTT sequences were selected. Treatment failure was inferred from glaucoma prescription change (adding or removing a topical treatment, surgery, or laser therapy). Treatment durations preceding failure were compared by applying Wilcoxon's test to survival curves. Adjustment on confounding variables was performed with a Cox model and a propensity score method. Unit costs were estimated from a UK National Health Service perspective. RESULTS: A total of 1592 patients received LLT, 110 BBT, and 114 TTT. Their mean age was 68 years and the sex ratio almost 1 male:1 female. No significant demographic or comorbidity differences were observed between treatment sequences. Treatment persistence at 36 months was achieved in 60.0% of LLT, 55.5% of BBT, and 70.3% of TTT patients (P = 0.005). Resources consumed and associated monthly costs were significantly less for the TTT group (£17.74) compared with BBT (£21.30) and LLT (£22.37) groups. CONCLUSION: Analysis of data obtained from the UK-GPRD suggests that the TTT treatment sequence achieved longer treatment persistence at lower cost than LLT and BBT.

Do two intravenous iron sucrose preparations have the same efficacy?

BACKGROUND: Intravenous (i.v.) iron sucrose similar (ISS) preparations are available but clinical comparisons with the originator iron sucrose (IS) are lacking. METHODS: The impact of switching from IS to ISS on anaemia and iron parameters was assessed in a sequential observational study comparing two periods of 27 weeks each in 75 stable haemodialysis (HD) patients receiving i.v. iron weekly and an i.v. erythropoiesis-stimulating agent (ESA) once every 2 weeks. Patients received IS in the first period (P1) and ISS in the second period (P2). RESULTS: Mean haemoglobin value was 11.78 ± 0.99 g/dL during P1 and 11.48 ± 0.98 g/dL during P2 (P = 0.01). Mean serum ferritin was similar for both treatment periods (P1, 534 ± 328 µg/L; P2, 495 ± 280 µg/L, P = 0.25) but mean TSAT during P1 (49.3 ± 10.9%) was significantly higher than during P2 (24.5 ± 9.4%, P <0.0001). The mean dose of i.v. iron per patient per week was 45.58 ± 32.55 mg in P1 and 61.36 ± 30.98 mg in P2 (+34.6%), while the mean ESA dose was 0.58 ± 0.52 and 0.66 ± 0.64 µg/kg/week, respectively (+13.8%). Total mean anaemia drug costs increased in P2 by 11.9% compared to P1. CONCLUSIONS: The switch from the originator IS to an ISS preparation led to destabilization of a well-controlled population of HD patients and incurred an increase in total anaemia drug costs. Prospective comparative clinical studies are required to prove that ISS are as efficacious and safe as the originator i.v. IS.

Comparison of outcomes with multifocal intraocular lenses: a meta-analysis.

PURPOSE: To compare the clinical outcome of different multifocal intraocular lenses (IOLs) based on information reported in the international literature. METHODS: All comparative clinical trials that involved implanting at least one multifocal IOL in patients with cataract or presbyopia were extracted from the literature. Clinical outcomes included uncorrected near visual acuity, uncorrected distance visual acuity, visual acuity, spectacle independence, and halos. Random effects meta-analyses were conducted to compare outcomes for the different IOL types. RESULTS: Twenty papers were identified describing 11 monofocal IOLs and 35 multifocal IOLs (19 diffractive, including 12 ReSTOR(®), 14 refractive, and two accommodative) patient cohorts. Multifocal and monofocal uncorrected distance visual acuity was 0.165 (0.090-0.240) and 0.093 (0.088-0.098), respectively. Compared with monofocal IOLs, multifocal IOLs produced better uncorrected near visual acuity (0.470 [0.322-0.618] versus 0.141 [0.131-0.152]; P < 0.0001), resulting in higher spectacle independence (incidence rate ratio [IRR] 3.62 [2.90-4.52]; P < 0.0001). Compared with refractive multifocal IOLs, diffractive multifocal IOLs produced a similar uncorrected distance visual acuity (0.105 [0.098-0.111] versus 0.085 [0.029-0.140]; P ≤ 0.78, not significant) and better uncorrected near visual acuity (0.217 [0.118-0.317] versus 0.082 [0.067-0.098]; P < 0.0001) resulting in higher spectacle independence (IRR 1.75 [1.24-2.48]; P < 0.001). Compared with other multifocal IOLs, ReSTOR produced a better uncorrected distance visual acuity (0.067 [0.059-0.076] versus 0.093 [0.088-0.098]; P < 0.0001) and better uncorrected near visual acuity (0.064 [0.046-0.082] versus 0.141 [0.131-0.152]; P < 0.006), resulting in higher spectacle independence (IRR 2.06 [1.26-1.36]; P < 0.004). Halo incidence rates with different types of multifocal implants did not differ significantly. CONCLUSION: Multifocal IOLs provide better uncorrected near visual acuity than monofocal IOLs, leading to less need for spectacles. Multifocal IOL design might play a role in postsurgical outcome, because better results were obtained with diffractive lenses. ReSTOR showed better uncorrected near visual acuity, uncorrected distance visual acuity, and higher spectacle independence rates compared with other multifocal IOLs.

The cost of managing HIV infection in highly treatment-experienced, HIV-infected adults in France.

BACKGROUND: Highly active antiretroviral therapy (HAART) has greatly enhanced HIV management, lowering the risk of clinical disease progression and death by substantially improving HIV-induced immune deficiency. Lower CD4 cell counts have consistently been associated with higher direct costs of HIV patient care. The aim of this study was to analyze HIV costs of care in France at different levels of HIV-induced immune deficiency (as measured by the CD4 cell count) using recent data from treatment-experienced patients. METHODS: This analysis used data from the French Hospital Database in HIV, containing data on approximately 50% of the French HIV population. Patients were included in the analysis if they had visited a participating centre from 2003 to 2005, had CD4 cell counts determined at least twice during the study period, and had been prescribed at least two nucleoside reverse transcriptase inhibitors, one non-nucleoside reverse transcriptase inhibitor and two protease inhibitors since their first consultation. Resources consumed were counted and aggregated according to the CD4 cell count level. Standard costs were applied. RESULTS: Periods with the lowest CD4 cell counts were associated with increased prescription rates of antiviral agents (other than anti-HIV agents), antiparasitic drugs and antimycobacterial agents. Antiretroviral treatments accounted for 80% of all medications prescribed during the study period. Hospitalization rates decreased with increasing CD4 cell counts, with 0.72 hospitalizations per patient-year for those with CD4 cell counts of 50 cells/mm³ or less compared with 0.05 per patient-year for patients with CD4 cell counts greater than 500 cells/mm³. There was a clear trend towards lower mean healthcare costs per patient-year with decreasing immune deficiency; from €34,286 to €12,361. CONCLUSIONS: Our study showed an association between the degree of HIV-induced immune deficiency (measured by CD4 cell count) and the costs of managing HIV infection among highly pre-treated, HIV-infected individuals in France in the HAART era.

Modelling the budget impact of darunavir in the treatment of highly treatment-experienced, HIV-infected adults in France.

BACKGROUND: A key element for payers in the assessment of the economic profile of a medication is its anticipated impact on the evolution of healthcare budgets. OBJECTIVES: To forecast the impact of the use of darunavir with low-dose ritonavir 600/100 mg twice a day (bid) in highly treatment-experienced, HIV-infected adults who have failed one or more protease inhibitor (PI)-containing regimen on the budget of the French Sickness Fund (French healthcare system) over a 3-year time horizon. METHODS: A transition state model based on disease severity was developed that compared the evolution of antiretroviral and non-antiretroviral-related direct costs of care in the target population over 3 years (2007-2009) under two scenarios: (1) darunavir enters the French market in year 1; (2) darunavir is not available to the target population during 2007-2009. Model inputs were derived from a targeted analysis of the French hospital database in HIV, the darunavir POWER 1 and 2 trials and other relevant clinical studies. RESULTS: In the scenario where darunavir was available from year 1, the proportion of patients in the lower, more costly CD4 cell count strata (≤ 100 cells per mm³) was consistently lower than in the scenario without darunavir in each year of the model (17.0% vs 19.2%, 13.9% vs 18.3% and 10.8% vs 16.8% for years 1, 2 and 3, respectively). As a result, over the entire 3-year period, the net increase of antiretroviral drug costs (+ 5.6 million Euros; €), resulting from the substitution of older, cheaper PIs by darunavir, is expected to be fully compensated by savings in hospitalization costs (€-9.7 million) and expenditures for other HIV-related (non-antiretroviral) medications (€-7.3 million), leading to a net saving of €11.4 million or 2.9% of the total budget in the scenario without darunavir. Various sensitivity analyses confirmed these projected savings. CONCLUSION: The use of darunavir/ritonavir (DRV/r) 600/100 mg bid, in combination with other antiretroviral agents, in highly pre-treated, HIV-infected adults who have failed one or more PI-containing highly active antiretroviral therapy regimen is not expected to increase the budget of the French healthcare system, in comparison with a scenario without darunavir. Further research is needed to estimate the budget impact of the use of DRV/r in less treatment-experienced, HIV-infected individuals in France.

Measurement of treatment compliance using a medical device for glaucoma patients associated with intraocular pressure control: a survey.

OBJECTIVE: To identify and characterize treatment compliance profiles of glaucoma patients and evaluate the association with intraocular pressure (IOP). METHODS: A computerized device (Travalert((R))) that recorded daily instillation times and eye-drop counts was given for 3 months. Patients were declared compliant when at least 2 drops were instilled per day. Compliance rates were calculated for weekdays and weekends, separately, over 8 consecutive weeks. A principal components analysis (PCA) was followed by an ascendant hierarchical classification (AHC) to identify compliance groups. RESULTS: 140 patients were recruited (mean age 65.5 years; 51.8% female) of whom 83.6% had primary open-angle glaucoma with mean IOP 23.9 mmHg before Travalert((R)) use. 60.7% were treated with DuoTrav((R)) (travoprost timolol fixed combination) and 39.3% with travoprost. The PCA identified two axes (compliance and treatment weeks). The AHC identified 3 compliance groups: 'high' (56.6%, approx. 80% compliance), 'medium' (21.2%, approx. 50% compliance), and 'low' (22.1%, approx. 20% compliance). Demographics and glaucoma parameters did not predict low compliance. Final mean IOP was 16.1 mmHg, but higher in the low compliance group (17.7 mmHg, P = 0.02). CONCLUSIONS: Compliance measurement by a medical device showed compliance rates <80% by 50% (approx.) of patients, significantly impacting IOP control. No demographic or glaucoma variable was associated with low compliance.

Neodymium:YAG laser rates after bilateral implantation of hydrophobic or hydrophilic multifocal intraocular lenses: twenty-four month retrospective comparative study.

PURPOSE: To compare 2-year neodymium:YAG (Nd:YAG) laser capsulotomy rates after bilateral implantation of hydrophobic or hydrophilic multifocal intraocular lenses (IOLs). SETTING: Private practice, southwest France. METHODS: This retrospective study included patients with cataract or clear lenses who had bilateral implantation of AcrySof ReSTOR hydrophobic or Acri.LISA hydrophilic acrylic multifocal IOLs between May 2004 and June 2009 by the same surgeon at 1 clinic. Data were extracted from patients' files maintained by the surgeon and ophthalmologists involved in postoperative care. Time from IOL implantation to Nd:YAG laser capsulotomy was analyzed with Kaplan-Meier survival curves. Imbalances in confounding variables were adjusted with a Cox model. RESULTS: The hydrophobic IOL group comprised 80 patients and the hydrophilic IOL group, 76 patients. There were significantly more men in the hydrophobic group (51.3%) than in the hydrophilic group (30.7%) and patients were significantly younger in the hydrophobic group (63.0 years versus 65.8 years) (both P<.01). Eighteen months postoperatively, 4.4% of eyes in the hydrophobic group and 14.6% of eyes in the hydrophilic group required Nd:YAG laser capsulotomy. After 24 months, the respective rates were 8.8% and 37.2% (P<.0001). Eyes in the hydrophilic group had a 4.50-fold (2.28 versus 8.91) higher risk for Nd:YAG laser capsulotomy (P<.0001) that persisted after adjusting for age (relative risk 4.64, 2.32 to 9.29) (P<.0001). Patients younger than 63.5 years in the hydrophilic group were more likely to require Nd:YAG laser capsulotomy. CONCLUSION: Capsulotomy was significantly less frequent after hydrophobic IOL implantation than after hydrophilic IOL implantation 24 months postoperatively. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. An additional disclosure is found in the footnotes.