National Healthcare System Perspective Research Articles

PIN38 - CLINICAL AND ECONOMIC IMPACT OF THE TREATMENT OF CHRONIC HEPATITIS C IN PRISON INMATES IN SPAIN

World Health Organisation recommends the treatment of all HCV+ patients in order to achieve virus elimination. Although chronic hepatitis C (CHC) prevalence amongst prisoners is high, many prisoners with CHC remain untreated. The objective of this study was to evaluate long-term healthcare benefits and economic outcomes of treating prisoners with CHC with direct-acting antivirals (DAAs) in Spain. A lifetime Markov model was used to simulate the treatment and disease pathway of a cohort of 4,408 CHC prisoners treated with DAAs versus no treatment. It was assumed that the cohort was treated over two years (50% of patients each year). Cohort baseline characteristics (average age, genotype distribution and fibrosis) were identified from published Spanish prisoner studies and sustained virological response rates from Spanish real-world data. Untreated patients progressed according to the disease’s natural history. Transition probabilities, utilities and cost of health states were obtained from published literature and drug costs from Spanish public sources. The model estimated the cumulative incidence of liver complications and deaths, quality-adjusted life years (QALY), total costs, and incremental cost-effectiveness ratio (ICER). A National Healthcare System perspective was adopted with a 3% annual discount rate for costs and health outcomes. One-way sensitivity analyses (OWSA) were conducted. In the DAA treated cohort, the model estimated 88% reduction in liver-related deaths (-1,110 deaths) and relevant reductions in liver complications: 92% in decompensated cirrhosis (-951 cases), 83% in hepatocellular carcinoma (-650 cases) and 90% of liver transplants (-132). DAA treatment yielded 5.0 additional QALYs (21.2 vs 16.2) and incremental cost of €3,473 (€24,088 vs €20,615), resulting in an ICER of €690/QALY. OWSA confirmed the robustness of the results. DAA treatment of all prisoners with CHC not only decreases morbidity, mortality and the need for liver transplantation but is also a highly cost-effective strategy.

PMD16 - Comparing the Long-Term Impact on Healthcare Resources and Costs Due to Single-Piece Acrylic Intraocular Lens (IOL) Implantation During Cataract Surgery: A Cost-Consequence Analysis From Italian Healthcare System Perspective

Posterior Capsular Opacification (PCO) is a key secondary complication of IOL implant following cataract surgery and clinically significant PCO requires Nd: YAG laser capsulotomy treatment which in turn could lead to further complications. The objective of this analysis was to develop a cost-consequence model to estimate the healthcare resource utilization and cost impact of YAG procedures due to different single-piece acrylic IOLs. A cost-consequence model from Italian national healthcare system perspective was developed. For input parameters, three year incidence of Nd:YAG laser capsulotomy for five single-piece acrylic IOL s (2.4% for AcrySof, 5.1% for Tecnis, 9.2% for Akreos, 12.3% for Lenstec and 12.6% for Rayner) were derived from a retrospective electronic medical records database study. Weighted average calculations were performed to derive 3 year post-YAG incidence of retinal detachment (4.4%), glaucoma (8.8%), and cystoid macular edema (16.9%) using published data. National average of published YAG (€95.4) and Vitrectomy (€1641) DRG tariffs were used, and glaucoma (€522) and CME treatment costs (€79.8) were sourced from the literature. Number of cataract procedures per annum was derived from Eurostat statistics. For 526,966 cataract procedures carried out in a year, in 3-years post cataract surgery, single-piece hydrophobic AcrySof IOLs could result in substantially fewer Nd:YAG procedures compared to Tecnis (n=14,228), B&L Akreos (n=35,834), Lenstec (n=52,170) and Rayner (n=53,751) IOLs with subsequent reductions in vitrectomy, glaucoma and CME treatments. Total cost savings for the Italian healthcare system due to AcrySof IOLs could be in the range of €3.2 to €12.2 million. These results suggest that single-piece hydrophobic AcrySof IOLs are associated with significantly lower incidence of Nd:YAG capsulotomy compared to comparator IOLs resulting in significant reduction in healthcare resource utilization for facilities and cost savings for budget owners.

Delayed diagnosis and treatment of tuberculosis in HIV+ patients in Mozambique: A cost-effectiveness analysis of screening protocols based on four symptom screening, smear microscopy, urine LAM test and Xpert MTB/RIF.

BackgroundTuberculosis (TB) represents the ninth leading cause of death worldwide. In 2016 are estimated 1.3 million TB deaths among HIV negative people and an additional 374,000 deaths among HIV positive people. In 2016 are estimated 1.4 million new cases of TB in people living with HIV (PLHIV), 74% of whom were living in Africa. In light of these data, the reduction of mortality caused by TB in PLHIV is strongly required specially in low-income countries as Mozambique. According to international guidelines, the initial TB screening in HIV+ patients should be done with the four symptoms screening (4SS: fever, current cough, night sweats and weight loss). The diagnostic test more used in resource-limited countries is smear microscopy (SMEAR). World Health Organization (WHO) recommended Lateral Flow urine LipoArabinoMannan assay (LF-LAM) in immunocompromised patients; in 2010 WHO endorsed the use of Xpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) test for rapid TB diagnosis but the assay is not used as screening test in all HIV+ patients irrespectively of symptoms due to cost and logistical barriers. The paper aims to evaluate the cost-effectiveness of three screening protocols: standard (4SS and SMEAR in positive patients to 4SS); MTB/RIF; LF-LAM / MTB/RIF.MethodsWe developed a model to assess the cost-effectiveness of the MTB/RIF protocol versus the common standard and LF-LAM / MTB/RIF protocol. The model considered a sample of 1,000 HIV+ antiretroviral treatment naïve patients in Mozambique. We evaluated disability-adjusted life year (DALY) averted for each protocol, cost per DALY, and incremental cost-effectiveness ratio (ICER), over 1-year, assuming a national healthcare system perspective. The model considered the delayed diagnosis as the time elapsed between a false negative test and the diagnosis and treatment of TB. Additional health system organization delay is defined as the time interval between positive test and treatment initiation caused by a delay in the delivery of results due organization of services. We conducted a sensitivity analysis on more relevant variables.ResultsThe MTB/RIF protocol was cost-effective as compared to the standard protocol with an ICER of $56.54 per DALY saved. In a cohort of 1,000 patients MTB/RIF and LF-LAM / MTB/RIF protocol generated 1,281 and 1,254 DALY’s saved respectively, with a difference of 174 and 147 DALY respect to the standard protocol. The total cost of MTB/RIF protocol was lower ($92,263) than the standard ($147,226) and the LF-LAM / MTB/RIF ($113,196). Therefore, the cost per DALY saved including new infections due to delayed diagnosis with the standard protocol was $79.06, about 5 fold higher than MTB/RIF and LF-LAM / MTB/RIF protocols. The cost of additional TB infections due to delays in diagnosis plus health system delay seemed the more relevant costs. The low sensibility and sensitivity of the standard protocol led to a high number of false negatives, thus delayed TB diagnoses and treatment lead to the development of newly transmitted TB infections.ConclusionsOur study shows that the MTB/RIF adoption could lead to an increasing of TB case-finding and a reduction in costs compared with standard and LF-LAM / MTB/RIF protocols.

Budget impact of continuous subcutaneous insulin infusion therapy in patients with type 1 diabetes who experience severe recurrent hypoglycemic episodes in Spain

ObjectiveHypoglycemia is one of the most common complications to achieve a good metabolic control, and has been listed by several scientific associations as a common indication to start treatment with continuous subcutaneous insulin infusion (CSII). Use of CSII is still residual in Spain as compared to neighboring countries, and cost of acquisition cost is one of the main reasons.This study estimates the budget impact of treatment with CSII, as compared to multiple daily insulin injections, of patients with type 1 diabetes mellitus who experience recurrent severe hypoglycemia episodes from the National Healthcare System perspective. MethodsBudget impact was based on a retrospective, observational study evaluating the efficacy of CSII in patients with type 1 diabetes mellitus conducted at Hospital Clínic i Universitari in Barcelona, where one of the main indications for switching to CSII were recurrent severe hypoglycemia episodes. The mean number of annual episodes was 1.33 in the two years prior to CSII start and 0.08 in the last two years of follow up (p=0.003). Costs of treatment and major hypoglycemic events over a four-year period were considered. Costs were taken from different Spanish data sources and expressed in € of 2016. ResultsTreatment with CSII increased costs by €9509 per patient as compared to multiple daily insulin injections (€11,902–€2393). Cost associated to severe hypoglycemic events decreased by €19,330 per patient treated with CSIII (€1371–€20,701). Results suggest mean total savings of €9821 per patient during the four-year study period. ConclusionThe higher costs associated to CSII therapy may be totally offset by the severe hypoglycemic events prevented.

Impacto presupuestario de la infusión subcutánea continua de insulina en el tratamiento de pacientes con diabetes tipo 1 que presentan episodios de hipoglucemia grave recurrente en España

ObjectiveHypoglycemia is one of the most common complications to achieve a good metabolic control, and has been listed by several scientific associations as a common indication to start treatment with continuous subcutaneous insulin infusion (CSII). Use of CSII is still residual in Spain as compared to neighbouring countries, and cost of acquisition cost is one of the main reasons.This study estimates the budget impact of treatment with CSII, as compared to multiple daily insulin injections, of patients with type 1 diabetes mellitus who experience recurrent severe hypoglycemia episodes from the National Healthcare System perspective. MethodsBudget impact was based on a retrospective, observational study evaluating the efficacy of CSII in patients with type 1 diabetes mellitus conducted at Hospital Clínic i Universitari in Barcelona, where one of the main indications for switching to CSII were recurrent severe hypoglycemia episodes. The mean number of annual episodes was 1.33 in the two years prior to CSII start and 0.08 in the last two years of follow up (p=0.003). Costs of treatment and major hypoglycemic events over a four-year period were considered. Costs were taken from different Spanish data sources and expressed in € of 2016. ResultsTreatment with CSII increased costs by €9,509 per patient as compared to multiple daily insulin injections (€11,902-€2,393). Cost associated to severe hypoglycemic events decreased by €19,330 per patient treated with CSIII (€1,371-€20,701). Results suggest mean total savings of €9,821 per patient during the four-year study period. ConclusionThe higher costs associated to CSII therapy may be totally offset by the severe hypoglycemic events prevented.

Recurrent laryngeal nerve injury in thyroid surgery: Clinical pathways and resources consumption.

The impact of recurrent laryngeal nerve (RLN) injury management in thyroid surgery seems to be relevant to patients, National Healthcare System (NHS), and society. We studied resource consumption in the management of patients with RLN injury versus noninjured patients investigating 3 perspectives (patients, NHS, and society) in 5 clinical pathways. Direct medical costs supported by the NHS range from a minimum of euro (€) 79.46 to a maximum of € 3261.95. From the patient's perspective, the direct medical costs supported by the patient increased from a minimum of € 3.60 to a maximum of € 499.45. Productivity losses were accounted in € 156 per day per patient. From the NHS perspective, the percentage increase ranged from 43.25% to 98.14%. From the patient's perspective, it ranged from 51.52% to 80.60%. The analysis shows a significant economic impact of RLN injury management, which varies depending on the damage, duration, and severity. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1708-1716, 2016.

Cost–effectiveness analysis of simeprevir with daclatasvir for non-cirrhotic genotype-1b-naïve patients plus chronic hepatitis C

Background: The cost of interferon-free combination therapies remains high to provide widespread access to treatment, regardless of fibrosis stage. Aim: To estimate the cost–effectiveness of simeprevir/daclatasvir (SMV/DCV) therapy in treatment-naïve chronic hepatitis C genotype-1b patients with moderate fibrosis. Methods: A Markov model was developed to simulate the natural history of chronic hepatitis C progression. The model estimated lifetime healthcare costs and quality-adjusted life-years (QALY) for a cohort of patients from the Spanish National Healthcare System perspective. The cost–effectiveness threshold considered was €40,000/QALY. The treatment strategies analyzed were SMV/DCV, peginterferon/ribavirin/telaprevir, and peginterferon/ribavirin/boceprevir. A sensitivity analysis was carried out. Results: The incremental cost–effectiveness ratios of the SMV/DCV strategy were €23,774/QALY and €28,524/QALY compared with that of telaprevir or boceprevir triple therapy, respectively, for genotype-1b patients with moderate fibrosis. Conclusions: SMV/DCV combination compared with the standard of care previous to the arrival of second-generation direct-acting antivirals fell below generally accepted willingness-to-pay threshold. Results obtained should be supported by ongoing clinical trials.

Genomic profile of breast cancer: cost–effectiveness analysis from the Spanish National Healthcare System perspective

Background: Cost–effectiveness analysis of MammaPrint® (70-gene signature) in the diagnosis of early breast cancer as a prognosis assay to study the risk of tumor recurrence to administer adjuvant chemotherapy. Methods: Markov model assuming a cohort of 60-year-old women with breast cancer. Treatment costs and effects were assessed by comparing the 5-year, 10-year and lifetime risk of recurrence using Adjuvant! Online® (online algorithm), 70-gene signature or Oncotype DX® (21-gene assay). Results: 70-gene signature showed a life expectancy of 23.55 years at lifetime. Life expectancy was lower for 21-gene assay and online algorithm, with associated quality-adjusted life year gains up to 0.23 and 0.75, respectively, with 70-gene signature. At year 5, the mean cost of 21-gene assay, 70-gene signature and online algorithm was €7100, €6380 and €4580, respectively. 70-gene signature was dominant versus 21-gene assay at any time horizon and would be cost–effective from year 7 versus online algorithm (lifetime: €1457 per quality-adjusted life years gained). Conclusions: 70-gene signature was a dominant strategy over 21-gene assay and was highly cost–effective versus online algorithm.

COST-EFFECTIVENESS OF APIXABAN AS COMPARED WITH WARFARIN AND ACETYLSALICYLIC ACID IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION IN THE RUSSIAN FEDERATION

Background. For prevention of thromboembolic events in patients with non-valvular atrial fibrillation (NVAF) the following types of antithrombotic therapy are used: anticoagulant therapy with vitamin K antagonists (such as warfarin), antiplatelet therapy (such as acetylsalicylic acid) and novel oral anticoagulants such as apixaban, rivaroxaban and dabigatran. Administration of vitamin K antagonists (VKA) is complicated by the need for individual dose adjustment and frequent monitoring of international normalized ratio (INR). Both warfarin and acetylsalicylic acid are widely used for thrombosis prevention in patients with NVAF in the Russian Federation. Aim. To evaluate the cost-effectiveness ratio of apixaban compared with warfarin and acetylsalicylic acid in patients with NVAF from the Russian Federation national health care system perspective. Material and methods. This analysis used a Markov model that allowed estimation of the incremental cost-effectiveness ratio (ICER) for apixaban as compared with warfarin and acetylsalicylic acid over lifetime horizon in VKA suitable and VKA unsuitable patients with NVAF respectively. The model enclosed cardiovascular event rates based on the results of the randomized clinical trials comparing clinical effectiveness and safety of apixaban with warfarin (ARISTOTLE) and acetylsalicylic acid (AVERROES). The following cardiovascular events were taken into consideration: ischemic and hemorrhagic stroke, systemic embolism, intracranial hemorrhage, other major bleeds, clinically relevant non-major bleeds and myocardial infarction. Direct medical costs were determined based on the rates of the compulsory national medical insurance system. The price of the antithrombotic drugs was taken as a weighted average tender price for the year 2013. In the model both costs and benefits (quality-adjusted life years and life-years) were discounted at 3.5%. Cost-effectiveness threshold was set at 1.4 million rubles per quality-adjusted life year (QALY) gained and corresponded to the three times GDP per capita in 2013 in the Russian Federation. Sensitivity analysis explored the impact of the treatment discontinuation rates, patients’ age and quality of INR monitoring on the cost-effectiveness of apixaban. Results. In the base case analysis it was demonstrated that apixaban as compared with warfarin and acetylsalicylic acid provided additional 0.187 and 0.255 life years as well as additional 0.187 and 0.214 QALYs respectively. Over lifetime horizon apixaban as compared with warfarin and aspirin required additional treatment costs equal to 112.72 and 101.35 thousands rubles, respectively. With that estimated incremental cost-effectiveness ratio for apixaban as compared with warfarin and acetylsalicylic acid was 603.92 and 473.02 thousands rubles per QALY respectively. The results were robust in sensitivity analysis. Conclusions. Apixaban is expected to be a cost-effective alternative to warfarin and acetylsalicylic acid in patients with NVAF from the Russian Federation national health care system perspective. Apixaban may be recommended for inclusion into formulary reimbursement lists as an alternative to warfarin.

Resource use and costs of exenatide bid or insulin in clinical practice: the European CHOICE study

PurposeCHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) assessed patterns of exenatide bid and initial insulin therapy usage in clinical practice in six European countries and evaluated outcomes during the study.MethodsCHOICE was a 24-month, prospective, noninterventional observational study. Clinical and resource use data were collected at initiation of first injectable therapy (exenatide bid or insulin) and at regular intervals for 24 months. Costs were evaluated from the national health care system perspective at 2009 prices.ResultsA total of 2515 patients were recruited. At the 24-month analysis, significant treatment change had occurred during the study in 42.2% of 1114 eligible patients in the exenatide bid cohort and 36.0% of 1274 eligible patients in the insulin cohort. Improvements in glycemic control were observed over the course of the study in both cohorts (P < 0.001 for both), but mean weight was reduced in the exenatide bid cohort (P < 0.001) and increased in the insulin cohort (P < 0.001) by 24 months. Across all countries, total per patient health care costs for the 24 months post baseline were €3997.9 in the exenatide bid cohort and €3265.5 in the insulin cohort (€1791.9 versus €2465.5 due to costs other than those of injectable therapy). When baseline direct cost and patients’ and disease characteristics were controlled for, mean direct costs differed by country (P < 0.0001), irrespective of treatment initiated, and the mean cost difference between treatments varied by country (P < 0.0001).ConclusionMuch of the higher mean cost of exenatide bid, compared with insulin, therapy was compensated for by lower mean costs of other health service utilization. Costs associated with exenatide bid or insulin initiation varied across countries, highlighting the need to avoid generalization of resource use and cost implications of a particular therapy when estimated in specific country settings.

Costs of treatment and complications of adult type 1 diabetes

Background and aimsCosts associated with diabetes represent a large burden for patients and the health-care system. However, few studies examined the costs for diabetes treatment in adults with type 1 diabetes (T1DM). This analysis was aimed to assess the costs of treatment associated with T1DM among adults in Italy from the national health-care system perspective. Methods and resultsData were collected using a questionnaire assessing resource consumption retrospectively (drugs, visits, diagnostics, hospitalisations and self-monitoring of blood glucose (SMBG)). One-year costs were calculated for the 12 months preceding the survey. Cost estimation, referred to 2006, was carried out using univariate and multivariate Poisson regression models. Fifty-eight centres enrolled 1193 patients (49.5% women; aged between 18 and 55 years, average diabetes duration was 16.1 ± 9.8 years). The average annual cost for an adult patient with TDM1 was €2450 (95% confidence interval (CI): 2358–2544). Insulin therapy and SMBG accounted together for 71.2% of total costs (35.6% and 35.6%, respectively); the remainder was shared by hospitalisations (18%), visits (4.0%), diagnostics (3.9%) and other drugs (2.9%). Univariate analyses showed that the presence of complications was associated with excess of costs, mainly related to the hospitalisation and drugs. Multivariate analyses confirmed these results showing that the presence of micro-vascular plus macrovascular complications doubles the cost of treatment. ConclusionStrategies of care for T1DM that can improve disease management and prevent or delay the onset of complications could represent the most important tool to reduce costs in the long term while improving clinical outcomes and quality of life.

PCN72 Cost - Effectiveness Analysis of Cervical Cancer Vaccination Strategies in Spain

Assess clinical and economic outcomes of vaccination (Va) with human papillomavirus (HPV) 16/18 AS04-adjuvanted vaccine (16/18Vac) added to screening programmes (Scr) in cervical cancer (CC) prevention, from the National Healthcare System perspective. A lifetime Markov cohort model with yearly cycles was populated using national epidemiological, cost and treatment data to simulate the natural history of HPV and assess the effect of Va+Scr strategies versus Scr alone. Base case considers vaccinating a cohort of 206.788 girls aged 11, 80% of vaccine coverage and screening each 3 years from age 25 to 65. Efficacy of 16/18Vac was 95% against HPV-16/18 and cross-protection against 5 oncogenic non-vaccine types of 68%. Outcomes measured were number of CC cases, CC deaths, quality adjusted life years (QALYs), costs and incremental cost-effectiveness ratio (ICER) between both strategies. The model also tested a broader campaign vaccinating both 11 & 18 years old during 7 years (100,000 individuals per cohort and year) versus vaccination girls aged 11 only. A discount rate of 3% over costs and outcomes was applied. Sensitivity analyses were performed to assess influence of different parameters. Base case scenario would avoid 817 CC cases and 188 deaths (undiscounted) versus Scr alone and generate 1,018 additional QALYs, resulting in an ICER of € 29.295/QALY (discounted). Vaccination of the cohorts aged 11 & 18 would avoid 2,448 CC cases and 602 CC deaths (undiscounted) compared with vaccination only of the 11 years cohort, and represents an ICER of 28,931€/QALY (discounted). Sensitivity analysis shows more favourable cost-effectiveness with higher coverage. HPV vaccination with 16/18Vac added to current screening programmes in Spain is a cost-effective strategy. More favourable cost-effectiveness results may be obtained by expanding vaccination to 18 years old women and increasing vaccination coverage. Results are in accordance with other studies published at national level.

Prophylaxis against febrile neutropenia with pegfilgrastim in Italy: a budget impact analysis

Introduction: prophylaxis with granulocyte colony-stimulating factors (G-CSF) is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy. Objective: to evaluate the budgetary impact for the Italian NHS. Design: a decision-analytic model has been developed to analyze the budget impact from the national health care system perspective. Costs include direct healthcare costs to the public payer of G-CSFs as well as their administration costs and costs of FN-related events. The comparison has been done using prophylaxis with G‑CSF (filgrastim for 11 days, pegfilgrastim, lenograstim for 11 days) and antibiotics. Patients and participants: The population of interest for the analysis were patients with breast cancer in stage II and III and patients with non-Hodgkin’s lymphoma (NHL). Main outcome measures and results: for all the three patients group (NHL, Breast II and III), and for all the chemotherapy regimens (CHOP 21 and R-CHOP 21 for NHL, AC-T, TAC and TC for Breast stage II and III) the budget impact analyses shows a cost reduction for the Italian NHS, as a result of an increase of the use of pegfilgrastim. Conclusions: in Italy, a treatment strategy including pegfilgrastim as either primary or secondary prophylaxis provides value for money.

Cost-Effectiveness Analysis of Raltegravir in Treatment-Experienced HIV Type 1-Infected Patients in Spain

Raltegravir, a novel HIV-1 integrase inhibitor, has superior efficacy with optimized background treatment (OBT) vs. placebo + OBT in treatment-experienced HIV-1 patients. This study assessed the long-term cost effectiveness of raltegravir from a Spanish National Healthcare System perspective. A cohort-state-transition model was used to estimate clinical and economic outcomes associated with raltegravir + OBT vs. OBT alone. Subjects were stratified into health states according to HIV RNA level, CD4 count, and opportunistic infection (OI) history, and could transition into different health states over time based on projected long-term efficacy. Each health state was associated with a distinct treatment cost and utility (QoL) score. Model inputs for mortality, resource utilization, unit costs, OI risk, and long-term durability of viral suppression were obtained from clinical trials, published studies, and database analyses. Model outcomes were reported as incremental cost-effectiveness ratios (ICERs) in 2007 Euros per quality-adjusted life-year (euro/QALY) gained. Costs and QALYs were discounted at 6% per year based on Spanish cost-effectiveness guidelines. Extensive sensitivity analyses were conducted. Five years of treatment with raltegravir + OBT resulted in an additional 4.5 years of undiscounted life expectancy vs. OBT alone. The ICER of raltegravir + OBT vs. OBT alone was euro22,908/QALY and euro31,431/QALY for 3- and 5-year use, respectively. Lower ICERs were observed with lower discount rates (3%) for costs and benefits, lower raltegravir price (20%), and shorter treatment duration (3 years). ICER was also sensitive to analytical time horizon and alternative sources of QoL scores. In treatment-experienced Spanish patients, raltegravir was projected to provide survival benefits and be cost effective.

TPF versus PF as induction therapy in unresectable head and neck cancer: A pharmacoeconomic analysis

6075 Background: Adding docetaxel to induction therapy with PF has been shown to improve overall survival of patients with head and neck cancer. On the basis of the raw data from the EORTC trial 24971/TAX 323 a pharmacoeconomic analysis has been performed. A National Healthcare System perspective and a 5-years temporal horizon have been adopted. Methods: A decision-analytic approach has been adopted, and a Markov model has been used to represent patient's weekly transitions among different health states, related to treatment (chemotherapy, radiotherapy, surgeries, palliative care) and disease status (complete/partial/no response, progression, recurrence). Constant or time-variant costs and quality of life adjustment factors have been assigned to each health state, together with transition probabilities to other states. A 3% discount factor has been used for costs sustained after the first year. The model allowed calculating expected life years (LYs), quality adjusted life years (QALYs) and costs. From these figures, incremental cost/effectiveness (ICER) and cost/utility (ICUR) ratios have been calculated. Robustness of results obtained with baseline values has been tested with probabilistic multivariate sensitivity analysis. Results: In the base case analysis, treatment with TPF yields an expectancy of 2.38 LYs and 1.53 QALYs at a cost of Euro (E) 23,018, which for PF were 1.93 LYs, 1.11 QALYs, and E 19,567, respectively. ICER and ICUR were E 7,669/LY and E 8,217/QALY, respectively. Sensitivity analyses were performed varying transition probabilities of 10%, costs of 30% and utility scores of 20% of their basal values. The analyses showed that 86% and 84% of the results lie below the threshold of E 50,000/LY and E 50,000/QALY, respectively. Conclusions: In our analysis TPF induction chemotherapy proved to be cost-effective with respect to PF, having an ICER and ICUR comparable to other widely accepted healthcare interventions. [Table: see text]

Pharmacoeconomic analysis of adjuvant therapy with exemestane, anastrozole, letrozole or tamoxifen in postmenopausal women with operable and estrogen receptor-positive breast cancer

To compare the efficiency of adjuvant therapy with aromatase inhibitors or with tamoxifen in postmenopausal women with operable breast cancer and positive estrogen receptors. A cost-utility analysis was performed based on a Markov model, from the Spanish National Health Care System perspective, comparing the treatment with exemestane (EXE: 25 mg/day) or tamoxifen (TAM: 20 mg/day) after 2-3 years of monotherapy with TAM; anastrozole (ANA, 1 mg/day) or TAM (20 mg/day) without previous TAM therapy; and letrozole (LET: 2.5 mg/day) or placebo after 5 years of monotherapy with TAM. The follow-up of a hypothetical cohort of women starting treatment at 63 years of age was simulated during 10 and 20 years. The probabilities of transition between health states and quality adjusted life years (QALYs) were obtained from the literature, and the unit costs (euro corresponding to 2004) from a Spanish database. After 10 and 20 years of follow-up, more QALYs per patient would be gained with the EXE scheme (0.230-0.286 and 0.566-0.708, respectively) than with ANA (0.114 and 0.285) and LET (0.176 and 0.474). The cost of gaining one QALY was lower with the EXE scheme (50,801-62,522 euro and 28,849- 35,371 euro, respectively) than with ANA (104,272 euro and 62,477 euro) and LET (91,210 euro and 49,460 euro). The result was stable for the cost per life-year gained (LYG) and in the sensitivity analysis. The EXE scheme after TAM is more cost-effective than the ANA and LET schemes.

Una prima valutazione economica dell’impiego di rofecoxib versus FANS convenzionali nell’artrosi

Randomised clinical trials have demonstrated that rofecoxib has a better gastrointestinal tolerability profile than conventional nonsteroidal anti-inflammatory drugs (NSAIDs) in osteoarthritis, which results in a reduced utilisation of gastroprotective agents (GPA). The aim of this study was to estimate, from the national healthcare system perspective, the total drug costs in patients switched from NSAIDs plus GPAs to rofecoxib. In this longitudinal, observational study, drug prescriptions for symptomatic treatment of osteoarthritis were recorded. A decision tree was used to compare the mean daily drug cost of the following therapeutic options for ostheoarthritis: conventional NSAIDs and rofecoxib/conventional NSAIDs. Azienda Unita Sanitaria Locale 110, Ravenna, Italy. 56,827 patients affected by osteoarthritis were monitored from January 1997 to December 1999. Of this group, we considered the first 2,935 patients who were examined by 21 General Practitioners in the period July 2000-October 2000, in order to point out changes in GPAs co-prescription after the introduction of rofecoxib in the Italian market. Alternative treatments compared were: NSAIDs either alone or combined with GPAs (NSAIDs option), and just after the introduction of rofecoxib, NSAIDs or rofecoxib alone and NSAIDs or rofecoxib combined with GPAs (rofecoxib/NSAIDs option). 27,511 out of 56,827 patients (48.4%; IC 95%: 48.0–48.8%) treated with NSAIDs also received a GPA co-medication. In the aforementioned subgroup of 2,935 patients, 1,814 (62%) received multiple prescriptions of NSAIDs or rofecoxib. In this subgroup, rofecoxib was associated with a statistically significant reduction of GPAs utilisation of 58.8% (IC 95%: 30.7–80.1; p = 0.012) compared with what was recorded during treatment with NSAIDs. In fact, the mean daily cost per patient of the NSAIDs option was € 1.66 versus € 1.55 of the rofecoxib/NSAIDs option (6.6% lower). Our preliminary results suggest that the use of rofecoxib is associated with cost savings in terms of total drug costs compared with conventional NSAIDs.