Farmeconomia. Health economics and therapeutic pathways
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[Budget impact analysis of delayed-release dimethyl-fumarate in the treatment of relapsing-remitting multiple sclerosis in Italy]
Full text linkINTRODUCTION: Multiple Sclerosis (MS) is a condition with a significant economic and social burden that affects young adults, in their active working phase. The most recent evaluations show an annual average social cost of € 38-39 thousand per patient. Today the approval of the new oral therapies allows physicians to select further options that can meet patients’ clinical unmet needs.OBJECTIVES: To evaluate the economic impact of a recently approved therapy, delayed-release dimethyl-fumarate (DMF; also known as gastro-resistant DMF), on the overall management costs of relapsing-remitting multiple sclerosis (RRMS) in Italy.METHODS: A budget impact model, adopting the perspective of the Italian National Healthcare Service (NHS), was used to compare healthcare costs of two different treatment scenarios: a) base-case, where DMF is not available for RRMS patients (Scenario A), vs. b) alternative-case, where DMF is available for RRMS patients (Scenario B). Healthcare costs sustained by the Italian NHS to manage the RRMS population (drug treatment, administration, therapy and disease monitoring, relapse management, treatment-related adverse events) have been calculated over 3 years and compared for the two scenarios. Impact of relapses for the disease modifying therapies (DMTs) included in the analysis was estimated using an elaboration of the results from published mixed treatment comparison. RRMS population treated with DMTs was estimated using Italian prevalence and incidence data. According to these estimates, the number of treated patients amounted to 36,078 at Year 1, 38,832 at Year 2, and 40,673 at Year 3.RESULTS: According to the current price and to the assumptions reported in the methodology section, it was estimated that the introduction of DMF (Scenario B) determines a decrease of the budget impact, if compared with the base case (Scenario A) in the perspective of Italian NHS. Over three years, the budget impact would be € 1,376 mln in the Scenario A and € 1,354 mln in the Scenario B (-22.18 mln €; -1.61% relative budget variation). The main drivers for cost-saving were pharmacological treatment costs and reduced burden of relapses (corresponding to more than 1,800 avoided relapses).CONCLUSIONS: At the current cost conditions applied in Italy and according to the described assumptions, the use of DMF is economically sustainable for the Italian NHS. Plausibly, the introduction and usage of this new therapy in RRMS patients will ensure clinical benefits for patients without resulting in additional costs for the Italian NHS.[In Italian
Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy
Full text linkBACKGROUND: Radioiodine ablation is an adjuvant procedure used to treat patients with differentiated thyroid cancer. For ablation to be successful, patients must have elevated levels of thyroid stimulating hormone (TSH). This can be achieved by withholding thyroid hormone therapy (endogenous stimulation), or by administration of recombinant human thyroid stimulating hormone (rhTSH; Thyrogen®; exogenous stimulation) to patients in the euthyroid state.AIM: To compare the estimated health benefits, cost and cost-effectiveness of TSH stimulation with and without Thyrogen® in the Italian setting.METHODS: A cost-utility analysis was undertaken to assess the impact of exogenous vs. endogenous TSH stimulation before radioiodine remnant ablation of patients with newly diagnosed, well-differentiated papillary or follicular thyroid cancer who have undergone total or near-total thyroidectomy. A Markov model was developed to simulate treatment costs and health outcomes associated with exogenous and endogenous stimulation in four distinct health states: pre-ablation, ablation, post-ablation, and well/recovery. Treatment was stratified by patients who receive high- and low-activity (30-100 mCi, respectively) in the ablation state. The Italian National Health System perspective was adopted in the base case scenario while the impact of indirect costs was explored in a sensitivity analysis. Costs and quality-adjusted life years (QALY) specific to each health state were estimated, summarized and converted into a corresponding incremental cost-effectiveness ratio (ICER).RESULTS: We calculated a cost-effectiveness ratio of 18,357.18 €/QALY gained whereas the inclusion of indirect cost and accident cost produced reductions of the ICER to € 14,609.51 and € 15,515.26 per QALY, respectively. Finally, all results in the sensitivity analysis are below the lower bound of national and international cost- effective threshold.CONCLUSION: Thyrogen® represents a cost-effective option for patients with differentiated thyroid cancer who underwent total or near-total thyroidectomy in Italy. Our findings are consistent with other cost-utility analyses
Cost of care of chronic non-communicable diseases in Jamaican patients: the role of obesity
Full text linkOBJECTIVE: To estimate the economic cost of Chronic Non-Communicable Diseases (CNCDs) and the portion attributable to obesity among patients in Jamaica.METHODS: The cost-of-illness approach was used to estimate the cost of care in a hospital setting in Jamaica for type 2 diabetes mellitus, hypertension, coronary heart disease, stroke, gallbladder disease, breast cancer, colon cancer, osteoarthritis, and high cholesterol. Cost and service utilization data were collected from the hospital records of all patients with these diseases who visited the University Hospital of the West Indies (UHWI) during 2006. Patients were included in the study if they were between15 and 74 years of age and if female, were not pregnant during that year. Costs were categorized as direct or indirect. Direct costs included costs for prescription drugs, consultation visits (emergency and clinic visits), hospitalizations, allied health services, diagnostic and treatment procedures. Indirect costs included costs attributed to premature mortality, disability (permanent and temporary), and absenteeism. Indirect costs were discounted at 3% rate.RESULTS: The sample consisted of 554 patients (40%) males (60%) females. The economic burden of the nine diseases was estimated at US 1,157,173 (males 23%; females 77%). Total direct cost was estimated at US 1,932,241 with female patients accounting for 50.6% of this cost. The greater cost among women was not found to be statistically significant. Overall, on a per capita basis, males and females accrued similar costs-of-illness (US 10,758.18).CONCLUSIONS: In a country with per capita GDP of less than US 10,239 for CNCDs is excessive and has detrimental implications for the health and development of Jamaica
[Cost-effectiveness analysis of ocriplasmin in the treatment of vitreomacular traction in Italy]
Full text linkBACKGROUND: Vitreomacular traction (VMT) caused by vitreomacular adhesion (VMA), is a pathological condition when the vitreous humor has an abnormally strong attachment to the central part of the retina. Ocriplasmin recently approved for the treatment of VMT, including when associated with macular hole (MH) of diameter less than or equal to 400 microns, is a recombinant truncated form of the human serine protease plasmin with retained enzymatic activity, administered by intravitreal injection. We estimated long-term benefits and costs associated with the resolution of traction, following treatment with ocriplasmin versus Standard of Care (SoC), from National Health Service (NHS) perspective.METHODS: A lifetime Markov model has been adopted for Italy in order to estimate costs and outcomes, gained for patients with VMT, with and without MH, treated with ocriplasmin. Health effects have been expressed as Life Years (LY) and Quality adjusted LY gained (QALY), and estimated based on time spent in Visual Acuity (VA) states, defined by best and worst seeing eye, disutility impact associated with surgical interventions, adverse events and metamorphopsia. Deterministicand probabilistic analysis have also been conducted.RESULTS: Over a lifetime ocriplasmin versus SoC generated incremental benefits in terms of QALYs and overall treatment costs in each patients subgroups. Patients with VMT and VMT+MH treated with ocriplasmin had an incremental survival benefits of 0.1123 and 0.0772 QALYs respectively. Therefore, it is expected to come at an incremental cost of 1,873 € and 2,185 € for VMT and VMT+MH patients respectively. The associated ICER is 16,683 € and 28,294 € per QALY gained. Both sensitivity analyses for each of the subgroups confirmed the robustness of the model results.CONCLUSION: Compared to SoC, ocriplasmin is a cost effective therapy option in the treatment of VMT, including whenassociated with MH.[Article in Italian
Impact of new healthcare legislation and price policy on healthcare services provider at the time of financial crisis. A 10 years study
Full text linkMonitoring, calculation and assessment of healthcare services prosperity in the community pharmacy with the help of financial analysis indicators for the years 2003-2012, using financial statements was conducted, with respect to profitability, debt, liquidity, working capital, and efficiency parameters. These ratios reflect various changes that hold between years 2003 and 2012. Under the time of financial crisis, recession and serious socio-economic changes the profitability parameter Gross Profit ranged from 2003-2011 = 16.12-22.79% (average = 19.20%; mean = 19.78%; σ = 2.41), but in 2012 decreased on 14.35%. Net Profit ranged 2003-2011 = 10.96-18.3% (average = 14.62%; mean = 16.62%; σ = 4.92), while in 2012 reached only 2.29%. Debt ratio ranged from 2003-2012= 2.33-4.81 (average = 3.44; mean = 3.07; σ = 0.82). Liquidity parameters Current Ratio spread between 2003-2012 = 1.13-1.71 (average = 1.43; mean = 1.46; σ = 0.15) and Quick Ratio spread between 2003-2012 = 0.72-1.27 (average = 1.07; mean = 1.09; σ = 0.15). Working Capital Ratio ranged from 2003-2012 = 2.66-12.94 (average = 9.58; mean = 10.06; σ = 3.1) and efficiency ratios were measured either. All changes that have taken place in the society had an impact on community pharmacy finance by worsening its profitability, liquidity, working capital and some of efficiency parameters. Therefore the stability of community pharmacy may be threatened and may affect its future performance
The regulatory and Health Technology processes in Europe and drug market access. The case of cystic fibrosis
Full text linkIn order to reach the European market, a new drug needs to receive a positive evaluation regarding its quality, safety and efficacy by regulatory health authorities and also obtain a positive HTA appraisal regarding its cost-effectiveness by HTA bodies. Regulators and HTA bodies are collaborating in several projects at European level in order to harmonize the scientific requirements of both evaluations to the maximum extent possible. The comparison of the regulatory evaluation performed by EMA for Kalydeco and the HTA appraisals issued by several EU bodies exemplifies the dilemma between scientific evidence and local economic considerations and the difficulties in the achievement of harmonization and therefore equity in the access to drugs
Process reengineering: the experience of electrophisiology center of the Local Health Unit of Viterbo
Full text linkCost analysis of inappropriate treatments for suspected dermatomycoses
Full text linkSuperficial mycoses are estimated to affect more than 20-25% of the world’s population with a consistent increase over the years. Most patients referred to our clinic for suspected dermatomycoses have already been treated with pharmacotherapy, without a previous mycological examination and many show changes in the clinical manifestations. Indeed, some medications, such as steroids, antiviral, antibiotics and antihistamines are not able to erase a fungal infection, but also they can cause atypical clinical manifestations. The consequences of inappropriate treatment include delayed diagnosis, prolonged healing time, and additional costs. The aims of this study were (1) to evaluate the incidence of increased costs attributable to inappropriate therapy sustained by the National Health Service and patients and (2) to highlight the importance of mycological evaluation before starting treatment, in order to improve diagnostic accuracy. An observational retrospective and prospective study was performed from September 2013 to February 2014, in 765 patients referred to our center (University Hospital “ Federico II”) in Naples, Italy, for suspected mycological infection. The following treatments (alone or in combination) were defined as inappropriate: (1) cortisone in a patient with at least one positive site; (2) antifungals in (a) patients with all negative sites or (b) ineffective antifungal treatment (in terms of drug chosen, dose or duration) in those with all positive sites; or (3) antibiotics; (4) antivirals or (5) antihistamines, in patients with ≥ 1 positive site. Five hundred and fifty patients were using medications before the assessment visit. The total amount of avoidable costs related to inappropriate previous treatments was € 121,417, representing 74% of the total treatment costs. 253/550 patients received drugs also after the visit. For these patients, the cost of treatment prescribed after mycological testing was € 42,952, with a decrease with respect to the total consumption of drugs at the time of access to the Mycology Laboratory of € 34,781. Thus, our cost analysis shows that it is important to obtain a reduction of costs for pathologies that need to be confirmed by examinations before starting treatment