Summary
What is known and background: The introduction of vaccines has lead to a significant reduction in morbidity and mortality from diseases such as measles, rubella and poliomyelitis, as well as the eradication of smallpox (Ertl HC, Xiang Z (1996) The Journal of Immunology, 156, 3579–3582). A recent vaccine approved by the Food and Drug Administration (FDA) is the recombinant quadrivalent human papillomavirus (HPV) vaccine (Merck, Gardasil®). Concerns raised with this preventive measure include safety and efficacy issues as well as the financial implications. Furthermore, the use of the vaccine in women outside the currently approved age ranges and in adolescent boys and men has also been a source of debate.
Objective: A review of two licensed HPV vaccines (Gardasil, Merck and Cervarix, GalxoSmithKline) in the light of these issues.
Methods: Literature searches were conducted using the MEDLINE (1966 – December 2008) and PubMed databases in addition to the Centers for Disease Control and Prevention website. Bibliographies of selected references were also evaluated for relevant articles. Published guidelines and press releases were utilized as were the manufacturer’s package inserts. The collection of information for this review was limited to the most recently available human data.
Results and discussion: The HPV quadrivalent vaccine has been effective in the management of HPV by preventing vaccine subtype‐related persistent infection and precancerous lesions as evidenced by numerous clinical trials. It is also regarded as a generally safe and well‐tolerated vaccine, based on an assessment of reported adverse events submitted through governmental databases and analyzed by independent researchers. The majority of adverse events were non‐serious and the vaccine has not been conclusively implicated with serious events. The FDA continues to focus on routine post‐marketing surveillance monitoring of reported adverse events. The bivalent vaccine has also been shown to be effective in reported trials. Its adverse effect profile also appears acceptable.
What is new and conclusion: The HPV vaccines appear safe and effective. Additional clinical research on the vaccines on women outside the currently approved age ranges and in males is necessary. Studies on longer‐term outcomes, including cervical cancer and the emergence of new viral genotypes are also necessary.
The VAP diagnostic threshold for quantitative BAL in trauma patients should be >10 colonies/mL. One may consider a threshold of >10 colonies/mL in severely injured patients with Pseudomonas or Acinetobacter species.
With disk diffusion, the following zone diameters are suggested to be resistant and susceptible breakpoints, respectively: for susceptibility testing of Campylobacter coli, no inhibition zone and 15 mm or more for erythromycin, and 20 mm or less and 25 mm or more for ciprofloxacin, in the absence or presence of an inhibition zone around the nalidixic acid disk; and for susceptibility testing of C. coli and Campylobacter jejuni, 20 mm or less and 26 mm or more for tetracycline.
0 1 7 ) A 3 9 9 -A 8 1 1 A555 were elicited from an expert panel of 6 hematologists with the Delphi technique. Unit costs were taken from officially published Greek sources (Ministry of Health, Social Insurance Funds). Utility data were taken from a published UK study. Only direct costs were considered in the analysis and the cost base year was 2016. The time horizon was lifetime and the perspective adopted was the societal. Future costs and outcomes were discounted at 3.5%. Probabilistic sensitivity analysis (PSA) was performed to test robustness of model results. Results: GClb was associated with higher mean costs (€ 24,874) but also with higher life years gained (LYs -5.70) and quality adjusted life years (QALYs) 3.95 versus all comparators. The incremental cost effectiveness ratio (ICER) of GClb versus RClb was estimated at € 15,679 per LY and € 16,614 per QALY gained. The respective ICERs versus Clb, OClb and RBenda were estimated at € 17,258, € 9,587 and € 9,445 per LY and € 19,269, € 9,967 and € 10,026 per QALY gained. PSA showed that the probability of GClb being cost effective at a threshold of € 50,000 per QALY was 98.9%. ConClusions: GClb appears to be a cost effective treatment option versus all comparators in first line treatment of CLL in the Greek health care setting.objeCtives: Idiopathic Pulmonary Fibrosis (IPF) is a rare, progressive disease of unknown aetiology with a median survival of 3 years. To date, nintedanib and pirfenidone are the only antifibrotic agents indicated for the treatment of IPF in Western countries. The aim of this study is to conduct a systematic review of the literature on the cost-effectiveness of these two medicines. Service. Ten studies used a Markov model while 1 other study used a microsimulation model. When compared to best supportive care (BSC), neither nintedanib nor pirfenidone had an incremental costeffectiveness ratio inferior to € 30,000 in any studies except in one which aimed to assess the impact of different models. Seven studies compared nintedanib to pirfenidone. Six of them showed economic dominance of nintedanib over pirfenidone (less costs, more quality-adjusted life years [QALY]), while one showed that pirfenidone was a cost-effective strategy (more QALYs but more costs) compared to nintedanib. ConClusions: Overall, the cost-effectiveness of IPF treatments has been well studied. Nintedanib and pirfenidone have demonstrated important clinical benefits for patients with IPF. Due the lack of alternative treatment, nintedanib and pirfenidone are rarely cost-effective versus BSC. When compared together, nintedanib dominates pirfenidone in most analyses (less costs, more QALYs).
OBJECTIVES:Biologic treatments had dramatically changed the therapeutics, outcomes and cost of management of psoriasis, a common chronic disease that strongly affects quality of life of patients. The aim of this study was to assess the cost-effectiveness of biologic alternatives currently available in Mexico for treatment of moderate to severe psoriasis from an institutional perspective. METHODS: A decision-tree model was developed to simulate the clinical course of patients treated with etanercept, adalimumab, infliximab or ustekinumab as first-line therapies, as well as treatment associated costs (2-year timeframe with a 5% annual discount rate). Effectiveness measures were the proportion of patients reaching 75% improvement in the Psoriasis Area and Severity Index (PASI-75) and quality adjusted life years gained (QALY=s). Costs considered included: biologics drugs, concomitant medication, medical follow-up and side effects management. Clinical response of alternatives was extracted from published literature, while unit costs were collected from Instituto Mexicano del Seguro Social (IMSS) official databases. Probabilistic sensitivity analyses were completed. RESULTS: After two years, the proportions of patients reaching PASI-75 were 59%, 62.1%, 62.7%, and 64.5% for adalimumab, etanercept, infliximab and ustekinumab, respectively (pϭ0.077, Friedman test); QALY=s associated to each alternative were: 1.5554, 1.5633, 1.5650 and 1.5695, respectively (pϭ0.392, Friedman test). Given that in the timeframe considered there are no differences between effectiveness of therapies, a costminimization rather than a cost-effectiveness analysis was performed.
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