Health care burden and treatment patterns in commercially insured children with chronic idiopathic/spontaneous urticaria: A real-world study in the United States.

BACKGROUND: Chronic idiopathic urticaria (CIU)/spontaneous urticaria (CSU) is defined by the presence of wheals, angioedema, or both for ≥6 weeks, with or without an identifiable trigger. Real-world health care data among children with CIU/CSU remain scarce. OBJECTIVES: To describe treatment patterns, health care resource utilization (HRU), and costs in pediatric patients with CIU/CSU (<12 years old) and to compare these with pediatric patients without CIU/CSU. METHODS: A commercial administrative claims data base (September 2013 to June 2016) was used. The CIU/CSU cohort included pediatric patients with either two or more claims for a diagnosis of urticaria ≥6 weeks apart or one or more claims for a diagnosis of urticaria and one or more claims for a diagnosis of angioedema ≥6 weeks apart (index was defined as the first claim). The control cohort comprised pediatric patients without urticaria or angioedema (index randomly assigned). Patients with <6 months of eligibility before and after the index date were excluded. HRU and costs were compared between the cohorts during the observation period after propensity score matching. RESULTS: A total of 6109 pediatric patients with CIU/CSU were selected, and 6107 were 1:1 matched with controls. The patients with CIU/CSU who had a mean ± standard deviation age of 4.58 ± 3.36 years, and 47.9% were girls. CIU/CSU-related medication use increased after diagnosis (e.g., baseline versus 6-month follow-up, 2.2 versus 8.0% for nonsedating prescription H1 antihistamines; 7.4 versus 17.4% for oral corticosteroids). Relative to the controls, the patients with CIU/CSU had higher rates of HRU (incidence rate ratios of 1.71, 2.39, and 2.07 for inpatient, emergency department, and outpatient visits, respectively; all p < 0.01), and higher all-cause per patient per year costs (mean cost differences of $2090, $1606, and $483 for total, medical, and pharmacy costs, respectively; all p < 0.01). CONCLUSION: This study highlighted unmet needs in pediatric patients with CIU/CSU who had increased medication (e.g., oral corticosteroids) and HRU burden after a diagnosis for CIU/CSU, and higher rates of HRU and costs relative to those without CIU/CSU.

Central nervous system effects of the second-generation antihistamines marketed in Japan--review of inter-drug differences using the proportional impairment ratio (PIR)-.

BACKGROUND: Second-generation antihistamines (AHs) have, in general, fewer sedative effects than the first-generation. However, important inter-drug differences remain in the degree of cognitive and/or psychomotor impairment. The extent to which a particular compound causes disruption can be conveniently compared, to all other AHs, using the Proportional Impairment Ratio (PIR). Although the PIR can differentiate the relative impairment caused by individual drugs, there is no indication of the reliability of the ratios obtained. OBJECTIVE: To calculate the PIRs -together with 95% confidence intervals (CIs), as an index of reliability- and compare AHs currently, or soon to be, available in Japan, with respect to their intrinsic capacity to cause impairment. METHODS: Results from studies of cetirizine, desloratadine, ebastine, fexofenadine, levocetirizine, loratadine, mequitazine, and olopatadine were included in the PIR calculations. All data utilised came from crossover studies in healthy volunteers which were randomised and placebo and positive-internal controlled. Existing databases from studies reporting the sedative effects of AHs on objective (speed, accuracy, memory) and subjective (feeling) psychometrics were augmented, via results from suitable studies published after the previous reviews. The null value for a PIR was one. RESULTS: A total of 45 studies were finally included for this review. Of the AHs assessed, fexofenadine, ebastine, and levocetirizine showed a PIR for objective tests of 0. However, only fexofenadine (PIR = 0.49) had an upper limit of the 95% CI of less than 1. Fexofenadine, levocetirizine, desloratadine, olopatadine, loratadine, and mequitazine all had a PIR for subjective ratings of 0, but the upper limits of the 95% CIs were all in excess of 1, although fexofenadine (PIR = 2.57) was the lowest. CONCLUSIONS: The results show that there are differences between second-generation AHs in the extent of sedation produced. However, subjective ratings indicate that patients may not necessarily be aware of this.

Assessing the chiral switch: approval and use of single-enantiomer drugs, 2001 to 2011.

OBJECTIVES: A "chiral switch" occurs in the pharmaceutical market when a drug made up of 2 enantiomer forms is replaced with a purified single-enantiomer version, often in the context of a patent expiration. We studied the prevalence of chiral switching in the United States over the past decade, including trends in use of, and expenditures on, these products in Medicaid. STUDY DESIGN: Retrospective analysis. METHODS: We used US Adopted Names prefixes (lev/levo/ar/es/dex/dextro) to identify all single-enantiomer drugs approved from 2001 to 2011. From publicly available US Food and Drug Administration (FDA) approval documents, we extracted the characteristics of the pivotal premarket trials for the single enantiomers. Specifically, we evaluated whether the single enantiomer was directly compared with the precursor racemic drug and whether there was evidence of superior efficacy. We used quarterly drug expenditure data from each state Medicaid program to chart trends in use of, and spending on, the single-enantiomer products and their racemic precursors during the study period. RESULTS: From 2001 to 2011, the FDA approved 9 single-enantiomer products: dexlansoprazole, levoleucovorin, levocetirizine, armodafinil, arformoterol, eszopiclone, escitalopram, dexmethylphenidate, and esomeprazole. Of those 9 drugs, 3 had at least 1 pre-approval randomized trial that included the racemic precursor as a direct comparator, but there was no evidence of superiority of the single enantiomer over the racemic at comparable doses. Between 2001 and 2011, US Medicaid programs spent approximately $6.3 billion on these 9 single-enantiomer drugs. CONCLUSIONS: Recently approved single-enantiomer drugs showed no evidence of superior efficacy over the older racemic precursors in the pivotal trials leading to their approval, and in a majority of cases, they were not directly compared.

The cost-effectiveness of treatment with desloratadine in patients with persistent allergic rhinitis.

OBJECTIVES: A new classification of persistent allergic rhinitis (PER) has been developed by the ARIA working group. Although the burden of AR is significant, treatment itself is also costly. It is unclear if treatment based on the new definition of PER is cost-effective. METHODS: The current study simulated the cost-effectiveness of desloratadine compared to placebo in the treatment of PER from the French societal perspective. Decision analysis was used to model the costs, effectiveness and cost-effectiveness over 12 months. Costs included medical expenditures (physician visits and prescription drugs) attributable to PER and related comorbidities and lost productivity due to absenteeism and presenteeism. Prices, tariffs and national wages were estimated from French national sources. MEASURES OF EFFECTIVENESS INCLUDED: symptom-based visual analogue scale (VAS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Total 5 Symptoms Score (T5SS), categorical improvement in therapeutic response, interference with activities of daily living (ADL) and sleep outcomes. Mild or symptom-free days and 'responders' were also captured as outcomes. Univariate and second-order multivariate probabilistic sensitivity analyses were conducted. RESULTS: Treatment with desloratadine dominated placebo (cost less and resulted in greater effectiveness) for all measures of effectiveness. Of the individuals taking desloratadine 46.8% were classified as 'responders' vs. 34.8% for placebo (p = 0.0012). Individuals taking desloratadine experienced mild/no symptoms for 57.6% of study days vs. 36.5% for placebo (p = 0.002). The expected annual cost of treatment with desloratadine (1819 euro) was less than placebo (2618 euro). Lost productivity was the most significant contributor to total cost. Results of the 10,000 Monte Carlo simulations showed that treatment was cost-saving in 99.6% of simulations. CONCLUSIONS: Treatment of PER with desloratadine resulted in improved effectiveness and significant savings. While the cost of drug treatment is greater than that of no treatment, the downstream costs associated with not treating PER significantly outweigh the cost of treatment. Key limitations include the comparison of desloratadine to placebo and the sources of cost and effectiveness measures. Future studies should examine the cost-effectiveness of all available treatments for PER. In addition, many utilization, productivity and effectiveness measures were taken from clinical trials and may not accurately reflect 'real world' treatment patterns and outcomes.

Cost and resource utilization comparisons of second-generation antihistamines vs. montelukast for allergic rhinitis treatment.

This study evaluates the costs and utilization burden associated with oral, branded second-generation antihistamines (BSGAs) compared with montelukast (MTLK) as first-choice treatment in newly diagnosed allergic rhinitis (AR) patients without asthma. We compared annual medical costs of illness and utilization changes from 1 year before index AR diagnosis to 1 year after for continuously enrolled AR patients initiating therapy with BSGA or MTLK. Multivariate regressions for each outcome variable adjusted for confounders including age, sex, geographic region, Charlson Comorbidity Index, RxRisk Score, 18 comorbidity groups, and payer type. Treatment selection bias was evaluated by propensity score with all covariates plus instrumental variables including physician type and likelihood of prescribing MTLK versus BSGA. Insurance claims data for the years 2003-2007 included AR patients in all regions of the United States. The final sample included 13,703 AR patients taking BSGAs (84%) or MTLK (16%). After confounder adjustment, MTLK patients experienced higher total medical costs ($1,542 versus $989), drug costs ($714 versus $477), AR drug costs ($474 versus $298), and outpatient visit costs ($480 versus $277) than BSGA patients (all values of p < 0.025). MTLK patients experienced higher total visits (0.96), AR outpatient visits (0.71), and comorbidity visits (0.12) than BSGA patients (all values of p < 0.01). MTLK patients were more likely to add additional AR therapy medications (MTLK, 43.2%; BSGA, 31.6%; p < 0.01). New AR patients prescribed MTLK as first-line medication therapy have higher medical costs and resource utilization than those prescribed first-line oral BSGAs. These differences persisted after adjustment for patient fixed effects, available confounders, and treatment propensity scores.

Costs of second-generation antihistamines in the treatment of allergic rhinitis: US perspective.

OBJECTIVE: To review the pharmacoeconomic literature evaluating use of antihistamines in treating allergic rhinitis (AR) in the US. METHODS: Three independent reviewers conducted a comprehensive search of the current literature with PubMed. They identified articles describing original research comprising US cost analyses or pharmacoeconomic evaluations that reported both costs and consequences of using second-generation anthistamines (SGAs), first-generation antihistamines (FGAs), or both for the treatment of patients with AR. The search was limited to studies performed in humans and published in English between 1998 and 2008. RESULTS: Five of 200 articles met the inclusion criteria and examined costs associated primarily with chlorpheniramine, diphenhydramine, cetirizine, and fexofenadine. The first two studies retrospectively analyzed a claims database and concluded that fexofenadine was associated with slightly lower overall costs than loratadine and cetirizine. A third study compared total healthcare costs associated with FGAs and SGAs, concluding that despite their higher prescription cost, SGAs result in lower medical resource use and lower cost for treatment of AR versus FGAs, although no individual SGA could be distinguished as providing substantial healthcare cost savings or increased cost-effectiveness over the other SGAs. Two studies investigated the impact of transitioning a prescription SGA to over-the-counter status and concluded that such a transition would provide cost savings to healthcare plans, but did not address the cost or health effect of such a switch on specific populations whose plans might no longer cover prescription SGAs. CONCLUSIONS: Preliminary evidence suggests that newer SGAs offer clinical, pharmacodynamic, and pharmacokinetic advantages that may translate into superior cost-effectiveness in the treatment of AR. Further study is warranted to clarify the pharmacoeconomic impact of the newer SGAs and to establish their relative cost-effectiveness.

Levocetirizine for chronic idiopathic urticaria: a review.

Only recently available on the US market, levocetirizine has emerged as an effective new option in the treatment of chronic idiopathic urticaria (CIU). Levocetirizine is the active isomer of cetirizine and demonstrates twice the affinity for the H1 receptor compared with the parent compound. In the treatment of CIU, levocetirizine has consistently demonstrated high response rates, fast onset, and a favorable side effect profile.

Impact of the reduction of the prescription charge in Wales on the prescribing of non-sedating antihistamines in primary care.

OBJECTIVE: Determine the impact of the phased reduction of the prescription charge in Wales on prescriptions for non-sedating antihistamines. METHOD: Prescription items for non-sedating antihistamines dispensed in 22 Local Health Boards (LHBs) in Wales and 15 Primary Care Trusts in the South East of England were analysed between October 2001 and September 2006. RESULTS: There was an increase in percent change (median (interquartile range [IQR])) in prescription items for non-sedating antihistamines dispensed in Wales in the 24 months after the first reduction of the prescription charge in October 2004 compared to the 24 months prior to this (13.7 [10.9-17.1] vs. 7.3 [5.0-10.7], p<0.001). In the South East of England there was no change over the same periods (4.4 [3.4-7.5] vs. 4.5 [0.8-7.9], p=0.73). In the five least deprived LHBs the percent change in prescriptions for non-sedating antihistamines increased in the 24 months after the reduction of the prescription charge compared to the previous 24 months (14.3 [11.5-19.4] vs. 9.0 [9.1-13.5], p=0.04). In contrast there was no change over the two periods in the five most deprived LHBs (13.1 [10.9-17.5] vs. 9.5 [2.9-10.4], p=0.08]. CONCLUSIONS: The phased reduction of the prescription charge in Wales coincided with an increase in the number of non-sedating antihistamines dispensed in Wales. This was only evident in the least deprived LHBs.

[Influence of the difference in the pollen count on medical costs in an allergen-specific immunotherapy for Japanese cedar pollinosis].

BACKGROUND: We studied medical economic efficacy and influence by the different number of pollen scattering in patients treated with allergen-specific immunotherapy for Japanese cedar pollinosis. METHODS: We calculated medical treatment costs and the medicine expense from medical records in eighteen cedar pollinosis patients treated with allergen-specific immunotherapy (IT-G) and with medications (M-G). We examined with the same patients for three years of different pollen scattering, mass scattering year (2005), moderate scattering year (2003), a few scattering year (2004). Furthermore, satisfaction of treatment and symptom score measured by visual analog scale in both subjects was studied in a mass scattering year. RESULTS: Total medical costs at hospital was cheaper in IT-G than in M-G. The result was depended on prescribed medical costs. In addition, prescribed medicine agents and total medical costs did not increase by the mass scattering year of pollen. Satisfaction of treatment and symptom score in IT-G was better than that in M-G. CONCLUSION: Immunotherapy had a benefit on a medical economy.

Diphenhydramine versus nonsedating antihistamines for acute allergic reactions: a literature review.

First-generation antihistamines can have adverse effects on the central nervous system and thereby complicate discharge planning from the emergency department (ED). Newer antihistamines are potentially safer, causing less sedation with similar efficacy. The aim of this study was to review the literature to better define which antihistamines are good options for the treatment of acute allergic reactions. A Medline search was conducted to identify English language articles published between January 1975 and March 2006 on antihistamines, sedation, and acute allergic reactions. Bibliographies from included studies were further investigated. We focused on sedative potential, effect on cognitive function, efficacy, onset of clinical activity, and cost of antihistamines. Diphenhydramine impairs psychomotor performance and cognitive function. Loratadine and desloratadine are nonsedating but less efficacious than cetirizine or fexofenadine. The incidence of sedation with cetirizine is less than that of first-generation antihistamines but is greater than placebo. Cetirizine has the fastest onset of action among the newer antihistamines. Fexofenadine does not impair psychomotor or cognitive skills and shows no dose-related increase in sedation but has a slower onset of action than diphenhydramine and cetirizine. Newer antihistamines cost approximately $0.52-2.39 more per dose than diphenhydramine ($0.37). Newer antihistamines provide similar efficacy as first-generation antihistamines but with less sedation. We believe this benefit outweighs the small increase in cost and that newer antihistamines should be considered in the management of acute allergic reactions. Although comparative ED-based trials are not available, newer antihistamines are an option for management of acute allergic reactions when sedation is a concern.

Counter sampling combined with medical provider education: do they alter prescribing behavior?

OBJECTIVE: To observe if medical providers alter their prescribing patterns of three relatively expensive categories of medications provided as samples by manufacturers (focus medications) when they receive additional education from pharmacists concerning the appropriate use of lower cost alternatives (counter samples) that are made available to dispense. DESIGN: Pretest, post-test with a control group. SETTING: Two rural, private care clinics in southeastern Idaho providing immediate care services. PARTICIPANTS: Eight medical providers at a clinic where interventions were employed (active intervention group) and seven medical providers in a clinic where no interventions occurred (control group). INTERVENTIONS: Medical providers in the active intervention group had: 1) education from pharmacists concerning the appropriate use of lower-cost alternatives compared with expensive focus medications 2) counter samples and patient sample handouts available to dispense to patients at their own discretion. MAIN OUTCOME MEASURES: The percentage of the total yearly prescriptions for nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, and acid-relief medications that consisted of focus-COX-2 NSAIDs, nonsedating antihistamines, and proton pump inhibitors (PPIs), respectively. RESULTS: The prescribing behavior of medical providers in the active intervention and control groups were significantly different at baseline in all three categories of focus medications. This suggested that the results should focus on changes across the two years of the study within the intervention and control groups rather than across the two groups. Medical providers in the intervention group significantly decreased the use of COX-2 NSAID prescriptions relative to total NSAID prescriptions following active intervention (38.9% in year 1 versus 23.7% in year 2, P < 0.05). Over the same two time periods, a nonstatistically significant decrease in COX-2 NSAID prescribing was seen at the control site (67.5% versus 62%, P > 0.05). Education and counter sampling did not stop medical providers from significantly increasing the total yearly prescriptions for antihistamines and acid-relief medications that consisted of focus-nonsedating antihistamines (86.7% versus 93.1%, P < 0.05) and PPIs (68.9% versus 86.2%, P < 0.05). Statistically significant increases in the prescribing of focus-nonsedating antihistamines (77.9% versus 98.3%, P < 0.05) and PPIs (77.5% versus 91.4%, P < 0.05) were also observed in the control group. CONCLUSIONS: Education by pharmacists, combined with access to counter samples, may or may not have an effect on medical provider prescribing, depending on the category of medication targeted for cost control.

Cost and utilization impacts of oral antihistamines in the California Medi-Cal program.

OBJECTIVES: Newer oral allergic rhinitis (AR) medications, the second-generation antihistamines (SGAs) have gained widespread acceptance because of their efficacy and reduced side effects relative to first-generation antihistamines (FGAs). There are no empirical studies comparing the costs of treatment of SGAs relative to FGAs. METHODS: We analyzed data from a 20% beneficiary sample (approximately 120,000 continuously enrolled beneficiaries per year) for the Medi-Cal Fee-for-Service program during 1999 to 2000. AR medications available under Medi-Cal included three SGA medications (loratadine, fexofenadine, and cetirizine) and over 200 FGA products containing either diphenhydramine or chlorpheniramine or both. Because multiple medications were evaluated, a sample selection model was estimated using a two-stage multinomial logistic--variance components regression framework. RESULTS: SGA medications have significantly lower total direct health-care treatment costs per patient than FGA medications with costs ranging from US 347 dollars to US 448 dollars less (P < 0.001), despite higher AR medication costs. Total drug expenditures were also not significantly different for patients using SGA or FGA medications despite SGA prescriptions averaging US 47 dollars higher than FGAs. Emergency department visits, inpatient admissions and physician office visits were also significantly lower for patients using SGA medications. CONCLUSIONS: Significant cost and utilization reductions were associated with all of the SGA medications relative to FGA drugs, despite their higher acquisition costs. If facing higher copayments for prescription AR drugs, many patients, particularly lower income patients, may choose cheaper over-the-counter (OTC) FGAs rather than SGAs. Our analysis finds this might lead to increased overall health-care treatment costs, unless Medicaid and health insurance plans subsidize OTC AR medications.

Levocetirizine improves quality of life and reduces costs in long-term management of persistent allergic rhinitis.

BACKGROUND: Allergic Rhinitis and its Impact on Asthma in collaboration with the World Health Organization initiative reclassified allergic rhinitis, like asthma, by duration and severity. The Xyzal in Persistent Rhinitis Trial is the first large, long-term clinical trial studying patients with persistent rhinitis as defined by Allergic Rhinitis and its Impact on Asthma. OBJECTIVES: Two primary objectives were defined: comparison of the Rhinoconjunctivitis Quality of Life Questionnaire overall score and Total 5 Symptoms Score (rhinorrhea, sneezing, nasal congestion, and nasal and ocular pruritus) over a period of 4 weeks between levocetirizine 5 mg and placebo. Secondary endpoints included similar evaluations at 1 week and 3, 4.5, and 6 months, summary scores for a general health status questionnaire (Medical Outcomes Survey Short Form 36), a pharmacoeconomic assessment, comorbidities, and a safety evaluation. METHODS: The Xyzal in Persistent Rhinitis Trial was a 6-month double-blind, placebo-controlled, multicenter, multinational trial in 551 patients. Adults with persistent rhinitis sensitized to both grass pollen and house dust mite were randomized to receive levocetirizine 5 mg/d or placebo. RESULTS: A total of 421 patients completed the full study. Levocetirizine significantly improved both the Rhinoconjunctivitis Quality of Life Questionnaire overall score and the Total 5 Symptoms Score from week 1 to 6 months (all P values <.001). Medical Outcomes Survey Short Form 36 summary scores were also improved in the levocetirizine group compared with the placebo group. Treatment cessation because of lack of effect, comorbidities, and overall costs of disease, and comorbidities per working patient per month (160.27 vs 108.18) were lower in the levocetirizine group. CONCLUSION: Levocetirizine was shown to improve quality of life and symptoms and to decrease the overall costs of the disease over the 6-month treatment period.

The economic impact of payer policies after the Rx-to-OTC switch of second-generation antihistamines.

OBJECTIVE: As a result of the over-the-counter (OTC) introduction of loratadine, health plans have been struggling to determine the best policy to incorporate this change within their existing drug benefit structure for second-generation antihistamines (SGA). The objective of this study was to examine the economic impact of payer policies in response to the Rx-to-OTC switch of loratadine. STUDY DESIGN: Decision analysis was used to model the budgetary impact and cost-effectiveness of four policies for SGA benefits for the managed care organization (MCO), employer, and Medicaid perspectives separately. PATIENTS AND METHODS: Outcomes included direct medical costs and lost productivity (employers only), discounted, quality-adjusted life-years (QALYs) saved because of amelioration of allergic rhinitis symptoms and avoidance of unintentional injuries associated with the use of first-generation antihistamines (FGA). Bayesian probabilistic sensitivity analysis was conducted using second-order Monte Carlo simulation. RESULTS: Providing limited OTC and second-tier prescription benefits would cost approximately 0.13 dollars and 0.30 dollars compared to third-tier prescription benefits for employers and MCOs, respectively, and would save Medicaid 0.02 dollars per member per month (PMPM). Providing limited coverage for OTC loratadine while retaining second-tier prescription benefits for SGA was the optimal policy for a willingness to pay below 26,200 dollars per QALY for all payers. CONCLUSIONS: Offering second-tier prescription and limited OTC benefits provides greater effectiveness and is not significantly more expensive PMPM than discontinuation. Some of the drug savings from limiting coverage of prescription SGA may be attenuated by the cost of lost productivity and direct medical expenditures due to unintentional injuries associated with increased FGA use in addition to the increased cost of therapeutic substitutes.

Review of cetirizine hydrochloride for the treatment of allergic disorders.

Cetirizine hydrochloride is an orally-active and selective histamine (H(1))-receptor antagonist. It is a second-generation antihistamine and a human metabolite of hydroxyzine. Therefore, its principal effects are mediated via selective inhibition of peripheral H(1) receptors. The antihistaminic activity of cetirizine has been documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical studies, however, dry mouth has been seen more commonly with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for receptors other than H(1) receptors. Auto-radiographical studies with radiolabelled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H(1) receptors. Impairment of CNS function is comparable to other low-sedating antihistamines at the recommended dose of 10 mg/day for adults. It has anti-inflammatory properties that may play a role in asthma management. It does not interact with concomitantly administered medications, it has no cardiac adverse effects, and it does not appear to be associated with teratogenicity. Cetirizine is predominantly eliminated by the kidneys with a mean elimination half-life is 8.3 h. It is rapidly absorbed, and significant clinical inhibition of a wheal and flare response occurs in infants, children and adults within 20 min of a single oral dose and persists for 24 h. No tolerance to the wheal and flare response occurs even after 1 month of daily treatment. The clinical efficacy of cetirizine for allergic respiratory diseases has been established in numerous trials. There is evidence that cetirizine improves symptoms of urticaria. Concomitant use of cetirizine also decreases the duration and amount of topical anti-inflammatory preparations needed for the treatment of atopic dermatitis. Interestingly, several clinical studies suggest that cetirizine may be useful in the treatment and prevention of mild asthma.

Transitioning the second-generation antihistamines to over-the-counter status: a cost-effectiveness analysis.

BACKGROUND: A U.S. Food and Drug Administration advisory committee deemed the second-generation antihistamines (SGA) safe for over-the-counter use against the preliminary opposition of the manufacturers. As a result, loratadine is now available over-the-counter. First-generation antihistamines (FGA) are associated with an increased risk of unintentional injuries, fatalities, and reduced productivity. Access to SGA over-the-counter could result in decreased use of FGA, thereby reducing deleterious outcomes. The societal impact of transitioning this class of medications from prescription to over-the-counter status has important policy implications. OBJECTIVE: To examine the cost-effectiveness of transitioning SGA to over-the-counter status from a societal perspective. RESEARCH DESIGN: A simulation model of the decision to transition SGA to over-the-counter status was compared with retaining prescription-only status for a hypothetical cohort of individuals with allergic rhinitis in the United States. Estimates of costs and effectiveness were obtained from the medical literature and national surveys. Sensitivity analysis was performed using a second-order Monte Carlo simulation. MAIN OUTCOME MEASURES: Discounted, quality-adjusted life-years saved as a result of amelioration of allergic rhinitis symptoms and avoidance of motor vehicle, occupational, public and home injuries and fatalities; discounted direct and indirect costs. RESULTS: Availability of SGA over-the-counter was associated with annual savings of 4 billion dollars (2.4-5.3 billion dollars) or 100 dollars (64-137 dollars) per allergic rhinitis sufferer and 135,061 time-discounted quality-adjusted life years (84,913-191,802). The sensitivity analysis provides evidence in support of these results. CONCLUSION: Making SGA available over-the-counter is both cost-saving and more effective for society, largely as a result of reduced adverse outcomes associated with FGA-induced sedation. Further study is needed to determine the differential impact on specific vulnerable populations.

Access to allergy care: implications for quality healthcare and public safety.

Some managed care companies are considering reducing or eliminating coverage for several second-generation antihistamines prescribed to treat patients with allergic rhinitis, chronic idiopathic hives, and other allergy-related conditions. Treatment options for all patients with allergic and immunologic diseases should reflect accepted standards of medical care. Prescription policies limiting coverage and/or use of second-generation antihistamines are medically inappropriate, below current national standards of practice in the field of allergic and immunologic diseases, and may increase health expenditures in the long-term. Any action to reduce or limit coverage will not only diminish the quality of medical care for allergy patients but have significant health and safety implications for the general public.