Cost-effectiveness of omalizumab for the treatment of chronic spontaneous urticaria.

BACKGROUND: Chronic spontaneous urticaria (CSU) is a skin disease with itchy hives and/or angio-oedema that last for at least 6 weeks without an obvious external trigger. OBJECTIVES: To determine the cost-effectiveness of omalizumab relative to standard of care (SoC; up to four times the daily dose of H1 -antihistamines) in the Netherlands from a societal perspective. METHODS: The Markov model used consisted of five health states based on Urticaria Activity Score over 7 days. Model settings and characteristics of the Dutch patient population were based on an online survey among clinical experts and were validated during an expert committee meeting. Transition probabilities were derived from the GLACIAL trial. Healthcare consumption, quality of life (using EuroQol-5D) and productivity losses were derived from a burden-of-illness study (ASSURE-CSU) among 93 Dutch patients. Healthcare consumption and productivity losses were evaluated using the Dutch costing manual. The comparator treatment was SoC, consisting of (updosed) antihistamines. A 10-year time horizon was used. RESULTS: The incremental cost-effectiveness ratio (ICER) of omalizumab vs. SoC was €17 502 per quality-adjusted life-year (QALY) gained. Productivity costs played an important role in the value of the ICER; discarding productivity costs resulted in an ICER of €85 310 per QALY. CONCLUSIONS: Omalizumab is cost-effective compared with SoC. The outcomes of this study were used to establish omalizumab as third-line therapy in the Dutch treatment guidelines for CSU.

A comprehensive evaluation of rationality of cough and cold medicines available in Indian market.

To analyse various cough and cold formulations available in the Indian market and to study their pharmacological rationale and cost effectiveness, a cross-sectional, observational study was carried out for evaluation of the drugs listed in Current Index of Medical Specialities (CIMS) India, September 2010.The formulations were assessed for their total number, type of dosage form, number of constituents in each formulation, their pharmacological group and rationality. The total daily cost and its association with type of dosage form was analysed. Out of a total 1297 preparations evaluated, 94% were fixed dose combination. The mean number of constituents was 3.20 +/- 1.03. Liquid oral formulations were largest in number (64.4%). The formulations contained various antitussives (30.30%), expectorants (33.92%), antihistamines (71.09%), mucolytics (35.62%), decongestants (56.28%), bronchodilators (16.81%) and analgesics/antipyretics (31.30%). None of the preparation was listed in the Model list of Essential Medicines, WHO (March 2011) under section 25 of "Medicines acting on the respiratory tract". Only 2% of the preparations had pharmacological rationale for their use in cough and common cold; 9.6% were containing more than one ingredient of the same pharmacological group and 6.85% were containing both antitussive and expectorant having opposing action. Highest number of preparations (36.85%) was having cost of therapy of Rs 6-10 per day. Liquid oral dosage forms had significantly higher cost than solid dosage form (p < 0.0001) and topical nasal dosage forms had significantly higher cost than liquid (p < 0.03) and solid (p < 0.001) dosage forms. It is conducted that various cough and cold medicines available in Indian market lacked therapeutic rationale for their use, leading to wasteful expenditure.

Alcaftadine for the prevention of itching associated with allergic conjunctivitis.

OBJECTIVE: To evaluate the safety and efficacy of alcaftadine for the prevention of itching associated with allergic conjunctivitis. DATA SOURCES: A medical literature search was conducted in MEDLINE/PubMed (2006-February 2012) and EMBASE (2006-February 2012) using the search terms alcaftadine and Lastacaft. References from these publications were reviewed for additional resources. Additional information was collected from Web sites of the US government (http://www.clinicaltrials.gov, http://www.fda.gov) and of Allergan Inc., the manufacturer of Lastacaft (http://www.lastacaft.com). STUDY SELECTION AND DATA EXTRACTION: All identified articles and publications in English were reviewed for pharmacology, pharmacokinetics, efficacy, and safety data. Priority was placed on clinical trials. DATA SYNTHESIS: Two published clinical trials evaluated the efficacy of alcaftadine in the prevention of ocular itching and conjunctival redness associated with allergic conjunctivitis. One trial compared alcaftadine to placebo, and another trial compared alcaftadine to placebo and olopatadine HCl to placebo. Both studies showed superior efficacy, both clinically and statistically, in the prevention of ocular itching associated with allergic conjunctivitis compared to placebo. Although conjunctival redness was evaluated in the 2 trials, neither trial demonstrated both clinical and statistical significance. Both trials demonstrated a rapid onset of action of less than 15 minutes, as well as a duration of action greater than 16 hours, which supports the use of once-daily administration. Overall, alcaftadine was well tolerated, and common adverse effects, reported in less than 4% of patients, included ocular irritation, pruritus, erythema, and stinging or burning upon instillation. Ocular adverse effects were typically mild in severity and self-limiting. CONCLUSIONS: Alcaftadine is a safe and effective option for the prevention of ocular itching associated with allergic conjunctivitis, is dosed once daily, and is competitively priced among prescription medications for allergic conjunctivitis. Additional studies are needed to further evaluate the comparative efficacy among ocular antihistamine/mast cell stabilizing medications.

Drugs for insomnia.

INTRODUCTION: Sleep is a vital neurochemical process involving sleep-promoting and arousal centers in the brain. Insomnia is a pervasive disorder characterized by difficulties in initiating or maintaining or non-refreshing (poor quality) sleep and clinically significant daytime distress. Insomnia is more prevalent in women and old age and puts sufferers at significant physical and mental health risks. This review summarizes published data on the current and emerging insomnia drug classes, rationale for development and associated risks/benefits. (Summary of Product Characteristics and Medline search on "hypnotic" or specific drug names and "Insomnia"). AREAS COVERED: GABA(A) receptor modulators facilitate sleep onset and some improve maintenance but increase risk of dependence, memory, cognitive and psychomotor impairments, falls, accidents and mortality. Melatonin receptor agonists improve quality of sleep and/or sleep onset but response may develop over several days. They have more benign safety profiles and are indicated for milder insomnia, longer usage and (prolonged release melatonin) older patients. Histamine H-1 receptor antagonists improve sleep maintenance but their effects on cognition, memory and falls remain to be demonstrated. Late-stage pipeline orexin OX1/OX2 and serotonin 5HT2A receptor antagonists may hold the potential to address several unmet needs in insomnia pharmacotherapy but safety issues cast some doubts over their future. EXPERT OPINION: Current and new insomnia drugs in the pipeline target different sleep regulating mechanisms and symptoms and have different tolerability profiles. Drug selection would ideally be based on improvement in the quality of patients' sleep, overall quality of life and functional status weighed against risk to the individual and public health.

[Cost-effectiveness analysis of pre-seasonal medication for cedar pollinosis in Japan].

Pre-seasonal medication is recommended for cases of cedar pollinosis that are expected to manifest severe symptoms during the season, according to the standard clinical guideline in Japan. This study aims to appraise the value for money of additional costs that accompany the choice of pre-seasonal medication from payer's perspective. Based on the 12 reports of controlled clinical trials with Symptom Score (SS) and Medication Score (MS) comparing pre-seasonal medication with intra-seasonal symptomatic medication, 15 incremental cost-effectiveness ratios (ICERs) and 4 integrated ICERs of each group of targeted agents are estimated. Incremental effects are estimated by reading SS charts, and incremental costs are estimated by reading MS charts and using National Health Insurance Medical Fee Schedule and National Health Insurance Drug Price Standard. Estimated ICERs range from ¥322,195 per quality-adjusted life-year (QALY) to ¥57,088,063 per QALY. Integrated ICERs are: ¥1,128,286 per QALY for 2nd generation histamine H(1) receptor antagonists, ¥2,248,018 per QALY for leukotriene receptor antagonists, ¥2,692,911 per QALY for prostaglandin D(2) and thromboxane A(2) receptor antagonists, ¥1,150,943 per QALY for Th2 cytokine suppressors, and ¥1,291,341 per QALY for all agents. Pre-seasonal medication for cedar pollinosis is cost-effective regardless of the choice of the prophylactic agent among 2nd generation histamine H(1) receptor antagonists, leukotriene receptor antagonists, prostaglandin D(2) and thromboxane A(2) receptor antagonists, or Th2 cytokine suppressors, taking the suggested threshold of ¥5,000,000 per 1 QALY gain in Japan. The use of 2nd generation histamine H(1) receptor antagonists and Th2 cytokine suppressors are found more favourable.

Simultaneous determination of cyclodol and diprazin by thin layer chromatography and high performance liquid chromatography.

Ciklodol (trihexyphenidil)--the central and peripheral m-cholinoblocker is currently used with other antipsychotic drugs such as phenotiazines and tricycle antidepressants. For the purpose of simultaneous determination of ciklodol and diprazine, were selected two methods of analysis: Thin Layer Chromatography (TLC) and High Performance Liquid Chromatography (HPLC). During development of TLC method was studied the 10 visualizing system and 24 mobile systems. For individual or simultaneous determination of ciklodol and diprazine were recommended the following solvents' systems: 1. Toluene-acetone-ethanole-25%NH(4)OH (45:45: 7.5:2.5), 2. Hexane-ethyl acetate (15:5), 3. Chloroform-heptene-25%NH(4)OH (16:3:3), 4. Ethylacetate-hexane (10:10), 5. Acetonitrile-metanol (10:10) and 6.Heptene-chloroform-ethanol-25% NH(4)OH (5:10:3:1). As visualizing systems were chosen: Iodine vapors, blacklight (UV254) and reagent of FNP. Reagent of FNP gives colored spot just with diprazine and it is also could be used for separation of both objects in simultaneous analysis. Developed HPLC method of simultaneous determination of ciklodol and diprazine: like mobile phase is recommended: Acetonitril- 0.05M KH(2)PO4 (55:45) (v/v) +H(3)PO(4) (pH3.5), column EC250 x 4.6mm, with solid phase Nucleosil, flow rate 1ml/min, sample volume 40 microl. In given conditions, the retention time of ciklodol is 6.005min and diprazine 7.227min. Developed method of simultaneous determination and separation of ciklodol and diprazine in respective mixtures could be successfully applied as in the pharmaceutical, as well in the chemical-toxicological laboratories.

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.

[Comparison of clinical efficacy and cost-quality of antihistamines in early treatment for Japanese cedar pollinosis].

BACKGROUND: Japanese cedar pollinosis (JCP) affects more than 16% of the Japanese population. The estimated direct and indirect costs for this disease totaled 286 billion yen in 1998. In JCP therapy, antihistamines are first line agents. It is well known that starting treatment for JCP with antihistamines before initial day of the pollen scattering can relieve nasal symptom severity during pollen season. The aim of this study is to assess the clinical efficacy and cost-quality of 7 major second-generation antihistamines in early treatment for Japanese cedar pollinosis (JCP). METHODS: Patients were randomly selected from 16 ENT clinical sites in Osaka and Wakayama between February 24 and March 8, 2003 (peak pollen season). Effectiveness was assessed using patient'ratings of nasal and ocular symptoms and overall assessment in their condition compared to previous season ones. Costs include direct costs of the drugs used for treatment to JCP from January to March. RESULTS: One hundred seventy-five patients who were treated with antihistamine monotherapy (azelastine: n=15, cetirizine: n=15, ebastine: n=36, epinastine: n=16, fexofenadine: n=16, loratadine: n=60, oxatomide: n=17) and 510 non-treatment patients were evaluated. Among 8 groups, there were significant differences in sneezing, rhinorrhea, ocular itching and overall health condition. However, among 7 monotherapy groups, there were no differences in each symptom or the overall assessment. In cost-quality analysis, there were significant differences in a cost for each effective patient (defined as those with improvement in their overall condition) among 7 drugs. The top three cost-efficacious drugs resulted in azelastine, loratadine and fexofenadine. CONCLUSION: These results show that there were no significant differences in clinical efficacy in early treatment for JCP among 7 antihistamines. But Japanese National Health Insurance drug price scheme led to significant differences in cost-quality.

Medication characteristics beyond cost alone influence decisions to underuse pharmacotherapy in response to financial pressures.

BACKGROUND AND OBJECTIVE: Little is known about how patients facing medication cost pressures make choices about whether to underuse one or more of their prescription drugs. We calculated the probability that older adults would underuse prescription medications for common chronic illnesses because of cost concerns. We also identified differences in cost-related underuse between symptom-relief medications (e.g., analgesics) and primarily "preventive" medications (e.g., antihypertensives). MATERIALS AND METHODS: Older chronically ill patients using both symptom-relief and preventive medications (N = 2,008) were identified as part of a nationwide survey in the United States and reported information about their cost-related underuse of 16 medication types. We used regression models to estimate the probability of underuse for each medication type, assuming average out-of-pocket costs, no prescription coverage, and the sociodemographic characteristics of a typical American aged 50+. RESULTS: 23% of respondents reported forgoing medication in the prior year due to cost. The likelihood of cost-related underuse was higher for symptom-relief medications (27%) than for primarily preventive medications (20%, P < .001). Among the subset of patients who cut back on adherence due to cost, the likelihood of forgoing symptom-relief medication (69%) was higher than that for preventive drugs (54%, P < .001). CONCLUSIONS: Medication characteristics beyond cost alone influence decisions to underuse treatment in response to financial pressures.

Pharmacotherapy of allergic eye disease.

Allergic eye disease is a term that refers to a number of disease processes that affect about one-fifth of the world's population. Although the more advanced forms of the disease can be sight threatening, the most disabling effects are due to the clinical manifestations, and hence quality of life, with some patients having seasonal exacerbations of their symptoms, whereas others have symptoms that are present throughout the year. Recent increased understanding of the cellular and mediator mechanisms that are involved in the various disease manifestations has greatly facilitated the development of more effective treatment options. Newer topical medications are being used that have multiple actions, such as an antihistaminic effect coupled with mast-cell stabilisation, and which require reduced daily dosing due to their longer duration of action. With greater research into newer therapies and more effective modes of delivery, improved healthcare outcomes with a lower economic burden will be achieved for patients with allergic eye disease.

Analysis of the cost-effectiveness of varicella vaccine programmes based on an observational survey in the Latium region of Italy.

Varicella is the most widespread childhood disease in Italy. However, as in many parts of the world, the country does not yet have a unified approach to the management of the disease. A cost-effectiveness analysis of varicella vaccination strategies, using the Latium region in Italy as a case study, was undertaken. Mass vaccination is only recommended if the immunization programme can achieve coverage of over 85% in a short time. However, experience in Italy with non-compulsory vaccinations has shown this is difficult to achieve. Consequently, eradication of the disease is not seen as an attainable short-term goal. For mass varicella vaccination to be successful, it must be run at a national as well as regional level in combination with education programmes, and a reliable surveillance system. The interaction between varicella and herpes zoster must also be taken into account when considering vaccination strategies, as zoster vaccination strategies may have an impact on varicella coverage.

Cost-benefit analysis of first-generation antihistamines in the treatment of allergic rhinitis.

BACKGROUND: The majority of individuals with allergic rhinitis in the US take first-generation antihistamines (FGAs). Although FGAs have been proven effective in alleviating allergic rhinitis symptoms, they have been associated with an increased risk of motor vehicle, aviation and occupational injuries and deaths, reduced productivity and impaired learning. OBJECTIVE: The objective of this analysis was to quantify the total costs and benefits of FGA use in the US from the societal perspective. METHODS: We used a decision-analytic model to quantify the annual societal costs and benefits of treatment with FGAs compared with the hypothetical alternative of no treatment for the population of individuals with allergic rhinitis and taking FGAs in the US in 2001. The benefit associated with FGA use was estimated using the willingness-to-pay framework and projected to the US population using published estimates of the prevalence of allergic rhinitis. The costs of FGA-associated sedation included lost productivity and the direct and indirect cost of unintentional injuries (including motor vehicle, occupational, public and home injuries and fatalities). The incidence of injuries and fatalities associated with FGA use was estimated using the risk of injury attributable to the sedentary effects of FGAs in the allergic rhinitis population. To evaluate uncertainty in the model assumptions, a probabilistic sensitivity analysis was conducted using Bayesian second-order Monte Carlo simulation. Costs and benefits are expressed in 2001 US dollars, using a 3% discount rate. RESULTS: Based on current utilisation, the total societal benefit (95% credible interval) associated with the use of FGAs for the treatment of allergic rhinitis was US 7.7 billion dollars (US 1.3 billion dollars to US 21 billion dollars). The societal cost of purchasing FGAs was only US 697 million dollars. However, the societal cost of FGA-associated sedation was US 11.3 billion dollars (US 2.4 billion dollars to US 50.8 billion dollars). The annual societal net benefit of FGA use for the treatment of allergic rhinitis in the US was -US4.2 billion dollars (-US 36 billion dollars to +US 0.296 billion dollars). The net benefit was negative in 97% of the 10,000 Monte Carlo simulations. CONCLUSIONS: The societal benefits of FGA use in alleviating the symptoms of allergic rhinitis are significant. However, based on the assumptions, probability distributions and parameter estimate ranges used in the current model, it is very likely that the costs associated with sedation exceed the benefits of FGA use in the US. The cost of FGA-associated sedation is comparable to estimates of the cost of all medical care expenditures on respiratory conditions in the US (US 12.1 billion dollars to US 31.3 billion dollars) [1996 values] and provides compelling evidence of the economic burden of sedation associated with FGA use.

Effects of an increase in prescription copayment on utilization of low-sedating antihistamines and nasal steroids.

BACKGROUND: Health plans are using 3-tier copayment designs and other methods to control utilization that shifts drug costs to plan members. There is a need to determine the effects of increased member cost sharing on drug utilization and drug costs. OBJECTIVE: To assess the impact of a 10 US dollars increase in prescription copayment in a public employer health plan for 2 classes of drugs used for allergic rhinitis. METHODS: Changes in the number of prescriptions dispensed for 2 therapeutic classes.low-sedating antihistamines (LSAs) and nasal steroids (NSs).were examined 1 year prior to and 1 year after copayment increase. Relative price effects were measured as arc price elasticity, the ratio of the percent change in prescription utilization over the percent change in price, an indicator of how responsive patients are to the copayment increase. RESULTS: Of 8,643 continuously enrolled health plan beneficiaries, 2,150 patients (24.8%) received at least 1 NS or LSA during the 2-year period of the study, from January 1, 1998, through December 31, 1999. An average 10 US dollars increase in copayment per prescription was associated with no statistically significant change in utilization of combined LSA and NS prescriptions, 2.89 per patient in 1998 and 2.94 in 1999 (P = 0.597). Health plan costs for study drugs, unadjusted for inflation, decreased by 16.3% from 86.86 US dollars per patient in 1998 to 72.68 US dollars in 1999 (P = 0.004). Health plan costs per patient per month (PPPM) for all drugs for the 2,150 allergic rhinitis patients decreased by 13% from 41.33 US dollars PPPM in 1998 to 35.93 US dollars in 1999 (P<0.001), and health plan drug costs for all 8,643 members decreased by 13% from 14.93 US dollars per member per month (PMPM) in 1998 to 12.99 US dollars in 1999 (P<0.001). The actual average copayment increase was 7.23 US dollars (a 41% increase) for LSAs, which was associated with a 14.8% increase in utilization of LSAs and an 11.8% increase in the number of patients using LSAs; the number of LSA prescriptions per patient per year was unchanged at 2.68 in 1999 versus 2.61 in 1998 (P = 0.429). The actual average copayment increase was 10.98 US dollars (71%) for NSs, which was associated with an 11.3% decrease in utilization of NSs and a 10.2% decrease in the number of users of nasals steroids in 1999; the number of nasal steroid prescriptions per patient per year was unchanged at 2.05 in 1999 versus 2.07 in 1998 (P =.842). The combined utilization of LSA and NS prescriptions increased by 8.9% following the increase in copayments for these 2 therapeutically interchangeable drugs for allergic rhinitis. LSA prescriptions were less elastic, with an unadjusted arc elasticity of 0.39, while nasal steroid prescriptions were more responsive to the copayment change, with an unadjusted arc elasticity of.0.22. CONCLUSIONS: An average 10 US dollars increase in patient cost sharing per prescription (46.9% copayment increase) was associated with an increase in combined utilization of 2 drug classes used for allergic rhinitis (LSAs and NSs) but no change in the number of prescriptions per patient. Health plan costs decreased significantly for allergic rhinitis drugs, all drugs used by allergic rhinitis patients, and all drugs used by continuously enrolled health plan members. NSs exhibited a greater arc price elasticity compared with low-sedating oral antihistamines.

The economic burden of allergic rhinitis: a critical evaluation of the literature.

Although a large number of economic analyses of allergic rhinitis have been published, there are relatively few empirically based studies, particularly outside the US. The majority of these analyses can be classified as burden-of-illness studies. Most estimates of the annual cost of allergic rhinitis range from dollars US 2-5 billion (2003 values). The wide range of estimates can be attributed to differences in identifying patients with allergic rhinitis, differences in cost assignment, limitations associated with available data and difficulties in assigning indirect costs (associated with reduced productivity) of allergic rhinitis. Approximately one-third of burden-of-illness studies include direct and indirect costs of allergic rhinitis, about one-third focus on direct costs only, and the remaining one-third focus exclusively on indirect costs due to reduced productivity. Indirect costs attributable to allergic rhinitis were higher in studies only estimating indirect costs (dollars US 5.5-9.7 billion) than in those estimating both direct and indirect costs (dollars US 1.7-4.3 billion). Although there are many economic evaluations of allergic rhinitis treatments in the published medical literature, very few represent formal cost-effectiveness evaluations that compare the incremental costs and benefits of alternative treatment strategies. Those that are incremental cost-effectiveness analyses have several limitations, including small samples, short study periods and the lack of a standardized measure of effectiveness. To date, the medical literature is lacking a comprehensive economic evaluation of general treatment strategies for allergic rhinitis. In undertaking such an analysis, serious consideration must be given to the study population of interest, the choice of appropriate comparators, the perspective from which the analysis is conducted, the target audience, the changing healthcare marketplace and the selection of a measure of effectiveness that incorporates both positive and negative aspects of treatments for allergic rhinitis. Future work would benefit from the development of a consensus on a summary measure of effectiveness that could be used in cost-effectiveness analyses of therapies for allergic rhinitis as well as additional empirical work to measure the association between severity of disease and its impact on worker productivity.

The economic burden and symptom manifestations of chronic rhinosinusitis.

BACKGROUND: The aim of this study was to delineate patient symptoms and economic burdens of chronic rhinosinusitis (CRS). METHODS: Adult patients with CRS were assessed prospectively with a survey instrument. Symptom scores for major and minor symptoms of CRS, medication use, physician visits for CRS, and work days missed were determined. Cost analyses were conducted. RESULTS: Three hundred twenty-two patients were studied prospectively (mean age, 42.3 years). Nasal obstruction and facial congestion were the most common and severe major symptoms, and headache and fatigue were the most common and severe minor symptoms. Patients received an average of 2.7 antibiotic courses and used nasal steroids and prescription antihistamines 18.3 and 16.3 weeks, respectively, in a 12-month period. Mean medical resource costs were 921 dollars per patient-year. CRS caused an average of 4.8 days of missed work per 12-month period. The overall yearly economic cost of CRS was 1539 dollars per patient. CONCLUSION: Nasal and facial symptoms prevail over systemic and oropharyngeal symptoms in CRS. Significant medical resource expenditures and global economic costs accompany CRS.

Cost-effective pharmacotherapy for inhalant allergic rhinitis.

The otolaryngologist is one of the decision leaders for patients who seek to learn more about their problems of respiratory allergy. Although these patients do not have a life-threatening illness, the reduction of quality of life and performance can significantly restrict their overall sense of well being. Patients with allergic rhinitis desire the relief of the bothersome problems without other side effects. Second-generation antihistamines were introduced to reduce the significant impairment brought on by the sedation of the first-generation products. Most physicians prescribe the intranasal corticosteroids as the prescription drug of first choice for most patients with chronic allergic rhinitis. Second-generation H1 receptor antagonists are better for the patient than the first-generation drugs because of the reduced side-effect profile and improved tolerance. Compliance factors certainly need to be addressed with medications that need more than once-daily dosing. Patients with only sporadic problems in season or on limited exposure are best treated with oral antihistamines, topical cromolyn, and short-term decongestant therapy.

Cost-effectiveness of H1-antihistamines.

In the health care arena, assessment of a medication's clinical efficacy is no longer enough. It is important to confirm the medication's cost-effectiveness and the improvement in quality of life it provides in relationship to other options in therapy. H1-antagonists are widely used in the treatment of many atopic disorders, especially allergic rhinitis. This review has pointed out cost-effectiveness and quality-of-life studies comparing the different H1-antagonists among themselves, and with other treatments used in allergic rhinitis, such as intranasal corticosteroids and allergen immunotherapy. Cost-effective analyses among H1-antagonists in other allergic diseases, such as atopic dermatitis, urticaria and angioedema, and asthma, are lacking at this time.

The effect on social welfare of a switch of second-generation antihistamines from prescription to over-the-counter status: a microeconomic analysis.

BACKGROUND: The US Food and Drug Administration (FDA) recently held a meeting to determine whether the status of second-generation antihistamines (SGAs) should be switched from prescription (Rx) to over-the-counter (OTC) status. OBJECTIVE: This article provides a conceptual microeconomic framework for addressing issues regarding the impact of such a switch on social welfare. METHODS: A review of the economic literature on Rx-to-OTC switches was conducted. Relevant articles published in English between 1990 and 2001 were identified through searches of ABI Info, EconLit, PsychInfo, MEDLINE, CANCERLIT, AIDSLINE, and HealthStar, as well as a general Internet search for statements in the press or on the FDA Web site. The search terms used were Rx, prescription, OTC, over-the-counter, second-generation antihistamines, nonsedating antihistamines, first-generation antihistamines, and sedating antihistamines. Microeconomic models focusing on consumer surplus were employed to determine the potential price response and social-welfare implications of a switch of SGAs to OTC status. RESULTS: Unlike the agents involved in previous Rx-to-OTC switches, SGAs are still under patent protection. Economic theory suggests that a firm that is protected by a patent will price aggressively. The market for OTC SGAs is likely to be more elastic due to a lack of insurance coverage for OTC products; hence, drug manufacturers would be likely to charge a lower price if SGAs were sold OTC. However, a lower price does not necessarily guarantee an improvement in social welfare; the net impact is determined by whether the increase in consumer surplus outweighs the deadweight loss (losses of consumer and producer surplus not transferred to other parties). Additionally, the assumption of a price reduction would be called into question if there were inequalities in marginal costs between the Rx and OTC markets. In this situation, the postswitch price might increase or not be reduced significantly. CONCLUSIONS: It is uncertain whether granting OTC status to SGAs would be cost saving to society, particularly as these drugs are patent protected. The social-welfare implications of such a switch would depend heavily on pricing strategies and consumer behavior. Further analyses are needed to determine how both factors influence social welfare; only then can the costs and benefits of a switch be understood completely.