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.

Immunotherapy for patients with persistent allergic rhinitis unsatisfied with free chronic pharmacotherapy.

BACKGROUND: Chronic pharmacotherapy is recommended to patients with persistent moderate-severe (PM-S) allergic rhinitis (AR). The cost of pharmacotherapy is the main barrier to achieve symptoms control. AIMS OF THE STUDY: To determine the benefits of mite subcutaneous immunotherapy (SIT) in patients with PM-S AR not satisfied with chronic pharmacotherapy received free of charge. METHODS: Open study with seven (7) patients with PM-S AR not satisfied with chronic pharmacotherapy. Prior to enrollment patients had received monthly for more than five months and free of charge, optimal pharmacotherapy. We compared, off pharmacotherapy, symptoms and quality of life (QOL) before and during SIT. RESULTS: Mite SIT improved nasal symptoms, non nasal symptoms and QOL. Off pharmacotherapy patients reported adequate control of symptoms and were satisfied. CONCLUSIONS: Not all patients with PM-S AR are satisfied with chronic pharmacotherapy, even if medication is received free of charge. SIT control symptoms and satisfies patients with PM-S AR unsatisfied with free chronic pharmacotherapy.

The effect of the Rx-to-OTC switch of loratadine and changes in prescription drug benefits on utilization and cost of therapy.

BACKGROUND: Numerous prescription products have become available over the counter (OTC) in recent years. Previous simulation models have shown the Rx-to-OTC switch of loratadine to be cost effective. OBJECTIVE: To empirically assess the overall effect of the Rx-to-OTC switch of loratadine and the specific effect of different pharmacy benefit structures on prescription drug utilization and cost among different plan sponsors. METHODS: Data from a national pharmacy benefit management organization covering lives throughout the United States were used. The analysis included a comparison of the before and after change in prescription utilization and cost for plan sponsors that instituted 1 of 3 second-generation antihistamine (SGA) benefit responses: made no change, moved SGAs to the third tier, or restricted SGA benefits through a requirement for prior authorization. Multivariate regression analysis was used to control for differences across the study groups. RESULTS: There was a substantial decrease in utilization and cost of all prescription drugs and combinations of drug classes. Patients with allergic rhinitis facing restricted prescription benefits for SGAs did not appear to increase utilization of other allergic rhinitis medications or other medications used to treat comorbid conditions such as asthma, sinusitis, and otitis media. CONCLUSIONS: Utilization and cost decreased substantially for all types of medications and all pharmacy benefit structures. Future studies need to examine the effect of the Rx-to-OTC switch of loratadine and resultant prescription benefit policies on medical utilization and OTC antihistamine utilization.

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.

The costs of nonsedating antihistamine therapy for allergic rhinitis in managed care: an updated analysis.

OBJECTIVE: To update a prior study evaluating the use and costs of new-generation antihistamines for the treatment of allergic rhinitis in a managed care population. STUDY DESIGN: A retrospective database review of rhinitis-related medical and pharmacy-related claims during a treatment period of 12 months. METHODS: Patients who had been diagnosed as having allergic rhinitis and had at least 1 prescription claim were identified from a database containing patient-level medical and pharmaceutical claims. The treatment patterns for patients meeting study criteria were documented for a 12-month period to describe how nonsedating antihistamines are being used in allergic rhinitis, and to assess the associated costs of various medications. Subanalyses of patients categorized by comorbidity status were also performed. RESULTS: A total of 105,696 patients were included in this updated analysis, covering calendar year 1999. Nonsedating antihistamines were used by 68% of the sample, with loratadine and fexofenadine being the most commonly prescribed agents. The mean annual rhinitis-specific charge for fexofenadine-treated patients was $409 (standard deviation [SD] 727), which was significantly lower compared with charges for loratadine-treated patients, $424 (SD 740), P = .0144, or cetirizine-treated patients, $444 (SD 625), P < .0001. This trend was also observed in comparisons of patient subgroups. CONCLUSIONS: Consistent with our prior study, loratadine and cetirizine were generally associated with significantly higher treatment charges than fexofenadine. This result was observed across different stratifications of patients, including those with comorbid respiratory illness, concomitant use of nasal steroids, and asthma and/or sinusitis. These results provide further useful insights into the differential costs associated with the use of nonsedating antihistamines for allergic rhinitis treatment.

A descriptive analysis of the use and cost of new-generation antihistamines in the treatment of allergic rhinitis: a retrospective database analysis.

OBJECTIVE: This retrospective database analysis was conducted to evaluate the use and cost of new-generation antihistamines (i.e., those that are nonsedating) in the treatment of allergic rhinitis in a managed care population. STUDY DESIGN: The study is a retrospective database review of medical and pharmacy-related claims linked by episodes of care. METHODS: Patients who had been diagnosed as having allergic rhinitis and had at least 1 prescription claim were identified from a database containing patient-level medical and pharmacy-related claims. The treatment patterns of patients with allergic rhinitis who met the study criteria were documented for a 12-month period in which the use of nonsedating antihistamines was described and the associated costs of various medications were assessed. Subanalyses of patients categorized by comorbidity status were also performed. RESULTS: A total of 202,426 patients participated in the study. Nonsedating antihistamines were used by 71% of the patients; the most commonly prescribed drugs were loratadine and fexofenadine. The mean annual charges per patient for the treatment of allergic rhinitis in the study population were $465.21 (standard deviation [SD], 548). The greatest departmental cost was that of pharmacy-related charges (mean, $236.02; SD, 233); the next highest cost was that of outpatient charges (mean, $216.31; SD, 396). Comparisons of departmental charges indicated the use of loratadine was associated with significantly higher treatment costs than that of fexofenadine in a number of patient subgroups. CONCLUSION: In this analysis, loratadine was associated with significantly higher treatment charges than was fexofenadine. This result was observed consistently across different stratifications of patients, including the presence of comorbid respiratory infection, concomitant use of nasal steroids, and the presence of asthma and/or sinusitis. These results provided useful insights into the differential costs associated with the use of nonsedating antihistamines in the treatment of rhinitis.

Impact of interventions designed to increase market share and prescribing of fexofenadine at HMOs.

The impact of interventions designed to shift prescribing from loratadine to fexofenadine at HMOs was studied. Pharmacy claims data for a six-month preintervention period at four HMOs were analyzed to identify all new and refill prescriptions for loratadine, fexofenadine, astemizole, and cetirizine. The interventions consisted of a mandatory lockout of loratadine in favor of fexofenadine (at HMO A), a voluntary switch to fexofenadine promoted through letters to both physicians and members (HMO B), and a voluntary switch promoted through letters to physicians only (HMO C). There was no intervention at HMO D. Pharmacy claims data for the six months after each intervention program was implemented were analyzed to determine changes in the market share and prescribing of the study drugs. After the intervention programs were implemented, the market share of fexofenadine increased from 18.9% to 65.2% at HMO A, from 14.8% to 21.0% at HMO B, and from 20.7% to 23.8% at HMO C. Loratadine's market share decreased from 62.3% to 8.7% at HMO A, from 67.5% to 58.6% at HMO B, and from 70.5% to 65.3% at HMO C. HMOs A, B, and C each had greater shifts in market share for fexofenadine and loratadine than the control HMO. Changes in prescribing followed a similar pattern for the 25 physicians at each HMO who had most frequently prescribed loratadine during the preintervention period. The average cost per antihistamine prescription decreased 22.3% at HMO A. Prescription costs continued to rise at HMOs B, C, and D. Mandating the use of fexofenadine produced a significant increase in its market share, reduced the cost of nonsedating antihistamines, and successfully influenced prescribing behavior. Voluntary programs had a more modest impact on market share and did not stop increases in prescription costs.

Action alert: drug-patent bill could cost patients $3 billion+; hearing July 1.

AIDS: A bill (H.R. 1598) to extend the patents on Claritin and a half dozen other drugs is scheduled for a congressional hearing on July 1. While the legislation does not affect AIDS drugs, activists fear the setting of a precedent when AIDS drugs go off patent in coming years. Schering, Claritin's manufacturer, is financing a huge effort to have the patent extension bill passed. Information is provided for those wanting more information about H.R. 1598.^ieng

Treating allergic rhinitis with second-generation antihistamines.

Allergic rhinitis afflicts close to 40% of the nation's population and costs more than $1.8 billion a year. The toll exacted by this disorder has been greatly alleviated by nonsedating second-generation antihistamines loratadine, terfenadine, and astemizole. The three agents effectively reduce symptoms without the sometimes intolerable adverse effects of older drugs, but they are not completely equivalent. For example, terfenadine requires twice/day dosing, whereas the others can be given once/day. Astemizole has a slow onset and extremely prolonged duration of action. Both terfenadine and astemizole may have cardiotoxic effects (e.g., torsades de pointes) when serum concentrations rise due to overdosing or drug interactions. Cetirizine, a recently approved second-generation antihistamine, has sedative and anticholinergic effects, although to a lesser degree than the first-generation antihistamines.