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Study Demonstrates That QVAR(R) is More Cost-Effective Than Other Inhaled Corticosteroid (ICS) Asthma Therapy Options
Date:9/16/2009

VIENNA, Sept. 16 /PRNewswire/ -- Teva Respiratory, a division of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA), today announced results from an analysis of the cost-effectiveness of three different inhaled corticosteroids (ICSs) in a "real-life" asthmatic population. The study found QVAR(R) (beclomethasone dipropionate HFA), an ICS that is able to effectively treat both large and small airway inflammation, to be on average more effective than CFC-beclomethasone dipropionate (BDP) and fluticasone propionate (FP), and intermediary in cost between the two. This "real-life" study followed more than 4,000 asthma patients in the UK for 12 months, and data was presented at the European Respiratory Society's Annual Congress in Vienna, Austria.

Several short-term, randomized controlled trials (RCTs) demonstrated that QVAR(R) and other ICS therapies, including CFC-BDP and FP metered dose inhalers (pMDI), are efficacious. This year-long "real-life" study was designed to assess the cost-effectiveness of QVAR(R) compared to other ICS therapies in patients identified from the UK General Practice Research Database (GPRD), the world's largest primary care computerized database of anonymized longitudinal medical records. This "real-life" analysis showed that the choice of ICS may impact overall asthma control in the real world, including asthma exacerbation rates.

"ICSs are considered the most effective anti-inflammatory therapy for persistent asthma and are the preferred treatment for initiating maintenance therapy. However, the cost of ICS therapy can be quite high," said David Price, GPAG professor of primary care medicine, University of Aberdeen's Center of Academic Care and lead investigator of the study. "QVAR(R) was on average more cost-effective than fluticasone, and more effective than CFC-beclomethasone dipropionate, although CFC-beclomethasone dipropionate was lowest in cost."

Professor Price added, "The asthma control findings may support that the fine particle size of QVAR(R) distributes medication throughout the entire lung while allowing for more effective penetration into small airways than other ICSs. Research has shown that the 1.1 micrometer mass median aerodynamic diameter (MMAD) of QVAR(R) allows for more effective penetration of the agent into small airways, with lung deposition of up to 58% as compared with 12%-13% with fluticasone CFC."

Teva offers QVAR(R) in the U.S., UK, France, several other European countries as well as Israel. In Germany QVAR(R) is sold under the brand name Ventolair(R) and in the Scandinavian countries QVAR(R) is sold under the brand name Aerobec(R).

About the Study

With the aim of comparing cost-effectiveness for QVAR(R) versus CFC-BDP and FP delivered via pressurized metered dose inhalers in asthmatic patients, investigators identified 4,133 patients (8% QVAR(R), 15% FP, 77% BDP-CFC) from among 450 primary care practices throughout the UK in the GPRD who had increases in ICS use between January 1997 - June 2006. Included patients were age 5-60 years.

A cost-effectiveness analysis, performed from a UK National Health Service perspective, compared total healthcare costs (THCC) for the year before the ICS use increase (baseline cost) with the year after (outcome cost). The analysis, after adjustments for age, sex, baseline asthma control status and baseline THCC, showed outcome cost increases for each treatment regimen, with FP costing pounds Sterling 33.00 (-pounds Sterling 2.53 to pounds Sterling 68.54) more than QVAR(R) and BDP costing pounds Sterling 22.51 (-pounds Sterling 43.96 to -pounds Sterling 1.06) less than QVAR(R). The mean outcome cost for QVAR(R), at pounds Sterling 547.94 was intermediate between that of FP (pounds Sterling 580.94) and of BDP (pounds Sterling 525.43). Asthma control rates were higher in the QVAR(R) group, making the odds ratio (OR) for successful asthma control lower for BDP-CFC (OR=0.85; 95% CI, 0.76-0.96) and for FP (OR=0.91; 95% CI, 0.75-1.10) as compared with QVAR(R).

About GPRD

The GPRD is the world's largest computerized database of anonymized longitudinal medical records from primary care. Data are being collected on over 3.6 million active patients (approximately 13 million totals) from around 450 primary care practices throughout the UK. It is the largest and most comprehensive source of data of its kind and is used worldwide for research by the pharmaceutical industry, clinical research organizations, regulators, government departments and leading academic institutions. GPRD is considered the gold standard of research databases.

About QVAR(R)

QVAR(R) (beclomethasone dipropionate HFA) Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age or older. QVAR(R) is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR(R) may reduce or eliminate the need for systemic corticosteroids.

Important Safety Information

QVAR(R) is not a bronchodilator and is not indicated for relief of acute bronchospasm. Common side effects associated with the use of QVAR(R) and placebo in clinical trials includes, but is not limited to, headache (12% and 9%, respectively) and pharyngitis (8% and 4%, respectively). Caution: Adrenal insufficiency may occur when transferring patients from systemic steroids (see WARNINGS, Prescribing Information). A reduction in growth velocity in growing children and teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment.

About Teva

Teva Pharmaceutical Industries Ltd., (Nasdaq: TEVA) headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.


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SOURCE Teva Respiratory, a division of Teva Pharmaceutical Industries, Ltd.
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