Real-world Effectiveness and Cost-effectiveness of Qvar Versus FP, a US Study

• No recorded hospital attendance for asthma, including admission, Emergency Room (ER) attendance or Out-Patient Department (OPD) attendance, AND
• No prescriptions for acute courses of oral steroids, AND
• No GP consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics.

Where exacerbations are defined as an occurrence of:

• Unscheduled hospital admissions / Emergency Room attendance for asthma, OR
• Use of acute courses of oral steroids

No recorded hospital attendance for asthma, including admission, Emergency Room (ER) attendance, out-of-hours attendance, or Out-Patient Department (OPD) attendance, AND No prescriptions for acute courses of oral steroids, AND No GP consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics.

Average daily, prescribed dose of ≤180mcg salbutamol / albuterol or ≤500mcg terbutaline

Where control is defined as the absence of the following during the one-year outcome period:

• Asthma-related :

• Hospital attendance or admission, OR
• A&E attendance, OR
• Out of hours attendance, OR
• Out-patient department attendance
• GP consultations for lower respiratory tract infection
• Prescriptions for acute courses of oral steroids.

Success: defined as the absence of

• Exacerbation:

• Unscheduled hospital admissions / ER attendance for asthma, OR
• Acute use of oral steroids

AND

• No consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics

AND

• No change in therapeutic regimen:

• Increased dose of ICS, and/or
• Change in ICS and/or
• Change in delivery device, and/or
• Use of additional therapy as defined by: long-acting bronchodilator (LABA), theophylline, leukotriene receptor antagonists (LTRAs).

• Exacerbation:

• Unscheduled hospital admissions / A&E attendance for asthma, OR
• Acute use of oral steroids

AND

• No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics§

AND

• No change in therapeutic regimen:

• Increased dose of ICS, and/or
• Use of additional therapy as defined by: long-acting bronchodilator (LABA), theophylline, leukotriene receptor antagonists (LTRAs).

Mean number of respiratory-related hospitalizations and referrals per patient during the outcome year

Where control is defined as the absence of the following during the one-year outcome period:

• Asthma-related :

• Hospital attendance or admission, OR
• A&E attendance, OR
• Out of hours attendance, OR
• Out-patient department attendance
• GP consultations for lower respiratory tract infection
• Prescriptions for acute courses of oral steroids.

AND where the average prescribed daily dose of albuterol or terbutaline is ≤200mg

• Drug costs:

• Short acting beta2 agonist (SABA) costs;
• Fixed dose combination inhaler costs;
• Leukotriene receptor antagonists (LTRA) costs;
• Long acting beta agonists (LABA) costs;
• Inhaled corticosteroids (ICS) costs;
• Prednisolone costs;
• Antibiotics costs;
• Asthma-related drug costs (including ICS); and
• Asthma-related drug costs (excluding ICS).
• Lower respiratory primary care consultation costs;
• Total respiratory in-patient hospitalisation costs;
• Total respiratory ER attendance costs;
• Total respiratory out-patient attendance costs;
• Other Lower respiratory Medical costs.

Treatment costs will be compared via differences in mean respiratory-related health care costs per patient/year. Treatment effectiveness will be compared via difference in proportion of patients controlled during the outcome period.

Differences in costs and proportions of patients controlled will be displayed graphically on a cost-effectiveness plane. The four quadrants of the cost-effectiveness plane represent QVAR being:

• Quadrant I: more costly and more effective (a trade-off);
• Quadrant II: more costly and less effective (FP dominant);
• Quadrant III: less costly and less effective (a trade-off); and
• Quadrant IV: less costly and more effective (QVAR dominant)

Where the point estimates indicate 'trade-off' between treatments, incremental cost-effectiveness ratio will be calculated:ICER = cQVAR - cFP/eQVAR - eFP (cQVAR and eQVAR are the cost and effectiveness of QVAR respectively and CFP and EFP are the cost and effectiveness of FP).