Patients Will Be Adequately Served Richard P. Rozek* *The underlying economic research was conducted with Emily Bishko. GlaxoSmithKline provided financial.

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Presentation transcript:

Patients Will Be Adequately Served Richard P. Rozek* *The underlying economic research was conducted with Emily Bishko. GlaxoSmithKline provided financial support. Pulmonary-Allergy Drugs Advisory Committee Meeting June 10, 2004

FDA Criteria for Designating Albuterol Non-Essential Non-ODS Products Available –Same Indication –Same Level of Convenience of Use –Sufficient Supply and Production Capacity –Adequate Post-Marketing Data Patients Adequately Served (Access and Other Issues) Slide 1

Distribution of Albuterol MDIs Slide 2

Stable Demand for Albuterol Slide 3

Simplifying Assumptions No Additional Samples No Manufacturer Rebates to Government Programs above Legally Mandated Minimum Two Non-ODS Products Available No Other Discounts above Current Levels for HFA MDIs No Price Competition for HFA Products Slide 4

Increase in Cost to Patients (Under Simplifying Assumptions) Type of Patient (Share of Total Units)Net Increase per MDI Retail-Cash (11%) $ 8.61 Retail-Private Insurance (60%) $10.57 (tiered co-pay) Retail-Medicaid (13%) $ 0.00 Clinics/Universities/HMOs (4%) $ 0.00 Non-Federal Hospitals (6%) $ 0.00 Federal Facilities/Prisons (6%) $ 0.00 Data sources include IMS, Verispan, NACDS, ALA, and the Federal Government. Slide 5

Overall Impact on Patients and Third-Party Payers in the First Year (Under Simplifying Assumptions) Average Price per MDI-Current/Projected: $18.38/$28.25 (all channels, all forms, 50 million MDIs) Increase in Cost per MDI: $9.87 Patient Incurs: $7.33 Third-Party Payer Incurs: $2.54 Daily Increase in Cost: Per Capita: $0.005 [or 0.5¢] Per Asthma/COPD Patient: $0.044 [or 4.4¢] First Year Increase in Cost: Per Capita: $ 1.69 Per Asthma/COPD Patient: $16.02 Slide 6

Market Factors That Ensure Access Patient Assistance Programs (e.g., DC Healthcare Alliance, Bridges to Access) Patient Discount Programs (e.g., GSK Orange Card, Together Rx) Better Information on Programs (e.g., PhRMA Website) Additional Samples (e.g., 2 million from GSK alone) Additional Competition (e.g., IVAX, Sepracor, Other 3M Licensees) Medicare Rx Coverage (Beginning in 2006) Buyer Power Slide 7

Conclusion Patients Will Have Access. Slide 8