1. Pharmacy 483 Outcomes & Cost Management in Pharmacy Practice Janet Kelly, Pharm.D., BC-ADM February 24, 2004

2. Health Care Cost Over Time

3. Factors Contributing to Increasing Medication Costs

4. Outcomes & Cost Management Clinical Pharmacists Formulary Management Providers (RN, MD, etc)

5. What is a Drug Formulary?  List of Drugs Which May Be Prescribed Developed by the P&T Committee based on: Efficacy Safety Cost Effectiveness  Therapeutic Equivalency  Treatment Guidelines

6. How Can a Formulary Optimize Outcomes & Costs?  Standardization of Care  Appropriate Utilization  Improved Safety  Less Potential for Errors  Bulk Purchasing  Contract Pricing

7. Role of Clinical Pharmacists in Outcomes & Cost Management Identification Reality Check Expertise Implementation

8. Therapeutic Equivalency Ondansetron (Zofran) Granisetron (Kytril) Dolasetron (Anzemet) UW Medicine Example: 5HT3 Antagonists

9. Equipotent Dosing IV Dosing Ondansetron 8mg Dolasetron 100mg Granisetron 1mg == Oral Dosing Ondansetron 16mg Dolasetron 100mg Granisetron 2mg ==

10. Treatment Guidelines For Chemotherapy Induced Nausea/Vomiting

11. Cost Savings Associated with the 5HT3 Program at UW Medicine Net Savings = $534,000

12. New Drug Evaluation for Formulary CLINICAL EFFICACY 1.Therapeutically superior to current formulary options 2.Effective for the treatment of condition which previously had no effective therapy SAFETY 1.Improved safety and/or tolerability compared to current therapeutic options while maintaining therapeutic effectiveness COST EFFECTIVENESS 1.Offers cost advantages to the institution for a given outcome compared to current formulary options

13. How is Cost Effectiveness Defined? Therapeutic Outcomes Economic Evaluation Cost Per Outcome & = Therapeutic Outcomes

14. Steps in an Economic Evaluation 1.Determination of Total Cost 2.Determination of Reimbursement 3.Calculation of Potential Revenue

15. Darbepoetin: Formulary Evaluation Clinical Evaluation (compared to Epoetin)  Similar efficacy with less frequent dosing ? Equivalent dosing ? Dose escalation  Similar safety ? Improved compliance

16. Economic Evaluation of Darbepoetin Determination of Costs: Drug Acquisition Rebates and Incentives for Other Amgen Products Convenience Less frequent administration Dollar Value ? Drug Administration Cost Clinic vs. Self Administered

17. Economic Evaluation of Darbepoetin Determination of Reimbursement: Ambulatory vs. Hospitalized Insurance Mix % Medicare, Medicaid, & Private Patient Responsibility Co-pays

18. Economic Evaluation of Pegfilgrastim Calculation of Profit Margin: Reimbursement Total Cost - = Profit Margin

19. UW Medicine Clinical Pathway for Darbepoetin for Anemia of CRI Hgb<11 g/dL Supplement with iron if: 1.Serum ferritin<100 mg/ml 2.Transferrin saturation<20% Previously untreated pts 0.9 mcg/kg q 2 weeks* 2 week Follow Up Has Hgb Increased > 1g/dl over baseline? YesNo Decrease Dose by 25% Continue Therapy NO DOSE INCREASE 6 week Follow Up Has Hgb> 1g/dl from baseline? Yes No Increase dose to next vial size Maximum of 200 mcg q 2 weeks Continue Therapy If Hgb>12 decrease dose to next vial size GOALS OF DARBEPOETIN THERAPY Resolution of Anemia : Hgb=12 g/dL Recheck nutritional cofactors Hgb<11 g/dL Previously untreated pts 0.9 mcg/kg q 2 weeks 2 week Follow Up Has Hgb Increased > 1g/dl over baseline? Decrease Dose by 25% Continue Therapy NO DOSE INCREASE 6 week Follow Up Has Hgb> 1g/dl from baseline? Check nutritional cofactors Increase dose to next vial size Maximum of 200 mcg q 2 weeks Continue Therapy If Hgb>12 decrease dose to next vial size Recheck nutritional cofactors

20. UW Medicine – Clinical Pathway for Darbepoetin use in Chemotherapy Induced Anemia Hgb<11 g/dL Supplement with iron if: 1.Serum ferritin<100 mg/ml 2.Transferrin saturation<20% 2 week Follow Up Has Hgb Increased > 1g/dl over baseline? YesNo 6 week Follow Up Has Hgb> 1g/dl from baseline? Yes No GOALS OF DARBEPOETIN THERAPY Resolution of Anemia : Hgb>12 g/dL Reduced need for transfusion Recheck nutritional cofactors Hgb<11 g/dL Starting Dose: 200 mcg q2 wk or 300 mcg q 3wk 6 week Follow Up Has Hgb Increased > 1g/dl over baseline? Continue Therapy Increase dose to 300 mcg q 2 wks 12 week Follow Up Has Hgb> 1g/dl from baseline? Consider discontinuing - Depending on Pt’s symptomatic response Monitor Hgb –hold if Hgb>13 Resume Tx when Hgb<12 200 mcg q3wks Recheck nutritional cofactors

21. Comparison of Cost Effectiveness Darbepoetin vs. Epoetin Economic Evaluation Beneficial Cost Per Outcome Decreased & = Therapeutic Outcome Equivalent

22. Darbepoetin Added to Formulary With Usage Guidelines Economic Impact at 6 months: No Absolute Cost Savings (  # Pts) Relative Cost Savings $250,000 Drug Usage Evaluation Results: Response Rate only 61% Inadequate Monitoring of Iron Stores Doses given when not anemic