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Impact of New Drugs and Patent Losses on Pharmacy Budget

Learn about the new drug approvals and brand name drug patent losses targeted for 2014/2015 and their impact on the pharmacy buyer's budget. Discuss the FDA's implementation of a new breakthrough category for drug approvals and different inventory management strategies to maximize profit.

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Impact of New Drugs and Patent Losses on Pharmacy Budget

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  1. New Drugs and Patent Losses for 2014/2015 Their Effect on the Pharmacy Buyer Sherrie L. Lane PD

  2. Learning Objectives • Understand which new drug approvals are targeted for 2014/2015 • List the brand name drug patent losses that are targeted for 2014/2015 • Describe the impact new drugs and patent losses targeted for 2014/2015 will have on the Pharmacy’s budget

  3. Learning Objectives Cont: • Discuss the FDA’s implementation of a new breakthrough category for drug approvals and it’s budget impact • Compare and choose different inventory management strategies to maximize profit and minimize cost, for new drug additions to formulary as well as brand to generic product conversion

  4. Why Is This Important To A Buyer? • Pharmaceutical costs in U.S. hospitals (excluding Federal facilities) are projected to increase $285 million - $1.14 billion in 2014 over the 28.5 billion spent in 2013[1] • Your healthcare facility may have up to 20% of its total budget allotted to the Pharmacy Department.[1]

  5. Why Is This Important To A Buyer? • Of that 20% - 80% of the Pharmacy’s budget may be attributable to medication cost [1] • Declining reimbursement in healthcare facilities

  6. Why Is This Important To A Buyer? • Demonstrates your value! • Assists in making the case for your inclusion in the budgeting process and a seat on the P & T Committee

  7. Selected Drugs and Biologicals That May Receive FDA-Approved Labeling in 2014[3,4,]

  8. Selected Drugs and Biologicals That May Receive FDA-Approved Labeling in 2015[4]

  9. Resources For Determining New Drug Approvals Publications and Periodicals • Pharmacy Purchasing Outlook • American Journal of Health System Pharmacy has an annual article in March of each year with trends and projections

  10. The Ultimate Resources! http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.MonthlyApprovalsAll http://www.biopharmcatalyst.com/pdufa-calendar/

  11. What is PDUFA? Prescription Drug User Fee Act

  12. PDUFA CALENDAR • Shows drugs up for approval or review for new indications on a monthly basis. • PDUFA Priority Reviews • Advisory Committee • PDUFA

  13. Selected Potential Patent Expirations in 2014[2]

  14. Selected Potential Patent Expirations in 2014 Cont:

  15. Selected Potential Patent Expirations in 2015[2]

  16. Selected Potential Patent Expirations in 2015 Cont:

  17. FDA’s New Breakthrough Therapy Designation • The drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition [4] • “Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” [4]

  18. Criteria For Breakthrough Therapy Designation • Serious Condition • Existing (or Available) Therapies • Preliminary Clinical Evidence • May Demonstrate Substantial Improvement on at Least One Clinically Significant Endpoint

  19. FDA’s New Breakthrough Therapy Designation If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug.  All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request. [5]

  20. CDER Breakthrough Therapy Products Approved Jan. 1, 2014 – June 27, 2014[6]

  21. Inventory Management Strategies • Utilize PDUFA dates to proactively plan for new drug approvals • Track brand to generic conversion by calendar • Plan brand stock depletion and formulary switches within category

  22. Inventory Management Strategies • Pareto’s Principle • Partner with a Clinical Pharmacist • Therapeutic Interchanges • IV to PO switches • Protocols and guidelines

  23. Remember the Two C’s! COLLABORATION COMMUNICATION

  24. References • Am J Health-Syst Pharm 2014; 71:482-99 • http://pharma.about.com/od/BigPharma/a/Which-Popular-Drugs-Are-Going-Off-Patent-In-2013-2016.htm • http://lab.express-scripts.com/insights/drug-options/fda-approvals-expected-in-2014 • http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.MonthlyApprovalsAll • Sec 506(a) Food Drug and Cosmetic Act • http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm373418.html • http://www.biopharmcatalyst.com/pdufa-calendar/

  25. QUESTIONS?

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