1. C14: Drug Shortages and the Impact on Managed Care Pharmacy Sherry L. Andes, PharmD, BCPS, BCPP, BCACP, PAHM Sr. Drug Information Specialist SXC Health Solutions

2. Conflict of Interest Disclosure I, Sherry Andes, declare no conflicts of interest or financial interests with any pharmaceutical manufacturers, medical device company, or in any product or service mentioned in this program, including grants, employment, gifts, stock holding, and honoraria with the exception of: ‒ Shire stock in 401k plan ‒ Receipt of consulting fees from Novo Nordisk and Daiichi Sankyo 2

3. 3 Objectives Outline the challenges and potential impacts associated with drug shortages Review the prevalence and scope of drug shortages Discuss factors managed care organizations should consider/evaluate with respect to drug shortages Present examples of drug shortages that have affected managed care organizations and actions taken Review AMCP actions and resources relating to drug shortages Identify resources for drug shortage-related information

4. Drug Shortages in the News 4 Pharmaceuticals Inside America’s Drug Shortage The first in a two-part series investigating why critical prescription drugs are in short supply in the U.S. Time. 2012 March 19 http://healthland.time.com/2012/03/19/w here-have-all-our-drugs- gone/#ixzz1rHOxvdjH

5. Drug Shortage Challenges Need for increased communication between stakeholders, including reasons for shortages and real-time updates on affected drugs Need to examine the gray market impact, including drastically increased pricing for shorted drugs Increased incidents of medication errors with the use of alternative therapies Need for standard alternative therapy guidelines Complex economic issues with shortages Need for a more stable supply chain Call for a more standardized allocation process 5 FDA CDER Drug Shortage Public Workshop. September 26, 2011. Available at: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM275801.pdfhttp://www.fda.gov/downloads/Drugs/NewsEvents/UCM275801.pdf

6. Potential Impact of Drug Shortages on Managed Care Therapy disruption or delay Stockpiling/hoarding occurrences Increased risk of adverse events Increased risk of medication errors Increased costs 6 Berger JE. AJPB. 2012 Jan/Feb; 4(1):10-11. ASHP. Am J Health-Syst Pharm. 2009;66:1399-1406. Le P et al. Journal of Generic Medicines. 2011;8(4):210-218.

7. Drug Shortage Prevalence 7 Le P, et al. Journal of Generic Medicines. 2011;8(4):210-218. Prevalence of drug shortages ~ 11% of FDA-approved/marketed active ingredients 8.5% 1.1% 11.0% 12.2% 6.1% 2.0% 18.4%

8. Scope of Drug Shortages 8 IMS Institute for Healthcare Informatics. Drug Shortages: A Closer Look at Products, Suppliers, and Volume Volatility. November 2011. Le P, et al. Journal of Generic Medicines. 2011;8(4):210-218.

9. How Drug Shortages Are Affecting Healthcare Organizations 9 Modern Healthcare Poll. Drug Shortages Affecting Healthcare Organizations. March, 28, 2012. N=55 “To what extent has the shortage of certain drugs or medications affected delivery of care at your organization?” 16% 13% 42% 29%

10. How Drug Shortages Are Affecting Community Pharmacy 10 Schweers K. New Survey Reflects Impact of Drug Shortages on Community Pharmacists, Patients. NCPANET. 2012 February 9. 52 % 62% 81% 80% 23% 59% 96% N=675

11. Factors MCOs/PBMs Should Consider Regarding Drug Shortages Copay differentials / Multisource penalties Benefit design Reimbursement / pricing Formulary status / alternatives / tier placement Utilization management strategies Retrospective DUR programs Care path programs Therapeutic substitution programs Member and Provider communication initiatives / web portal information Claim processing messaging RFP language Clinical newsletters / monitoring Manufacturer relationships 11 AMCP Drug Shortages. Available at: http://www.amcp.org/Tertiary.aspx?id=13654.http://www.amcp.org/Tertiary.aspx?id=13654 Kelly LF. Drug Benefit News. 2012 Jan 27; 13(2). Berger JE. AJPB. 2012 Jan/Feb; 4(1):10-11. Carroll J. Managed Care. 2011 November.

12. Example – Mail Service & Specialty Pharmacy Impact Increase in workload ‒ Calls to patients and prescribers ‒ Calls to distributors/wholesalers ‒ Compounding Therapy impacts ‒ Delays in therapy while waiting for drugs ‒ Changes in therapy to available alternatives Increase in costs ‒ Dispensing brands at generic copays ‒ Higher acquisition costs Reimbursement issues 12

13. Examples of Drug Shortages Affecting Mail Service & Specialty Pharmacies Mail Service ‒ ADHD Products ‒ Methotrexate ‒ Antihypertensives ‒ Anticholinergics Specialty ‒ Leucovorin ‒ Fertility products ‒ INTRON A ‒ Cyclosporine 13

14. 14 Example - Drug Shortages Resulting in MCO/PBM Formulary Adjustments 2009 isosorbide mononitrate (IMDUR, MONOKET); diltiazem hydrochloride (TIAZAC) 2010 hydrocortisone (CORTEF) 5 mg & 10 mg; paroxetine (PAXIL) suspension 2011 doxycycline monohydrate (VIBRAMYCIN); cefuroxime axetil (CEFTIN) 125 mg/mL; hydrocortisone/lidocaine (LIDA MANTLE HC) cream 2012 oxcarbazepine (TRILEPTAL) suspension

15. Example - Drug Shortages & Resultant Actions Drug(s)Client Actions/Trends Seen ADHD medications Suspend mandatory mail / mandatory generic Reference based pricing adjustments New contracting/rebate opportunities Copay overrides/multisource penalties suspended Shifts to PROVIGIL/NUVIGIL fluticasone & flunisolide nasal sprays Adjust/suspend step therapy protocol acyclovir, famciclovir, valacyclovir Copay overrides/multisource penalties suspended metaxalone, tizanidine Copay overrides/multisource penalties suspended Increased costs for Worker’s comp clients clonidine patches Copay overrides/multisource penalties suspended VOLTAREN gel Coverage of compounded product Shifts to PENNSAID topical solution 15

16. Example – Drug Shortages Affecting MCOs/PBMs Trend 2011 ‒ Gabapentin » #1 drug in anticonvulsant category for Managed Medicaid LOB » Top 5 drug by utilization for Managed Medicaid LOB » Over 50% price inflation » Temporarily removed from MAC list ‒ Vancomycin HCl injection » Over 5000% price inflation 16

17. 17 AMCP Actions & Resources Relating to Drug Shortages Professional Practice Committee (PPC) ‒ Policy digest statement » AMCP encourages health care stakeholders, government agencies, and the pharmaceutical industry to work collaboratively to seek proactive and strategic solutions to minimize the number and impact of drug shortages on the drug distribution process and patient outcomes (Approved by AMCP Board October 2011) ‒ Drug shortages resource page AMCP Legislative/Regulatory Briefing and Federal legislative tracking chart (www.amcp.org/federaltrackingchart)www.amcp.org/federaltrackingchart AMCP News AMCP Daily Dose AMCP comment letters to congress and FDA http://www.amcp.org/2012/ http://www.amcp.org/2012/

18. 18 Resources for Drug Shortage Information Food and Drug Administration (FDA) Drug Shortages Homepage http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm American Society of Health-System Pharmacists (ASHP) Drug Shortages Resource Center http://www.ashp.org/shortages http://www.ashp.org/shortages Centers for Disease Control and Prevention (CDC) Vaccine Shortages & Delays http://www.cdc.gov/vaccines/vac- gen/shortages/ http://www.cdc.gov/vaccines/vac- gen/shortages/ Wholesalers / Distributors Pharmaceutical companies GPOs PBMs

19. 19 Thank You AMCP Professional Practice Committee & AMCP Staff Clinical Account Managers: Danielle Nichols, PharmD; Julie Ryba, RPh; Barbara Rogler, PharmD; Jennifer Svec, RPh; John Nicolosi, PharmD Analysts: Valerie Kehoe; Kristy Scheinfeldt Mimi Davis, RPh, VP/GM, informedMail Rick Couillard, RPh, Director, Pharmacy Practices, Ascend Gintare Adomaityte, Pharmacy intern Jennifer Wilbanks, PharmD, Drug Info Specialist Sina Carlson, PharmD, Sr. Manager, Drug Information Services David Calabrese, RPh, MPH, VP Clinical Services & Chief Pharmacy Officer

20. Questions/Comments? Contact Info: Sherry L. Andes, PharmD, BCPS, BCPP, BCACP Sr. Drug Information Specialist sherry.andes@sxc.com 502-254-9531 20