5 th Annual PBM Pharmacy Informatics Conference KEYNOTE ADDRESSES

1. 5th Annual PBM Pharmacy Informatics Conference KEYNOTE ADDRESSES

2. Michael Valentino, RPh, MHSAChief Consultant for the Pharmacy Benefits Management Strategic Healthcare Group 5th Annual PBM Pharmacy Informatics Conference

3. Medical Advisory Panel for Pharmacy Benefits Management 5th Annual PBM Pharmacy Informatics Conference C. Bernie Good, MD MPH Chair Medical Advisory Panel 2

4. Objectives • Discuss the structure of MAP/VPE/PBM Clinical Pharmacy Staff • Discuss role of MAP with formulary management • Challenges, opportunities, issues, policies • Discuss MAP/PBM drug safety initiatives

5. PBM Structure- Clinical • Medical Advisory Panel (MAP) • Practicing physicians (12, with one vacancy) • Represent Primary Care, Psychiatry, and Medical Specialties • VISN Pharmacy Executives (VPE) • One per VISN • Meetings • Monthly Conference Calls • Face-to-Face Quarterly meetings (combined)

6. PBM Structure- Additional Groups • VA Center for Medication Safety (VA Medsafe) • Works with MAP and VPEs • Do not vote in decision making • MAP Advisors • Also have MAP advisors on as needed basis (Women’s Health, Substance Abuse, etc) • Do not vote in decision making

7. MAP/ VPE Decision Making • MAP Physicians and MAP Clinical Pharmacists are voting members of MAP • MAP physicians must have more votes than clinical pharmacists • MAP and VPE’s have separate votes • When there is discordance between PBM and VPE votes, attempts are made to reconcile the differences • In the (unusual) situation where the differences cannot be resolved, the MAP vote rules

8. Medical Advisory Panel (MAP)(With VPE’s) Role in VA • Maintain the VA National Formulary • Assess new drugs in a timely fashion • Safety and efficacy • Consider for addition to VANF • Develop Criteria for Use (CFU) in selected cases • Review formulary for new safety and efficacy data • Change CFU • Add/ Remove from VANF • Drug Safety Issues (VA Medsafe) • Drug Policy Issues

9. MAP/VPE’s Goal: Provide a High-Quality, Cost-Effective Pharmacy Benefit • Consider needs of patients and clinicians • Maintain “buy in” from patients and providers • Identify areas in which quality is not compromised by cost-saving efforts • Carefully assess for quality and safety in the pharmacy plan on a regular basis • Encourage use of evidence-based therapies • Discourage unnecessary costly therapies

10. Maintain VA National Formulary • New drugs reviewed in a timely fashion • Comprehensive, well-balanced drug monographs • Develop fair, evidence-based criteria for use (CFU) • Whether formulary or non-formulary, CFU should ensure access to needed drugs by patients who should benefit from them • Seek broad input on draft documents (monographs, CFU) • Request input from Subject Matter Experts (SME) as well as VA Field Advisory Committees (FAC), and broad field input • Modify based on feedback, as appropriate

11. VANF Challenge: Needs of Patients and Providers • Patients are affected by direct to consumer advertisements • Providers are affected by personal preferences, local (university) practices, and advertising • Many patients present to VA with complex medical problems, with need for access to very high cost, newer therapies

12. VANF Challenge: Needs of Patients and Providers • Accept that costly treatments are part of the cost of caring for a complex patient population • Regularly look for variation in practices across VISN, VA • If facilities, or VISNs have little or no use of a drug that has relevance to VA population, investigate • Provide timely, relevant, VA-Centric bulletins

13. Variations in Care • Identify areas where quality is not compromised by cost-saving effort • Many examples where costly drugs may be used in situations where either not needed or preferred • Indication creep after FDA approval • Careful review of “opportunities” for interventions

14. Dealing with Cost Issues • New drugs • Develop criteria for use • Encourage use where evidence supports clinically relevant outcomes • Attempt to avoid unnecessary use, off-label use without supporting evidence • Old drugs, new labels (colchicine, etc) • Identify cost effective strategies in light of new cost • Hope to expand comparative effectiveness, coverage with evidence development, and cost-sharing opportunities

15. MAP/ VPE’s: Additional Roles in VA • Drug Safety Issues • VA Medsafe • Active collaboration with FDA and other agencies • Serve as member on FDA Drug Safety Board • National Drug Use Evaluations • Convey emerging safety issues to VA field • Policy Issues • Outside prescriptions/Dual Care • Conflicts of interest • Risk Evaluation and Mitigation Strategies (REMS) programs- Discussions with VA and FDA

16. Safety Issues and VA Formulary • Promote safe and effective use of pharmaceuticals • Drug Use Criteria • Alerts, newsletter, feedback • Drug Use Evaluations • VA Center for Medication Safety

17. VAMedSAFE: World-Class Medication Safety Initiative • Pharmacovigilance/Post-Marketing Surveillance • To evaluate known or suspected Adverse Drug Event (ADE) signals • To link results of safety event analyses to formulary activities and medication use systems and policies within VA • Risk Education – • To Develop background material, literature and programs for communication to field to improve medication safety • Risk Reduction • To intervene on known ADE risks to improve prescribing practices and safe medication use • PBM Communications and Alerts • “Medication in Seconds” - monthly PBM newsletter • Work with FDA warnings and alerts- develop consistent action as indicated by individual issues

18. In Summary • MAP continues to be involved in complex formulary decisions • PBM/MAP has developed an impressive drug safety program • PBM/MAP will continue to address policy issues relating to formulary management

19. Dr. Lance Davis, PharmD, MBADeputy Network Director and VISN Pharmacist Executive for VA Healthcare System of Ohio (VISN 10). 5th Annual PBM Pharmacy Informatics Conference KEYNOTE ADDRESSES