0. 5th Annual PBM Pharmacy Informatics Conference KEYNOTE ADDRESSES

1. 5th Annual PBM Pharmacy Informatics Conference
Michael Valentino, RPh, MHSA Chief Consultant for the Pharmacy Benefits Management Strategic Healthcare Group

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

3. 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

4. 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)

5. 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)

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 5th Annual PBM Pharmacy Informatics Conference KEYNOTE ADDRESSES
Dr. Lance Davis, PharmD, MBA Deputy Network Director and VISN Pharmacist Executive for VA Healthcare System of Ohio (VISN 10).