Transcript Keynote addresses

5th Annual PBM Pharmacy Informatics Conference
KEYNOTE ADDRESSES
5th Annual PBM Pharmacy Informatics Conference
Michael Valentino, RPh, MHSA
Chief Consultant for the Pharmacy Benefits Management Strategic Healthcare Group
5th Annual PBM Pharmacy Informatics Conference
Medical Advisory Panel
for Pharmacy Benefits Management
C. Bernie Good, MD MPH
Chair Medical Advisory Panel
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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
VETERANS HEALTH ADMINISTRATION
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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)
VETERANS HEALTH ADMINISTRATION
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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
VETERANS HEALTH ADMINISTRATION
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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
VETERANS HEALTH ADMINISTRATION
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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
VETERANS HEALTH ADMINISTRATION
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MAP/VPE’s Goal: Provide a HighQuality, 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
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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
VETERANS HEALTH ADMINISTRATION
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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
VETERANS HEALTH ADMINISTRATION
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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
VETERANS HEALTH ADMINISTRATION
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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
VETERANS HEALTH ADMINISTRATION
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
VETERANS HEALTH ADMINISTRATION
MAP/ VPE’s: Additional Roles in VA
• Drug Safety Issues
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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) programsDiscussions with VA and FDA
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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
VETERANS HEALTH ADMINISTRATION
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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
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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
VETERANS HEALTH ADMINISTRATION
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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).