VA Pharmacy Conference March 2008

1. VA Pharmacy ConferenceMarch 2008 Know Your National PBM: Who are they and what do they do? Pharmacy Benefits Management Service www.pbm.va.gov

2. Objectives • Discuss the functions of the VA PBM • Introduce the National PBM staff • Familiarize audience with National PBM documents • Review the document development and approval process • Review why participation from the field is vital to the decision making process • Inform attendees how they can stay up-to-date with National PBM activities and changes Pharmacy Benefits Management Service www.pbm.va.gov

3. Mission of the VA PBM To improve the health status of veterans by encouraging the appropriate use of medications in a comprehensive medical care setting Pharmacy Benefits Management Service www.pbm.va.gov

4. Key Functions of the National PBM Service • Drug benefit design • Evidence-based formulary management • Utilization management • Patient safety (VAMedSafe, adverse drug event (ADE) reporting, post marketing surveillance) • Staff education (CE / CME) Pharmacy Benefits Management Service www.pbm.va.gov

5. VA MedSafe Improve the safety of prescribing practices and medication administration for veterans • Identify and track ADEs • Address preventable ADEs • Evaluate interventions • Educate and communicate • Promote medication safety research in VA Pharmacy Benefits Management Service www.pbm.va.gov

6. VA MedSafe • Risk reduction projects • Alpha-blocker monotherapy • Cilostazol safety evaluation • High dose statins and fibrates • Drug surveillance projects • Varenicline • Bisphosphonates Pharmacy Benefits Management Service www.pbm.va.gov

7. Key Objectives of the Formulary Process • Promote formulary decisions that are evidenced-based, not preference-based • Promote appropriate drug therapy and discourage inappropriate drug therapy • Reduce the geographic variability in utilization of pharmaceuticals across the VA • Promote portability and uniformity of the drug benefit • Initiate patient safety of the drug benefit • Design and implement relevant outcomes assessment projects Pharmacy Benefits Management Service www.pbm.va.gov

8. PBM-MAP Drug Use Management Process ID areas of opportunity • Review: • RX volume • RX expenditures • New Drugs Monitor Performance Assess feasibility • Contract Participation • Utilization Management • Use of Criteria • Review: • Medical Literature • VA Prescribing • Clinical Need START Implement action(s) • One or more of: • Issue Drug Use Criteria • Conduct Solicitation • Negotiate BPA Present issue to stakeholders • Medical Advisory Panel (MAP) • VISN Formulary Leaders (VFLs) • Get input from front • line clinical staff • Chief Clinical Consultants • DoD • Pharmacoeconomic Center • P & T Committee Determine action(s) • Nothing • One or more of: • Guideline • Criteria for Use • National Contract • Incentive Agreement

9. Introduction to the National PBM Clinical Staff Fran Cunningham, Pharm.D. Research VA Med Safe ADE Outcomes Anesthesiology Janet Dailey, Pharm.D. Sedative/Hypnotics Education EZ Minutes Elaine Furmaga, Pharm.D. Hypertension Heart Failure Antiarrhythmics Nephrology Mark Geraci, Pharm.D., BCOP Oncology Antiemetics Smoking Cessation Pharmacy Benefits Management Service

10. Introduction to the National PBM Clinical Staff Francine Goodman, Pharm.D., BCPS GI Dermatology Pain Management Substance Abuse Disorders Zoster vaccine Cathy Kelley, Pharm.D., BCPS Lipid disorders Osteoarthritis Natural Products Vaccines (excluding zoster) Lisa Longo, Pharm.D., BCPS Anticoagulation Antiplatelet Ischemic Heart Disease Pulmonary HTN Women’s Health Deb Khachikian, Pharm.D. COPD/Asthma Diabetes Antifungals Allergic rhinitis Pharmacy Benefits Management Service

11. Introduction to the National PBM Clinical Staff Melinda Neuhauser, Pharm.D. Antimicrobial agents (excluding antifungals) HIV Hepatitis B Ocular antimicrobial agents Marie Sales, Pharm.D. DMARDs Ophthamology (excluding ARMD) Kathy Tortorice, Pharm.D., BCPS Parkinson disease, Epilepsy Multiple Sclerosis, Migraine Hepatitis C Age-related macular degeneration (ARMD) NDF Todd Semla, MS, Pharm.D, BCPS Psychiatry Dementia Osteoporosis Urinary Incontinence Erectile Dysfunction Obesity/Weight loss Pharmacy Benefits Management Service

12. How the National PBM Supports the VANF, Providers, and Patients Clinical Document Development • New Molecular Entity Drug Monographs (NMEs) • Criteria for Use (CFU) • Drug Class Reviews • Guidance and White Papers • Clinical Practice Guidelines Pharmacy Benefits Management Service www.pbm.va.gov

13. New Molecular Entity Drug Monographs • Review efficacy, safety, cost, and other data of NMEs • “A medication containing an active substance that has never before been approved for marketing in any form in the United States” • Includes drug and biologic products • Involve an extensive literature review and evidence-based medicine approach • Assess the evidence and clinical significance • Recommend place in therapy • Support criteria for use decisions Pharmacy Benefits Management Service www.pbm.va.gov

14. Criteria for Use • Outline appropriate place in therapy • Use clinical trial results (drug monograph) and expert / field opinions to determine appropriateness • Consist of • Inclusion and exclusion criteria checklists • Renewal or discontinuation criteria checklist • Dosing, monitoring, and special considerations • Discourage inappropriate use • Encourage safe and cost-effective use • Aim to provide uniform pharmacy benefit Pharmacy Benefits Management Service www.pbm.va.gov

15. Drug Class Reviews • Use evidence-based evaluation to determine • Therapeutic interchangeability • Eligibility for competitive solicitation • Compare data for efficacy, safety, tolerability, monitoring, drug interactions, drug administration, cost, and other pharmaceutical issues • Are similar to NME monographs Pharmacy Benefits Management Service www.pbm.va.gov

16. Peer Review Process Pharmacy Benefits Management Service www.pbm.va.gov

17. Peer Review Process for Documents • Review of document by multiple disciplines: • Medical Advisor and/or subject matter experts • MAP Committee • VISN Formulary Leaders (VFLs) Committee • Suggestions/comments/changes from the above individual(s) and/or groups are incorporated into the document • Presentation to both MAP and VFLs Committees for approval of the document Pharmacy Benefits Management Service www.pbm.va.gov

18. Peer Review Process for Documents NME Monographs, Drug Class Reviews, and CFU sent to • VFLs for dissemination • VISN and local P&T Committees • Pharmacy Chiefs • Chief Medical Officers • Local subject matter experts • Field Advisory Committees (FACs) or Technical Advisory Groups (TAGs) • VHA Chief Consultants Pharmacy Benefits Management Service www.pbm.va.gov

19. Peer Review Process for Documents Conflict of Interest (COI) • Required with comments on Drug Class Reviews for national contracting • Requested of field reviewers on CFU documents Pharmacy Benefits Management Service www.pbm.va.gov

20. National PBM Supports Implementation of Formulary Change • Announcement of National Formulary changes in PBM-MAP Ez Minutes • Letters to prescribers and patients • Addition of drug-drug interactions to the NDF • ADE reporting and monitoring Pharmacy Benefits Management Service www.pbm.va.gov

21. What is your role? • Comment on documents sent for review • Make sure interested providers see document and encourage comments • Include COI form when appropriate • VA ethics standard • Disclosing a COI does not exclude comments made Pharmacy Benefits Management Service www.pbm.va.gov

22. What is your role?-cont. • Dissemination of materials to stakeholder groups • Participation in PBM supported research • Feedback and communication • To your VISN Formulary Leader • To the PBM • To the Clinical Pharmacy Mailgroup Pharmacy Benefits Management Service www.pbm.va.gov

23. Keeping up with changes • PBM INTRAnet site vaww.pbm.va.gov • PBM INTERnet site www.pbm.va.gov • PBM-MAP Broadcast Programs • PBM-MAP Ez Minutes Pharmacy Benefits Management Service www.pbm.va.gov

24. PBM-MAP Broadcast Programs - 2008 • CE available for all programs including when viewed via CDN (Content Distribution Network) http://vaww.pbm.va.gov/pbm/dislearning.htm • MDS-Myelodysplastic Syndrome • Emerging Therapeutic Targets for Multiple Myeloma • Oral Agents for Type 2 Diabetes • Multidisciplinary Approach to Managing Chronic Pain Pharmacy Benefits Management Service www.pbm.va.gov

26. Pharmacy Benefits Management Medical Advisory Panel Ez-Minutes To subscribe: Send e-mail to stxcollage@va.gov with “PBM subscribe” in the subject line. Pharmacy Benefits Management Service www.pbm.va.gov

27. Pharmacy Benefits Management Service www.pbm.va.gov