1. Sources of DoD Information Libby Hearin, PharmD Harsha Mistry, PharmD

2. 2 Objectives Describe sources of Uniform Formulary and clinical information that local MTF personnel can use for formulary decision making Focusing on the following tools: –TRICARE pharmacy webpages –PEC website –RxNET –Formulary search tool

3. 3 Knowing Our Audience Clinical background Years within the military system Participated in P&T Committee meetings Exposure to the Uniform Formulary and related resources Your favorite resource

4. 4 Overview Describe DoD Uniform Formulary (UF) –What is it? Answer DoD UF specific questions –Where do I find the answers? Prepare for local MTF formulary decisions –How can I prepare a presentation with pertinent information? Stay current with new drugs and UF information

5. DoD Uniform Formulary (UF)

6. 6 DoD Uniform Formulary (UF) Terminology BCF vs. ECF –www.pec.ha.osd.milwww.pec.ha.osd.mil –BCF (basic core formulary) list of medications required to be on formulary at all full- service Military Treatment Facilities (MTFs) –ECF (extended core formulary) Therapeutic classes that are used to support more specialized scopes of practice than those on the BCF. MTFs may choose whether or not to include an ECF therapeutic class on formulary. –If an MTF chooses to have an ECF therapeutic class on formulary, it must have ALL ECF medications in that class on formulary.

7. 7 BCF and ECF Information PEC website www.pec.ha.osd.mil

8. 8 DoD UF and P&T Committee Key points The DoD P&T Committee makes recommendations regarding the formulary status of medications on the BCF, ECF, and UF to the Director, TRICARE Management Activity (TMA).DoD P&T Committee The Director, TMA, makes final decisions after considering comments from the Beneficiary Advisory Panel (BAP). The minutes are available approximately 2-3 months after the meeting.

9. 9 DoD P&T Committee Minute Websites P&T Committee minutes & future meeting information –www.pec.ha.osd.milwww.pec.ha.osd.mil –www.tricare.mil/pharmacywww.tricare.mil/pharmacy P&T Committee cumulative minutes –www.dodrxnet.orgwww.dodrxnet.org BAP handouts –www.tricare.mil/pharmacy/BAP/default.htmwww.tricare.mil/pharmacy/BAP/default.htm

10. DoD UF Scenarios

11. 11 Objectives Part 1: Understand the question –Rumor or Truth? Part 2: Evaluate the question –Related to UF or local formulary decisions Part 3: Answer the question –PEC drug class written reviews –Other evidence-based medicine reviews –Other drug literature websites

12. 12 Part 1: Understand the Question Scenario 1 Dr Snow asks the technician at the MTF pharmacy window: Why can’t my patient get her pregabalin? Understand what the question is asking… –Does the medication have formulary restrictions? –Are there supply or distribution issues ?

13. 13 Part 2: Evaluate the Question Does this medication have formulary restrictions? Fast facts: –TRICARE formulary search tool: www.tricareformularysearch.org –TRICARE Pharmacy pages www.tricare.mil/pharmacy

14. 14 Part 2: Evaluate the Question www.tricareformularysearch.org pregabalin

15. 15 Part 2: Evaluate the Question Does this medication have formulary restrictions? Effective date pregabalin

16. 16 Part 3: Answer the Question Why can’t my patient get pregabalin at the local MTF pharmacy? Short Answer: –MTF pharmacies do not carry non-formulary medications, such as pregabalin. Long Answer: –MTF pharmacies do not carry non-formulary medications, but if the patient meets the medical necessity criteria, the patient may qualify to receive the medication at the MTF.

17. 17 Follow-Up Questions: What are the formulary alternatives Fast Facts –TRICARE formulary search tool: www.tricareformularysearch.org RxNET: Formulary Management document –www.dodrxnet.orgwww.dodrxnet.org

18. 18 Formulary alternatives www.tricareformularysearch.org pregabalin Formulary alternatives

19. 19 Formulary alternatives www.dodrxnet.org

20. 20 Formulary alternatives www.dodrxnet.org

21. 21 What are the medical necessity criteria for pregabalin? Medical necessity criteria and forms RxNET: Word version –www.dodrxnet.orgwww.dodrxnet.org TRICARE pharmacy pages: PDF version –www.tricare.mil/pharmacywww.tricare.mil/pharmacy

22. 22 Medical necessity criteria and forms www.dodrxnet.org

23. 23 Medical Necessity Criteria and Forms www.tricare.mil/pharmacy Medical Necessity Criteria Medical Necessity PDF form

24. 24 Follow-Up: TMOP & Retail Network Information Follow-Up: TMOP & Retail Network Information What if my patient wants to use TMOP or a network retail pharmacy? TRICARE formulary search tool: –Drug availability information –Copay ($3, $9, or $22) –Generic equivalents –Alternatives and their respective copays –Restrictions: Quantity Limits (QL), Prior Authorizations (PAs)

25. 25 TMOP & Retail Network Information www.tricareformularysearch.org Retail Mail Order

26. 26 Part 1: Understand the Question Scenario 2 Your P&T Chair asks you: What are we going to do with atorvastatin? Understand what the question is asking: –What is atorvastatin’s UF status? –Is atorvastatin a BCF agent? –What formulary options do local MTFs have in regarding atorvastatin?

27. 27 Part 2: Evaluate the Question What was the final UF decision for the statin drug class? –P&T minutes TRICARE Pharmacy pages RxNET –Formulary Management Document RxNET Which products are local MTFs required to carry? –BCF/ECF status Formulary Management Document: RxNET Complete BCF/ECF listing with changes: PEC website Do local MTFs have additional guidance? –Formulary Management Document: RxNETRxNET

28. 28 Part 3: Answer the Question What are we going to do with atorvastatin? Atorvastatin is Formulary Brand (Tier 2) on the UF BCF agents –Simvastatin –Pravastatin –Niacin extended release Atorvastatin is NOT a BCF agent Local MTFs can make local formulary decisions for atorvastatin Bottom Line: Our local MTF P&T Committee needs to make this decision

29. How to prepare for a local MTF P&T meeting

30. 30 How to prepare for a local MTF P&T meeting Pieces of the puzzle Know your topic –Drug class or a new drug Cite reputable literature sources –Evidence based medicine (EBM) reviews Package the right information –Know your audience Present a recommendation summary –What is the bottom line?

31. 31 How to prepare for a local MTF P&T meeting Know your topic Has the DoD P&T committee reviewed the drug class? –Table of Uniform Formulary decisions: www.pec.ha.osd.mil/MTF/UF_Info.htm www.pec.ha.osd.mil/MTF/UF_Info.htm –Future drug class evaluations: www.pec.ha.osd.mil/PT_Committee.htm www.pec.ha.osd.mil/PT_Committee.htm –RXnet: Formulary management documents www.dodrxnet.org www.dodrxnet.org If possible hold off on a decision if the DoD P&T committee will be reviewing the drug class in the near future

32. 32 How to prepare for a local MTF P&T meeting Cite reputable literature sources National EBM Resources –Oregon Evidence- based Practice Center Drug Effectiveness Review Project (DERP) www.ohsu.edu/drugeffectiveness/reports/final.cfm Written reviews, (caveat: narrow focus) –Veterans Affair PBM (VA-PBM) www.pbm.va.gov/default.aspx Written reviews, new drug monographs (caveat: unique patient population & bottom line) –Cochrane Database (OVID) –PEC written reviews @ RxNET www.dodrxnet.org/

33. 33 How to prepare for a local MTF P&T meeting Cite reputable literature sources International EBM resources –UK: National Institute for Clinical Reviews (NICE) www.nice.org.uk –UK: Trip database www.tripdatabase.com/index.html –UK: Bandolier www.jr2.ox.ac.uk/bandolier –Canada: Canadian Agency for Drugs and Technology in Health www.cadth.ca

34. 34 How to prepare for a local MTF P&T meeting Know your audience Health professionals –Pharmacology: therapeutic class, mechanism of action –Efficacy measures: report meta-analyses, DB PC trials, head to head trials if available –Safety: list common adverse events, special populations, potential drug-drug interactions, overall benefit vs risk ratio, and tolerability (drug discontinuation due to ADRs) –Other issues: administration, availability, distribution & packaging, dosage forms, patents, etc. –Conclusion Efficacy summary Safety summary Overall conclusion

35. 35 How to prepare for a local MTF P&T meeting Know your audience Health Care Administrators –Utilization of drugs Possible market shifts to other drugs Possible shifts to another point of service Supply mechanism –Cost issues Current therapies vs. “new drug” (remember cost/day of therapy) Formulary restriction such as quantity limits, prior authorization, medical necessity issues

36. 36 How to prepare for a local MTF P&T meeting Recommendation summary What is the bottom-line? –Very difficult to determine at times –Analyze clinical effectiveness in conjunction with cost effectiveness –The system (MTF personnel) must be able to handle the decision –Summarize ways to help the decision FAQ sheets Algorithms Pre-written order sheets Formulary management document

37. How to Stay Current with Drug Information

38. 38 How to stay current: FDA websites at www.fda.gov.cder How to stay current: FDA websites at www.fda.gov.cder Center for Drug Evaluation and Research –Drugs @ FDA section Package insert, approval letter Detailed medical, chemistry, statistical reviews often available –Generic drugs www.fda.gov/cder/ogd/approvals/www.fda.gov/cder/ogd/approvals www.fda.gov/cder/drug/shortages/default.htm –Safety warnings www.fda.gov/medwatch Dear Doctor letters; reverse chronological listing of safety alerts; changes in package inserts related to safety issues

39. 39 How to stay current: Auto-updates Sign up for auto-updates for: DoD UF specific information: –RxNET www.dodrxnet.org –DoD P&T minutes page www.tricare.mil/pharmacy www.tricare.mil/pharmacy Clinical information: –New drug approvals www.fda.gov/cder/cdernew/listserv.html www.fda.gov/cder/cdernew/listserv.html

40. 40 Where to find already prepared drug monographs VA PBM (Pharmacy Benefits Management) –www.pbm.va.gov/default.aspxwww.pbm.va.gov/default.aspx –VA’s equivalent of the PEC –Monographs, criteria for use are on-line AMCP dossier from individual companies Pharmacy Journals (AJHP, Pharmacotherapy) Still must critically analyze!

41. 41 Newly Approved Drugs – Free Monthly Journals (peer-reviewed) Formulary Journal - (www.formularyjournal.com)(www.formularyjournal.com –New drug monographs; class reviews, news alerts, drugs in the pipeline P&T Journal (www.ptcommunity.com/ptjournal/journalview.cfm)www.ptcommunity.com/ptjournal/journalview.cfm –similar info as the Formulary Journal; health policy Hospital Pharmacy Journal (www.hospitalpharmacyjournal.com)www.hospitalpharmacyjournal.com –Inpatient focused; lots of JCAHO tips –“Current FDA-related drug info”: Column on new drugs, drugs in the pipeline, drugs with new indications Free journals, but need to fill out card saying you are part of a P&T Committee

42. 42 Our Bottom Line is the Big Picture Resources with pre-packaged information are available to help you with your local formulary decision-making process, daily questions, and personal growth Our goal is to keep you well-informed regarding UF decisions and current clinical information PEC Website –www.pec.ha.osd.milwww.pec.ha.osd.mil