Sources of DoD InformationSources of DoD Information

Libby Hearin, PharmD

Harsha Mistry, PharmD

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ObjectivesObjectives

• 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

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Knowing Our AudienceKnowing 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

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OverviewOverview

• 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

DoD Uniform Formulary (UF)DoD Uniform Formulary (UF)

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DoD Uniform Formulary (UF)DoD Uniform Formulary (UF)TerminologyTerminology

• BCF vs. ECF– www.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.

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BCF and ECF InformationBCF and ECF InformationPEC websitePEC website

www.pec.ha.osd.milwww.pec.ha.osd.mil

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DoD UF and P&T CommitteeDoD UF and P&T CommitteeKey pointsKey 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).

• 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.

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DoD P&T Committee Minute DoD P&T Committee Minute Websites Websites

• P&T Committee minutes & future meeting information

– www.pec.ha.osd.mil

– www.tricare.mil/pharmacy

• P&T Committee cumulative minutes

– www.dodrxnet.org

• BAP handouts

– www.tricare.mil/pharmacy/BAP/default.htm

DoD UF DoD UF ScenariosScenarios

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ObjectivesObjectives

• 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

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Part 1: Understand the QuestionPart 1: Understand the QuestionScenario 1Scenario 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 ?

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Part 2: Evaluate the QuestionPart 2: Evaluate the QuestionDoes this medication have formulary restrictions?Does this medication have formulary restrictions?

Fast facts:

–TRICARE formulary search tool:

www.tricareformularysearch.org

–TRICARE Pharmacy pages

www.tricare.mil/pharmacy

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Part 2: Evaluate the QuestionPart 2: Evaluate the Questionwww.tricareformularysearch.orgwww.tricareformularysearch.org

pregabalin

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Part 2: Evaluate the QuestionPart 2: Evaluate the QuestionDoes this medication have formulary restrictions?Does this medication have formulary restrictions?

Effectivedate

pregabalin

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Part 3: Answer the QuestionPart 3: Answer the Question Why can’t my patient get pregabalin at the local MTF Why can’t my patient get pregabalin at the local MTF

pharmacy?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.

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Follow-Up Questions: Follow-Up Questions: What are the formulary alternatives What are the formulary alternatives

Fast Facts–TRICARE formulary search tool:

www.tricareformularysearch.org

• RxNET: Formulary Management document

–www.dodrxnet.org

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Formulary alternativesFormulary alternativeswww.tricareformularysearch.orgwww.tricareformularysearch.org

pregabalin

Formularyalternatives

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Formulary alternativesFormulary alternativeswww.dodrxnet.orgwww.dodrxnet.org

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Formulary alternativesFormulary alternativeswww.dodrxnet.orgwww.dodrxnet.org

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What are the medical necessity criteria What are the medical necessity criteria for pregabalin?for pregabalin?

Medical necessity criteria and forms

• RxNET: Word version

– www.dodrxnet.org

• TRICARE pharmacy pages: PDF version

– www.tricare.mil/pharmacy

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Medical necessity criteria and formsMedical necessity criteria and formswww.dodrxnet.orgwww.dodrxnet.org

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Medical Necessity Criteria and FormsMedical Necessity Criteria and Formswww.tricare.mil/pharmacywww.tricare.mil/pharmacy

Medical NecessityCriteria

Medical NecessityPDF form

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Follow-Up: Follow-Up: TMOP & Retail Network InformationTMOP & 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)

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TMOP & Retail Network InformationTMOP & Retail Network Informationwww.tricareformularysearch.orgwww.tricareformularysearch.org

RetailMailOrder

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Part 1: Understand the QuestionPart 1: Understand the QuestionScenario 2Scenario 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?

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Part 2: Evaluate the QuestionPart 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: RxNET

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Part 3: Answer the QuestionPart 3: Answer the Question What are we going to do with atorvastatin?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

How to prepare for a local MTF How to prepare for a local MTF P&T meetingP&T meeting

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How to prepare for a local MTF P&T meetingHow to prepare for a local MTF P&T meeting Pieces of the puzzlePieces 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?

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How to prepare for a local MTF P&T meetingHow to prepare for a local MTF P&T meeting Know your topicKnow 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

– Future drug class evaluations: www.pec.ha.osd.mil/PT_Committee.htm

– RXnet: Formulary management documents 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

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How to prepare for a local MTF P&T meetingHow to prepare for a local MTF P&T meeting Cite reputable literature sources 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/

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How to prepare for a local MTF P&T meetingHow to prepare for a local MTF P&T meeting Cite reputable literature sources 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

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How to prepare for a local MTF P&T meetingHow to prepare for a local MTF P&T meeting Know your audience 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

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How to prepare for a local MTF P&T meetingHow to prepare for a local MTF P&T meeting Know your audience 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

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How to prepare for a local MTF P&T meetingHow to prepare for a local MTF P&T meeting Recommendation summary 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

How to Stay CurrentHow to Stay Currentwith Drug Informationwith Drug Information

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How to stay current:How to stay current:FDA websites at www.fda.gov.cderFDA 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/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

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How to stay current:How to stay current:Auto-updatesAuto-updates

Sign up for auto-updates for:

• DoD UF specific information:

– RxNET

www.dodrxnet.org

– DoD P&T minutes page www.tricare.mil/pharmacy

• Clinical information:

– New drug approvals www.fda.gov/cder/cdernew/listserv.html

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Where to find already prepared drug Where to find already prepared drug monographsmonographs

• VA PBM (Pharmacy Benefits Management)

– www.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!

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Newly Approved Drugs –Newly Approved Drugs –Free Monthly Journals (peer-reviewed)Free Monthly Journals (peer-reviewed)

• Formulary Journal - (www.formularyjournal.com)– New drug monographs; class reviews, news alerts, drugs in the

pipeline

• P&T Journal (www.ptcommunity.com/ptjournal/journalview.cfm)– similar info as the Formulary Journal; health policy

• Hospital Pharmacy Journal (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

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Our Bottom Line is the Big PictureOur 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.mil