feb 17 2016 webinar combined presentation slides...

CHS Formulary Management Process – Approval, Appeals, and BeyondCHS Pharmacy Education Series

ProCE, Inc.www.ProCE.com 1

2016 Pharmacy Education Series

February 17, 2016CHS F l M t P A l A l d B dCHS Formulary Management Process – Approval, Appeals, and Beyond

Featured Speaker:Heather Ann Wier Weese, PharmD, BCPSManager, Formulary and Pharmacy StandardsCHS Professional Services Corporation

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Deadline: March 18, 2016( l bl h )

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Code will be provided at the end of today’s activity



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2016 Pharmacy Education SeriesFebruary 17, 2016

CHS Formulary Management Process – Approval, Appeals, and Beyond

Featured Speaker:Heather Ann Wier Weese, PharmD, BCPSManager, Formulary and Pharmacy StandardsCHS Professional Services Corporation

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It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Heather Weese has no relevant commercial and/or financial relationships to disclose.

Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature.

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist CE)

– 2.0 contact hours

Funding:This activity is self‐funded through CHSPSC

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This activity is self funded through CHSPSC.



Community Health SystemsCommunity Health SystemsCommunity Health Systems Community Health Systems Formulary Management Process Formulary Management Process ––Approvals, Appeals, and BeyondApprovals, Appeals, and Beyond

Heather Weese, Pharm.D.

Director, Pharmacy Operations and Informatics

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Disclosure

I do not have (nor does any immediate family member have) an interest in or affiliation with any organizationhave) an interest in or affiliation with any organization offering financial support or grant monies other than reasonable honoraria and expenses for this continuing education activity. In addition, I have received no financial support of any kind from the manufacturer, developer or distributor of a product / device that will p f p /be discussed during my presentation.

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Learning Objectives

At the conclusion of this presentation, participants will be able to:• Describe the formulary status designation process for new drug requests and new FDA drug approvals

• Define the appropriate mechanism for submitting an appeal for a non‐formulary medication

• Identify and respond to commonly asked questions concerning the formulary process

• Explain the rationale behind therapeutic interchange and how it applies to our organization

• Evaluate scenarios for requests and appeals for appropriate escalation

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Goals of this Presentation

Deliverables:

• Enhance understanding of the formulary, the rationale behind the formulary, and commonly asked questions

• Review important documents, their location, and how to use themand how to use them

• Provide examples of situations and how to apply knowledge gained today

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Presentation Outline

• Rationale and argument for formulary t d di tistandardization

• Formulary structure

• Appeals Process

• Formulary Tools and Helpful Materials

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RATIONALE FOR FORMULARY STANDARDIZATION – WHY STANDARDIZE?

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What is a Formulary?

• A continually updated list of medications and related information, representing the clinical judgment of pharmacists, physicians, and other experts in the diagnosis and treatment of disease and promotion of health

• A formulary includes, but is not limited to, a list of medications and medication‐associated products or devices, medication‐use policies, important ancillary drug information, decision‐support tools, anddrug information, decision support tools, and organizational guidelines

‐ ASHP Statement on the Pharmacy and Therapeutics Committee and the Formulary System

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Why Have a Formulary?

• Governance

– Safety, cost‐effectiveness

• Internal processes/policies

• Compliance

• Billing

• Informatics

Boucher BA. Formulary decisions: then and now. Pharmacotherapy 2010;30:35S‐41S14



Why Have a Organizational Standard Formulary?

• Centralized platforms

– Electronic health record, smart infusion pumps

• Centralized processes

– Billing, order set development

• Centralized standards

C t ti f i t th ti– Concentrations, frequencies, routes, therapeutic interchange, etc.

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CHS Formulary History

• 2011 – Review process initiated

• 2012 – Obtained buy‐in from CHSPSC leadership

• 2013 – Formulary policy developed; integration time line to 2015 developed

• 2014 – Formulary rollout initiated

• 2015 – Formulary integration process completed2015 Formulary integration process completed

• 2016 – Maintenance phase

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Are other Organizations Doing This?

• YES!

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What Benefits are We Seeing?

• Centralized standardization

• Improved formulary adherence

• Feedback mechanism

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Why Therapeutic Interchange?

• Centralized platforms

• Drug cost optimization

• Minimization of therapeutic duplication

• Promotion of best practices and standards

• Contract optimization

Gray T et al. ACCP Position Statement: Guidelines for therapeutic interchange – 2004. Pharmacotherapy 2005;25(11):1666‐1680. 19

COMMUNITY HEALTH SYSTEMS FORMULARY MANAGEMENT SYSTEM

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RX08‐04 Formulary System Policy

Establishes:

• Enterprise‐wide formulary and formulary process

– Maintenance process

– Approval process

– Appeal processAppeal process

• Formulary Status Categories

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08‐03‐H Obtaining Non‐Formulary Drugs

• Establishes:

– Process for obtaining non‐formulary drugs

• Review by a pharmacist

• Determination that formulary drug is not appropriate for patient

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Recommending Bodies

• Clinical Pharmacy Council– A standing committee representing a clinical voice to assistA standing committee representing a clinical voice to assist CHS in implementing best practices in pharmacotherapy, including clinical initiative programs, pharmacy residency programs, and clinical interventional programs

– Made up entirely of pharmacists

• Formulary Management Committee– A collaborative group charged with conductingA collaborative group charged with conducting comprehensive reviews and analyses of medications for the purpose of making formulary recommendations to the Medication Management Committee

– Made up of both physicians and pharmacists

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Approving Bodies

• Medication Management Committee

– A standing committee tasked with oversight of pharmacy operations and formulary decisions

• Made up of representatives form Corporate Leadership

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Formulary Requests and Approval

• No local hospital P&T Committee may establish a medication as formulary withoutestablish a medication as formulary without prior addition to the CHSPSC Master Drug Formulary

• Requests may be made by requesting a New Drug Request form from Joanne Smyth (Joanne Smyth@chs net)([email protected])– This is noted on each week’s Weekly Formulary Update Newsletter

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New Drug Approvals by the FDA

• Newly marketed medications default to C t B d i i thi t t til thCategory B and remain in this status until the medication is requested, reviewed, and admitted to the formulary

• New drugs approved by the FDA are announced on the Weekly Formulary Update y y pNewsletter

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Affiliate Formulary Management

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How to Initiate a Request

Request may come from a physician or other

ib t DOP

Request may come from a physician or other

ib t DOP

Use Micromedex Formulary Advisor to D t i F l

Use Micromedex Formulary Advisor to D t i F l

Appeals are a separate process that we will review later in the

Appeals are a separate process that we will review later in theprescriber to DOPprescriber to DOP Determine Formulary

StatusDetermine Formulary

Status

review later in the presentation

review later in the presentation

Please consider closely your own opinion of the

request

Please consider closely your own opinion of the

request

Remember that DOPs have the ability to deny requests for additions of

medications

Remember that DOPs have the ability to deny requests for additions of

medications

Send email to [email protected]. If you forget this, it appears weekly on the Weekly Formulary Update

Send email to [email protected]. If you forget this, it appears weekly on the Weekly Formulary Update

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Formulary Status Categories

• Category A: Full Formulary Status– Category A1: Therapeutic Equivalents: agents so similar in efficacy and safety

that they can be interchanged without any risk to the patient or compromisethat they can be interchanged without any risk to the patient or compromise in efficacy. Equivalents currently not included on the formulary would fall in non‐formulary category C

– Category A2: Class Representatives: agents with similar efficacy and safety, but some differences preclude auto‐substitution. Prior therapy would be continued, but orders for initiation of therapy would be directed to the formulary agent. Other agents considered acceptable to represent the class but not currently on the formulary would fall in category B

– Restricted Use: Despite formulary status, restrictions may be imposed on use of medications. Criteria outside restrictions, would follow non‐formulary request procedures (Policy 08‐03‐H)request procedures (Policy 08‐03‐H)

• Take home message(s):– Category A products are the only products eligible for addition to local

hospital formularies– Hospitals may choose to exclude some Category A products from their local

formulary if they are unneeded

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• Category B: Non‐Formulary:– These agents are not routinely available for use or stockedThese agents are not routinely available for use or stocked in the pharmacy. In certain circumstances, these agents may be ordered for specific patient needs in accordance with Policy 08‐03‐H. Non‐formulary class representatives would fall into this category, unless otherwise stated

• Take home message(s):– Category B products may not be considered for addition to local hospital formulary

– Category B products should not be presented to individual hospital P&T committees for formulary consideration

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• Category C: Non‐Formulary; Not‐AvailableThese agents have specifically been singled out for no– These agents have specifically been singled out for no patient care use within CHS affiliates. These will not be ordered nor stocked at affiliate facilities. These would typically include medications with high‐risk or pose safety concerns, but also include medications for which therapeutic equivalents exist. Alternatives will be designated when an agent is placed in this g g pcategory. Rare exceptions to this must be approved through the affiliate resolution process, documented in the quarterly action plans, and reviewed with the Regional Pharmacy Directors, no less than quarterly.

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Patient Case

• Mrs. M is a 73 year old female patient who is b i d itt d t h it l Whilbeing admitted to your hospital. While processing her orders you notice that the physician has ordered a Category B drug for Mrs. M. How do you proceed?

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Patient Case ‐ Answer

• Follow the process outlined in Policy 08‐03‐H– As the pharmacist processing orders for Mrs. M, you p p g , yshould reach out to the physician and determine why he or she ordered a Category B medication for Mrs. M. If, after discussion with the prescriber you and the prescriber are able to determine that an alternative formulary agent is not appropriate and that the therapy is necessary for the patient admission then the Category B medication may be obtained

• Take home message(s):• Take home message(s):– Hospital pharmacists may determine the appropriateness of a Category B medication on their own and justify it using their clinical judgment

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How are Category Statuses Assigned?

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How are Category Statuses Assigned?

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Formulary Category Status Assignment Example

• One of your cardiologists is interested in prescribing a new antihypertensive medicationprescribing a new antihypertensive medication that has not been used at your facility. After checking Formulary Advisor to determine the formulary status of the medication, you learn that it is a Category B medication. You agree that there is merit to this medication becoming a Category A product since there are no therapeutically equivalent medications on formulary. What do you do?

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• Step 1 – email Joanne Smyth (J S th@ h t) t bt i([email protected]) to obtain a new drug request form

• Who is responsible for filling out the request form?

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– Affiliate Pharmacy Directors

– CHSPSC Pharmacists

– Physicians requesting medications for addition

• As described above proposals should beAs described above, proposals should be submitted to the CHSPSC Clinical Director of Pharmacy or designee– Formulary manager

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• Upon receipt of the new drug request form, the Formulary Manager conducts and independent review of the antihypertensive medication– Review includes:

• Monograph• Review of primary literature• Review of similar medications• Discussion with major Formulary Management Committee stakeholderC t i• Cost comparison

– Formulary Manager creates initial recommendation of Category A for medication given that no other therapeutic equivalents exist

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• Formulary Manager presents initial d ti t CHSPSC Phrecommendation to CHSPSC Pharmacy

Leadership

– CHSPSC Pharmacy Leadership agrees with recommendation

• Formulary Manager presents y g precommendation to Clinical Pharmacy Council

– May be presented at a live meeting or over email (about a week turn around time)

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• Clinical Pharmacy Council agree with recommendation but feel that it would berecommendation, but feel that it would be justified to add in an additional stipulation that this antihypertensive should be used as second‐line therapy– Restriction

• Formulary Manager adds the restriction• Formulary Manager adds the restriction proposed by the Clinical Pharmacy Council to the monograph

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• Formulary Manager presents revised monograph and recommendation to the Formulary Management Committee– May be presented at a live meeting or over email (about a week turn around time)

• Formulary Management Committee agrees that this antihypertensive should be added to formulary and also agrees with the Clinical Pharmacy Council that it should have a restriction for second line therapy useshould have a restriction for second line therapy use only or for patients that have come in on the therapy from home– Monograph updated to add additional restriction criteria

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• Formulary Manager updates Weekly Formulary Update to reflect approval statusUpdate to reflect approval status

• Open comment period commences

• Recommendation presented to Medication Management Committee– During regularly scheduled quarterly meetings

• Decision communicated through Weekly• Decision communicated through Weekly Formulary Update Newsletter

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Formulary Assignment Communication

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Notes About Medication Proposals

• Medications that are not FDA‐approved or h b i d ithi th t illhave been reviewed within the past year will not be considered

– May be reviewed through appeals process for medications reviewed within the last year only

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What are Appeals and How to they Work?

• Appeals happen when:

– A hospital physician disagrees with a formulary Category Status

– A hospital physician disagrees with a clinical i iti tiinitiative

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Appeal Basics

• Appeals should come from the hospital through the Director of Pharmacythrough the Director of Pharmacy

• Essential elements– Letter from physician

• Explaining rationale

• Defending recommendation

Supplemental literature– Supplemental literature

• Appeal materials should be forwarded to the Formulary Manager

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Appeal ‐ Example

• Cangrelor (KengrealTM) was reviewed in July 20152015

• Communication regarding new request received in October 2015– Recommended by CHSPSC Pharmacy Leadership to come through appeals process

A l l tt i d i J 2016• Appeal letter received in January 2016– Presented article that was reviewed in original monograph

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Appeal ‐ Example

• Appeal reviewed by Formulary Management Committee in January 2016Committee in January 2016– Letter

– Evidence

– Previous monograph• Decision‐making rationale

• Literature included in review

– Input of interventional cardiologist on committee

• Appeal was denied citing lack of sufficient additional evidence

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What is Special about the Maintenance Phase?

• Formulary perfection

• Review of new and requested medications is ongoing

• Appeals

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Where is My Voice in the Process?

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Where do Items Enter the Formulary Process?

• Three main places

– Represented by yellow hexagons

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Examples of Items Entering the Formulary Process

• New drug requested by a h i i t th h it lphysician at the hospital

level

• New drug approved by the FDA

• Appeal to long‐standingAppeal to long‐standing clinical initiative

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How Does the Formulary Process Relate to Clinical Initiatives?

• Clinical Initiatives are all reviewed and d d b th F l M tendorsed by the Formulary Management

Committee

– Some are also reviewed by the Clinical Pharmacy Council

• Appeals for Clinical Initiatives are reviewed by pp ythe Formulary Management Committee

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IMPORTANT FORMULARY‐RELATED RESOURCES

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Formulary Policy/Obtaining Non‐Formulary Drugs Policy

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Formulary Policy/Obtaining Non‐Formulary Drugs Policy

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Notes Regarding Communication

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Formulary Flow Map

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Formulary Flow Map ‐ Key

• Yellow hexagon – point of entry into formulary processformulary process

• Green square – internal, person‐to‐person or person‐to‐committee communication

• Red diamond – decision• Blue parallelegram – decision flow

h tchart• Purple oval – widespread communication to large group of people

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Micromedex Formulary Advisor

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Micromedex – Logging In

• Username: Commhealth

• Password: Commhealth

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Formulary Advisor ‐ Site

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Formulary Advisor ‐ Site

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Formulary Advisor ‐ Corporate

• Category assignment of all medications h d b t i t thpurchased between one year prior to the

formulary reset and present

• Unable to re‐send an upload at present

– Future

• Any file downloaded from here does not• Any file downloaded from here does not contain NDCs

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Formulary Advisor ‐ Affiliate

• Each hospital is responsible for maintaining a i f F l Ad i ifi f th iversion of Formulary Advisor specific for their

own formulary

• Autonomy to be more restrictive

• Enter information unique to your hospital

• Display accurate information to your• Display accurate information to your prescribers

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Formulary Monographs/Formulary Resources

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Formulary Monograph Organization

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Formulary Monographs/Formulary Resources

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Formulary Monograph Layout

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Formulary Study Review Layout

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Clinical Initiative Toolkits

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Clinical Initiative Toolkits ‐Website

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Clinical Initiative Toolkits ‐Website

Summary of Clinical Initiative

Documents section:ToolkitFAQ

Medication Use Evaluation (if applicable)Key Articles

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Clinical Initiative Toolkits ‐ Format

• New format going f dforward

– Title

– Approval Dates

– Version Information

– Hyperlinked Table ofHyperlinked Table of Contents

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Weekly Formulary Update Newsletter

• Weekly Newsletter containing important formulary‐related informationformulary related information

• Main sections:– This Week’s News– Formulary Request Tracker– Clinical Pharmacy Website Additions– Therapeutic Interchanges GuideF l St t f N FDA R i d D– Formulary Status of New FDA‐Reviewed Drugs

• Yellow = New this week• Green = Anticipated Date

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This Week’s News

• Upcoming clinical initiatives• Outsourced compounding products informationp g p• Reminders• Open comment periods• Formulary changes in status

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Formulary Tracker

• Tracks medications through the formulary process

• Use your voice!

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Website Updates

• Important additions to the Clinical or F l R th PhFormulary Resources pages on the Pharmacy Intranet

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Therapeutic Interchange Guide Updates

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FDA Drug Approvals

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How to Use the Weekly Formulary Update

• Link to CHS Pharmacy Leadership

• Start with one week and stay up‐to‐date with yellow information

• Identify key information impacting your hospital

Share with others!– Share with others!

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Speaking to Your P&T/Physicians about the Corporate Formulary

• Importance of standardization

– Ordersets

– Electronic health record

– Safety

– Waste reduction

• Group purchasing organizationGroup purchasing organization

• Big picture

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Community Health SystemsCommunity Health Systems

Questions?Questions?

Community Health Systems Community Health Systems Formulary Management Process Formulary Management Process ––Approvals, Appeals, and BeyondApprovals, Appeals, and Beyond

Heather Weese, Pharm.D.

Director, Pharmacy Operations and Informatics

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U d t C tU d t C t PhPhUpdate on Current Update on Current Pharmacy Pharmacy Initiatives and StrategiesInitiatives and Strategies

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Robert Fink, Pharm.D., M.B.A., FASHP, FACHE, BCNSP, BCPS

Chief Pharmacy Executive

Community Health Systems

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