3 22 Chapter 12 Pharmacoeconomic Research and Applications in Managed Care
`
`52. Rich D .D., Experience with a rwo-Liel'ed clma(cid:173)
`peucic incorchange policy. Am J Hosp Phann.
`1989; 46: 1792-l798.
`53. Greeu E.R.. Chrym..ko M.M., Rozek S.L.
`Kltrenos ).G.> Clinical considerarions and costs
`associate<l with
`formulary conversjon
`from
`tobran1ycln co gemamk.in. Am J HQsp Phann.
`198~; 46: 7l4-719.
`54. Bailey M. and Feno K., Innovative drug formu(cid:173)
`lary rmrnagcmenc chrnugh computer assisted pro(cid:173)
`tocols. J Mdnag Care Pharm. 1998; 4(3):
`246-252.
`55. Bull S., Shoheiber 0, Bailey M., Uciliµcion of
`pharmac.y clallus daca. co evaluate therapeutic
`inrerchange programs.] Ma11t1g Gd.re Phann.
`56. Horn S.D., Uninm1ded consequences of drug
`formularie.s. Am j Hcnlth-Syst Phnrm 1996; 53:
`2204-2206.
`57. Curti.'iS ER., Drug formul:irie.s provide a parh co
`best care. Am j Healrh-Syst Pharm. 1996; 53:
`2201-2203.
`58. Kravit-,; R.L and Romano P.S., Managed care
`cosr concaimnent and che law of unfoccnded con(cid:173)
`sequenc.es. Am/M11nag Car" 1996; 2: 232-234.
`59. Cranor C.W, Christensen D.B., The Asheville
`Project: long-term clinicaJ and economic out(cid:173)
`comes of a community pharmat.y diabetes care
`program. J Am Phann Asso<' (Wash). 2003; 43(2):
`173-184.
`60. Goldberg K.B., Managing cl1e plrmnacy benefit:
`die fornmlary system. f M11r1ag Cai~ Pham;.
`1997; ':$(5): 565-573.
`61 Navarro R.P., "Ji-emk· 'tnd FcreetLm. CibaGc::neva.
`Phannacy Benefit Rcporr. Summit, Nf Ciba(cid:173)
`Gi::nevni 1996.
`62. Rascaci K.L., Drummond M .F., Annemans L ..
`Davey l~G., Education in phannacoeconomics:
`au international multidisciplinary vic:.:w. Pharma(cid:173)
`coeconomics. 2004; 22(3): 139-147.
`63. Gumer M.J., Worley A.V., Carrer S., er al.,
`Impact of a t;eizure disorder disc-.ise mana.gt::menr
`
`64.
`
`65.
`
`66.
`
`67.
`
`68.
`
`69.
`
`70.
`
`71.
`
`72.
`
`Communications; 1998.
`73. Drummond M., Brown R., l~mlrd M11:l{
`Use. of pharmacoeconomics infoan;ttio•1~1
`of cb.e ISPOR Task Force on use uf p~
`economic/health oconomic lnfurmoaon ftl'f
`care decision making. Value Health. lO~~
`407-416.
`
`PHARMACY & THERAPEUTICS
`COMMITTEES IN MANAGED
`CARE ORGANIZATIONS
`
`ROBERT P. NAVARRO
`DANIEL C. MALONE
`HAI NE MANIERI
`RAULO S. FREAR
`TIMOTHY S. REGAN
`PAUL N. URICK
`T. JEf f REY WHITE
`
`Drng product evaluations and selec't:ions have been made as long as drug choices have
`been available. In open and unmanaged systems, the prescriber makes the medication
`Ghokc afi:er considering pharmacological properties of alternative drngs, rhe unique
`, .pacicnr care needs, and patiem cost. Within organized healthcare delivery systems, such as
`1 'h11>pitcls or managed care organizations, Pharmacy & Therapeutics (P & T) Committees
`~ ~uthn ri·tt:d by the organization to conduct drug reviews and analyses, and make popu(cid:173)
`Urion-levd drug formulary decisions. The formulary is rhen provided co participating
`pliysid.ans co select agems when making parienc-level prescribing decisions. However, the
`r~ponsibilicies of the P & T Comminee rranscend simply compiling a list of recom(cid:173)
`rhentled drugs. According w the American Sociecy of Health-Syscem Pharmacists (ASHP)
`~·Stizrl'mmt on the Pharmacy and Therapeutic> Committee, the Commi tree " ... evaluates the
`~k:J use of drugs, develops policies for managing dcug use and drug administration,
`•\Ud manages the formulary system . . . is a policy-recommending body to the medical
`· ·~faff and the administration of the organization on marters related w the therapeutic use
`~f <lrugs." 1 The Commitree must consider how drugs will be di1mibured, admiuisrered,
`ii10nirorcd, and managed, as well as the cost impact to all srakeholders, and muse also
`,~l'ternpc to determine if outcomes suggested by clinical trial efficacy data will be borne out
`,b\ rc:al world practice, given the myriad of benefit design structures that may influence
`drug use an<l adherence.
`
`1
`
`J23
`
`CFAD Exhibit 1080
`CFAD v. NPS
`IPR2015-01093
`
`

`
`J 14 Chapter 13 P & T Committees in Managed Care Organizations
`
`Genesis of P & T Committees in Managed Care J l.S
`
`The responsibilities of the P & T Committee have far-reaching implicuio114~·
`healthcare professionals, plan sponsors, patient members, and indeed the health !!afe Qt
`nization itself Appropriate selection and use of a pharmaceutical is often the rnos
`effective form of prevention or therapy for many medical conditions. It "is ,,,
`responsibility of the P & T Comminees, using a standardized drug evaluation p~'
`make pha~macorherapy recomn:iendations for al_l healthcare profe~sionals and me~'
`the orgamzanou as well as consider and expedmously process pat1ent-spec1flc cxt:epti~'
`This chapter describes die genesis of managed care Pharmacy & Thcra.peuri&~~
`m!ttees, th_e~r role and struct~r~, the_dmg evalua~ion a1~d review process, and how~~
`nuttee dec1s10ns become mamfested m the orgamzanons drug formulary.
`·
`
`.
`
`-.
`, ,
`•1
`
`'fuddpandem, critical evaluation of available drugs, they began forming their own Phar-
`• rria!;)' & Therapeutics Committees fashioned after the hospital model. In fact, the princi(cid:173)
`·e!~ of.~rug review are quire. similar, althou~h the .type of drugs reviewed, administration
`~d unhzauon parameters (i.e., controlled m-panenr vs. uncontrolled out-patiem envi(cid:173)
`•ronrnc:nts), and organizational goals and objectives are qufre different.
`" HM Os began developing P & T Committees and publishing their own drug formu(cid:173)
`al')' (formularies are discussed in depth in Chapter 9). The use of a P & T Committee,
`·,,~rnpriscd largely of independent community-based physicians and pharmacists lends
`./ ~!;linfoal credibility to the decisions. An HMO making its own drug decisions would be
`\ct:used of selecting drugs based upon paroimony rather than outcomes. One current
`~MCO published Drug Fonm1laries: Myths and Facts, and defonds its formulary decision
`; pr11cess as follows5:
`_ ... ..:)~
`GENESIS OF P & T COMMITTEES IN MANAGED CARE
`Myth #4: Bean counters determine which drug appears on any formulary.
`. .. , "''.
`.
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`.
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`Organll.ed healthcare delivery systems, such as hospitals and managed care organ1~ib'it{-
`fi
`·
`f. kn
`The fact rs, a formula1y is established by a chmcal comnuttee of doctors and
`'() ) h
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`bl h
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`owe gea e ea t care pro ess10na s, u
`1
`, s , ave empowere a group o
`(Mc
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`phannac1sts. Ih1s commmee compares each drugs safety, side effects, effective-
`·b·1·
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`t e aut 10nty an respons1 1 ity to m· e p arm:icma· 1.-
`p ys1c1ans an p armac1sts, wit
`h
`'1ifi:"·
`·
`f- h
`ness, and relative costs. Based on research and d1scuss10n, the cluucal commutee
`d
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`b half
`.·
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`d
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`t e ennre 10sp1r or sys1cm. :nilt
`apy ev uanons an
`recommen anons on e · o
`al
`d P''-
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`decides which ones are besr for the formulary. In addmon, our doctors and phar-
`.
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`c.
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`group is now gener y terme a narmacy CF
`~erapeutu:s ommz. ee or
`.
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`mac1sts stay current on the newest nauonw1de developments m medicme, and
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`:. ·.·.·.
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`.ommzt_tee._
`,ommittee s eclSl?ns are c nven Y organ_izanona P osop y, Ill
`u date our formular based on the latest research.
`ie
`.
`,'1• •<-~
`~?-
`and obiecuves, and serve as the basis for drug therapy dec1s1ons made by all he:tlili~L
`P
`Y
`·~" To emphasize the focus on quality of care, many P & T Committees will consider a drug's
`professionals within the system. The Committee communicates their decisions to (.~ ~ ;,
`. . -.'' 1'Gi>st or contract impact only after they make a favorable formulary decision based upon
`....,, • •
`sionals via the publication of a compendium of drugs approved by the Committee.
`; ':. . clinical and safety data.
`This compendium was initially termed a pharmacopeia in the United States in tR~Ja""
`18th century, 1 and mday it is often cal!ed a drugformulary. In the 1~20s, U.S. h0$Fft 'f- ~~V P & T Committees are now de rigueur within MCOs, and are largely accepted by
`began creating drug formularies ro eliminate therapeutic duplication.2 By the 1960~glf;:,;,
`·tfRP''public and private plan sponsors, physician providers, or individual members. Ofi:en there
`cually every hospital in the United States had established a fonnulary ~ystem, largclfl~E~ :'.
`• ~'( · ~re two layers of P & T Committees in formulary decisions. Pharmacy benefit managers
`a·
`enced by the publication of the American Hospital Formulary Semce by the Atn~Q~~·{
`(PBMs) (see Chapter 4) have their own P & T Committee, and often their MCO cus(cid:173)
`Society of Hospital Pharmacisrs (ASHP) in 1959. 3 In addition ro the identificaridy;ef~~· ~ -~, rorners also have their own P & T Committee. Large employer groups are becoming more
`drug compendium or drug formulary for the health system or hospital, the P & T ~~., ·.,
`'~phisticaced in managing its employee's health. One way thar employers are taking an
`mittees became involved in drug storage, administrarion, monitoring, outcomes reseai~!h·' -~ ·, '\-
`,a€ti ve part in taking care of their employees is by employing physicians, nurses, and phar(cid:173)
`physician and patient drug use e~uca~ion, an~ o;her activities that w?uld promc:i\g".tii~.' .~~,
`-ma~"!$. ~r~e em~loyer .groups i~1ay form, their o":'n P & T Committee or beco~e an
`~·.a<;rrve participant 111 theu MCO s P & 1 Comrruttee. Although the vast maionty of
`appropnate use of formulary medtcanons, gu1del111es for use of non-formulary mcilf.·.
`:-
`'~ • · · MCOs use a PBM for some or mosc pharmacy benefit management services (see Chapters
`v-' .. ·;
`rions, and procedures for procurement and use of investigational drugs.
`The use of formularies has spread beyond the institurional setting. As dcscrib_~ ·l· t' 2 ~d 4), approximately 80% of MCOs who use a PBM also make their own formulary
`·decisions with their own P & T Committee.6 They evaluate the PBM recommendations
`Chapters 1 and 2, by the 1970s, health maintenance organizations (HMOs) ~-~19,.. ·_·
`flourish in several regions of the Unired States. As d1ese HM Os expanded their ben~\W-~ ·;r~ - -and may rake advantage of PBM contracting but ultimately use their own P & T Com(cid:173)
`beyond medical and hospital, and added pharmacy benefits, they namrally hi.rcd-ph~~ ;)y
`"rrutree for plan formula1y decisions.
`cists to manage the pharmacy benefit. Many early managed care pharmacy direcrol'$~··..
`~~ ~ MCO and PBM P & T Committees are evolving. In 2003, the Medicare Modemiza(cid:173)
`out of hospiral practice, and they logically applied the p_ractices _and principles of dru~<·,:~ ·:~- cion_ Act ~MMA) ?rovided for the devel~pr:ienr of Medicare Part D pharmacy benefit.
`mulary development and management they learned m hospitals ro the managcl~;.·
`. . ·i:; Pamctpanng Medicare Advanrnge-Prescnpnon Drug (MA-PDs) plans and prescription
`practice environment. HMOs began developing drug fonnularies, and co provide~e~; f;<' _drug plans (PDPs) were required to make drug formulary decisions for members through
`
`2
`
`

`
`3 2C5 Chapter 13 P & T Committees in Managed Care Organizations
`
`Role of the Managed Care P & T Committee 317
`
`a P & T Committee. MMA legislation required that the Committee include at least one'
`pharmacist and physician member with expertise in the care of geriatric patients, ~~:
`those mtm?ers be free of c~nflicts of interest. Additional language specified .the C:ccquei~~ ..
`of P & T Conunmee meermgs, che types of formulary managemeut and utthzat1on 11\ail{ _
`agemem acriviries for which t~e co~mittee was resp~11sible, and als? spe~ified t~t drug/'
`and drug classes should be reviewed m a regular and timely manner. fhe mcreas1ng use'b
`specialty pharmaceuticals will require the P & T Committees to include or regularly~~­
`suit with specialises who commonly use such injecrable biologicals and other sp~cialty "~
`medications ro make certain this class of medications is fairly and appropriately ev:tlua~· ~
`"
`Due ro the eXlremdy high cost of specialty pharmaceuticals, which in many cases w' ·
`extend the life of a patient only b.y a few months, P & T Committees are increasingly ..
`adding or consulting with ethicists ro consider the ethical issues involved on these dni&~~·
`selection additions.
`....
`
`ROLE OF THE MANAGED CARE P & T COMMITTEE
`
`Members of any organization's P & T Committee have the opportunity and cesponsibil\cy;:
`to offer what their experience and analysis shows to be the best drugs available to paricnt
`members of their organization. Their decisions will affect patiem care and clinical ouf. ·
`comes, have a significant financial impact on the MCOs and cusromers, arid may cwri,
`influence the lives of many individuals with medication therapy needs. However, the Corn-~
`mittee's first responsibility is to rhe patient, a.11d to select the safest and most cost·elfu-rivei"'
`drugs available for formulary inclusion.
`In 1999, a. coalition of several organizations convened to discuss the priuciples of ca
`sound drug formulary system. The Coalition Working Group participants met to identify
`the principles of a sound drug formula1y system (Table 13-1). The Working Group fl~
`cinctly emphasized that the responsibilities of the P & T Committee go beyond creacihg
`the formulary, and include promoting the effective use of formula1y products through rh~
`following statemenr7:
`'
`
`TABLE 13-1 Pri nciples of a Sound Drug Formulary System Coalition Working Group Memb•N:
`
`• Academy of Managed Care Pharmacy (AAMC)
`• American Medical Association (AMA)
`• American Sociecy of Health-System Pharmacists (ASHP)
`• Department ofVe,erans Affairs (VAJ
`Nadonal Businm Coalirion on Health (NBCH)
`• U.S. Pharmacopoeia (USP)
`• Americm Association of Retired Persons (AARP; observed
`Suurcr:: AMCI~ PrUKf/la ofa Souud D111.f Fr:mttJm,, Alexandria, VA:. Academy of M:m:iged Gm Pharm:tL)', October 2000. Av.lllotblc a1
`lucp1llw""'""'lq>.01yd.ia/a.,,_<DIU<Jltldiui;fumiubry.pd( Accessed 19 Aug 2008.
`
`''ihc l'lllll'macy and Therapeutics (P & T) Comminee .. , is t:he mechanism for
`adminisccring the furmuhuy system, which includes developing and maintaining
`d1c forornlary and amb/ishing tmd impl~mmting policies on the use of drug prod(cid:173)
`ucts" (emphasis added).
`
`Recommendatkins of the Working Group Coalition for P & T Comminee activities are
`found in Table l3-2.
`The Academy of Mru1nged Care Pharmacy published the Formulary Management
`coocepr p:ipcc ihar also emphasizes the broad responsibility of the Pharmacy & Therapeu(cid:173)
`tics Couunircec ro include the following8:
`
`"A formu.lary system is much more thau. a list of medications thac are approved
`for use by a managed healthcare organha.cion ... Policies and procedures for rhe
`procuring, dispensing, and administering of rhe medications are also included in
`the syslc:m. F<iauul~rics often contain additional prescribing guidelines and din(cid:173)
`ical informacion which assi5ts heald1ca.c profo~siooals ro promote high qunliiy,
`affordable care for paticn~. Fiually, for quality assurance purposes, managed
`healthcare systems char use formul:u:ies have policies in place co give physici:i.n~
`and patients access to 11011-fotmulary drugs where medically necessary."
`
`Clearly, when a P & T Committee evaluates a drug for formulary consideration, rhe
`members also musr determine how rhe organization can ensure chat the product is effec(cid:173)
`rivcly managc:d, accur:ndy moulcored, and optimally used.
`Whtn a P & T Commirn:c: ev:tluarcs a dcug for formukcy c:onsidc:r:ufon, che mem(cid:173)
`bers musr determine how rht: physici:ins aou pharmacis1s of rhe orgauiwrion will P"'(cid:173)
`s01ibc, dispetl$c1 monitor, and ensure appropciare milli.adon. P&T Commirtees also
`rtview :ind evaluate clinical programs •nd udllzation management scraccgies. These P & T
`
`TABLE I 3-2 Wor king Group Coalition Recommendations for P & T Committee Activities
`
`• Obj.c:dvdy appraises, cviiiua'es, and ~d<as dmgs for rhe foanul:try.
`• Mecll! as fi<.'quemly as is necessary Lo review and update the appropriiucness of rhc founulru:y
`oystcm in ligbt of new drngs and new i.u<licacions, uses, or warnings llflCaing o:isciug drugs.
`• l!smb!ishe.s policies uod pmccdun:s ~o c:Jue>.lc :ind inform hc:ilchc:irc providers :tbout drug
`produc~. usngc, and ooinmittcc decisions.
`• Oversees qualiry improvemem programs that employ drug llSe evaluation,
`• lmplcmoms generic mbstituti.on w1d th=pcuLlc Interchange programs d121 ~uthorizc
`exchange of chcr:ipcucic ahcmaiives b>Sed upon wrir:tcn guidelines or prorocols wi1Wn a
`forruulary sysrcm. (Nuce: Thernpcucic subrutution, rhe dispensing of d1crapcucic alrcm:nes
`wichouc 1he prei;criUcr's approv:il, is illegal and should nol be ellowcd.)
`Develops pro10<:ols aild procedures for cbe use of and acces$ to no11-fonnulary drng produces.
`S'""" AMCP. l'rilld/!ti of• S .. .,,/ Dr/If l'.lr.,•/.oy. Aloo:,ndci>, Vk AO>domy of M.n-g<d C:nc Phacnw:y, October 2000. Av.illablc"
`IM1~'//"""-"'"'l'·q1g/J.1Ai11n_IDll1C1U/dnefoomulcuy.pd(.~ l9 Aug 200&.
`
`3
`
`

`
`J 28 Chapter 13 P & T Comminees in Managed Care Organizations
`
`An Illustrative Example of a P & T Committee Structure J 29
`
`Committee decisions touch all participating providers and members, and have fuMc;ijifi~
`implications on health and economic outcomes. Decisions made by rhe P &T Comrnl~'•'
`may be challe~ged .or appealed. In some :ituari.ons, a Committee may reconsider ~~;,
`reverse a dec1S1011. For this reason, many Conumttees have a consumer member whoS<!;f~'tl
`is to represem the imerests of parienrs. Howeve1; the Conuniuee operates incl~cnd~~
`and decisively in the best imerest of the patiem, and ideally is uninfluenced by any o!lfc' ·
`imernal or excernal special incerest person or group.
`·. · l
`
`In addition co clinical expertise, ideal committee members understand managed care
`,, bi~1incss principles, the organizacion's pharmacy benefit managemenr philosophy, and the
`plan sponsor base. They also must appreciate and consider rhe impact of cheir decisions
`on participating physicians, pharmacisrs, case managers, quality assurance directors, and
`most importantly, paciencs. Commictee members agree to serve often for a staggered one
`' Of cwo year term, so that the committee continuously evolves yet maintains cominuity.
`A typical mid-sized open-model health plan P & T Commirree may consist of the
`fellowing members, usually with equal voring authority:
`
`AN ILLUSTRATIVE EXAMPLE OF A P & T COMMITTEE STRUCTURE
`
`Committee Chair (independent community-based participating physician or the
`plan medical director)
`• Nine to fourteen additional independent community-based participating physicians
`• Health plan medical director (if not the Committee chair)
`• Healch plan pharmacy director
`• Geriatrician for Medicare Part D programs
`
`Pharmacy and Therapeutics Comminees ~re g_enerally simil~r in their , sm1cLUre, ~- ..,, ,•'''\';"'
`aurhonty, and the pro.cess they observe, allow.mg for d1fferenc~ m model type (e.g., opcn~Rf."~dh~-:•;
`closed, and prodL1ct lme: HMO, PPO, POS), and membership (e.g., commercial, M~
`aid, Medicare). The reader '.s advised that while we dis~uss. the P & T Committee of a r;1Jt~·
`cal m1d-s1ze health plan ro 1llusrrate an example, orgamzanons are different. Organracion-J .
`by-laws as well as the slate-filed Certificate of Coverage provide the authority and respo11J;'
`-In addition, the pharmacy department clinical pharmacists and rhe phannaceurical con(cid:173)
`biliry for the formation and fi.mction of a "fonnulary decision entity," (e.g., a P & T Corri·
`tract manager often attend Committee meetings as non-voting staff members rn present
`mitree) to make drug product selection decisions for the organization. The Commlid
`and discuss clinical and financial impact or contract informarion. Plans may differ. Larger
`consists of healthcare professionals, usually physicians and pharmacists, although n~
`hcalrh plans and PBMs may have broader Commirrees char may include an economise, an
`quality assurance directors, ec:hiciscs, or economises may be committee members <1f ~~1
`ethicist, quality assurance representatives, or a non-clinical lay plan member. Organiza(cid:173)
`larger organizations. In very select instances, MCOs have begun including plan membtw.lli,!f
`tions may also use therapeucic category subcomminees that have the responsibility co
`the role of patient advocates as members of P&T Commitrees. At 1he rime of this wnriog. if.
`review and render expert opinion recommendations to the foll P & T Committee on spe(cid:173)
`is unclear as co whether this practice will become more widespread. The Committee me@J
`cific rherapeuric categories. Multi-stare MCOs and PBMs may have a corporate or
`bers are predominantly independent practitioners not employed by the sponsoring MC'..0&~
`national P & T Committee rhac constructs a primary organizarional formulary (or
`PBM, but generally are participating plan providers. Staff or group model plans may ~ft.­
`National Formulary for organizations with a national presence) that is "customized" at a
`physicians employed by the health system or the exclusively comracred medical gm1ip;1: '
`state or regional plan level, for large self-insw·ed plan sponsors, or by MCO cliencs of
`Some organizations may include faculty members from medical and/or pharmacy schoQ!s;,~:'
`PBMs char have their own P & T Commim:e. Some organizations separate discussions of
`While chis committee often is named the Pharmacy & Therapeutics Commic1ct;•(1 '
`drug cost or pharmaceucical manufacturer conrract cerms from clinical discussions, and
`may be termed the Drug Formulary Committee or a similarly named group. The ComniJt.J.>! '
`only review che contracts or the financial impacr after a drug has received a positive review
`(e.g., a "may add" or a "must add" decision) from the P & T Committee. Typically, med(cid:173)
`tee size varies among organizacions, and some large MCOs or PBMs may have rhtra~liG.
`subcommittees of the National P & T Committee. In general, a typical medium si1.e MOO
`ications given "do not add" designation by the P & T Committee are not lisred or added
`has a P & T Committee consiscing of IO co 15 members, alchough some :have up 1o'Jii'
`to formularies irrespective of financial considerations.
`members. The largest group represented is comprised of physician members who gen~~
`Frequently, subcommittees are formed to conduct reviews of highly sophisticated or
`unique therapies generally limited to specialises. For example, large organiza,ions may
`represent the specialties who are experts in the most commonly used therapeutic cattgQ~
`including family practice, general internal medicine, oncology, pulmonology, c:utliolo~-
`have oncology, neurology, rheumatology, or hemophilia subcommirrees ro review emerg(cid:173)
`obsretrics and gynecology, or pediatrics, Committees oti:en invite addir.ional speciali~ts JO
`ing biotechnology agents ofi:en disuibuted through specialty pharmacies. Subcomminees
`attend a specific meeting to discuss certain therapeutic categories if the Committee d~,
`also. are useful ro perform emergency reviews between foll committee meetings, such as
`nor believe the members have adequate expertise or experience (e.g., endocrinology, i~~
`the release of a new break-through therapy, black box safety warnings, or the publication
`rious diseases, neurology, psychiatry, gastroenterology, or other specialties). Due ro ihf:·
`ofpost-marketing drug research with important results.
`growing number of elderly and individuals with special needs with drug benefits covc1cll/
`It is important to note that new drugs are nor reviewed in isolation, bur are compared
`under Medicare Part D, many P&T Committees include physicians and ph::irmacisrsw)iifL
`with orher existing or soon-to-be-launched pharmacotherapy opcions, regardless of their
`specialize in geriarrics in order to consider the unique needs of these subgroups.
`therapeutic category. This is key difference between the functions of chi:: Committee and
`·
`·'Ui"~
`
`4
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`

`
`3 3 0
`
`Chapter 13 P & T Committees in Managed Care Organizations
`
`·-
`the role of chc FDA. The FD~ .only evaluates .one emity at a time in terms ~fclfccci~~~­
`and safety. Whereas the P & I conumtree will consider all viable alternative trcarntcntt ·
`induding those n-eatmems that may not be pharmacological, or the off-label use ot ~ltis'(~
`ing medications_
`
`PHARMACY DEPARTMENT ROLE IN NEW DRUG EVALUATION
`
`As discussed in previous chapters, MCO or PBM pharmacy departments have the l"llsp)'.i~
`sibility to design and administer an effective pharmacy benefit for organization clirnr;,A,,. ,·
`dynamic drng formulary, developed by the I' & T Committee and executed by the pJi;t_,.
`macy departmem, is a seminal requirement for an effective pharmacy bendlt design~(B~ '
`optimize clinical and economic outcomes.
`Connection berween the P & T Committee and the MCO or PBM is maimaim;d 1~.
`the sponsoring organization through the medical director of pharmacy staff membcwou
`the P & T Committee. The organization's pharmacy department generally coordinates a{ia;"
`supports the P & T Comminee meerings and activities by orchestrating and schcduliJ!R
`meetings, providing drug review rnacerial and smnmaries to Committee members, ICCQ~(f;· <
`in~ and distributing Com~ittee me~tin¥ minmes, ~nd putting_ Committee decisions lll_~{
`acnon (e.g., changmg claim adiud1cauon drug hie, pubhshmg formulary changl:f Ii> •
`providers and members)_ Figtue 13-1 illustrates the flow of information among the p~t­
`macy department groups, the I' & T Committee, and health plan providers.
`
`1. Pharmacy Department
`Clinical Group
`• Collecl.S and analyzes all data
`(internal and•extemal)
`• Ptepares and provides review
`material to P '& T Committee
`
`3_ Pharmacy Department
`Administrative Group
`• Executes· P &. T Committee
`de<:;ision
`•Secures conlract (rebate or
`discount)
`• Miikes formulary and drug
`file changes
`•Publishes formulruy changes
`
`2. P & T Committee
`• Revl8Ws rria.terlal provided
`• Conducts personal nterawre search
`• Revfews cflnlcal experief\06
`• Conlers with colleagues
`• Makes fOlmulaly <lecisl!ln
`
`Provider feedback
`to Committee
`
`4. Providers
`Prescribe and dispense according.(cid:173)
`to new formu1,11y change
`
`FIGURE 13-1
`and Providers.
`
`Information Flow among Pharmacy Departments, P & T Committee,
`
`5
`
`Pharmacy Department Role in New Drug Evaluation 3 3 I
`
`There are three basic pharmacy department activities involved in supporting and exe(cid:173)
`cuting rhe P & T Committee decisions:
`
`1. C!iniml Pharmacy Activities. The clinical pharmacists manage che data and informa(cid:173)
`tion colleccion and analysis process, prepare and disseminate P & T Commitcee
`meeting macerials, imerface with Committee members and consultants, and 'coordi(cid:173)
`nate the P & T Comminee agenda.
`2. Pht1rmt1ceuticaf Relations and Conmzct Management. The contracc manager will review
`P & T Committee decisions and complete negotiations as appropriate rdated to
`pharmaceutical manufacnucr discoulll or rebate com:racts.
`3_ PhtimlMJ Bmefit Program Ma111J~e111m1. Formulaiy chang~ musr be reflected in drng
`file and claims adjudkatio11 processe5, and ex-ecured in accord:tnce with pharmacy
`bem:fir design conmiet.1~ th.is includ.:s coordination of priming member and provider
`formularies as well as developing a Web site application.
`
`Clinical pharmacists play a central role in rhe drug review and drug formulary manage(cid:173)
`ment processes, and are an important conduit through which critically analyzed new drug
`information reaches the members of the P & T Committee. For each evaluation of a new
`c· dnrg produce by the Comminee, clinical pharmacists gather a broad array of new drug
`and related clinical data. They will review, analyze, and organize, and then transform che
`_•information into a cogent summary, usually rermed a net11 drug monograph, of evidence(cid:173)
`based information for fnrcher review by the P & T Committee members. The informa(cid:173)
`tion sources consulted by clinical pharmacists when conduccing a drug review and
`analysis are discussed later in this chapter. Clinical pharmacists review cosc and utilizacion
`data of relevance within cheir own organization, and often model the ucilization and cosr
`impact of potential fonnulary changes.
`Physician and orher healthcare professional P & T Commirree members have addi(cid:173)
`tional sources of information upon which they will make thdr formula1y decision,
`induding personal clinical and research experience, recommendations of key opinion
`leaders, their own review of published peer-reviewed literature, scienrific meetings and
`abstracts, continuing educacion programs, and pharmaceutical company sciencific and
`marketing material.
`
`"-
`Pl:!AllMACEUTICAL RELATIONS AND CONTRACT MANAGEMENT
`
`A pharmaci•1 gcncr'.i.lly will lead chc work group responsible for managing cht busiucss
`a11d COLHract cdacionships between chc MCO or PBM and pharmaceutical companies.
`Discount and rebate contracts with pharmaceutical companies a.re important to pharmacy
`benefit managcmc:n1, as the rd,1a1e income: reduces tht ace COSl of conrract.:d produas
`t~-ce Chapters 14 and 15). Although cost rcH'lains sec:ondary co clinical and s:ife1y <:onsid(cid:173)
`eracions in P & T Committee deci.s.ions, a lower net CoH may Jn.lluence drug furmulary
`positioning (see Chapter 9) when the therapeutic outcomes expected from comparable
`
`

`
`3 3 l. Chapter 13 P & T Committees in Managed Care Organizarions
`
`Drug Evaluation and Review Process in Managed Care 3 3 3
`
`medicarions_ are considered to ~e equal or very si'.11ilar. _MCOs may operate tu~dety~
`phannaceut1cal co'.1tracts of theu PBM, or mamtam theu own contraccual rdauonsq{
`J
`with drug compames.
`Net drug cost is an important consideration in drug comparisons and formulary Pttlt•:
`tioning whe~1 comp~rative drugs are therapeutically undifferentiated. The_~~O or p~
`?harmaceuncal relanons a1:d contract management grou~ ha~ the respons1b1hty cif pu~f..
`mg rebate contracts (or discount contracts when orgarnzanons, such as gronp or~-.
`model plans or PBMs with mail service, take possession of drugs) and assessing the fiu~i
`"Ji!
`cial impact on forecast drug utilization.
`While the net cost of reviewed drugs is imp01tant, various MCOs and PBMs incrod~ ...
`the financial dara at different times in the drug review process. Traditiona\ly, rhe pbar~
`departrnem contract manager would pursue a contract offering from a pbarma.cemic:tl cg~·.
`pany prior to the P & T Committee meeting, w that the drug cost and a drug cost ini~
`assessment can be presented to the Committee when formulary addition and pos.iriori~."
`a_re considered. Comract details are usually not s?ared, but the pharmacy _d~panmcm ~
`s1ders the contract rebate level, the pharmacy re1mb1irsement level, the likt!y <:Opayri\ii!JJ,.
`and uses the estimated net cost in pharmacy budget impact analysis models.
`!:;"-'!
`However, some MCOs and PBMs do nor share cost or contract information witli"18·c~·
`P & T Comminee ro make certain Iormulary decisions are made solely on c:ffimcy -a,nij
`safery data. Cost is not considered umil after the drug under review offers clinical ·val~
`In this latter situation, a contract is pursued only after the P & T Committee d<:remiii\~~'.
`the drug receives a positive review. If the Committee renders a "must add" or "may adq~-· .
`decision, the pharmacy contract manager pL1rsues a contract offering so that a pharitta.ll'f .. :.
`budget impacr model may be constructed to reflect anticipated cost ro the organi~tlo.ii;'~
`Based upon the contract obtained, net cost, and anticipated budget impact, the pharm~
`deparcment will determine the appropriate formulary position based upon guidannl"ltr."\li:
`·
`vided by the P & T Committee.
`
`PHARMACY BENEFIT PROGRAM MANAGEMENT
`
`Once a Committee's decision has been made, changes in the drug files used for pharm\~-­
`claims adjudicarion must be made as soon as possible to allow accurate rc:i.InbursemC.OI bf
`formulary products. Alrhough a rarher detailed and often tedious process, pharni;r~1S'1t<
`working wirh customer account managers make certain formulary additions or dd~ciQ,~
`are consistent with customer benefit designs and fonnularies. & drug formulary chan~y
`it is important to incorporate this new information into client formularies in accord~
`with their benefit design requirements and specific formllla.ry expectations. M~ny P,