3 22 Chapter 12 Pharmacoeconomic Research and Applications in Managed Care
`
`52. Rich D .D., Experience with a rwo-Liel'ed clma-
`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: 7 l4-719.
`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-
`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 Assot (Wash). 2003; 43(2) :
`173·184.
`60. Goldberg K.B., Managing cl1e plrmnacy benefit:
`die fornmlary system. f M11r1ag Cai~ Pharm.
`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.
`
`73.
`
`,~"13
`
`·""" ··
`
`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
`
`!!)rug product evaluations and selec-i:ions have been made as long as drug choices have
`~en available. In open and unmanaged systems, the prescriber makes the medication
`Ghokc afi:er considering pharmacological properties of alternative drngs, rhe unique
`, .pacianr care needs, and patiem cost. Within organized healthcare delivery systems, such as
`h11>pit;tls or managed care organizations, Pharmacy & Therapeutics (P & T) Committees
`~ ;tui.hnri-ted by the organization to conduct drug reviews and analyses, and make popu(cid:173)
`~rion-levcl drug formulary decisions. The formulary is rhen provided co participating
`pliysid.ans co select agems when making parienc-level prescribing decisions. However, the
`rtsponsibiliries of the P & T Comminee transcend simply compiling a list of recom(cid:173)
`ri1entled drugs. According w the American Society of Health-System Pharmacists (ASHP)
`Statt'ment on the Pharmacy and Therapeutic> Committee, the Commi tree " .. . evaluates the
`l!illimd use of drugs, develops policies for managing dcug use and drug administration,
`•\ind manages the formulary system ... is a policy-recommending body to the medical
`· ·<taff 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,
`monirorcd, and managed, as well as the cost impact to all scakeholders, and muse also
`~tterr"tpc to determine if outcomes suggested by clinical trial efficacy data will be borne out
`.b\ real world practice, given the myriad of benefit design structures that may influence
`drug use an<l adherence.
`
`J23
`
`CFAD Exhibit 1080
`CFAD v. NPS
`IPR2015-00990
`
`1
`
`

`
`m!ttees, th_e~r role and struct~r~, the.drug evalua~ion a1~d review process, and how 4,
`
`nuttee dec1s10ns become mamfested m the orga111zat1ons drug formulary.
`
`·
`
`' )Addpaodem, critical evaluation of available drugs, they began forming their own Phar-
`• trial;)' & Therapeutics Committees fashioned after the hospital model. In fact, rhe princi(cid:173)
`·e!eS of.~rug review are quire. similar, althou~h the _rype of drugs reviewed, administration
`~d ut1hzat1on parameters (i.e,, controlled m-panenr vs. uncontrolled out-patient envi(cid:173)
`<ronr11c:n1s). and organizational goals and objectives are qufre different.
`HM Os began developing P & T Committees and publishing their own drug formu(cid:173)
`ary (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
`pin.isl credibility to the decisions, An HMO making its own drug decisions would be
`:act:used of selecting drugs based upon parsimony rather than outcomes. One current
`'1JCO published Dmg Fonm1laries: Myths and Facts, and defonds its formulary decision
`(p:llcesi; as follows5:
`GENESIS OF P & T COMMITTEES IN MANAGED CARE
`~·-·
`.
`.
`.
`. .,
`,
`.
`.
`.
`Myth #4: Bean counters determme wluch drug appears on any formulary.
`.
`_ . . ,
`.
`.
`. .
`. .
`.
`.
`Organll.ed healthcare delivery systems, such as hospitals and managed care oq;an1~t8fuf
`.-~·
`f' kn
`fi
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`d
`1 d
`bl h
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`,
`The fact rs, a formula1y is established by a chmcal comnuttee of doctors and
`owe gea e ea t care pro ess10na s, u ·
`.
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`, s , ave empowere a group o
`1
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`·
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`phannac1sts, Ih1s commmee compares each drugs safety, side effects, effective-
`:' :;:i,;
`t e aut 10nty an respons1 1 1ty w m· e p a.rmacmutt.:
`.
`.
`.
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`.
`p ys1c1ans an p armac1sts, wit
`h
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`f. h
`~--·
`d
`·
`b half
`.·
`· al
`d
`1
`ness, and relative costs. Based on research and d1scuss10n, the cluucal commutee
`apy ev uanons an
`recommen anons on e · o t e ennre 10sp1r or sysrcrn. ni\f
`.
`,
`al
`d P''-
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`all
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`decides which ones are besr for the formulary. In addition, our doctors and phar-
`. ·· f>' ·
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`c:.
`group is now gener y terme a narmacy CF
`.
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`~erapeutu:s ommz. ee or
`rug rorm
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`b
`macms stay current on the newest nauonw1de developments m medicme, and
`C
`,'!Jr;<·-
`,ommittee s ec1S1?ns are c nven Y organ_izanona P osop iy, II! .
`.ommzt_tee._
`ie
`u dare our formular based on the latest research.
`and obiecuves, and serve as the basis for drug therapy dec1s1ons made by all he:t!!f[~L
`;.J ~"
`P
`Y
`professionals within the system. The Committee communicates their decisions to p!ji~·
`:K"i" To emphasize the focus on quality of care, many P & T Committees will consider a drug's
`sionals via the publication of a compendium of drugs approved by the Committee, ~· , •
`, . -.'" i'tli>St or contract impact only after they make a favorable formulary decision based upon
`; \. . clinical and safory data.
`This compendium was initially termed a pharmacopeia in the United Srates in tR~Ja ~
`18th century, 1 and mday it is often cal!ed a drugformulary. In the 1~20s, U.S. hospiC Y-
`1.,~·:
`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&; ~- -it~' public and private plan sponsors, physician providers, or individual members, Ofi:en there
`rually every hospital in the United States had established a fonnulary ~ystem, largdy'lpE{!i :'_
`.·;'( · ~re two layers of P & T Committees in formulary decisions, Pharmacy benefit managers
`enced by the publication of the American Hospital Focmulary Service by the Aln~~~·{ a·
`(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 identific:arioy;iff~· ~ "'i'lic 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 ~~': ·
`"~phisricatcd in managing its employee's health. One way thar employers are taking an
`mittees became involved in drug storage, administrarion, monitoring, outcomes rese~i·· -~
`:active part in taking care of their employees is by employing physicians, nurses, and phar-
`physician and patient drug use e~uca~ion, an~ o;her activities that w?uld promo1g:lhfi:.'
`-ma~'ll). ~r~e em~loyer ,groups i~1ay form, their o":'n P & T Committee or beco~e an
`appropnate use of formulary medtcanons, gu1del111es for use of non-formulary mcil(·.
`~·.ac;rrve parnc1pant m theu MCO s P & 1 Comnuttee. Although the vast maionty of
`:.-
`7:'·.
`· · MCOs use a PBM for some or mosc pharmacy benefit management services (see Chapters
`rions, and procedures for procurement and use of investigational drugs.
`The use of focmularies has spread beyo~d the institurio~al ~ening. As describ~
`_2 ~d 4), a~proxi~ately 80% of MCOs_ who u~e a PBM also make their own formulary
`dec1swns with thelr own P & T Comnuttee,6 1hey evaluate rhe PBM recommendations
`Chapters 1 and 2, by the 1970s, health mamtenance orga111zat10ns (HMOs) ~~,.. .
`flourish in several regions of the Unired States. As d1ese HM Os expanded rheir btnep~-~ -~.'~ · -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 naturally bi.ccd-ph~~ ;~ "mkree for plan formula1y decisions.
`cim to manage the pharmacy benefit. Many early managed care pharmacy dirc:ctol'$'~'·., .~ ~ ~ MCO and PBM P & T Committees are evolving. In 2003, the Medicare Modemiza(cid:173)
`
`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 implicitioll4''fl'
`healthcare professionals, plan sponsors, patient members, and indeed the health rtaR::~">r
`nization itself Appropriate selection and use of a pharmaceutical is often the lllOS
`effective form of prevention or therapy for many medical conditions. It '·
`responsibility of the P & T Comminees, using a standardized drug evaluation p
`make pharmacorherapy recommendations for all healthcare professionals and me~
`the organizariou as well as consider and expeditiously process patient-specific except(~
`This chapter describes die genesis of managed care Pharmacy & Tbcrapeuci.;t·~
`
`.·~1- _ .... _:)~
`,,,.,.
`
`out of hospiral practice, and they logically applied the p_ractices _and principles of dm~<·,;7 tr 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 managel#;:.: ~ .·i:; Pamc1pw.ng Medicare Advanrage-Prescnpt1on Drug (MA-PDs) plans and prescription
`practice environment. HMOs began developing drug fonnularies, and to provlde~ei; 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, an'\
`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 tljaii(
`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\i
`specialty pharmaceuticals will require the P & T Committees to include or regularly c~~­
`sult 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 drur/~'
`selection additions.
`•
`
`ROLE OF THE MANAGED CARE P & T COMMITTEE
`
`Members of any organization's P & T Committee have the opportunity and tesponsibil\ty;·(cid:173)
`to offer what their experience and analysis shows to be the best drugs available to paticn1
`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 fVcl),
`influence the lives of many individuals with medication therapy needs. However, the Corn- t
`mittee's firsr responsibility is to rhe patient, and to select the safest and most cost·effivciv:ei
`drugs available for formulary inclusion.
`In 1999, a coalition of several organizations convened to discuss the priuciples ora
`sound drug formulary system. The Coalition Working Group participants met to idonrify
`the principles of a sound drug formula1y system (Table 13-1). The Working Group Sl~
`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 M embe~
`
`• Academy of Managed Care Pharmacy (AAMC)
`• American Medical Association (AMA)
`• American Sociecy of Health-System Pharmacists (ASHP)
`• Department of Veterans Affairs (VAJ
`National Businm Coalirion on Health (NBCH)
`• U.S. Pharmacopoeia (USP)
`• Americm Association of Retired Persons (AARP; observer)
`Suurcr:: AMCI~ PrUKf/la ofa Souud Dnt.t fmM"1m].. Alexandria, VA:. Academy of M:m:iged Gm Pharm:tL)', October 2000. Av.lllotblc a1
`lucp11w1¥w..iJiq>.<>1yd.ia/a:all_<MJ<ntldiui;fumiuh7.pd( Accessed 19 Aug 2008.
`
`"The l'l=rnacy 3nd Thcrapeucics (P & T) Comminee ... is t:he mechanism for
`adutlnisccring chc furmubry system, which includes developing and maintaining
`d1c foromlary a11d esmb/i.shing o.nd impl~mmting policies on the use of drug prod(cid:173)
`ucts" (emphasis added).
`
`Recommendatkins of the Working Group Coalition for P & T Commirtee activities are
`fuund in Table 13-2.
`The Ac:idemy of Mru1nged Care Pharmacy published the Formulary Management
`coocepr·p:ipcr ihar also emphasizes the broad responsibility of the Pharmacy &Therapeu(cid:173)
`tics Couunirrcc ro include the following8:
`
`"A fommlary zy~tem is much more thau a list of medicu.ions thar are approv~"<i
`for we by a managed healthcare organiiacion ... Policies and procedures for rhe
`procuring, dispensing. and administering of rhe medications arc also included in
`the system. foanufarics ofccn contain additional prescribing g\lidelines and clin(cid:173)
`ical iuformarion which assists healrhcu-c profossionals ro promote: high qunliiy,
`affordable care for paticnr~. Fiually, for quality assurance plltposes, managed
`healthcare systems rhar ust formulacics have policies in place co give physici:i.n~
`and patients access to non•formulary drugs when: m.:dic-.illy necessary."
`
`Clearly, when a P & T Committee evaluates a drug for formulary consideration, the
`members also must determine how the organization can ensure chat the product is effec(cid:173)
`tively managed, accur:ndy moulcored, and optimally used.
`Wh~n a P & T Commirn:c cv:t.luan:s a dcug for formukcy c;onsidcr:irfon, the mem(cid:173)
`bers must dcrc11nine how the: physicians aou pharmacis1s of the orgauiznrion will P"'(cid:173)
`soribc, dispe11$c, moniror, and ensure appropciarc urilli.adon. P&T Committees also
`review :ind evaluate clinical programs •nd utilizarion mana.gcmcnr suarcgic:s. These P & T
`
`TABLE I 3-2 Wor king Group Coalition Recommendations for P & T Committee Activities
`
`• Obj<crlvdy npp~iscs, cviiiuares, and ~d<as dmgs for the fonnubry.
`• Mec[lj as frt.'<jUeLuly as is necessary lo review and update the appropri:ifct1ess of rhc formubty
`oystcm in light (If new dmgs and new i.mlicacions, uses, or warnings uf!Caing existing drugi.
`• l!smb!ishe.; policies und pmccdurcs 10 «:lue>.te and inform hc:llthc:ire providers :thoui drug
`produc~. usnge, and coinmirtcc decisions.
`• Oversees qualiry improvement programs that employ drug llSe evaluation.
`• lmplemcms generic substitution and therapeutic lnicrchange programs d121 ~uthorizc
`e.xchange of thcmpcucic ahcma1ives b;sed upon written guidelines or prorocols witltln a
`forruulary sym:m. (Nurc: Thernpcucic subrutution, rhe dispensing of d1e1apcutic alfcrrunes
`wichout the prcscriticr's :ipproV:t.l, is illegal und sbould not be allowed.)
`Develops pror0<·ol~ and procedures for the use of and acce.ss 10 1101Aoanulary t.lrng products.
`So11rc" AMCP. l'rlod/ln of• S.•.J Dr/If l'.lr ... J.oy. Aloo:,ndci>, Vk AO>domy of M.n-g<d Care Phacnw:y, October 2000. Av.dhbl<"
`IM1v.:J/www..,,iq>,qcgldo<A/11n_,,..1C1U/dnefomi11!1uy.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 fur-r<"3llf\ffif·
`implications on health and economic outcomes. Decisions made by rhe P &T Comro.i~'~
`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<!1-~lc ·
`is to represcm the imerests of parienrs. Howeve1; the Conuniuee operates inclepcnd~~
`and decisively in the best imerest of the patiem, and ideally is uninfluenced by any o!llr
`imernal or excernal special incerest person or group.
`·. · l
`
`In addition ro clinical expertise, ideal committee members understand managed care
`,, business principles, the organization'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, patiencs. Committee members agree to serve often for a staggered one
`' 01 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
`following members, usually with equal voring authority:
`
`AN ILLUSTRATIVE EXAMPLE OF A P & T COMMITTEE STRUCTURE
`
`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.?., opcn~9f.~l~-.'•;
`
`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 i;1J~~·
`cal m1d-s1ze health plan ro 1llusrrate an example, orgamzanons are different. OrganracitmJ .
`by-laws as well as the slate-filed Certificate of Coverage provide the authority and respon~f
`bility for the formation and fi.mction of a "fonnulary decision entity," (e.g., a P & Tex,...;._,;/,
`mitree) to make drug product selection decisions for the organization. The Commii
`consists of healthcare professionals, usually physicians and pharmacists, although n~
`quality assurance directors, ec:hiciscs, or economists may be committee members af SQ.~j
`larger organizations. In very select instances, MCOs have begun including plan memhcfS'.Jli,f
`the role of patient advocates as members of P&T Commitrees. At 1he rime of this wnri~ i{;.
`is unclear as ro whether this practice will become more widespread. The Committee 1ntiift·
`bers are predominantly independent practitioners not employed by the sponsoring MC'..01~
`PBM, but generally are participating plan providers. Staff or group model plans may 'df~· ...
`physicians employed by the health system or the exclusively comracred medical gm1ip;1:'
`Some organizations may include faculty members from medical and/or pharmacy schoQ\s;,~:'
`While this committee often is named the Pharmacy & Therapeutics Commiricei'Ct.'
`may be termed the Drug Formulary Committee or a similarly named group. The Coa~J." ~ ·
`tee size varies among organizacions, and some large MCOs or PBMs may have rherapcy_!iq
`subcommittees of che National P & T Committee. In general, a typical medium si1.e MOO
`has a P & T Committee consiscing of IO co 15 members, alchough some :have up 10~·
`members. The largest group represented is comprised of physician members who ge11~. ~ \
`represent the specialties who are experts in the most commonly nsed therapeutic cattgQ~
`including family practice, general internal medicine, oncology, pulmonology, c:utliolo~·
`obsretrics and gynecology, or pediatrics, Committees oti:en invite addir.ional speci:tli.~ts JO;.~
`attend a specific meeting to discuss certain therapeutic categories if the Committee d~.
`nor believe the members have adequate expertise or experience (e.g., endocrinology, infii:
`rious diseases, neurology, psychiarry, gastroenterology, or other specialties). Due ro ihf:_:·
`growing number of elderly and individuals with special needs with drug be.nefics ~-ovc1cll/
`under Medicare Part D, many P&T Committees include physicians and pharmacisrsw}ljL
`specialize in geriarrics in order to consider the unique needs of these subgroups.
`·
`·w:9?PR
`
`Committee Chair (independent community-based participating physician or the
`plan medical director)
`• Nine to fourceen additional independent community-based participating physicians
`• Health plan medical director (if not the Committee chair)
`• Health plan pharmacy director
`• Geriatrician for Medicare Part D programs
`
`-In addition, the pharmacy department clinical pharmacists and rhe pharmaceurical con(cid:173)
`tract manager often attend Committee meetings as non-voring staff members rn present
`and discuss clinical and financial impact or concract information. Plans may differ. Larger
`healrh plans and PBMs may have broader Commirrees that may include an economise, an
`ethicist, quality assurance representatives, or a non-clinical lay plan member. Organiza(cid:173)
`tions may also use therapeutic category subcommittees that have the responsibility to
`review and render expert opinion recommendations to the foll P & T Committee on spe(cid:173)
`cific therapeutic categories. Multi-state MCOs and PBMs may have a corporate or
`national P & T Committee rhat constructs a primary organizarional formulary (or
`National Formulary for organizations with a national presence) that is "customized" at a
`state or regional plan level, for large self-insw·ed plan sponsors, or by MCO clients of
`PBMs that have their own P & T Commim:e. Some organizations separate discussions of
`drug cost or pharmaceutical manufacturer conrract cerms from clinical discussions, and
`only review the contracts or the financial impacc 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)
`icarioos given "do not add" designation by the P & T Committee are not lisred or added
`to formularies irrespective of financial considerations.
`Frequently, subcommittees are formed to conduct reviews of highly sophisticated or
`unique therapies generally limited to specialists. For example, large organiza,ions may
`have oncology, neurology, rheumatology, or hemophilia subcommirrees ro review emerg(cid:173)
`ing biotechnology agents ofi:en disrributed through specialty pharmacies. Subcommittees
`also. are useful ro perform emergency reviews between foll committee meetings, such as
`the release of a new break-through therapy, black box safety warnings, or the publication
`ofpost-marketing drug research with important results.
`It is important to note that new drugs are not reviewed in isolation, bur are compared
`with orher existing or soon-to-be-launched pharmacotherapy options, regardless of their
`therapeutic category. This is key difference between the functions of tht: Committee and
`
`4
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`
`3 3 0
`
`Chapter 13 P & T Committees in Managed Care Organizations
`
`Pharmacy Department Role in New Drug Evaluation 3 3 I
`
`'
`the role of chc FDA. The FD~ .only evaluates .one emity at a time in terms ~f clfccci~e~.
`and safety. Whereas the P & I conumtree will consider all viable alternative tr<:arntcntt ;
`induding those treatmems that may not be pharmacological, or the off-label use l:Jt ~'4$/
`ing medications.
`·
`
`PHARMACY DEPARTMENT ROLE IN NEW DRUG EVALUATION
`As discussed in previous chapters, MCO or PBM pharmacy departments have the ritsp:tii\t
`sibility to design and administer an effective pharmacy benefit for organization clirn~:,A .. •·
`dynamic drng formulary, developed by the I' & T Committee and executed by the P~f"
`macy department, is a seminal requirement for an effective pharmacy bendlt design~(o~'
`optimize clinical and economic outcomes.
`Connection berween the P & T Committee and the MCO or PBM is maintained 1~1
`the sponsoring organization through the medical director of pharmacy staff membcl'S"ou
`the P & T Committee. The organization's pharmacy department generally coordinates aiil!i. ·
`supports the P & T Comminee meerings and activities by orchestrating and schcdull!)f.
`meetings, providing drug review rnacerial and smnmaries to Committee members, recotdi"
`in~ and distributing Com~ittee me~tin¥ minmes, ~nd putting_ Committee decisions i".~i .
`acnon (e.g., changmg claim adiud1cauon drug hie, pubhshmg formulary chang1:1 !Ji .
`providers and members). Figtue 13-1 illustrates the flow of information among the p~(i:
`macy department groups, the I' & T Committee, and health plan providers.
`
`1. Pharmacy Department
`Clinical Group
`• Collecl.S and analyzes all data
`(internal and, external)
`• 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
`• Revlews material provided
`• Conducts personal nterature search
`•Revrews cffnlcaf experienoe
`• Conlers with colleagues
`• Makes fomiuiaJy Cleclsl!ln
`
`Provider feedback
`to Committee
`
`4. Providers
`Prescribe and dispense according:
`to new formu1,11y change
`
`FIGURE 13-1
`and Providers.
`
`Information Flow among Pharmacy Departments, P & T Committee,
`
`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 rhe 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 manufu.cnucr discoum or rcbace com:racts.
`3. PhlimlMJ JJimefit Program Mam1gemm1. Formulaty changcS must be reflected in drng
`file and claims adjudkatio11 processes, and ~xecured in accordance with pharmacy
`b<:11d11 design conrraets; di.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 product by the Commitcee, 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 cost
`impact of potential fonnulary changes.
`Physician and orher healthcare professional P & T Comminee 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, scientific meetings and
`abstracts, continuing educacion programs, and pharmaceutical company scientific and
`marketing materiaL
`
`)J:!Al\MACEUTICAL RELATIONS AND CONTRACT MANAGEMENT
`A pharmaci~-i gcncr'.i.lly will lead che work group responsible for managing che busiucss
`a11d contract cdacionships bcLwec.n che MCO or PBM and pharmaceutical companies.
`Discounr and rebate comracts with pha.cmaceurica.l companies a.re important LO pharmacy
`benefit managemel)t, as the rc:l.>are income reduces rht ace cosi of conrract.:d products
`t~-cc ChapLcrs 14 and 15). Alchougb cost remains sec:ondary co clinical and rnfc1y <:onsid(cid:173)
`eracions i11 I' & T Commitrec deci.s.ions, a lower net co~r may Jn.flu~ce drug furmulary
`positioning (see Chapter 9) when the therapeutic outcomes expected from comparable
`
`5
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`
`3 3 l. Chapter 13 P & T Committees in Managed Care Organizarions
`
`Drug Evaluation and Review Process in Managed Care 3 3 3
`
`CMS is very specific with respect to rhe timing and frequency of formulary changes
`,;11 Medicare Part D programs. In general.. must pharmacy benefo management companies
`will evaluate medications throughout the year for addition ro the formulary, with dele(cid:173)
`tions from the fonnulary made only at the beginning of the plan or calendar year.
`
`filuG EVALUATION AND REVIEW PROCESS IN MANAGED CARE
`
`Although P & T Committee schedules vary among organizations, many health plans con(cid:173)
`vene rheir committee on a quarterly basis, others more frequently, such as monthly. The
`Committee meeting agenda is usually set 60 to 90 days in advance of the meeting to make
`certain the health plan pharmacy department has adequate time to complete their drug
`'information collection, analysis, and evaluation, and prepare and distribme materials for
`the P & T Committee members well in advance of the meeting. Some organizations also
`schedule an annual review of all important therapeutic categories on a staggered schedule.
`
`1
`
`medicarions_ are considered to ~e equal or very si'.11ilar. _MCOs may operate til~dci'ilij
`phannaceut1cal co'.1tracts of theu PBM, or mamtam theu own contraccual rdauo0~· ·
`.J
`with drug compames.
`Net drug cost is an important consideration in drug comparisons and formulary pttl{,
`tioning whe~1 comp~rative drugs are therapeutically undifferentiated. The_~~O or PiMj
`?harmaceuncal relanons a1:d contract management grou~ ha~ the respons1b1hty cif pij~~ ..
`mg rebate contracts (or discount contracts when orgarnzanons, such as gronp or"'~lf.
`model plans or PBMs with mail service, take possession of drugs) and assessing the fo~i
`cial impact on forecast drug utilization.
`")jl
`While rhe net cost of reviewed drugs is imp01tant, various MCOs and PBMs incrod~ ...
`rhe financial dara at different times in rhe drug review proc_ess. Traditiona\ly, rhe ~barnisw
`departrnem contract manager would pursue a contract offermg from a pliarma.ceuac:tl C§~ ·.
`pany prior to the P & T Committee meeting, w that the drug cost and a drug cost im~
`assessment can be presented to the Committee when formulary addition and pos.irioriljii.<'
`are considered. Comract details are usually not shared, but the pharmacy d~paruncmgri}~
`siders the contract rebate level, the pharmacy reimb1irsement level, the likdy <:opaym_~'.
`[,,"-'!
`and uses the estimated net cost in pharmacy budget impact analysis models.
`However, some MCOs and PBMs do nor share cost or contract information wi cl{i~·e:
`P & T Comminee ro make certain Iormulary decisions are made solely on cffi~ 911H
`safety 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<:n:rm1Q~:'.
`the drug receives a positive review. If the Committee renders a "must add" or "may adq"·' .
`decision, rhe pharmacy contract manager pL1rsues a contract offering so that a pharrtJ.i.~· :
`budget impacr model may be constructed to reflect anticipated cost ro the organizMlo,iii
`Based upon the contract obtained, net cost, and anticipated budget impact, the phar