contemporary management strategies for fibromyalgia

8/14/2019 Contemporary Management Strategies for Fibromyalgia

1/22

Managed Care &Healthcare Communications, LLC

VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S197

On ma 21, 2009, The American Journal o Managed Care

(AJMC) l a ontabl o lnal, patnt avoay,

an ana a xpts to xplo sss n t anoss

an anant o boyala. T attns a a onsnss

on t ollown sss:

1. T pvaln, patnt bn, an ono bn assoat

wt boyala t al anoss an tatnt, atonalaton o t al onty (patlaly pay a

pysans), an appopat anant by alt plans, nl-

n patnt ass to uS oo an d Anstaton (dA)-

appov boyala atons.

2. Pysans, pays, an patnt avoats sol wok to satsy 3

tal oto oans o boyala patnts: clinical-

as syptos an pov pysal nton; economiclow

boyala-lat alta osts; an quality o lieontn

nvolvnt n ploynt, aly, an soal atvts.

3. T nt tatnt an anost lns o boyala

attpt to nty tatnt optons o an otn snstoo

sas stat, bt a not oonly s by pysans o pays as

a tatnt alot. T lns av lt tlty to py-

sans an pays bas ty p o o not ons nt

dA appovals o 3 paaolo ants o boyala; t

onatons o ot tatnts s o boyala a

bas on ata anly o nontoll, sall, opn-labl tals o

sot aton; ty lak a statowa tatnt alot (al-

to an alot t b poblat vn t osynat

nat o t sas); an ty n to b pat as avans nsas anant a a.

4. T vlopnt o a tapt atoy o boyala on

pay olas wol bnt patnts, pysans, an pay-

s as a stp towa t ltzn t sas stat, asn

awanss o boyala, atn pysans an patnts on

avalabl dA-appov tatnts, nann patnt ass

to pov an appopat onton o dA-appov

tatnts, an povn nstann o sas-sp

tlzaton by pays.

contpoay manant Statso boyala

n report n

AbstractA roundtable meeting that comprised clinical,

patient advocacy, and managed care experts

discussed issues regarding the diagnosis and

management of fibromyalgia. The panel

agreed that earlier diagnosis and treatment,

additional education for the medical community,

and appropriate management by health plans,including patient access to US Food and Drug

Administrationapproved fibromyalgia medi-

cations, are needed. In addition, physicians,

payers, and patient advocates must work to

improve clinical, economic, and quality-of-life

outcomes for fibromyalgia patients. Finally,

treatment and diagnostic guidelines must be

updated as advances in disease management

are made (including approvals of 3 new

pharmacologic agents), and development of

a therapeutic category for fibromyalgia on

payer formularies is needed.

(Am J Manag Care. 2009;15:S197-S218)

o patpant noaton an sloss, s n o txt.


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rpots

S198 n www.aj.o n JuNe 2009

SECTION 1. FIBROMYALGIA: CLINICAL

OVERVIEW AND ECONOMIC BURDEN

boyala (m) s a ltsypto onton

aatz by on wspa pan (cWP)

an sally aopan by a ltt o a-

tonal syptos.1-7 most popl wt m s oas pysal nton,2,3,8-10 w an la to

sablty.6,11,12 Slp stbans, at, an on-

n stnss a psnt n o tan 73% o m

patnts.1 many patnts av aas, ontv

pant, as wll-bn, pss oo,

pastsas, tabl bowl o bla syptos,

anxty, tpooanbla jont pan, stlss ls,

an/o ypsnstvty to nos, at, an ol.1-7,13

coobts, w a a o oon n m

patnts tan ontols, ay nl ot no-

pat o astontstnal (gi) sos, an,spatoy o latoy ontons, an ntal an

oo sos (Figus 1A and 1B).4

T pan o m s stntv. Patnts wt m

av cWP o 3 onts o lon n all 4 qa-

ants o t boy, bt not nt n t jonts, as

n Figure 1A. Patient-Reported Symptoms at Diagnosis of Fibromyalgia

n Figure 1B. Comorbidities Associated With Fibromyalgia

0 5 10 15 20 25 30

Painful neuropathic disorders

Musculoskeletal diseases

Digestive diseases

Respiratory diseases

Circulatory diseases

Migraine

Depression

Diabetes

Neoplasms

Fibromyalgia (n = 33,176) Controls (n = 33,176)

10

Patients,

%

8

6

4

2

0

Muscular

pain FatigueSleep

abnormalitiesJointpain

Headaches

Restlesslegs

Numbness

Impaired

memory

Legcramps

Impaired

concentration

NervousnessMajor

depression

109

7 7

6

5 5

4 4 4

3

2

Adapted rom Kranzler JD, et al. Psychopharmacol Bull. 2002;36(1):165-213.

Adapted rom Berger A, et al. Int J Clin Pract. 2007;61(9):1498-1508.


3/22

contpoay manant Stats o boyala


wt ato atts.1,4,14,15 m patnts av a

low pan tsol tan alty ontol sbjts9;

nalz tnnss nls alloyna (pan o

noally nonnoxos stl) an ypalsa (n-

as spons to panl stl).6,16 Alto ty

annot tt pss, ltal, o tal stlat low lvls tan ontols, t stls lvl tat

ass pan s low.9,14,17 Ts pnonon s n-

pnnt o psyoloal atos s as xptany

an ypvlan.17 T pan o m ay vn p-

sst at stl as.18

m s o wspa tan any a awa (Fig-

u 2) an s blv to b nanos an n-

tat. in t unt Stats t pvaln s 2%

to 4%2,4,19-21 wt onst sally at 20 to 55 yas,4 bt

pvaln nass wt a.21 T al-to-al

ato s p to 9:1.4,21 m s t son ost oon

so tat by atolosts, at ostoat-

ts.20 mana a patpants n t ontabl w

sps by t pvaln an sa patnts w -

lt to tak to s o a boa an o anoss

an va tlzaton. Sn pspton las

ata o not onsstntly nl International Classif-

cation o Diseases (ICD-9 o -10) anoss noaton

(alto t ata an b nl, t s not typally

q by pays, ts not apt), paay t-

lzaton ata annot b s wt tanty to nty

patnts wt m, bas any o t s an

lasss psb a also s o a vaty o ot

al ontons.

Wt ts any an vaabl syptos, so ow an o n ot sos, m an b -

lt to nty. rnt laboatoy, poston sson

tooapy,22 voxl-bas opoty,23 an n-

tonal ant sonan an (mri) sa

as sppot t ltay o m as a nn s-

o.6,7,20 Nvtlss, ltay as a st ntty

s stll not nvsally apt,5,20,24,25 w an -

slt n pobls o patnts aft wt m, o

sta to lty obtann aat anoss an

tatnt.

n Figure 2. Epidemiology of Fibromyalgia in the General Population

9

8

7

6

5

4

3

2

1

0

PercentW

ithFibromyalgia

Age Group, years

18-29

30-39

40-49

50-59

60-69

70-79

80+

Females

Males

Reprinted with permission rom Wole F, et al. Arthritis Rheum. 1995;38(1):19-28.

Dr. Goldenberg (Rheumatology): I discuss this as

a problem with pain volume control, that there is a

decrease in threshold to various noxious stimuli. Its

not just pain. Its all stimuli. So you hear these weird

symptoms from people that smells, sounds, or bright

lights bother them. If they have a CNS hypersensitivity

or hyperirritability, it makes perfect sense.


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T ponant toy o patonss n

m s ntal snstzaton to yslaton

o pan patways.10,12,18 Ban an as on-

stat ts alt pan possn, wt m pa-

tnts potn pan at al t pss q

to st pan n ontols.7,14,20 At t ntpsss q to pot sla pan, mri

sow t sa ban aas w nvolv n

pan possn, natn t m patnts an

ontols xpn t pan slaly wl t

stl w nt.7 Alto t xat tol-

oy s nknown,3,5 nts appas to play a ajo

ol n ssptblty.9 st- latvs o m

patnts av 8 ts t sk o m as t n-

al poplaton.9 m as bn assoat wt poly-

opss n t sotonn tanspot n an

t atolan-O-tyltansas nzy

tat natvats atolans.9,20 Ts poly-

opss at t tabols o tanspot o

t onoan notanstts sotonn an

nopnpn.9 copa wt ontols, m pa-

tnts av bn on to av low lvls o -

tabolts o sotonn an nopnpn n t

bospnal f.7,9 Sotonn an nopnp-

n a antnoptv9; tat s, ty as

t snstvty o pan possn systs to

t snn ntal nvos syst (cNS)

pan patways.7,9 Low lvls nat ysla-

ton o pan plss to as atvty n

snn antnoptv patways, sltn n

ypalsa an alloyna.7,9 T low lvls o s-

otonn an nopnpn tabolts pvalntn m sbjts9 sst tat sotonn an no-

pnpn ptak nbtos (SNris) t

lp aln alt pan possn n snn

cNS pan patways. Was SNris av a

anals ts n anal ols o ypalsa

an alloyna, sltv sotonn ptak n-

btos (SSris) av not, w lts t

patla potan o nopnpn n pan

olaton.19 On t ot an, m sbjts a

pot to av nas lvls o ponop-

tv tanstts sbstan P an ltaat tat

aply pan plss n t asnn pan pat-

way.7,9 ds s as antonvlsants a tot

to nton by n t las o ponop-

tv tanstts n t asnn patway.

FM Causes Functional Impairment

m s assoat wt ntonal sablty.

T on, pan syptos o m an

la to loss o nton, w natvly ats

n Table 1. Fibromyalgia (FM) Is Associated With Functional Disability

Employment and Productivity Other Functional Impacts Health-Related Quality o Lie (HRQOL)

20%-50% o patients can work ew or no

days

Limitations in activities o daily living are

as high as in rheumatoid arthritis

Beore-treatment HRQOL scores are signi-

cantly impaired compared with the general

population

36% are absent rom work > 2 d/mo Sleep impairment scores are well above

those in other chronic illnesses; sleep

decits exacerbate atigue and unc-

tional limitation

HRQOL has been reported to be worse than

in patients with congestive heart ailure,

rheumatoid arthritis, osteoarthritis, perma-

nent ostomies, chronic obstructive pulmo-

nary disease, and type 1 diabetes

31% have lost employment due to FM Social and amily activities may be

curtailed due to atigue, pain, and/or

depression; sports and physical exercise

may become dicult or impossible

26%-55% receive disability or Social

Security payments

Social diculties due to chronic pain

can lead to maladaptive illness behav-

iors (reduced activities and exercise,

involvement in disability and compensa-

tion systems), which can help perpetu-

ate unctional decline

Sources: Busch A, et al. J Rheumatol. 2008;35(6):1130-1144. Bennett R, et al. Arthritis Rheum. 2005;53(4):519-527. Mease P. J Rheumatol.2005;32(suppl 75):6-21. Dadabhoy D, Clauw DJ. Nat Clin Pract Rheumatol. 2006;2(7):364-372.


5/22



wok an ls atvts,26 ay nas ov

t, an s alt-lat qalty o l

(QOL).13,25 up to 50% o patnts an wok only

a lt nb o ays bas o t so-

,26 an p to 55% v sablty o Soal

Sty paynts.13,26 Patpaton n alyan soal atvts ay as bas o

at, pan, an/o oo syptos, an n-

aqat stoatv slp nass t ovall

at. evntally, so m patnts bo

opltly sabl an napabl o ontnn

ploynt (tabl 1).

m s also assoat wt a snant ost

bn on all nvolv, nln patnts an

t als, ploys, an pays. T on-

ton poss sbstantal t al osts27

an nt osts o lost wok potvty.27-29

La uS las atabas analyss av -

onstat ts osts.4,30,31 in a uS ns-

an atabas analyss o o tan 60,000 m

patnts an a- an sx-at ontols, m

patnts a an total alta osts ap-

poxatly 3 ts an an osts

5 ts tan ontols ($9573 vs $3291

an $4247 vs $822, sptvly, P


6/22


7/22



anost ta o m nln cWP o at

last 3 onts an pan on at last 11 o 18 sp-

sl tnon sts o oal tnnss (tn-

ponts;Figu 4) on tal palpaton sn a

o o appoxatly 4 k/2.1,4,7,9,17,20

Alto tn ponts w t ost pow-l snato btwn m patnts an

ontols, tnnss s sbjtv an pns

on t xans stnt o palpaton.1 Acr

anost ta a snstv (88.4%) an

sp (81.1%) an an stns m pan

o ot atolo ontons,1 bt w

onally ntn as a sa tool. T to

o 11/18 tn ponts s ons by any to

b sowat abtay. Tn ponts ay b as-

soat wt stss at tan pss pan

tsol,9,17 an so patnts av w tan

11 tn ponts bt stll av m.15,33 Won

a 11 ts o lkly tan n to x 11

tn ponts on pysal xanaton.9

Ot oans bss pan st b assss

o an aat m anoss. So atos av

sst t s o a stt ntvw wt

qstons abot nalz at, aa,

slp stban, nopsyat oplants,

nbnss o tnln, an tabl bowl syp-

tos.7,34 mo ntly, xpt panls av o-

n atonal o oans o m o sty

nvstaton, nln ltnsonal n-

ton, ontv ysnton, an alt-latQOL.10 A n xsts, spally n t pay

a onty, o btt anost ta an

objtv tools to assss llnss svty.

Delays in Diagnosis

it s possbl tat lty n anosn m ay

av ontbt to ts nonton an n-

anoss. danoss an tatnt an b lay

o yas wt any alta vsts, als, a-

nost tsts, a vaty o anoss, an lttl pat

on syptos.4,5,28 rontabl patpants not tat

aon to t Aan Pan onaton (AP),

on pan sos nln m tak 2 to 3 yas

an 8 to 13 alta possonals to b anos

aatly. danost lay ay slt o pys-

an skpts o t sas stat, spt objtv

vn an onton o m by ky oanzatons

nln t Acr, Soal Sty Anstaton,

n Figure 4. Illustration of Tender Points for Diagnosis of Fibromyalgia

Adapted rom Wole F, et al. Arthritis Rheum. 1990;33(2):160-172


8/22

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an Wol halt Oanzaton.1,35 So pysans

stll blv m s a anstaton o anot n-

lyn so,5,25 an ots qston t Acr

ta an to t valty o t anoss.6

rontabl patpants stat tat anost layay also slt o lak o onn on t pat

o PcPs to t n o an objtv anos-

t tst o onson abot t ol o tn ponts.

ralss o t ason, patpants aknowl

tat lay anoss nass osts o nsan

opans wl an to bn on patnts.

T pat o a lay anoss o m s at-

st on t patnt. Aon to t ontabl pa-

tpants, patnts wt nanos, ntat m

l stat an vlnabl, o not know wat s

won wt t, an ay qt wokn. T pat-

pants a tat lay anoss avsly ats

otos, bas t sas stat s o avan

by t t patnts v aqat anant.

Yas an b wast wt sanoss o no anoss

wl sas posson ontns. ealy anoss

an tatnt o not o otn no, bt wol

b bnal.5,9,20 Sts av sown tat syptos

an alt satsaton pov at anoss o

m.9,20 danoss ls ot ot o sos on-

tons, an tatnt vs patnts op an a sns

o ontol.5 At anoss, patnts wll-bn ay

pov, n pat, sply bas o t ontonabot t pan an llnss.5

dlay anoss an also nas osts to pay-

s an patnts.5,28 rtosptv atabas analyss

val tat al anoss o m was assoat

200

150

100

50

10 5

95% Confidence interval

Case

Control

0

Years Relative to Index Date

Ra

te

Per100

Person-Years

5

n Figure 5.The Impact of a Fibromyalgia Diagnosis on Utilization of Diagnostic Testing

Reprinted with permission rom Hughes G, et al. Arthritis Rheum. 2006;54(1):177-183.

Dr. Beltran (Managed Care): One of the biggest

challenges in healthcare management is treat-

ing chronic care illnesses like FM. It sounds

like an opportunity for a team approach. One

of the reasons there is delay in diagnosis is

that patients are referred to different spe-

cialists in different temporal time frames as

opposed to approaching the problem as a

team, where you are getting all the key spe-cialists, whether it be the rheumatologists,

neurologists, pain management, and psychia-

try, in the same room.


9/22



wt ost savns.5,28 At anoss o m, -

al so tlzaton as, nln vsts

o oobts.5,28 dass o n lat

tstn an laboatoy osts ( Figu 5), a-

ton osts, als, pysan vsts, an nypatnt vsts.5,28 On ato onl tat

alta povs t b ltatly on-

n not only wt t osts o anosn m

bt also wt t osts o not anosn m.28 T

ontabl patpants splat tat t o-

nt osts o lay anoss a pobably vn

n alty, wt o avan sas -

n nto osts at lat anoss.

The Need or Education About FM

T ontabl patpants a tat an

nstann o t m sas stat an an a-

at anoss o m by t al onty

stll qs onsabl aton, spally

o PcPs. Btt nstann o m sol b-

n wt o xpos to t n al sool.

unvsally apt anost an tatnt

alots o not xst, bt vn-bas n-

oaton s avalabl an sol b o wly

ssnat. Patnt avoay ops, alt

plans, an paatal opans an lp

ssnat ts noaton, spally to PcPs

an ns as anas, an altat nta-

ton o onty spalsts wt PcPs.

T patpants a tat at awa-

nss an nstann o m aon povs,

spally PcPs, an la to al, appopat

anoss an tatnt. Aat anoss an

ny patnt an o vsts,

anost tsts, an t s o ntv -

atons. Patnts l lv at vn an

aat anoss, w lts t bn o n-

tanty abot t alt. Ty ay to

t nb o s ty ontn tak-

n. eal, o tv tatnt an ast

o nz t ln o nton, nablnontn ploynt an at alt-lat

QOL. T patpants onl tat ntyn

patnts al n t sas ontn wol

pov patnt otos an lp ontol osts.

Another Need or Patients and Providers:

Treatment Access

Ass to tatnt o m s sots -

stt, an s ost vsbly sn wt spt to

tlzaton o sp taps. T on-

tabl patpants xpss onn tat ts

sttons ol p tv tatnt,

bt also not ts sss a oon to any

al aas, not jst m.

As an xapl, so ana a plans

anat stp-ts, po atozaton, o ot

poas to ana tlzaton o sp s

o lasss. Patpants wt ana a

bakons not tat ts a ant to po-

ot t ln-vn tapy o sally

sponsbl aton s. Otn ts poas

q s (an al) o n pots

bo atozn ban ants. Wt spt

to m, ts tanslats to s o s o-labl

bo s o ants tat a dA-appov o

tatnt o m.

o t psptv o t lnans at t

ontabl, nw atons wt dA na-

Dr. Garber (Managed Care): I was truly shocked

that we had as many [fibromyalgia] cases

diagnosed as we had. I think it would be

worthwhile for us to look into the cost of tak-

ing care of FM.

Ms. Gleason (Patient Advocacy): So many of the

healthcare providers are uneducated about

FM as a whole. Even for medications that

have been approved by the FDA, providers

may not have a treatment regimen in mind

or know what they are going to do with thepatient.

Dr. Garber (Managed Care): I think there is a pau-

city of information both among our nurse care

managers and our PCPs about the general

sense of what FM is. I think that is one place

we can use some help.

Dr. Draud (Psychiatry): From a cost perspective...

people are much more expensive to treat

after they have had 2 years of disease state

progression.


10/22

rpots


tons o m an b lt to obtan bas

o ts qnts, sltn n staton

o bot pysans an patnts, at avn

spnt yas skn an aat anoss an

tatnt.

gvn t vaablty o syptos an psn-

taton o m aon patnts an t lak o la

tatnt lns, an optal staton wol

b to pov pysans wt btt fxblty

to on an pov t ost appopat

tatnt. Ts onsaton was tp by

t ontnn n o vn o ay an

ost-tvnss o all ants s o t tat-

nt o m.

T ontabl patpants a tat at-

tnton an appopat anant by alt

plans s n. A ajo alln o ana

a s anant o on sass, an m

psnts oppotnts o sas anant

wt a nt o xlln ltsplnay

ta tatnt appoa. ronzn t osts

o m an t a osts o lay anoss

an ntv tatnts, alt plans an alt

pols to noa bst pats, nln:

Recognition of the diagnosis of FM

Assistance in provider education for the di-

anoss an tatnt o m

Coverage of pharmacologic and nonphar-

aolo tatnts tat av bn sown

to b tv

Appropriate formulary placement and utili-

zaton anant o tv atons,

patlaly s wt dA appoval.

Summary

m s a so o w aly, aat -

anoss an appopat tatnt a al to

pov lnal otos (, pvnt loss o

nton), osts, an antan o pov

QOL. evn an xpn sst tat -

pov awanss an aton abot m o

bot patnts an alta povs s an n-

t n. mana a oanzatons an play a

ol n assn ts nt n.

SECTION 2. CURRENT GUIDELINES FOR

THE MANAGEMENT OF FM

dspt yas o lnal sa an nt

dA appovals, onsabl abty ans

an m tatnt. in aton to paa-

olo tatnt, nonpaaolo taps

av bn t, nln patnt aton, x-

s, ontv-bavoal tapy (cBT), an

altnatv taps, otn n obnaton; an

ost a tat a obnaton o taps ay

b t bst appoa.3,7,9,10,26 many lnans, av-

n v lttl aton abot m, av sant

awanss o t onstat ay an saty

o tatnt optons. ea patnt s nq an

t obnatons o syptos vay wly; t-

o, tatnt nvalzaton s nssay an

a w an o optons sol b aly aval-

abl. howv, ass to so s s lt by

olay sttons, an so pysans a not

awa o t latst vn o vn nt dA

appovals. o all o ts asons, otn tatnt

o m s not vn-bas, pos on a tal-

an-o bass, an an ontn lon t wt-

ot snt ay. many patnts tak ltpl

atons o m syptos. glns o

Dr. Agin (Pain Specialist):When I prescribe a medi-

cation for my patient, and the patient attempts

to fill the prescription, the prescription may be

denied by their pharmacy plan outright or may

require prior authorization. A tedious process

begins. My office calls for authorization; the

pharmacy plan sends paperwork; our office

completes the paperwork and returns it. If the

patient actually fits their criteria and can get the

medication, the process can delay starting the

medications by days to weeks, or they can still

be denied after all of the paperwork is submit-

ted. If the patient is scheduled to follow up with

the prescribing physician in 2 weeks to see

how they are tolerating the medication, this

becomes an unnecessary office visit for both

the patient and the physician as the patient has

not yet had an adequate trial.

Dr. Flood (Rheumatology): It is very frustrating

I think for everybody involvedtrying to take

care of patients, and lots of confusion is gen-

erated when we are asked to use medicines

off-label for a condition. So we are sending a

lot of mixed messages, I think, through these

step-edits. I think there is a good opportunity

to rehabilitate that whole process.


11/22



oanzatons s as al spalty sots

lp lnans tat any ot sos; pat-

al lns o m wol b wlo.

Sval oanzatons av pbls -

lns o m n ts a (tabl 2). Ts

lns av o patal an abott ntaton an tatnt o a onton

tat an b lt to nty. moov, t

lns av sp ssson aon pa-

tn pan spalsts, atolosts, sa

nvstatos, an ots as to t nat an

tatnt o m an wat qstons stll n

to b answ. establsnt o lns n an

aa s as m s a stp towa pov an-

ant by povn pysans an patnts

wt a annl to nty potntal tapt

optons an a bas o w to vlop ollab-

oatv tatnt plans. in say, t nt

m lns a a sbstantal aly attpt to

n an otn snstoo sas stat an

t tatnt optons o t.

howv, t ost nt pbls lns

o m tatnt a 2 to 4 yas ol, w s alatvly lon t n an nvonnt o aply

ann snt nstann. Wn assss-

n t slnss o t nt lns, t s

nssay to balan t stnts an bnts

wt so waknsss, paps t ost appa-

nt o w s t pblaton bo t dA

appovals an ot potant nw vn.

Current Guidelines or FM

T Aan Pan Soty (APS) vlop

vn-bas lns o m anoss an

n Table 2. Current Fibromyalgia (FM) Guidelines

Association Objectives Methods Results

APS

(American Pain Society)

To provide evidence-based

guidelines or diagnosis

and management o FM

syndrome in children and

adults and to improve

quality o care

Review o clinical trials and

meta-analyses

Rating scheme ranked evidence

Guidelines reached by consensus

o interdisciplinary panel o

13 experts

Guidelines or diagnosis based

on American College o

Rheumatology criteria and other

symptomatic assessments

Guidelines or specic pharma-

cologic and nonpharmacologicinterventions

EULAR

(European League

Against Rheumatism)

To develop evidence-based

recommendations or

the management o FM

syndrome

Systematic review o pharmaco -

logic and nonpharmacologic

intervention studies

Rating scheme ranked evidence

Recommendations reached by

consensus o task orce o

19 international European

experts

2 General recommendations or

recognition/diagnosis and

multidisciplinary approach to

management

4 Recommendations or

nonpharmacologic management

4 Recommendations or

pharmacologic management

OMERACT

(Outcomes Measures

in Rheumatology

Clinical Trials)

OMERACT 7:

To identiy and prioritize

symptom domains to be

consistently evaluated in

FM clinical trials and

identiy domains and

outcomes measures or

research agenda

OMERACT 8:

To reach consensus on core

domains, evaluate outcomes

measures in recent trials,

conrm research agenda

Delphi exercise o 23 FM

researchers established

preliminary prioritization

Patient ocus groups and Delphi

exercise established patient-

identied core domains

OMERACT 7 and 8 workshop

attendees developed prioritized

list o core domains and

research agenda

Core domains and outcomes

measures were identied,

including patient global,

multidimensional unction,

dyscognition

Composite response (patient

improvement in >2 parameters

simultaneously) recommended

as outcomes measure or

clinical trials/research agenda

Sources: Burckhardt CS, et al. American Pain Society;2005. Goldenberg DL, et al. JAMA. 2004;292(19):2388-2395. Carville SF, et al. Ann RheumDis. 2008;67(4):536-541. Mease PJ, et al. J Rheumatol. 2005;32(11):2270-2277. Mease P, et al. J Rheumatol. 2007;34(6):1415-1425.


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rpots


tatnt.20,36 A onsnss panl o 13 xpts n

pan anant splns po a o-

pnsv vw o 505 p-vw lnal

tals an ta-analyss o t pn 25

yas.20 glns w a by xpt on-

snss an t s o a atn s ankn tvn o tatnt ay as ston, o-

at, o wak.20 T lnal tals s Acr

ta o m an as pan otos on

t boyala ipat Qstonna (iQ).20

T APS lns on o anoss

an assssnt a oplt stoy an pys-

al xanaton, nln laboatoy tstn;

lnal anoss bas on Acr ta, o-

pnsv pan assssnt (typ, qalty, loa-

ton, aton) an t on QOL; assssnt

o svty o ot m syptos, pat on

pysal/otonal nton an ovall QOL.36

Bas on t at vn, t APS lns

on ltpl stats o tatnt,

nln bot paaolo an nonpaa-

olo taps, wl stssn t potan

o patnt aton (tabl 3).20 T panl on

ston vn o cBT, aob xs, an

patnt aton.20 in paaolo taps,

t panl on ston vn o atptyln

an ylobnzapn, an oat vn tosppot t s o SNris, SSris, taaol, an

pabaln.20

T APS lns av so ltatons.

T valat sts a tonos tat-

nts, sot atons, an nonsstnt blnn

an ontols, w lts t nalzabl-

ty an patal lnal applaton. All o t

valat sts o bo t dA ap-

povals o m o pabaln, loxtn, an

lnapan. most o t sts os on pan

ton to t xlson o ot syptos an

otos nln patnt lobal povnt

an pov pysal nton. nally, any o

t tatnts sss n t lns stll

lak dA appoval o m to at an t osnt

n Table 3. Comparison of APS and EULAR Guidelines for Fibromyalgia (FM) Management

NonpharmacologicTherapy Pharmacologic Therapy Limitations o Study Analysis

APS

(American Pain

Society)

Strong evidence:

Patient education

CBT

Aerobic exercise

Multidisciplinary therapy

Moderate evidence:

Strength training

Acupuncture

Hypnotherapy

Bioeedback

Balneotherapy

Strong evidence:

Amitriptyline 25-50 mg/d

Cyclobenzaprine 10-30 mg/d

Moderate evidence:

SNRIs (milnacipran,

duloxetine; mixed

evidence or venlaaxine)

SSRI (fuoxetine 20-80 mg/d)

Tramadol 200-300 mg/d

Anticonvulsant (pregabalin

300-450 mg/d)

Heterogeneous treatments in studies

Study durations generally short term

Some studies unblinded and/or

uncontrolled

Outcomes measures oten exclusively

pain without assessment o

improvements in patient global,

physical unction, etc

All studies predated FDA approvals o

3 FM pharmacotherapies

Some agents listed still lack FDA

approval or FM

EULAR

(European LeagueAgainst Rheumatism)

Balneotherapy (Grade B)

Individually tailoredexercise including aerobic

and strength training

(Grade C)

CBT (Grade D)

Others: relaxation, rehabilita-

tion, physiotherapy, and/or

psychological support

(Grade C)

Tramadol (Grade A)

Analgesics (paracetamol/acetaminophen, weak

opioids) (Grade D)

Antidepressants (amitriptyline,

fuoxetine, duloxetine,

milnacipran, moclobemide,

pirlindole) (Grade A)

Tropisetron, pramipexole,

pregabalin (Grade A)

Outcome measures other than pain

by visual analog scale and unctionby FIQ specically excluded

Other limitations similar to those o

APS above

CBT indicates cognitive-behavioral therapy; FDA, US Food and Drug Administration; FIQ, Fibromyalgia Impact Questionnaire; SNRI, serotonin andnorepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor.Sources: Burckhardt CS, et al. American Pain Society; 2005. Goldenberg DL, et al. JAMA. 2004;292(19):2388-2395. Carvil le SF, et al. Ann RheumDis. 2008;67(4):536-541. Lyrica prescribing inormation.


13/22



appa tat any o ts ants wll b sbtt

to t dA o onsaton o appoval.

T eopan La Aanst rats

(euLAr) vlop lns o m ana-

nt bas on bst vn an xpt opn-

on (Tabl 3).37 A panl o 19 m xpts o11 eopan onts po a systat

ltat vw o 146 lnal tals pbls

o 2002 to 2005 tat s Acr anos-

t ta o m an os on m ana-

nt.37 T panl a 10 onatons

o m anant nln 2 nal o-

natons, 4 on paaolo tatnts, an

4 on nonpaaolo tatnts; a lts-

plnay tatnt appoa was pasz. T

panl on ston vn o antpssants

to as pan an pov nton, spy-

n lnapan, loxtn, atptyln, f-

oxtn, olob, an plnol. Ty

on ston vn o pan anant wt

taaol, pabaln, topston, an papx-

ol, an also on onsn spl

analss (paataol [atanopn]) an

wak opos.37 Sval nonpaaolo tat-

nts w also on. Waknsss o t

euLAr lns a sla to tos o t APS

lns an nl sa vn an ap-

povals sn t pblaton tat n so o

t noaton obsolt.

T Oto mass n ratoloy cln-

al Tals (OmerAcT) m woksop, a op o

21 ntnatonal sa an lnal xpts, pb-

ls a onsnss statnt tat a potant

avans n potzn o sypto oans

by nln patnt psptvs (tabl 4).10

T m woksops at OmerAcT 7 n 2004 an

OmerAcT 8 n 2006 w oanz to vlop a

onsnss ntyn an potzn ky m syp-

tos as o oans an to valat an stan-

az oto ass o lnal tals o m

taps.10 in aton to wll-stabls ta

s as pan, at, an slp qalty, OmerAcT

a as ssntal valaton ta patnt lobal,

ltnsonal nton, alt-lat QOL,

ysonton, an stnss.10 OmerAcT also -

pasz t val o opost spons (patnt

povnt n >2 paats sltanosly) as

an otos as. T onsnss statnt

not, T ablty to ns lnally annl

an n ltpl nsons o boyala t-

lzn a opost spon nx s sabl.10

Wn t OmerAcT onsnss statnt was

pbls, ost lnal tals o ost s s o

m a not nl opost spons. T pv-

otal tals o lnapan av nl opost

otos ass, an t ontabl patpants

op tat opost spons wll b nl n

t m sa as sp by OmerAcT.

n Table 4. OMERACT Addressed the Multiple Dimensionsof Fibromyalgia

Key Evaluation Criterion

Portion o Respondents Rating

Criterion as Essential, %

Pain 100

Fatigue 94

Patient global 94

Multidimensional unction 86

Tenderness 74

Sleep 66

Health-related quality o lie 65

Dyscognition 61

Stiness 60

OMERACT indicates Outcome Measures in Rheumatology Clinical Trials.Adapted rom Mease P, et al. J Rheumatol. 2007;34(6):1415-1425.


14/22

rpots


FM Guidelines and Current Knowledge About

Pharmacotherapies

many xpts, nln t AJMC ontabl

patpants, ons t nt m lns to

av lt tlty o patn lnans an

pays. On potant ason s tat t lnso not ft t dA appovals o 3 ants o

m. T lns p t dA appov-

als, so t paaolo tatnts sss

w by nssty o-labl (nln tos tat

lat v appoval). many s a s o

t ontol o nt m syptos, nln

SNris, antonvlsants, tyl antpssants

(TcAs), sl laxants, SSris, opos, non-stoal ant-nfaatoy s (NSAids), an

ylo-oxynas (cOX)-2 nbtos.9,19,38 how-

n Table 5. FDA-Approved Agents for Fibromyalgia (FM)

Lyrica41

(Pregabalin)

Cymbalta40

(Duloxetine Hydrochloride)

Savella39

(Milnacipran Hydrochloride)

Date o FDA approval Initial: 2004 (as an anticonvulsant)For FM: June 2007

Initial: 2004 (as an antidepressant)For FM: June 2008

January 2009 (indicated only orFM)

Mechanism o action Alpha2 delta ligand SNRI SNRI

Indications Neuropathic pain associated withdiabetic peripheral neuropathy,postherpetic neuralgia, adjunctivetherapy or partial-onset seizures,FM

Major depressive disorder, gen-eralized anxiety disorder, diabeticperipheral neuropathic pain, FM

FM

Studies that established

efcacy or FM

One 14-wk randomized, double-blind, placebo-controlled trial, one6-mo randomized withdrawal study

Two randomized, double-blind,placebo-controlled trials (3 moand 6 mo), 1 randomized, double-blind, dose-comparison trial

Two randomized, double-blind,placebo-controlled trials (6 moand 3 mo)

Primary end points/

outcomes measured

in FM pivotal trials

Pain reduction (VAS); improve-ments in patient global (PGIC) andunction (FIQ)

Pain reduction, improvements inpatient global (PGIC) and unction(FIQ)

Composite end point o painreduction (VAS) and improvementin patient global (PGIC). Also com-posite end point o pain (VAS),physical unction (SF-36 PCS), and

patient global (PGIC)

Recommended dose or FM 150-225 mg bid

75 mg bid

May increase to 150 mg bidwithin 1 wk

Maximum dose 225 mg bid

60 mg/d

Start 30 mg/d or 1 wk, increaseto 60 mg/d

50 mg bid (start 12.5 mg/d,increase on day 2 to 12.5 mg bid,on day 4 to 25 mg bid, ater day 7to 50 mg bid)

Maximum dose 200 mg/d

Warnings and precautions Angioedema, hypersensitivityreactions, peripheral edema

Suicidality in children, adoles-cents and young adults (allantidepressants); hepatotoxicity,orthostatic hypotension, sero-tonin syndrome (or neurolepticmalignant syndrome), bleeding,hypomania, seizures, urinaryretention, hyponatremia, altera-tions in blood pressure and bloodglucose levels. Interactions withinhibitors o CYP1A2, CYP2D6

Suicidality in children, adolescents,and young adults (all antidepres-sants); serotonin syndrome,elevated blood pressure and heartrate, seizures, hepatotoxicity,bleeding, hyponatremia, activationo mania, dysuria, narrow angleglaucoma, use with alcohol

Most common adverse

reactions

Dizziness, somnolence, dry mouth,edema, blurred vision, weightgain, diculty with concentration/attention

Nausea, dry mouth, constipa-tion, somnolence, hyperhidrosis,decreased appetite

Nausea, headache, constipation,dizziness, insomnia, hot fush,hyperhidrosis, vomiting, palpita-tions, heart rate increase, drymouth, hypertension

Scheduling and dependence Schedule V controlled substance;rapid discontinuation associatedwith withdrawal symptoms

Unscheduled; withdrawal symp-toms on abrupt discontinuation

Unscheduled; withdrawal symp-toms on abrupt discontinuation

FDA indicates US Food and Drug Administration; FIQ, Fibromyalgia Impact Questionnaire; PGIC, Patient Global Impression o Change; SF-36PCS, Short Form-36 Physical Composite Score; SNRI, serotonin and norepinephrine reuptake inhibitor; VAS, visual analog scale.


15/22



v, only 3 ants av v dA appoval o

ts naton: Savlla (lnapan),39 cybalta

(loxtn),40 an Lya (pabaln)41 (tabl 5).

dA appoval pls a lvl o stny an sp-

potn bas sa an lnal tal vn

tat s lakn o o-labl ss o s. in t aso t dA-appov m s, t lnal tals

sppotn t loxtn an pabaln appovals

a snln-pont otos ass, was

t pay n ponts o lnapan tals w

opost ass, a o opnsv as

o sltanos ay aoss ltpl syptos

vss plabo. Sn t nt m anant

lns pat t dA appovals, ty a not

nton n t onatons.

T dA-appov s o m blon to

lasss tat av onstat ay o m

anant. Pabaln s an antonvlsant, an

anoz ontoll tals av also sppot

t ay o anot antonvlsant, abapn-

tn.16,41 mlnapan an loxtn a SNris wt

onstat ay an saty n m; t so-

tonn- an nopnpn-ptak nbtn a-

tons ay ot ntonal ts n snn

patway pan possn.7,9,39,40 howv, 2 ot

SNris, vnlaaxn an svnlaaxn, av not

a ay o m stabls n lnal tals.9,42

So o-labl s a sss o on

n t lns,2,20,37 bt any s psb

o-labl o m ay av lt tlty o ts

ppos. clnal tal vn o t ay

an saty n m s lt o absnt. Sts av

al to on t ay o NSAids an cOX-

2s n m.13 Sot-t sts av onstat

so ay wt tyls, bt saty an tol-

ablty onns av lt t s.9,19 eay

n m lnal tals as not bn onstat

wt opos, w also ay t potntal o -

pnn an abs as wll as xabatn pan as

opo ypalsa.9,13 Only a w ontoll tals

av bn ont sn sl laxants o

m patnts, wt x slts.13 Taaol, w

obns so opo atvty wt SNri atv-

ty, ay av so ay, bt bas t sk o

wtawal syptos, abs, an sotonn syn-

o.7,9,12,43 Sts o SSris av sown ay

o oo an at n m, bt lt ay opan.13 To b optally sl, lns o m

anant sol ons t dA appovals,

lnal sts o s appov o m, an t

latst vn an all ants s oonly

on- an o-labl.

T nt lns also o not ft p-

at analyss o m tatnts. Two nt sys-

tat vws, w w oplt at t

nt lns, a sbstantally to t vn

bas an snt nstann o m tapy.

Nssnya t al systatally vw 10 an-

oz, plabo-ontoll tals o atptyln

o m.44 Alto atptyln 25 /ay was

assoat wt snant povnts n so

syptos, atptyln 50 not po s-

nantly btt tan plabo.44 O t 10 sts,

8 a atons o only 8 wks,44 an t 8-wk

ay sown o atptyln 25 was not ob-

sv at 12 wks n t sty o tat lnt.44 T

10 sts not pot avs vnts onsstntly

an oosly.44 T atos onl tat no v-

n sppots t ay o atptyln at oss

tan 25 /ay o o lon tan 8 wks.44

hs t al po a ta-analyss o 18 an-

oz, plabo-ontoll tals o antps-

sants s o m, nln TcAs, SSris, SNris,

an onoan oxas nbtos.25 T atos

on ston vn o ay o so o t

ants, bt not patnt pns an oo-

bts lat to potntal avs ts o ts

s sol b ons bo ntatn tat-

nt.25 T ta-analyss a sval ltatons.

it ol not opa lasss o nval s

bas o t nt obnatons o a-

Dr. Dunn (Managed Care): When we see [fibro-

myalgia] patients, they are on generic SSRIs,

generic muscle relaxants, generic antidepres-

sants, and opioids. What drives pharmacy

costs are [long-acting] opioids, which are

known to be generally ineffective.

Dr. Flood (Rheumatology): We have no data

about the safety of any of the [older] nonap-

proved drugs in FM patients. Whereas for the

approved agents, the FDA requires trials to

report safety data, and the FDA is watching

out to make sure that the safety data are rel-

evant and honest.


16/22

rpots


tons allow n a sty. most sts w only

8 wks n aton. A spaty n sapl szs b-

twn lasss (, sall n n TcA tals an

la n n SNri tals) ol at t o o

obsv t szs. Not nl w t pas

3 pvotal tals o lna-pan, otos assss-nt o opost spons o pysal nton,

o ssson o attbts o atons tat ay

at oplan, s as tolablty an t po-

tntal o ntatons.

T nt lns o m anant p-

at ts 2 analyss, w wol appa to wak-

n t as o so o-labl s on

n t lns.

Challenges or FM Guidelines

T AJMC ontabl patpants obsv

tat t nt m lns a not oonly

s by pysans o pays to ak tatnt o

olay sons. So pysans, spally

PcPs, n t lt to kp nt wt t latst

lns o t any sos ty tat an a

not ala wt t lns o m. glns

n nal an sots b too sttv to ap-

ply to t nq ns o nval patnts wt

any so, an nvalzaton s al n m

tatnt. Patpants not tat lnans sol

t lns to t patnt, not t patnt to t

lns. espally lns a ollow -

ly n olay postons, ty an b too st-

tv to nvalz patnt a an tat patnts

aly an tvly.

in t ssson, t ontabl pat-

pants onl tat t nt m lns

av lt patal tlty. Ty lak a stat-

owa on tatnt alot (al-

to an alot ol b lt bas a

m patnt as a nq st o syptos an -qs nvalz tatnt). mo potant,

t slnss o t latst pbls lns as

bn lt by t ap an n t sa

an lnal ls o m. T lns p o

o not ons nt dA appovals o 3 ants

o m o t pvotal tals, an so lns

ay ovpasz TcAs. T lns o not

nl vn o t latst systat vw

analyss. T otos asnts n tals

t o t APS an euLAr lns o not

nl valaton ta ssntal by

patnts an pysan xpts, as on

by OmerAcT. Patpants obsv tat -

lns an b obl- swos, s not only

to noa t s o tan tatnts bt to

jsty soan ot tatnts tat ay b

lpl o nval patnts. in t as o m,

pysans ay b o to s nappov s

o-labl bo tyn dA-appov s. o

lak o lns tat ft t latst nns,

lnans, ana a oanzatons, an ot-

stakols av vs nstanns an

vws on bst pats o t tatnt o m.

clnan psbn pats vay wly, an

ana a os not av sas anant

ntatvs n pla o m patnts.

upat lns o t anoss an an-

ant o m sol ft t aply ann

lansap o snt nstann an avan-

s n sas anant. Ty sol nan

lnan aton as wll as lnal pat, b-

as ty ol t ltz m an lay

nstann o t sas poss. halt plans

ol lp avan ts al aton by s-

Dr. Goldenberg (Rheumatology): I think I use guide-

lines and most people use guidelines to help

with our gestalt about what is an appropriate

individual therapy. Of course, the limitations

with guidelines in rheumatoid arthritis or in FM

are that its such an individual condition. So weas clinicians have to be aware of the fact that

it just gives us another way to think about the

condition.

Dr. Draud (Psychiatry): When you see real people

who have real disease, patients symptoms

dont always match the treatment guidelines. I

think its helpful to have them [guidelines], but

I treat symptoms, not rigid diagnostic criteriaand guidelines.

Dr. Beltran (Managed Care): In our organization

clinical guidelines never replace physicians

clinical judgment and experienceand ulti-

mately when the guideline doesnt fit the

patient, we defer to the physicians clinical

judgment and expertise.


17/22



snatn nw lns to lnans. upat

lns ol also noa t asn o -

nt olay sttons on ass to tv

m tatnts. T nt m lns a

aly s n olay vlopnt posss;

owv, o sl lns wol b wl-o. T nw lns sol b a to-

wa optzn t 3 tal oto oans o

m: lnal, ono, an QOL.

To npn an stntn nw lns, o

opaatv lnal tals a n to valat t

ay an saty o taps o m. Alay

avalabl to nl a t dA-appov ants

an t sppotn pvotal tals, w sol b

vn onsaton n pat lns. Also

avalabl a t nt ta-analyss sss

abov, w lay t vn to at an

so ants. Atonal nw a-to-a st-

s wol o valabl vn an lp solv

ontovss ov onftn ata. Nw tals an

nw lns sol ons patnt psptvs

(, by sn OmerAcT ta an opost

spons oto ass). glns sol

onz aly anoss an appopat tatnt,

tby pvntn t ntonal toaton,

psvn QOL, an alzn ost savns.

glns sol b s as a tool o optal

patnt a, w o m ans nvalza-

ton o tatnt. Otn tatnt nvalza-

ton an b bst av to a ollaboatv

ltsplnay ta, w t nl a

PcP, atolost, pan spalst, psyatst,

pysal tapst, an/o ots. Lstnn to t

patnts onns an vn onl an

ow to av a btt QOL wt a on llnss s

potant o optal otos an an b al-

tat by t atonal alta nonts tat

o wt ta tatnt. i t patnt os not

t lns, t ta an to lnal j-nt an xpn. evn wn tatn patnts

wt m wtot a ollaboatv ta, lnans

sol b abl to assss ts posson on t s-

as ontn an to lns ao-

nly. mana a ol vlop olas

an ntat on-a sas anant

poas tat n lns, t latst v-

n n t ltat, an a onsnss o vaos

spalsts wl allown fxblty o patnt

nvalzaton

Summary

T nt lns av bn an a a oo

attpt to nas awanss o m, a ltay

to t sas stat, an otln possbl tatnt

optons. howv, ty av sval ltatons,

nln t osson o nw tatnts an -

nt vn. upat o vs lns tat

nl so o t ost nt ata an noa-

ton ol bo an potant tool to a n t

sssl anant o m.

SECTION 3. CATEGORY MANAGEMENT

OF FM AGENTS: IMPLICATIONS FOR

PATIENT OUTCOMES AND UTILIZATION

MANAGEMENT

Summary o Roundtable Discussions o Issues

and Needs Relating to FM

T AJMC ontabl patpants a

tat to t pvaln, patnt bn, an

osts, all m patnts sol b anos an

ana appopatly. Ty also a tat

an oppotnty to at povs abot m

anoss an anant xsts; s a-

ton ol pov patnt otos an low

osts. T patpants not tat pysans

av sval os at t sposal to tat m,

nln 3 dA-appov ants, alon wt

nonpaaolo tatnts an so o-labl

atons. Ty on nt lns to

b a asonabl attpt to nty appopat

tatnts, bt not t lns a otat,

Dr. Flood (Rheumatology): I think in terms of how

you develop guidelines and treatment deci-

sions, we are just at the dawn of a new era in

American medicine. The president has placed

in the stimulus bill billions of dollars to do

comparative effectiveness studies. Those are

some of the areas that researchers need tolatch on to, so we can question whether there

is a difference between amitriptyline and a dif-

ferent drug, and whether there are variabilities

based on patient characteristics. These are

doable trials; we just need the researchers to

have the opportunity and the funds to do it.

Those funds are available as they have never

been before.


18/22

rpots


not wly s by plans o povs, an av

ltatons. Patpants a t bst ana-

nt appoa o m wol allow patnts opn

ass to all avalabl tatnts, wt nv-

alz tatnt sons a jontly btwn

t pysan an patnt. Patpants not tatnt ass to dA-appov ants to tat

m s otn stt, allow only at al

o tatnt wt ot ants (typally n

s), o w m s an o-labl s. Ts s

a oon pat o any al ontons,

nln m, n ana a nvonnts.

dssson tn tn to stablsnt o an m

atoy on pay olas as a stp towa l-

tzn t sas stat an atn pov-

s abot dA-appov an nondA-appov

tatnts.

Formulary Categories and Access to Treatment

A sp tapt atoy o m wt-

n pay olas os not xst wtn ost

olas toay. Ts, alon wt a lak o -

anoss on on pspton las, aks t

lt o alt plans to tak t pvaln o

t sas. Ts nablty to tak m ay av

lp pptat a sant awanss o t sas

n ana a an nattnton to t n on

sas anant plans, atonal poas,

an ot ntatvs. Lak o a atoy o m

also ans tat t s s (o-labl) o m

a on n ot atos bas on t ap-

pov natons. evn 2 o t dA-appov

s o m a lass n 1 o o ot at-

os bas on t appovals o ot on-

tons, w otn a t pay naton.

dloxtn ay b on n psson an/

o pan anant. Pabaln ay b lst

n antonvlsants an/o pan anant.

mlnapan, owv, s t st wt dA

appoval o m only, an no ontabl pat-

pant was awa o any olay wt a atoy

o m.

catoy qnts o t unt Stats

Paaopa (uSP) ay nfn ma Pat

d olay vlopnt n nsn tat s

n t atos a nl. T uSP ntly

lsts loxtn an pabaln n t pay

tapt atoy only (loxtn n an-tpssants, pabaln n antonvlsants).

T uSP olay as bn pat annally,

bt n ant wt t cnts o ma

& ma Svs (cmS), uSP s on to a

3-ya pat yl, lavn lna-pan -

ntly wtot a atoy. ma Pat d alt

plans a not q to ollow t uSP ol

olay o atozaton, bt ty a as

aanst t. As o oal olas, alt

plans qntly kp t oal an m-

a olas onsstnt, bt t plans a

to pos ltatons o sttons. Ts uSP -

qnts ay av a an nt nfn on

t vlopnt o olas tat o not nl

t dA-appov tatnts n an m atoy.

T lak o a atoy o m ay ntly

at patnt ass to appopat tatnts,

nln tatnts nat by t dA. o-

las oonly ontol ass to t dA-

appov s o m; loxtn an pabaln

s s stt on appoxatly al o o-

al alt plans.

Pobls wt ass to tatnt ontbt

to m patnts ssatsaton wt t alt-

a. A natonal patnt svy ont by

t AP an Natonal boyala Assoaton

(NA) onstat wspa nsan o

ana a pobls.45 coon lts

nl noplt ova o pan tatnt

optons, lays n patozaton an ass to

dA-appov atons, polon appals

posss, an pttv nals o ova.

45

Dr. Lee (Internal Medicine): With new medica-

tions, its very difficult to get approval [insur-

ance coverage]. There is a lot of paperwork, a

lot of step therapy, and it gets the physician

and patient frustrated. When they dont get

approved, they will often just give up.

Ms. Brown (Patient Advocacy): What a lot of these

barriers dois further delay the appropriate

care and management of these patients

making the condition far worse. So, what we

need to do is get to early intervention through

recognition and care thats appropriate and

that doesnt have other burdens from access

to care as well as the willingness to pay for

that care.


19/22



So o ts pobls t b lat to t

lak o an m atoy on olas. Wtot

a atoy o m, alt plans ay not av a

nq, opnsbl m tatnt paa

tat laly nts dA-appov taps.

Otn patnts tll t pysans abot t

ova pols, w an psbn

pats. m patnts lookn at olas ay

not s a ty an assoat wt t sas.

Lak o a atoy o m t la pysans an

patnts to look at atos lk pan anant

an possbly oos lss appopat tatnts,

s as opats. Pysans an slt any ,

bt any av lt aton on m o t 3

dA-appov ants. Ts t lak o a atoy

ay lav patnts as wll as t PcPs wtot

an o t alt plan o appopat m

anant.

Categorizing FM on Formularies to Beneft

Patients, Clinicians, and Payers

most potantly, t ontabl patpants

lt tat a nw atoy o m on pay o-

las ol lp ltz t m sas stat.

Patnts an pysans wol b abl to s t

sas lst n t olay at tan avn

to sa to sla atos o so-

tn tat ay apply to t staton. gat l-

tay o m wol noa o sa

ntst, btt pbl awanss, lss sta o pa-

tnts, an possbly o ovnnt nn o

sa. gat ltay ol to -

t t avannt o al poss aanst

ts on, bltatn sas.

A nw atoy wol also as awanss

o m as a anoss to ons. it wol lp

alt plans onz t anoss an ato-

z appopat tatnt. it wol also no-

a aton by lnans wo stat to anos

o tat to onson o snstann

abot t sas. A nw atoy wol sppot

t n o ntvnton n m, tby papslpn t t an ot wast on n-

aat anoss.

A nw m atoy wol sv as pat o a

boa ntatv to at t al o-

nty an patnts abot t m sas stat.

T atoy wol sppot t n o btt

aton nt n Ston 1 o ts sppl-

nt. Btt aton, n tn, an la to bt-

t otos. A nw atoy wol o m

patnts t valaton an assan ty n

wl lpn t lan abot t sas.

A nw atoy wol at povs abot

m an lp spaat lnans tnkn abot

tatn m o t tnkn abot tatn

pan alon, psson, anxty, o an nknown

anoss.

A nw atoy wol t at patnts

an pysans abot t optons avalabl o

m. Optons psnt n t atoy n o-

al plan olas wol nl t 3 dA-

appov ants. (Ot ants, s as TcAs,

ol b lst wt notatons tat ty o not av

dA appoval.) Lstn t dA appovals wtn

t m atoy wol noa appopat on-

labl tlzaton. in patla, appopat ato-

zaton o lnapan, w s nat only o

m, wol noa appov on-labl tlzaton

an soa t o-labl psbn tat ol

o t w lass n a non-m atoy.

A atoy o m wol ontbt to -

pov anant o m s by pays, as

Dr. Jain (Psychiatry): Legitimacy is what this dis-

order is begging for. Anything that can add to

the legitimacy will serve everyones interest

here. I look at formularies as one more layer

of protection for me, because I know they are

watching out or reading the picture at a level

that Im not, maybe. I actually like the fact that if

your plan says FM is the category and this drug

is approved, I know they have looked at it. I like

that. I know clinicians and primary physicians

like it too.

Ms. Brown (Patient Advocacy): If [milnacipran]

goes to its own category, its an opportunity

for the patient advocacy groups to design

outreach information to our constituents to

help them be better informed and how to askthe right questions. Not only would they say,

I saw this in a magazine, can I take this?

They can also look and determine whether it

is available through their insurance company.

If it isnt, they can ask why not and continue

with the inquiry.


20/22

rpots


t povs an oppotnty to lst an lnat

ants wt povn ay an tvnss.

Alto ntaton o m by pa-

ay ata alon s poblat, s o tat n-

oaton obn wt al tlzaton

ata an o aatly nty m patnts

an pov a plato o otos sa.

Wt ts o o ntat ata, assssnt

o ost-tvnss bos a alty an pts

pays n poston to btt bnt ov-

a o m tatnt an sas ana-

nt plans. Ts ol la to at patnt

ass to t ost tv tatnts an

stll nabl alt plans to ana tlzaton.

iplntaton o a nw m atoy wol vay

by oanzaton, an t poss to at s a

lass o atoy o m ay nl:

A literature review to establish an evidence

bas o ay an saty ata

Discussion with plan clinicians, including con-

sltaton wt xpt spalsts n nt

aas (pan, atoloy, noloy, t)

Consideration of FDA approvals, govern-

nt lns an avsos, an -

lns/statnts o al oanzatons

Inclusion of unapproved drugs with effec-

tvnss vn o m, bt wt annota-

tons to t lak o dA appoval Cost considerations or cost/benet analyses

o nval s to b lst n t

olay.

Summary

T AJMC ontabl patpants a

tat a spaat atoy o m n ola-

s wol t ltz m as a nq on-

ton an sppot aton o t al an

patnt onts. Wt ts stp owa, all

ky stakols, nln pysans, pays,

an patnt avoats, an wok ollaboatvly

on bal o t patnts to altat al a-

at anoss an o appopat tatnt,

nln pov patnt ass to t ost -

tv tatnts. Aat anoss an sa,

tv tatnt wll satsy t 3 tal ot-

os tat a t nq alln o m:

Clinical: allvatn syptos an pov-

n patnts pysal nton

Economic: n t t an n-

t osts assoat wt m

Dr. Lee (Internal Medicine): The thing is educa-

tion. Knowing that there is a category for

any condition, let alone FM, stimulates the

decision to look into the options and the evi-

dence behind it. For the patient, its actually

good, because we can then tell them what the

efficacy is. I think this is a way to open up a

dialogue.

Dr. Dunn (Managed Care): I think the way it could

be used is more of an educational approach,

which would be the purpose of having a

category.

Dr. Goldenberg (Rheumatology): A responsibility

for managed care is determining the most

cost-effective care for your clients. And I think

we have shown you that making a diagnosis

of FM is very important in cost-effectiveness.

It saves patients, doctors, and the government

money. We know that for sure. There is a lot

of data, and categorization might help you

with that.

Dr. Bitton (Managed Care): Guidelines are used in

the review of new products; and when those

products come up for review annually, we

will take into consideration changes to those

guidelines, as well as discussions from the

community, physicians, and from among fel-

low pharmacists.

Dr. Draud (Psychiatry): There has been attention

with regard to cost versus care versus patient.

The fact is we are on the same team, and there

shouldnt be this tension against managed

care. The bottom line is the patient is supposed

to be our primary focus. If, in fact, we raise

the level of awareness and education and help

everybody get on the same page, costs will go

down if we treat the illness earlier.


21/22



Quality o lie: pvntn sablty an

antann ploynt an soal n-

volvnt, tby povn QOL.

Participant Ailiations: o t dpatnt o Pan

mn, Assoat Posso, clnal Anstsoloy,Stony Book Sool o mn, Stony Book unvstyhosptal, Stony Book, NY (cWA); Otpatnt Svs,mona halta, ivn, cA (rB); Paay Svs,halt Plan o Nvaa/Sa halt & L, Las Vas,NV (rKB); conatons dpatnt, Aan Panonaton, Stsb, md (mAB); ost rsainsttt, Jsy cty, NJ (rd, id); mal dto oPsyaty an Aton mn, Baptst hosptalan ml Tnnss mal cnt, Nasvll, TN(JWd); Slthalt, in, Salt Lak cty, uT (Jdd);msloskltal mal Spalsts, T Oo Statunvsty coll o mn an Pbl halt,colbs, Oh (J); aly mn, Asvll, Oh(d); Jons hopkns haltca, LLc, gln Bn, md(hg); Natonal boyala Assoaton, Ana, cA

(rmg); dpatnt o ratoloy, Nwton-Wllslyhosptal, an Posso o mn, Tts unvstySool o mn, Nwton, mA (dLg); Alt anPsyo-Paaoloy rsa, r/d clnal rsa,in, Lak Jakson, TX (rJ); intnal mn, Asboo,Nc (KL); an Navao Paa, LLc, gn cov Spns,L (rPN).

Funding Source: Ts spplnt was sppot byost Laboatos, in., Nw Yok, NY, an cypssBosn, in., San do, cA, uSA.

Participant Disclosures: T atos (cWA, rB,rKB, mAB, JWd, Jdd, J, d, hg, rmg, dLg, rJ, KL,rPN) w bs o t pa avsoy boa o ostan v paynt o nvolvnt n t ppaa-ton o ts anspt; an ploy o ost rsa

insttt (rd, id) an own o ost Laboatos stok(rd); onsltant/pa avsoy boa b (dLg, rJ),v onoaa (dLg, rJ), an attn tns/onns (dLg, rJ) o ost, Pz, an Llly, anv lt s (dLg) o Pz; attn t-ns/onns o Llly (rJ), an boa b o Llly,ost, an Pz (rJ).

Participant Inormation: conpt an sn (cWA,rB, rKB, rd, JWd, J, d, rJ, KL); aqston o ata(mAB, JWd, Jdd, dLg); analyss an ntptaton oata (rd, JWd, Jdd, J, d, hg, dLg, KL); atn ot anspt (cWA, rB, rKB, mAB, JWd, hg, rmg,dLg, rJ, KL); tal vson o t anspt o po-tant ntlltal ontnt (cWA, rB, rKB, mAB, JWd,d, rd, id, Jdd, J, hg, rmg, dLg, rJ, KL, rPN); anlp spply sos o ts spplnt (rmg).

Address correspondence to: robt P. Navao,Pad, Navao Paa, LLc, 411 Walnt St, #4641,gn cov Spns, L 32043. e-al: [email protected].

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Dr. Flood (Rheumatology): I think this is a crucialtime in the history of FM and its diagnosis and

management. I think and I hope that some

of the data that we have covered today will

help people understand that if we treat people

early, if we diagnose them accurately, then

we can save the healthcare system, and we

can save patients a lot of money and a lot of

suffering.


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contemporary management strategies for fibromyalgia

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