contemporary management strategies for fibromyalgia
TRANSCRIPT
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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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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.
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contpoay manant Stats o boyala
VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S199
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.
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contpoay manant Stats o boyala
VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S201
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
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contpoay manant Stats o boyala
VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S203
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
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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.
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contpoay manant Stats o boyala
VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S205
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.
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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.
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VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S207
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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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.
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VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S209
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.
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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.
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VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S211
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.
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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.
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VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S213
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.
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S214 n www.aj.o n JuNe 2009
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.
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contpoay manant Stats o boyala
VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S215
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.
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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.
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contpoay manant Stats o boyala
VOL. 15, NO. 7 n The AmericAN JOurNAL O mANAged cAre n S217
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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