SUPPLEMENT TO CareCare...Continuing education credit is offered to physicians and pharmacists who read pages 3 through 21 of this publication, complete the post-test on page 22, and

M A N A G E DSUPPLEMENT TO

Managed Care Best Practices In the Treatment and Management of PsoriasisBased on a conference in Orlando, Fla., Feb. 3, 2003

HIGHLIGHTS

• Overview of Psoriasis: Update on Current and EmergingTreatment Options

• The Cost of Psoriasis

• Managed Care’s Perspective on Treatment of Plaque Psoriasis

• SPECIAL PRESENTATION AND ROUNDTABLE DISCUSSION

Improving the Standard of Care for Patients With Psoriasis

CareCare

Volume 12, No. 5May 2003

Continuing education credit for pharmacists and physicianssponsored by The Chatham Institute

Supported by an unrestricted educational grant from Genentech

WELCOME MESSAGE

The Age of Biologics:We’ve Never Seen Anything Like ThisDAVID M. PARISER, MD, FACPProfessor, Department of DermatologyEastern Virginia Medical SchoolNorfolk, Va.

The emergence of biologic response modifiers for the treatment ofplaque psoriasis heralds a promising era for a patient populationthat has long been underserved. It’s going to be exhilarating to

have a curative therapy for psoriasis, and patients and physicians havehigh expectations for this paradigm shift in treatment. Managed care or-ganizations, too, will rapidly take noticeas the pharmacotherapeutic focus movesfrom older drugs to the new biologics.

The issues inherent in this transitionwere discussed at “Managed Care BestPractices in the Treatment and Manage-ment of Psoriasis,”a meeting in Orlando,Fla., Feb. 3, 2003. There, an expert panelof managed care medical and pharmacydirectors, dermatologists, clinical re-searchers, and employers learned aboutthe evolution of therapy, economic im-plications of the disease, and managedcare’s attitudes toward newer treatments.We also discussed the American Acad-emy of Dermatology’s (AAD) new consensus statement on treatment ofpsoriasis. These presentations are excerpted herein.

Are biologics better? We know from controlled clinical trials thatthese drugs are highly effective, compared with clinical outcomes formethotrexate, cyclosporine, and ultraviolet light therapies. It seemsclear that the newer agents are safe, and while information about long-term side effects is limited at this time, we do know the risks of admin-istering older therapies and the expenses associated with monitoring pa-tients for those side effects.

There is much work to be done. Patients are frustrated with their treat-ments and are looking for something new; managing their expectationswill be extremely important. Part of this involves educating the profes-sion, as not all dermatologists prescribe systemic drugs for patients withmoderate to severe psoriasis; the AAD will take a leading role in educatingphysicians. Another part involves the creativity that health plans mustadopt in offering coverage for biologics without allowing the cost of careto reach levels that would make these agents less accessible.

It’s an exciting time that offers a new opportunity to provide more ef-fective care for psoriasis patients. I encourage all parties, includinghealth care professionals and payers, to focus on providing these promis-ing new therapies to those who stand to benefit from them most.

D A V I D M . P A R I S E R ,M D , FA C P

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About this publication

This MANAGED CARE special supplement is made possible through an unrestricted educational grantfrom Genentech.

The opinions expressed herein are those of the symposium faculty, and do not necessarily reflectthe views of Genentech,The Chatham Institute, or the publisher, editor, or editorial board of MANAGED CARE.

Clinical judgment must guide each clinician in weighing the benefits of treatment against the riskof toxicity. Dosages, indications, and methods of use for products referred to in this special supple-ment may reflect the clinical experience of the authors or may reflect the professional literature orother clinical sources, and may not necessarily be the same as indicated on the approved packageinsert. Please consult the complete prescribing information on any products mentioned in thisspecial supplement before administering.

Managed Care Best Practices In the Treatment and Management of Psoriasis

A CONTINUING EDUCATION ACTIVITY

Continuing education objectives and accreditation statements ............................2

FACULTY PRESENTATIONOverview of Psoriasis:Update on Current and Emerging Treatment Options ...............................3CRAIG L. LEONARDI, MD

FACULTY PRESENTATIONThe Cost of Psoriasis ....................................................................................10WILLIAM H. CROWN, PHD

FACULTY PRESENTATIONManaged Care’s PerspectiveOn Treatment of Plaque Psoriasis.....................................................................14TERRY J. SULLIVAN, MD, MPH

SPECIAL PRESENTATION AND ROUNDTABLE DISCUSSIONImproving the Standard of Care for Patients with Psoriasis ......................18DAVID M. PARISER, MD

Post-test ...........................................................................................................22

Answer sheets and evaluation forms..................................................................23

Continuing education credit is offered to physicians andpharmacists who read pages 3 through 21 of this publication,complete the post-test on page 22, and fill out the appro-priate evaluation form on either page 23 (physicians) or 24(pharmacists).

Purpose and overviewThis activity is designed to educate health care practi-

tioners and managed care professionals about current andemerging treatments for plaque psoriasis.The narratives inthis section are excerpted from presentations and panel dis-cussions on Feb. 3, 2003, at “Managed Care Best Practices inthe Treatment and Management of Psoriasis,” held in Or-lando, Fla.

Recent developments in the etiology of psoriasis haveprompted development of new therapeutic agents.Biologicresponse modifiers under development and coming to mar-ket show promise in clinical trials, prompting physicians, pa-tients,and payers to request information about the status andeffectiveness of current and emerging therapies.The agendafor this meeting was developed on the basis of faculty per-ceptions of significant trends or issues.

Educational objectivesAfter reading this, the participant should be able to:

1.Discuss the prevalence of plaque psoriasis,etiology of dis-ease, and comorbidities in patients with moderate to se-vere psoriasis.

2. Describe the range of therapies available to patients withmoderate to severe disease.

3. Define mechanisms of action and the comparative effec-tiveness of biologic response modifiers for psoriasis.

4. Describe the management principles in the AmericanAcademy of Dermatology’s 2003 consensus statement ontreatment of psoriasis.

5. Illustrate the economic burden of psoriasis on the healthcare system and society at large.

6. Outline potential considerations for managed care orga-nizations as biologic drugs in the treatment of psoriasiscontinue to emerge on the market.

Target audiencesManaged health care professionals, including medical di-

rectors, pharmacy directors, and other senior managers inmanaged care organizations; primary care physicians; der-matologists; and pharmacists.

Continuing medical education accreditationThe Chatham Institute is accredited by the Accreditation

Council for Continuing Medical Education (ACCME) to pro-vide continuing medical education for physicians.

The Chatham Institute designates this educational activ-ity for a maximum of 1.5 category 1 credits toward the AMAPhysician’s Recognition Award. Each physician should claimonly those credits that he/she actually spent in the activity.This CME activity has been planned and produced in accor-dance with the ACCME Essential Areas,Elements,and Policies.

Pharmacy accreditationThe Chatham Institute is approved by the American Council

on Pharmaceutical Education (ACPE) as a providerof continuing pharmaceutical education.

This activity provides 1.5 contact hours (0.15CEU) of continuing education for pharmacists.Credit will beawarded upon successful completion of the post-test and theactivity evaluation.

ACPE Universal Program Number (UPN):812-000-03-013-H01.

Release date: May 12, 2003.Expiration date: May 11, 2004.

Planning committee membersDavid M. Pariser, MD, professor, Division of Dermatology,

Eastern Virginia Medical School;Timothy P.Search,RPh,grouppublisher, MANAGED CARE, published by MediMedia USA;Michael D.Dalzell,editor,Managed Markets Publishing Group,MediMedia USA.

Conflict-of-interest policy and disclosures of significant relationships

As an accredited provider,The Chatham Institute requiresthat its faculty comply with ACCME Standards for Commer-cial Support of Continuing Medical Education and disclosethe existence of any significant financial interest or any otherrelationship a faculty member may have with the manufac-turer(s) of any commercial product(s) or device(s). It also re-quires the faculty to disclose discussion of off-label uses intheir presentations.

David M. Pariser, MD, has a consulting relationship withAmgen Inc.,Biogen Inc.,Centocor Inc.,and Genentech.He ac-knowledges grant and research support from Amgen, Bio-gen,Centocor,and Genentech.He is on speaker’s bureaus forAmgen, Biogen, and Genentech.

Craig L. Leonardi, MD, has consulting relationships withAmgen,Biogen,Centocor,and Genentech.He acknowledgesgrant and research support from Amgen, Biogen, Centocor,and Genentech. He is on speaker’s bureaus for Amgen, Bio-gen, and Genentech.

William H. Crown, PhD, acknowledges grant and researchsupport from Genentech.

Leon Kircik,MD,acknowledges grant and research supportfrom Amgen,Berlex Laboratories Inc.,Calderma,and Genen-tech. He is on speaker’s bureaus for Allergan Inc., Amgen,Genentech, GlaxoSmithKline, and Novartis.

Adelaide A.Hebert,MD,has a consulting relationship withGenentech.

Michael Boskello,RPh;Humberto Guerra-Garcia,MD,MPH;Terry Sullivan,MD,MPH;and Pamella Thomas,MD,MPH,havedeclared that they have no financial interest, arrangement,or affiliation that would constitute a conflict of interest con-cerning this educational activity.

SELF-STUDY CONTINUING EDUCATION ACTIVITYManaged Care Best Practices in the Treatment and Management of Psoriasis

®

2 MANAGED CARE / SUPPLEMENT

SUPPLEMENT / MANAGED CARE 3

sion, arthritis, or cancer. Onlydepression exacts a higher tollthan psoriasis, as indicated byscores on the mental healthcomponent of the SF-36(Rapp 1999).

When psoriatic plaquesoverlie joints such as elbowsor knees, bending the jointscan crack the skin and causebleeding. About 400 deathsrelated to psoriasis occur eachyear due to suicide, metabolicproblems, and complicationsresulting from treatment(NPF 2001).

Most treatment-relatedcomplications have been attributed to methotrexate andcyclosporine, which, in recent years, have been the mostwidely prescribed systemic agents for psoriasis.

Systemic and phototherapiesMethotrexate. Methotrexate is approved by the U.S.

Food and Drug Association (FDA) for psoriasis andrheumatoid arthritis (RA), and it has been used quitesuccessfully in treating psoriasis. Twenty-six percent ofpsoriatics achieve PASI-75 (a 75-percent reduction intheir Psoriasis Area and Severity Index scores; see ac-companying article describing PASI, page 7) after 12weeks on a methotrexate regimen (Callis 2002).

A chemotherapy agent at high doses, methotrexate isthought to act as an immunosuppressant at low doses.Adverse effects of methotrexate therapy include nauseaand fatigue. It is also associated with rare cases of pneu-monitis.

Psoriatics on methotrexate must be monitored withcomplete blood count and liver function tests monthly.

FACULTY PRESENTATION

Overview of Psoriasis:Update on Current and Emerging Treatment OptionsCRAIG L. LEONARDI, MDAssociate Clinical Professor of DermatologySt. Louis UniversityCentral DermatologySt. Louis

Disease prevalence and overview

Psoriasis affects more than 7 million Americans.The National Psoriasis Foundation (NPF) esti-mates that nearly 2 million individuals have mod-

erate to severe disease. For these people, psoriasis is apainful, disfiguring, dispiriting chronic condition. Themean age of onset is 28 years, and 20,000 children under10 years old are diagnosed with psoriasis each year. Morethan 1.5 million psoriatics seek help annually, generat-ing overall treatment costs that may exceed $3 billion(NPF 2001). Table 1 (page 4) highlights the results of a2001 NPF patient survey.

The most frequently experienced psoriasis symptomsinclude scaling (reported by 94 percent of NPF respon-dents), itching (79 percent), skin redness (71 percent),skin tightness (31 percent), bleeding (29 percent), burn-ing sensation (21 percent), and fatigue (19 percent)(Krueger 2001).

Psoriasis is exceeded only by congestive heart failurein patient-reported physical disability scores on the ShortForm (SF-36) Health Survey. This means that psoriaticsexperience greater physical disability than people withhypertension, myocardial infarction, diabetes, depres-

Psoriasis has not received widespread atten-tion because, traditionally, dermatologistshave not had effective treatments for mod-erate to severe manifestations of the dis-ease.With a change in the understanding ofthe nature of psoriasis — from what hadbeen thought to be a skin disease to what isnow known to be an immune disorder —such therapies are now becoming available.

SUMMARY

C R A I G L . L E O N A R D I ,M D


After every 1,500 mg (about 2 years, for average treatmentregimens), patients must undergo a surveillance liverbiopsy to check for early signs of cirrhosis (Spuls 1998).

Cyclosporine. Another immunosuppressant, cyclo-sporine, also has been highly effective and extremelyfast-acting in treating psoriasis. More than three quartersof patients on cyclosporine achieve a 75-percent reduc-tion in PASI scores, but only 10 to 15 percent of derma-tologists prescribe it. Due to the nephrotoxicity associ-ated with cyclosporine, the FDA limits its use to 1 year.This is problematic, as treatment for psoriasis is lifelong.

Side effects include hypertension, dysesthesia, tremors,gingival hyperplasia, and hirsutism. Laboratory abnor-malities associated with use of cyclosporine include re-duced creatinine clearance, elevated cholesterol andtriglycerides, and decreased Mg2+ levels.

Retinoids. Oral retinoids, such as acitretin, have beeneffective against pustular and erythrodermic forms ofpsoriasis on the hands and feet. Nevertheless, choles-terol and triglyceride levels rise with these drugs, andmany patients do not tolerate unpleasant side effectssuch as cheilitis, xerosis, hair loss, skeletal hyperostoses,and calcification of ligaments and tendons. Becauseretinoids are teratogenic, this form of therapy is contra-indicated in females of childbearing age.

Only 28 percent of patients with plaque psoriasis re-spond well to retinoid monotherapy, which is typicallycombined with phototherapy to boost its efficacy.

Ultraviolet (UV) phototherapy. Several factors havelimited the usefulness of UV phototherapy, another treat-ment modality for psoriasis. The equipment (a UV-lightbooth in which the patient stands) costs between $13,000and $17,000 and requires dedicated office space. Conse-quently, only one quarter of the 10,000 dermatologists inthe United States offer phototherapy.

Access is problematic because patients must come tothe dermatologist’s office two to three times weekly forphototherapy sessions, a regimen that is inconvenient

and can compromise adherence to therapy. New narrow-band UVB light bulbs emit the wavelengths to which pso-riasis responds best. All forms of UV therapy, however,are associated with photodamage and an increased riskof skin cancer.

Phototherapy also is understood poorly by payers,who sometimes authorize two or three treatments in-stead of the 40 or 50 treatments needed to clear patientsof psoriasis and to prevent symptoms from returning.Treatment frequency usually is reduced after 2 monthsas tolerated. It also can be reduced further in summermonths.

In an effort to control or reduce symptoms, avoid in-tolerable side effects, and minimize risk, some derma-tologists switch from one therapy described here to an-other.

Topical agentsThe challenges that persist with phototherapy and

systemic oral medications may explain why topical treat-ments constitute 87 percent of current prescription treat-ments for severe psoriasis; phototherapy (21 percent) andsystemic oral drugs (18 percent) are far less utilized(Krueger 2001). A recent survey of medical dermatolo-gists (Molowa 2002) indicates that topical steroids con-stitute the most common therapy for treatment of severepsoriasis (prescribed in 45 percent of cases), followed byUVB phototherapy, calcipotriene, psoralen with ultra-violet A (PUVA), and methotrexate (Figure 1).

Topical steroids. These drugs retard the growth ofskin cells and reduce inflammation. Some steroids are po-tent but can cause skin damage if used too frequently.They are available in many forms, including lotions,ointments, and sprays.

Calcipotriene. This form of Vitamin D3 also slowsthe rate of cell growth. It is not as potent as some steroids,but is safer. Calcipotriene is applied as an ointment,cream, or scalp solution.

Other topical agents. Low utilization rates for othertreatment modalities suggest that many available treat-ments for psoriasis are not well accepted by dermatolo-gists. Tazarotene, a Vitamin A derivative, is a topicalretinoid. Often, it causes skin irritation and makes theplaque bright red before it clears. Coal tar, also known asGoeckerman therapy, has been in use for a century. Ap-plied to the skin, it is left to dry for two hours and givesthe odor of hot pavement. Anthralin, a Vitamin E deriv-ative, is another century-old treatment. It has no long-term side effects, but it can irritate the skin and stainsmost of whatever it comes into contact with.

Biologic response modifiersResearch during the last two decades has radically al-

tered dermatology’s understanding of psoriasis. Psoria-

TABLE 1 Psoriasis prevalence in the UnitedStates

Disease specificsSevere disease (>10% body surface area) 39%Mean age of symptom onset 31Mean age of respondent 54Demographics

Women 56%Men 44%White 94%Native American 2%

Some college education 73%Average annual income $64,000

SOURCE: KRUEGER 2001

sis now is understood to bean immune system dys-function rather than a pri-mary skin disorder.

This understanding hasled to the development ofmany new biologic agentsthat target the immunesystem. Four importantagents in this category arealefacept and efalizumab,which target lymphocytes,and etanercept and inflixi-mab, which target cyto-kines. Table 2 highlights thecharacteristics of the bio-logic drugs discussed here.

Alefacept. The FDA ap-proved alefacept for use onJan. 31, 2003, for treatmentof adults with moderate tosevere chronic plaque pso-riasis.

Alefacept is a recombi-nant fusion glycoproteinthat binds to leukocytefunctional antigen number3 (LFA-3) and has an IgG1graft to promote stability. Itbinds to CD2 on T and NKcells, and inhibits secon-dary signaling. It kills lym-phocytes, especially the so-called memory-effector(CD45R0+) cells, by inducing apoptosis. It is adminis-tered by intravenous (IV) push and by intramuscular(IM) injection.

Twenty-one percent of patients being treated withIM-alefacept achieved PASI-75 attheir primary endpoint (week 14),compared to 5 percent on placebo.Of the patients who had achieved aPASI-75 reduction, the effect waslong-lived. This subset of patientsmaintained a PASI-50 response fora median duration of 216 days (Bio-gen 2003).

Alefacept is slow-acting. An 8- to12-week course is necessary to de-termine if this drug will be effectivein a patient.

One of our patients entered the alefacept trial with aPASI score of 301 after having discontinued methotrex-ate. The patient received a weekly 15 mg IV dose of ale-facept for 12 weeks, and his PASI score started to declineduring the 12-week observation period. A second 12-


UVB light therapy

Topical steroids

Calcipotriene

PUVA

Methotrexate

Tazarotene

Acitretin

Coal tar

Cyclosporine

Vitamin E

Antibiotics

OTC moisturizers/emollients

Hydroxyurea

Sulfasalazine

FIGURE 1 First-line therapies for moderate to severe patients

SOURCE: MOLLOWA 2002

20012002

TABLE 2 Summary of leading biologic therapies

Alefacept Efalizumab Etanercept Infliximab

Administration IM or IV push SC SC IV infusionResponse Remittive Suppressive Suppressive RemittiveSpeed of onset + +++ ++ ++++Durability +++ + + ++++Efficacy ++ +++ +++ ++++Safety +++ +++ ++++ +Pediatric use ? ? +++ ++Monitoring Weekly CD4+ None None WBCFDA status FDA approval BLA PsA 1/2002 Phase 2

1/31/2003 Late 2002 Phase 3Intangibles 1st to market, Fast, Safety, PsA Complex,

remittive convenient indication last resort

SOURCE: COMPILED FROM PRESCRIBING INFORMATION AND/OR CLINICAL TRIAL DATA

1PASI is determined on a scale of 0 to 72.The U.S. Food and Drug Administrationconsiders a PASI score that exceeds 10 tobe severe disease.

5% 15%10% 20% 25% 30% 35% 40% 45% 50%

week course of therapy reduced his PASI score to 0,where it remained beyond the length of the study.

The adverse effects associated with alefacept during thetrials were mild and well tolerated. Its adverse-event pro-file was comparable to placebo except for chills (1 per-cent among subjects receiving placebo versus 6 percentof subjects receiving alefacept), with CD4+ T-cell countsbelow 250 cells/µL and generally mild uncomplicatedinfections that responded to usual treatments. Alefaceptwas associated with no reports of disease rebound/flareon discontinuation of therapy. Because it depletes lym-phocytes, CD4+ lymphocyte counts are monitoredweekly during treatment (Ellis 2001).

Efalizumab. Efalizumab is a humanized monoclonalantibody against the CD11a chain of LFA-1 and is self-injected subcutaneously (SC) once per week. It does notdeplete lymphocytes but does inhibit lymphocyte move-ment into the dermis and epidermis. It decreases epi-dermal hyperplasia, keratin-16 expression, and ICAM ex-pression, all of which are features of active psoriasis.

Efalizumab is convenient to administer, has a rapid

onset of action, and achieved statistical significance in allendpoints. Unlike alefacept, this is a quick-acting drug(with efalizumab, results began to differ from placeboafter two doses). Twenty-nine percent of 1,095 patientswith moderate to severe disease who received 1.0 mg/kgof efalizumab achieved a 75-percent reduction in PASIscores by week 12 (Koo 2002).

The manufacturer conducted a yearlong trial of the 82percent of patients who achieved at least PASI-50 after 3months of weekly injections. The percentage of patientsachieving a PASI-75 has increased during the 12 monthsof therapy, demonstrating that efalizumab exerts tightcontrol on psoriasis (Gottlieb 2002).

Two representative patients from phase 1 trials are il-lustrated in Figure 2. In response to one subcutaneous in-jection per week for 12 weeks, one patient’s PASI scoredeclined from 59 to 10, while that of the other declinedfrom nearly 17 to <2.

Figure 3 demonstrates the response of a representativepatient during the longer-term trial. After 1 year, theprevalence of lesions dropped from 44 percent of his


FIGURE 2 Efalizumab: phase 1 multiple-dose trial

SOURCE: AUTHOR, CLINICAL INVESTIGATION

Patient 602 Patient 608

Day: 0 91 0 91PASI: 59.1 10.0 16.6 1.4


A patient’s PASI score is calculatedby observing, measuring, andrecording the anterior and poste-rior body surface area of the head,trunk, upper limbs, and lowerlimbs affected by psoriasis, thendetermining the severity of thedisease.

Body surface areaThe patient’s palm, which is

roughly equivalent to 1 percent oftotal body surface area (BSA),serves as the unit of measure.Thus, a “3”would mean that anarea equivalent to three of the pa-tient’s palms is affected by psoria-sis.

Anterior plus posterior mea-surements are calculated for thehead, trunk, upper limbs, andlower limbs, then each is dividedby the percentage of BSA repre-sented by those areas.The headrepresents 10 percent of BSA, thetrunk 30 percent, upper limbs 20percent, and lower limbs 40 per-cent.The results are then con-verted to area scores from 0 to 6,according to the following table:

0 = None1 = 0% – 9%2 = 10% – 29%3 = 30% – 49%4 = 50% – 69%5 = 70% – 89%6 = 90% – 100%

For example, an anterior trunkmeasure of 3 plus a posteriortrunk measure of 4 equals 7, whichis divided by 0.3 (because thetrunk represents 30 percent ofBSA), yielding a total BSA of 23.3percent. Because 23.3 percent fallswithin the 10–29 percent range inthe above table, it converts to anarea score of 2.

Severity scaleNext, erythema, thickness, and

scaling on head, trunk, upperlimbs, and lower limbs are ob-served and ranked on a severityscale from 0 to 4:

0 = None1 = Slight2 = Moderate3 = Severe4 = Very severe

The severity total for each bodyarea is multiplied by the corre-sponding area score, and the re-sult is multiplied by the percent-age of the total BSA representedby each of those areas (10 percentfor the head, 30 percent for trunk,20 percent for upper limbs, 40 per-cent for lower limbs).The resultsare added together to arrive at thePASI score.

For example, adding erythemaseverity of 2, thickness severity of1, and scaling severity of 1 for thetrunk totals 4, which is multipliedby the area score for the trunk of 2(from above), yielding 8. Multiply-ing 8 by .30 (because the trunkrepresents 30 percent of total BSA)yields 2.4.This subtotal for thetrunk is added to subtotals for thehead, upper limbs, and lower limbsto arrive at the PASI score.

LimitationsMost dermatologists do not use

the PASI in clinical practice. PASIscores are used mainly for research.In clinical trials, the U.S. Food andDrug Administration requires thata drug achieve PASI-75, whichmeans a 75-percent reduction inone’s PASI score, for a certain per-centage of patients over time.

The PASI is an artificial measureof psoriasis and its degree of im-

provement. Although it roughlycorrelates to the degree of im-provement, achieving PASI-75 isdifficult.The PASI scale is sensitiveon the low end of the scale andweighted heavily on the high end;thus, it is not linear. Factually, it ismost useful as a measure of dis-ease and clinical outcomes in themoderate ranges.

Most of us who conduct clinicaltrials and who see many patientsrealize that PASI-75 is an extremelyhigh bar that is unrealistic and un-necessary in clinical practice. It isnot a tool that a managed care or-ganization might consider usingto determine outcomes, becausemost practicing dermatologistsare neither trained nor required to use it.

Granted, the PASI is repro-ducible, semiquantitative, andtakes into consideration “howmuch”and “how bad.”These arepositive aspects of the index.TheFDA, however, has encouraged thedermatological community andindustry to develop a better scor-ing system that simplifies theprocess and would be meaningfulto patients, physicians, and payersalike.

PASI: PSORIASIS AREA AND SEVERITY INDEX


FIGURE 3 Declining PASI scores during efalizumab therapy

SOURCE: AUTHOR, CLINICAL INVESTIGATION

20

18

16

14

12

10

8

6

4

2

0

(%)50

40

30

20

10

00 28 56 84 112 140 168 196 196

Days

252 280 308 336 364

PASI (left scale)

Body surface area (%)

body surface area (BSA) to 3 percent and his PASI scoredeclined from 18 to 7.

The mean time to recurrence of psoriasis (loss of 50percent of improvement) is 9 weeks. The rebound rate(125 percent of baseline PASI after 12 weeks) is 3 percent.The disease came back quickly after treatment wasstopped during the observation period and, therefore,efalizumab is likely to be used as continuous therapy. Ef-ficacy and safety were shown through 15 months of con-tinuous treatment in clinical trials (Genentech 2003).Continuous dosing appears safe and effective.

This agent is well tolerated. Adverse effects associatedwith efalizumab, which does not deplete lymphocytes, aremild to moderate flulike symptoms (e.g., headache, chills,myalgia) that occur after the first two injections. Rates aresimilar to placebo by the third dose.

A biologics license application (BLA) was submittedto the FDA for this agent in December 2002 and is underevaluation by the FDA for the treatment of moderate tosevere plaque psoriasis. Phase 2 studies are underwayfor psoriatic arthritis (PsA) and RA.

Infliximab. Several characteristics link tumor necro-sis factor (TNF) with the psoriasis disease process, mak-ing it likely to play an important role in psoriasis ther-apy. TNF is released by injured keratinocytes, and it ispresent in elevated levels in the psoriatic dermis and epi-dermis, where it regulates proinflammatory cytokines.

PASI scores correlate with TNF expression, and serumand lesional TNF levels decrease after effective therapy inrelation to the degree of clinical improvement.

One of two TNF-α drugs, infliximab is indicated forCrohn’s disease and RA, but not for psoriasis or PsA. InCrohn’s disease, infliximab is indicated for reducing thesigns and symptoms of moderate to severe disease, andfor the closure of enterocutaneous fistulas in fistulizingCrohn’s disease. In RA, infliximab is indicated, in com-bination with methotrexate, for reducing signs andsymptoms, and for inhibiting the progression of struc-tural damage in patients with moderate to severe disease.

Infliximab is a chimeric (mouse/human) IgG1 mono-clonal antibody with approximately 25 percent retainedmurine sequences, which makes it more antigenic. Ad-ministered intravenously, infliximab binds transmem-brane-bound TNF-α, soluble TNF-α, and receptor-bound TNF-α with high specificity, high affinity, andhigh avidity (Knight 1993).

In a 33-patient study, infusions of infliximab were ad-ministered at week 0, week 2, and week 6. Eighty-two per-cent of patients achieved PASI-75 when results were mea-sured at week 10 (Chaudhari 2001). In addition, 53percent of patients maintained the response at the PASI-50 level after 8 months (Chaudhari 2001). The 5 mg/kgand 10 mg/kg doses of infliximab were equally effective.Multicenter studies are under way to confirm these results.

Photo below is of patient at day 0

In clinical trials, approximately 10 percent of patientswere antibody positive (Centocor 2003). The antibodiesare generally low titer and do not crossreact with otherapproved monoclonal antibodies. Antibodies to inflixi-mab are positive in approximately 10 percent of infusionsand negative in approximately 3 percent of infusions. In-fusion reactions are typically mild to moderate and aremanaged with acetaminophen or diphenhydramine HCl.

As of Aug. 23, 2001, 101 cases of tuberculosis world-wide were reported among the more than 170,000 pa-tients treated with infliximab. The majority of cases havebeen pulmonary, and a third of all cases were dissemi-nated. Fifteen deaths have been reported as a result oftreatment with infliximab; of these, 11 were attributableto tuberculosis.

Infliximab is associated with impaired cell-mediatedimmunity, leaving patients vulnerable to opportunisticinfections.

Etanercept. The second of the two TNF-α drugs, etan-ercept also is indicated not for psoriasis but for RA,PsA, and moderate to severe active polyarticular-course juvenile RA in patients who demonstrate an in-adequate response to one or more disease-modifyingantirheumatic drugs.

In its phase 2 trial, etanercept monotherapy achievedclinically meaningful and consistent efficacy in clearingpsoriasis. Etanercept was given subcutaneously twiceweekly to approximately 112 patients. Thirty percent ofpatients achieved a PASI-75 response at 12 weeks and 56percent by week 24 (Amgen 2003).

While some patients treated with etanercept have de-veloped tuberculosis, the incidence is similar to that ex-pected in the population receiving treatment. The over-all adverse-event profile was unremarkable.

DiscussionThe immunologic nature of psoriasis will likely make

biologic therapy the treatment of choice, replacing cur-rent topical, photo-, and systemic therapies. This im-portant class of drugs will continue to be developed,with smaller molecules already being tested in trials. Agoal of research in this area is development of an oral for-mulation of these medications.

Due to the convenience, safety, and efficacy of efali-zumab and etanercept, it is conceivable that these sub-cutaneous drugs will dominate the market. These newtherapies also offer the prospect of overall cost savings byarresting disease progression. Patients with PsA who takeetanercept, for example, may be less likely to developthe more severe forms of disabling PsA than patientswho do not. Alleviating the physical and mental burdensof chronic psoriasis also will pay dividends by lowering

illicit drug use, alcoholism, and depression, and by lib-erating millions of Americans to live productive lives.

According to the 2001 NPF survey, approximately 2million psoriatics report that their disease is severe. Nev-ertheless, estimates of the number of patients who willbecome candidates for these new treatments are low.Many psoriatics are disengaged from health care becausedermatology has had little to offer them until now. Whenthese individuals begin to see direct-to-consumer ad-vertising for these biologic agents, they are likely to startseeking out these drugs to obtain relief from this dis-abling condition.

ReferencesAmgen Inc., Thousand Oaks, Calif.: 2003. Data on file.Biogen Inc., Cambridge, Mass.: 2003. Data on file.Callis K, Krueger G. J Invest Dermatol. 2002 119:207–350. Ab-

stract. Presented at: Society for Investigative Dermatology63rd Annual Meeting; 2002.

Centocor Inc., Malvern, Pa.: 2003. Data on file.Chaudhari U, Romano P, Mulcahy LD, et al. Efficacy and safety

of infliximab monotherapy for plaque-type psoriasis: a ran-domised trial. Lancet. 2001;357:1842–1847.

Ellis CN, Krueger GG; Alefacept Clinical Study Group. Treat-ment of chronic plaque psoriasis by selective targeting ofmemory effector T lymphocytes. N Engl J Med.2001;345:248–255.

Genentech, South San Francisco, Calif.: 2003. Data on file.Gottlieb AB. Induction and maintenance treatment during a 12-

month trial in patients with moderate to severe plaque pso-riasis: preliminary findings. Poster P546. Presented at:American Academy of Dermatology 60th Annual Meeting;2002; New Orleans.

Koo JY. Efalizumab is safe and well tolerated in the treatment ofmoderate to severe plaque psoriasis: pooled results of twophase 3 clinical trials. Poster P548. Presented at: AmericanAcademy of Dermatology 60th Annual Meeting; 2002; NewOrleans.

Knight DM, Trinh H, Le J, et al. Construction and initial charac-terization of a mouse-human chimeric anti-TNF antibody.Mol Immunol. 1993;30:1443–1453.

Krueger G, Koo J, Lebwohl M, et al. The impact of psoriasis onquality of life: results of a 1998 National Psoriasis Founda-tion patient-membership survey. Arch Dermatol. 2001;137:280–284.

Molowa DT, Shenouda MS, Tublin PW, Fein AS. Trends in theTreatment of Psoriasis. JP Morgan 2nd Annual PsoriasisMarket Survey, April 5, 2002. Available at:«http://www.psoriasissupport.org/ipc/uploaded/news_psoriasissurvey2002slides.pdf». Accessed March 21,2003.

NPF (National Psoriasis Foundation). Statistics. Portland, Ore.:NPF, 2001. Available at:«http://www.psoriasis.org/resources/statistics/». Accessed April 22, 2003.

Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as muchdisability as other major medical diseases. J Am Acad Der-matol. 1999;41(3 Pt 1):401–407.

Spuls PI, Bossuyt PM, van Everdingen JJ, et al. The developmentof practice guidelines for the treatment of severe plaqueform psoriasis. Arch Dermatol. 1998;134:1591–1596.



One way to measure the cost of a disease or con-dition is to look at a large retrospective databaseand examine treatment costs for that particular

illness. This is what Medstat did, in conducting a studythat quantified the burden of illness associated with pso-riasis (Crown 2003). Yet in looking only at the primaryillness, it’s easy to overlook the cost of comorbid condi-tions. Many psoriasis patients, for example, also sufferfrom obesity or depression and complain that they havetrouble sleeping, have lost their interest in life, or are notas productive as they once were.

Beyond the direct medical cost of an illness, there arelarger, indirect costs. Employers, for example, are inter-ested in productivity.When an employee has psoriasis onthe bottom of his feet and can’t go to work, or when thecream that must be spread all over a patient’s body keepsher distracted and less productive, the employer suffersas well.

Many of our employer clients have medical claimsdata, as well as administrative data on incidental ab-sence, short-term disability, and workers’ compensationclaims. The more forward-thinking of these employersare merging their data to try a new approach called healthand productivity management. With Mark McClellan,MD, PhD — a physician and an economist — as the headof the U.S. Food and Drug Administration, I think thisinterest in managing productivity will grow.

Even so, relatively few large employers are thinkingprogressively about the cost of illness. It seems that manyof our employer clients read in the business press that

prescription drug expenditures are increasing roughly 20percent each year and, instead of looking at the big pic-ture, they just want to know what the drugs will cost andwhat the total cost of treating a patient will be.

In evaluating the burden ofillness, it is important to con-sider quality-of-life issues forpsoriasis patients who are un-dergoing treatment with cur-rent therapies. Quality-of-lifeissues are hard to quantify ineconomic terms, but there areways to integrate them intothe big-picture cost of an ill-ness. Studies that have beencompleted document a func-tional impairment amongpsoriasis patients; the health-related quality of life for thosewith moderate or severe pso-riasis and who are treated withcurrent systemic therapies is,in general, relatively low when compared with the pop-ulation at large.

The Medstat studyObjectives and methods

The objectives of our study were: (1) to compare theburden of moderate-to-severe psoriasis patients on thehealth care system to that of a randomly selected groupof patients without psoriasis, extrapolating to the largerpopulation; (2) to examine the prevalence of comorbidconditions in psoriasis patients; and (3) to identify thecost of serious adverse events, side effects, and monitor-ing.

Medstat pools data from large employer clients, suchas General Electric, Navistar, and Chevron — in all,about 70 of the Fortune 200 companies; these employ-ers are interested in benchmarking their health care ex-periences against those of other large employers, and sothey give us permission to pool their data. The databaseon privately insured employees and their dependentsholds information on 2.5 million covered lives per yearand can typically track de-identified individuals over


The Cost of PsoriasisWILLIAM H. CROWN, PHDVice President, Outcomes Research and EconometricsThe Medstat GroupAnn Arbor, Mich.

Crown discussed findings of a Medstat studyprobing the economic burden of psoriasisand the presence of comorbidity in psoriasispatients. He also discussed current eco-nomic issues in the marketplace, concludingwith some thoughts on health economicsand biologics — which are shifting the land-scape of pharmacotherapy.

SUMMARY

W I L L I A M H . C R O W N ,P H D


several years; if they switch healthplans, we can see them moving fromplan to plan.

The database includes informationabout inpatient, outpatient, and phar-maceutical costs, as well as the types ofhealth plans the employees are en-rolled in and the designs of thoseplans. Claims data are valuable in thatthey show comorbid conditions, thevarious treatments a patient received,and side effects, especially in the caseof systemic therapy. This is in contrastto survey data, which are not as de-tailed; when people are surveyed, theyoften find it difficult to remember thedetails of their treatments, office visits,and emergency room visits.

Our data consist of retrospectiveclaims for employees with psoriasis orpsoriatic arthritis (PsA) who were cov-ered by commercial insurance from1996 to 2000. Following the subjectsfor a minimum of 1 year and a maxi-mum of 5 years, our intent was to iden-tify long-term side effects of treatment.We annualized our measurements.

We divided the psoriasis patientsinto three categories (Figure 1):

• Patients whose psoriasis was mild and who receivedno treatment, monotherapy of a topical agent, orone or no prescriptions for topical agents. Thesesubjects were classified as limited topicals.

• Patients who were treated with 1 to 4 topical agentsand were given two or more refills of a topical agent.These were classified as more frequent topicals.

• Patients with moderate/severe psoriasis were thosewho had either PsA, any phototherapy, or any sys-temic therapy. Our focus was on this group, but wedo present some initial data for the other patients.

We matched the moderate/severe group to a controlgroup (nonpsoriasis group) comprising a random sam-ple from the rest of the population; the groups werematched by age, gender, geographic region, and length offollow-up.

In the moderate/severe group, 45 percent had psoria-sis alone, 28 percent had PsA as well as psoriasis, and an-other 28 percent had PsA alone. The patients’ ages rangedfrom about 47 to 52.

Results and discussionWe looked at the top 25 diagnoses for the moderate/

severe psoriasis and the nonpsoriasis groups, focusing onthose that are likely to be psoriasis-related side effects or

comorbid conditions. The moderate/severe group hadhigher rates of carcinoma, hepatotoxicity, and nephro-toxicity than the nonpsoriasis group, as one might expect.We are particularly interested in the higher rates of ane-mia, gastrointestinal disorders, hypertension, and de-pression found in the moderate/severe group, as com-pared with the control group (Figure 2, page 12).

We used the Charlson Comorbidity Score, a tool com-monly used to measure severe comorbidities associatedwith hospitalization (Charlson 1987). The moderate/severe psoriasis patients in our study had significantlyhigher scores than the control group.We also looked at thenumber of ICD-9 codes patients had, to see how many dif-ferent body systems were involved in their illnesses.

Carcinoma, depression, diabetes, and thrombocytosiswere the comorbid conditions that showed the greatestdifference between the moderate/severe and the non-psoriasis group in terms of cost. A large part of the costassociated with psoriasis patients is due to comorbidityrather than the psoriasis itself. If we could understand co-morbidities better, we might have a more thorough un-derstanding of how new treatments might affect pa-tients. It appears that there is a clinical path betweenobesity, diabetes, hypertension, and psoriasis. Whatmight the effect be of treating those comorbidities in apsoriasis patient? It is my belief that as the population

FIGURE 1 Stratification of disease and distribution of patients*

More frequent Limited topicals topicals Moderate/severe

• No treatment • Use of 1–4 topical agents • Psoriatic arthritisor and or• Monotherapeutic use • 2 or more refills • Any phototherapy

of topical agents for topical agentor or• <2 prescriptions • Any systemic therapy

for topical agents

* Nonpsoriasis control group was matched 3:1 to moderate/severe groupbased on age, gender, region, and length of follow-up.

SOURCE: MEDSTAT, ANN ARBOR, MICH., 2003

Limited topicals (59%)

More frequent topicals (20%)

Moderate/severe (21%)


ages, this will become a greater issue. Body systems arecomplicated; sometimes, when treating a patient with co-morbidities, improving one condition causes others toimprove in response — thereby offsetting treatment costsof the other conditions. Other times, treating one con-dition makes the others worse, and thus the cost of treat-ing those conditions also increases.

The most common treatments for moderate/severepsoriasis patients were methotrexate and psoralen withultraviolet A (PUVA). In this study, we did not try to un-derstand the timing of treatments — how many officevisits, the average duration of treatment, or why patientswent off treatments or switched to other ones. We sim-ply followed them through the data for as long as wecould, calculated the cost of the treatments they receivedand compared that to the treatments the controls re-ceived.

Not surprisingly, the moderate/severe psoriasis grouphad three times more lab tests and prescriptions than thecontrol group. It also had twice as many outpatient ser-vices and four times as many psoriasis-related emer-gency room visits than the nonpsoriasis group. In thecase of the moderate/severe group, inpatient costs wereabout a quarter of the total cost of treatment; the inpa-tient cost was $2,059 per psoriasis patient in the database,and the total cost of treatment was $7,639 per patient.These figures represent the direct cost of treatment only;

a claims-based study such as this cannot calculate the ad-ditional indirect economic impact of illness, such as lostproductivity.

A recent study estimated the total direct cost of careassociated with psoriasis (not including comorbidities)at $649.6 million per year in the United States (Javitz2002). If one considers indirect costs, such as lost pro-ductivity, the figures are much larger, ranging from $1.2to $3.2 billion per year (Javitz 2002). Our figures aresimilar. Extrapolating to the entire United States popu-lation, using Javitz’s estimate of 1.4 million Americanswith clinically significant psoriatic disease, we estimatedthe total cost of psoriasis to the health care system to be$705.6 million per year (Figure 3). The approximate $50million difference between our estimate and that of Javitzis largely due to our different estimates of inpatient costs(primary diagnosis of psoriasis); ours was $74.2 mil-lion, while Javitz estimates $30.5 million (Javitz 2002).

Our study suffers from the same limitations as allclaims-based studies — the lack of clinical data. A der-matologist who can actually examine a patient is muchbetter able to determine the severity of the patient’s pso-riasis than we, because we determine severity based onlyon a record of the treatments that a patient has received.We can see only the cost of the resources used, such asmedical attention, drug use, etc. Claims data do not pro-vide a complete patient history. For example, if a patient

had received ultraviolet therapy at somepoint prior to the time frame we analyzedin the claims (1996–2000), our data wouldnot reflect this. Claims data cannot cap-ture many of the indirect cost dimensionsof an illness, such as the effects of the illnessand treatments on quality of life. On theother hand, claims are sometimes able toprovide information on work loss and dis-ability in certain settings with integratedmedical claims, absenteeism, and disabilitysystems. Finally — and importantly forpsoriasis — claims cannot tell us about thecost to unsatisfied psoriasis patients whoare undertreated or who do not seek treat-ment — a cost that is difficult to measure.Ironically, the benefits of new treatments,when they draw formerly undertreated pa-tients back into the medical system, aregenerally neglected in the overall statisticsregarding increased drug and medical ex-penditures.

Market issues and biologicsOne important issue in the marketplace,

particularly among large employers andMCOs, is concern about pharmacy costs.

Melanoma

Epitaxis

Leukopenia

Nephrotoxicity

Nausea

Paraesthesia

Hepatoxicity

Carcinoma

Anemia

Depression

Headache

GI disorders

Hypertension

0% 5% 10% 15% 20% 25% 30% 35% 40%

Moderate/severe psoriasisNonpsoriasis


FIGURE 2 Potential side effects and comorbidities

Share of incidence among moderate/severe patients, compared to control group


scribing has been to try one ther-apy until there is physical evidencethat a patient is not responding,then initiate new therapy. This ap-proach adds expense to managedcare organizations and the healthcare system in general; they arepaying for care that results in noclinical benefit to patients. Al-though “personalized medicine”and biologics are relatively expen-sive, they may prove to be cost-ef-fective if they can indeed elimi-nate the cost of treating patientswho do not respond to treatment.This becomes especially true whenconsidering quality of life as an el-ement of cost.

Medstat has recently studied thecost-effectiveness of biologics inanother therapeutic area. We havefound that cost-effectiveness de-

pends, in part, on the sensitivity of the test used to iden-tify a condition and the cost of that test. It also dependson the probability of a response to a new therapy, the costof treating with a new therapy, the response to existingtherapy, and the cost of treating with existing therapy.Once these costs are considered, one can then answer thequestion,“Is this new treatment cost-effective comparedwith those already on the market?”

In the case of severe psoriasis, a diagnostic test may notbe as important as it would be in other areas of biolog-ics. For the practicing dermatologist, it is fairly easy to de-termine whether a patient is a good candidate for one ofthe new treatments. Because psoriasis is easily diagnosed,it may be a better candidate for biologics than other con-ditions from the perspective of payers. Perhaps most im-portantly, it is gratifying to see that, based on clinical trialdata, there is a high probability that severe psoriasis pa-tients will respond to biologics.

ReferencesCrown WH, Bresnahan B, Orsini L, Kennedy S. The burden of

illness associated with moderate-to-severe psoriasis. 2003(draft manuscript). Cambridge, Mass: Medstat.

Charlson ME, Pompei P, Ales KL, McKenzie CR. A new methodof classifying prognostic comorbidity in longitudinal stud-ies: development and validation. J Chron Dis. 1987;40:373–383.

Javitz HS, Ward MM, Farber E, et al. The direct cost of care forpsoriasis and psoriatic arthritis in the United States. J AmAcad Dermatol. 2002;46:850–860.

My impression is that, initially, the response of the healthcare system and managed care in particular was to try tokeep a lid on costs by imposing restrictions on use. Re-cently, there has been a shift away from that approach, be-cause it was not effective; instead, coverage of new ther-apies is permitted but employers and MCOs attempt tocontrol their utilization through economic incentives,such as copayments, coinsurance, and deductibles. Underthis scenario, moderate/severe psoriasis patients are givenaccess to biologics as they become available but mayhave to pay substantial copayments to use them. Copay-ments can amount to 20 percent or more of the total costof the drug. We don’t know how patients and the healthcare system will respond to higher copayments; it will beinteresting to see the implications of this development onhighly effective biologic therapies. If the trend towardshifting financial responsibility for care to consumerscontinues, then it is difficult, at this juncture, to predictconsumer acceptance of biologic agents.

Personalized medicine and biologics create a new eco-nomic world, because the treatments are typically tar-geted to a narrow and often severely ill population.Whether managed care will be willing to pay for thatmight depend on practitioners’ and manufacturers’ abil-ity to determine who will respond to treatment and whowill not, which would eliminate the expense of treatingpatients who will not respond.

For many years, the standard approach toward pre-

FIGURE 3 Mean annualized total psoriasis-related expenditures


(Millions)

$500

400

300

200

100

0Limited topicals

$113.4

More frequent topicals

$151.5

Treatment groupsModerate/severe

$430.6


Currently, we do not have step therapy in place for pso-riasis because available therapies have been relatively in-expensive. The economics of therapy do not support theneed, nor does step therapy make sense, clinically, forpsoriasis. If effective new biologic response modifiersbecome first-line therapy, then step therapy would, as amatter of course, be unnecessary; the issue simply wouldbe to make the drugs available. Managed care organiza-tions will continue to use resources at their disposal,such as Milliman guidelines, but the MCO’s decisionwill be for the physician to proceed with effective treat-ments.

All of our medical policy information is available tothe public on the Web. We have a national medical pol-icy committee that looks at the literature and evaluatestherapies for a disease or series of diseases. For psoriasisand this series of diseases, most clinics request ultravio-let light therapies. These requests are transferred to anurse, who will say “yes” if she or he determines that thephysician is calling about psoriasis and that the treatmentis on the list of approved indications for psoriasis. Therequirement that physicians call us is, in a sense, super-fluous, in that we have the literature and data to supportthe request, but our decision is ultimately based on thephysician’s diagnosis. We do not intervene beyond thatpoint.

It is my opinion that the managed care industry willintervene even less in the future, given the rich databaseof treatment guidelines and information at its disposal.In the future, it is conceivable that there will be specialtydisease management companies that will relieve man-aged care organizations of the responsibility for manag-ing psoriasis. There are companies that do this withrheumatoid arthritis (RA), for example, where the liter-ature demonstrates that biologics are an effective treat-ment for the disease. Although they are relatively costly,the biologic agents are effective; if you are a neurologist,rheumatologist, or dermatologist, you know that thesetherapies work. Once biologics become first-line therapyfor psoriasis, there will be no need for traditional MCOmanagement.

Managed care organizations generally ask physi-cians to request permission, typically via priorauthorization, before administering therapy.

For each illness or condition, a managed care organiza-tion will allow a certain range of therapies.

At Anthem Blue Cross Blue Shield of Colorado, for in-stance, physicians seeking approval for treatment of pso-riasis must receive prior authorization for ultravioletphototherapies (UVA and UVB), photochemotherapy,and Goeckerman therapy. Although there is probably asubset of patients for whom home therapy would bevaluable, home therapies generally are not covered be-cause there is insufficient peer-reviewed medical litera-ture to support them (Table 1, page 16).

There is also insufficient literature to support the useof laser therapy for treatment of psoriasis, despite the factthat this therapy has received approval from the U.S.Food and Drug Administration. FDA approval meansonly that a therapy is safe and efficacious; it does notmean that it has been rigorously studied in terms of clin-ical outcomes. Certainly, this is a promising therapy, andif research eventually proves that laser therapy works fora certain subset of patients, it will be considered a stan-dard method of treatment for those patients, as stated inour organization’s medical policy.


Managed Care’s PerspectiveOn Treatment of Plaque PsoriasisTERRY J. SULLIVAN, MD, MPHMedical DirectorAnthem Blue Cross Blue Shield of ColoradoDenver

Sullivan discussed the potential for accep-tance of biologic drugs for treatment of pso-riasis in the context of how managed careorganizations currently respond to newtherapies.The apparent effectiveness of bio-logic therapies, compared with conventionaltreatments, led Sullivan to suggest that tra-ditional methods of evaluating and “tiering”pharmaceutical products may not necessar-ily prove appropriate for biologic therapies.

SUMMARY


Effect of out-of-pocket paymentIn recent years, MCOs have implemented tiered phar-

macy benefits. In our system, older conventional thera-pies for psoriasis — including cyclosporine, methotrex-ate, calcipotriene, steroids, and tar preparations — are onthe first tier. Contract language and a drug’s acquisitionprice influence the placement of drugs incertain tiers, and thus each health plan hasits own system.

Anthem Blue Cross Blue Shield of Col-orado has developed a four-tier system;the fourth-tier benefit provides coveragefor higher-cost, self-administered inject-able drugs, such as those to treat hepatitisand RA. There is a 30-percent membercopayment for this tier, up to a per-claimmaximum of $250. Among biologic ther-apies for psoriatic arthritis, etanercept ison the fourth tier.

Clearly, health plans are beginning toengage their members financially with anincreasing number of therapies. While itwill be the clinician’s decision as towhether the patient requires a drug, it will be the patient’sdecision whether to comply with therapy. When the de-cision lies between the patient and the physician, the pa-tient often will ask for the drug with the less-expensivecopayment.

Most health plans, including HMOs, are now addingdeductibles to copayments. The level of members’ fi-nancial responsibility per tier is reevaluated each year.Next year, for example, the member’s responsibility forfourth-tier products might be raised from 30 to 36 per-cent. Higher copayments or coinsurance may result inimproved compliance, considering the increased patientinvestment in the product. An argument also can bemade that higher copayments act as a barrier to compli-ance. This is the subject of great debate, and we do notyet know what effect changing these amounts will haveon patients’ compliance with therapy.

Individuals are buying policies that not only excludecoverage for certain therapies, but also have $5,000 or$10,000 deductibles. Patients know that they have to payup to a certain amount; they may be willing to accept less-expensive treatments until they reach their deductible, atwhich point they begin to request more-expensive ther-apies. The outcome of this behavior is an intangible thatcannot be predicted.

Challenges facing insurersEconomic inequities involving specialty pharmacy

products present health plans with an enormous seriesof challenges.

When these products are administered in a physician’soffice, the issue of expense to the physician is raised.

MCOs are looking at variable office copayments, in-cluding sharing the cost of clinician-administered injec-tions with the member. The issue is complicated, in partbecause physicians do not always know how much tocharge, but we are working on possible solutions. For ex-ample, we might be able to prohibit physicians’ keeping

a drug supply in the office and require apatient copayment when a specialty phar-macy delivers the drug.

At-home injection by the patient addsto the difficulty of determining drug co-payment amounts. There is no rationalefor processing the cost of self-adminis-tered injections differently from those ofclinician-administered injections, yetMedicare, for example, covers in-officeinjections but does not cover at-home in-jections. The variation among MCOs’pharmacy benefit structures and betweenprivate and government systems createsan unequal coverage problem that mustbe addressed.

Another potentially complicating fac-tor, in terms of drug coverage, is that the emerging ther-apies for psoriasis are effective for, and being made avail-able to, middle-aged people. These are therapies that areuseful to people who are 30 to 50 years old, who are orcan be productive, and who are buying policies that re-quire out-of-pocket payment. We do not know yet, froma policy point of view, what the effect will be when thesemiddle-aged people turn 65 and suddenly realize that tocontinue with their therapy, it will cost them a certainamount per month.

An MCO would have strategies for when the middle-aged population begins to age. The use of biologics forRA is a good example. It took less than a year for RA bi-ologics to start moving to first-line therapy, and althoughthey are not all there yet, if a patient needs a drug, a pa-tient gets it. Managed care will do what is appropriate tosupport such decisions.

Disease and case management are big issues in man-aged care now, but disease management is most logicalfor only seven or eight chronic conditions and does notinclude psoriasis. Case management is provided for anyextreme illness, but again, probably not psoriasis; in pso-riasis, and dermatology in general, the diagnosis andtreatment occur quickly.

Coverage in the futureWe have been able to cover a wide range of dermato-

logical therapies because they are relatively inexpensive.When we put a new drug in the fourth tier, the challengewill be for the clinician to explain to the patient that afourth-tier drug is worth the coinsurance. The clinicianknows that only one third of patients takes a drug cor-

T E R R Y J . S U L L I V A N ,M D , M P H


Following Sullivan’s presentation, several of those inattendance discussed the issue of therapy administra-tion in the physician’s office versus in the patient’shome. Michael J. Boskello, RPh, William H. Crown, PhD,David M. Pariser, MD, Craig L. Leonardi, MD, and PamellaD.Thomas, MD, MPH, [see biographies on page 20] con-tributed the following points to this discussion:

Increasing a patient’s copayment — his or her fi-nancial stake in therapy — may lead to improvedcompliance, but the physician can be certain of com-pliance only when patients receive therapy in the of-fice. At home, patients could potentially take it uponthemselves to reduce their amount of therapy to alevel where they are willing to live with some psoria-sis to save money. In the medical office, if nurses orphysician assistants give injections, physicians savetime and increase revenue, yet the amount of rev-enue from a new therapy cannot be determined until

a number of patients are receiving it. Complicatingthis scenario, until a product is well established undercoverage policies, a physician might not purchaseand stock the product, even without having to obtainprior authorization. Some patients do not want to goto the physician’s office on a weekly basis to receivetherapy; physicians have to “chase down”some pa-tients to make sure they come in.

The patient’s point of view should be considered,including how often she or he wants to come in, andwhether she or he would prefer to self-administertherapy at home. During subcutaneous therapy trialsin a particular office, more than 90 percent of pa-tients chose at-home self-injection. Of the remaining10 percent, some patients chose in-clinic administra-tion for social reasons — to be with other peoplewho shared their problems — even though theywere physically able to self-administer the drug.

TABLE 1 Anthem Blue Cross Blue Shield of Colorado’s policy position and rationale

Policy position

Medically necessary: Psoralen with Ultraviolet A (PUVA) is considered medically necessary in thetreatment of the following: psoriasis, mycosis fungoides (cutaneous T-cell lym-phoma), atopic dermatitis, atopic eczema, lichen, vitiligo, and acute/chronicpityriasis lichenoides. Actinotherapy (UVA or UVB) is considered medicallynecessary in the treatment of the following conditions: psoriasis, chronic ur-ticaria, pruritus of renal failure, mycosis fungoides (cutaneous T-cell lym-phoma), eczema, pityriasis rosea, lichen, and pityriasis lichenoides. Goecker-man therapy is considered medically necessary in the treatment of psoriasis.

Not medically necessary: Ultraviolet light therapy (PUVA, UVA, or UVB) is not medically necessary as ahome therapy.

Investigational: The use of laser therapy (e.g., xenon-chloride, excimer) for the treatment ofpsoriasis or vitiligo is considered investigational.

RationaleUltraviolet light (with and without the introduction of psoralen) is widely used for the treatment

of skin conditions. Evidence in the peer-reviewed medical literature suggests that this treatment canprovide efficacious therapy for individuals affected by various types of skin conditions (listed abovein the “medically necessary”statement).This use of ultraviolet light as a home therapy is not sup-ported in the literature, as routine clinical evaluations are necessary to ensure that the exposure doseof radiation is kept to the minimum level compatible with adequate control of disease and the pre-vention of complications.While laser therapy emits ultraviolet light, there is currently insufficient evi-dence to support the use of this technology in individuals with skin conditions. Additional evidenceis needed to determine the efficacy of laser therapy before it can be considered a standard methodof treatment in individuals with specific skin conditions.

SOURCE: ANTHEM BLUE CROSS BLUE SHIELD OF COLORADO, UPDATED OCT. 21, 2002. REPRINTED WITH PERMISSION.

COLLEAGUES DISCUSS PATIENT SELF-INJECTION


rectly, another third incorrectly, and the final third notat all.

An interesting consideration is whether the pharma-ceutical industry should be dealing primarily with man-aged care companies or with patients. It is my belief thatin the future, drug manufacturers will work more directlywith patients. Direct-to-consumer advertising is an ex-ample of that. Direct-to-consumer advertising is an im-portant element in getting the patient involved, and ifcertain economics exist, the managed care company is leftout. Thus, the managing of these products is reduced tomanipulating consumer economic factors.

For example, a manufacturer might offer a coupon forthe first 3 weeks of therapy, until the drug begins to takeeffect. Or, if the health plan has a $250 deductible, themanufacturer might offer consumers a $100 coupon toget them to try its product over a competitive product inthe same class, as opposed to contracting with a phar-macy benefit manager for a discount. Those are the dy-namics that we will see — in essence, who gets the eco-

nomic benefit? If the clinician has three or four com-peting drugs that can be used appropriately for a patient’streatment, the question becomes whether the manufac-turer should approach the clinician or the patient. In-creasingly, manufacturers are deciding that they shouldapproach the patient instead of managed care.

Yet managed care plays many important roles in thehealth care system that benefit consumers and physi-cians, and it should be a part of the decision-makingprocess. Managed care tries to improve the public’shealth literacy in an effort to prevent illness and unnec-essary health care expenditures, and we have had somesuccess with this through the help of funding from thepharmaceutical industry. The true value of managedcare is better quality for the patient. Patients receive ac-cess to better-quality treatment, in part because MCOscan provide data to physicians who otherwise mightnot be able to obtain that information without havingcertain data capabilities. These are good services thatmanaged care provides.


Currently, one third of dermatologists in the United States usesystemic therapy for patients who have moderate to severepsoriasis. Of the other two thirds, some are surgeons or physi-

cians whose practices deal only with cosmetic dermatology. However,the majority of dermatologists who do not prescribe systemic agentsdo not do so because they are concerned about the risk of toxicityassociated with systemic drugs for treating psoriasis. The develop-ment of new biologic response modifiers for treating psoriasis islikely to change the current paradigm.

The American Academy of Dermatology (AAD) considers it im-portant to educate dermatologists on this new frontier of treatment,so it convened a consensus conference to address the use of the newbiologic and other, nonbiologic, treatments for psoriasis. The AADConsensus Statement on Psoriasis Therapies will be published soonin the Journal of the American Academy of Dermatology. The follow-ing summarizes the major points within the AAD statement.

Diagnosing psoriasis and psoriatic arthritisThe standard of care for diagnosing psoriasis and psoriatic arthri-

tis (PsA), as stated by the AAD, is that psoriasis should be diagnosed

SPECIAL PRESENTATION

Improving the Standard of Care For Patients With PsoriasisDAVID M. PARISER, MD, FACPProfessor, Department of DermatologyEastern Virginia Medical SchoolNorfolk, Va.

David M. Pariser, MD, presented an outline of the pro-posed American Academy of Dermatology consensusstatement (since approved by the AAD Board of Direc-tors), which he summarizes in this article. Pariser thenmoderated a roundtable discussion, in which partici-pants discussed recent developments in the treat-ment of psoriasis that led to the new consensus state-ment.The panelists also addressed how to apply thestatement to clinical practice, the effects its changeswill have on physicians and patients, how managedcare organizations might respond to new therapies,and how physicians can work with MCOs to ensure asmooth transition when integrating these therapiesinto their practices.

SUMMARYIn light of new and developingtherapies for psoriasis and pso-riatic arthritis, representatives of

the American Academy of Derma-tology gathered in Louisville, Ky.,last November to develop a con-sensus statement and to beginplanning for a multiyear educa-tional program for dermatologistsbuilt around psoriasis.The state-ment subsequently drafted at thePsoriasis Therapies EducationalSummit is intended to serve asguidance for clinicians until theAAD’s established guidelines fortreatment and care of patientswith psoriasis — written in 1991— are formally updated.


tion of psoriasis as mild, moderate, or severe. Rather, pso-riasis should be classified as limited — which, usually, canbe treated with topical therapy — and moderate to severe,which requires systemic therapy. Limited disease mayalso warrant phototherapy or systemic therapy, if it is notresponsive to topical therapies or if there is disruption inthe patient’s daily activities and/or employment.

Patients with PsA may have limited skin disease but re-quire more aggressive systemic therapies. The final ver-sion of the AAD consensus document includes the state-ment that psoriasis involving the hands, feet, head andneck, genitalia, or covering more than 5 percent of theskin surface may be considered severe disease warrant-ing systemic therapy.

Available therapiesFor treatment of limited psoriasis, there are many top-

ical agents available for treatment, including corticos-teroids, retinoids, and tar preparations. Topical im-munomodulators, which are commonly used to treatatopic dermatitis, are also being investigated for their ef-ficacy in treating limited psoriasis.

The currently available treatments for moderate tosevere psoriasis include phototherapy, which can be usedwith or without topical agents. Home phototherapy unitsare available and, while they present an initial cost tothose who use them, patients who respond to this treat-ment will find an overall cost benefit in contrast with vis-iting the dermatologist’s office three times a week for thesame treatment. Photochemotherapy also can be used totreat moderate to severe psoriasis. This treatment, whichmust be performed in the office, is being used far less fre-quently than in the past, however.

Older therapies for moderate to severe psoriasis, in-cluding methotrexate, oral cyclosporine, and oral retin-oids, are discussed in detail in this publication in the ar-ticle by Leonardi.

The four biologic agents listed in the AAD consensusstatement are acceptable as first-line agents for those pa-tients who require systemic treatment for plaque-typepsoriasis. These four agents are etanercept, alefacept,efalizumab, and infliximab. While not all these biologicagents have been approved by the U.S. Food and DrugAdministration for use in the treatment of psoriasis, theAAD has chosen to recommend these agents as first-linetherapies based on clinical experience that has been gath-ered to date.

For forms of psoriasis other than plaque types, thereare fewer data on treatment with biologic agents; there-fore, the AAD is not prepared to list them as first-linetreatment options for pustular, guttate, or erythrodermicpsoriasis. Clinical experience with real-world use of bi-ologic agents will determine the usefulness of such agentsin these forms of psoriasis.

by a dermatologist, after obtaining a patient history andperforming a physical examination. Skin biopsy is some-times, but not always, necessary to establish a diagnosisof psoriasis, and when possible, precipitating causes suchas drugs, stress, environment, and concomitant diseaseshould be considered. While no laboratory test is avail-able to screen for psoriasis, one of the hallmarks of PsAis seronegative arthritis.

Selecting therapyWhen deciding what therapy to use for the treatment

of psoriasis, the AAD recommends that physicians con-sider whether the disease is regular plaque-type psoria-sis or another form of psoriasis (such as guttate, pustu-lar, erythrodermic, palmar-plantar, PsA, scalp psoriasis,nail psoriasis, or inverse psoriasis). Choice of therapy notonly depends on the type of psoriasis being treated, butalso on the severity and locations of the psoriatic le-sions. The age of the patient and his or her ability to beaccessible for in-office treatment should also be consid-ered.

Economics are an important factor in the selection oftreatment. Because relatively few dermatologists havebeen prescribing systemic therapy, these treatments forpsoriasis have generally not had extensive scrutiny frommanaged care organizations. Yet now that drugs thathave been shown to be successful in treating moderate tosevere psoriasis are available — though at greater costthan traditional therapies — dermatologists must be-come more involved in determining cost-benefit ratiosand third-party coverage.

When selecting a therapy for psoriasis, the AAD alsorecommends that physicians consider patients’ quality oflife. Some issues related to quality of life include em-ployability and interpersonal relationships.

Finally, patients’ comorbid diseases or state of illnessare important considerations to take into account, lest thetreatment interfere with their care or patients find them-selves unable to follow through with a psoriasis-treat-ment regimen.

Categorizing diseaseThe severity of psoriasis is a qualitative measure and

has little to do with the extent of skin surface involved.For example, if psoriatic lesions manifest themselves on1 percent of a patient’s body, this may be consideredtreatable with topical therapy. If the 1 percent is on thesoles of a patient’s feet, however, making it difficult forthe patient to walk or work, systemic therapy may be war-ranted.

Severity hinges on measures of disease activity, resis-tance to prior therapy, and psychosocial considerations.Thus, it is important for physicians and managed careprofessionals to move away from the classic categoriza-


Goals of therapyWhen selecting a treatment for plaque-type psoriasis,

the goal should be long-term control of the disease.Complete clearing may be possible with available ther-apies.

Currently, success of therapy is often expressed interms of a patient’s improvement on the psoriasis areaand severity index (PASI), under which the aim of ther-apy is to achieve a 75-percent reduction in severity. PASI,however, is an imperfect proxy for clinical outcomesmeasurement; PASI is a tool designed for use in clinicaltrials, mandated by the FDA, and is not part of routineclinical care. While successful treatment roughly corre-lates to the degree of PASI improvement, a 75-percentimprovement from baseline is often an unrealistic ob-jective when considering treatment to improve a pa-tient’s health. In actuality, effectiveness of care is judgedindependently by both the patient and the physician,

whose definitions of successful therapy are framed by dif-ferent parameters. Therefore, it is widely recognized thatdermatology requires a better scoring system to measurethe success of treatment for psoriasis.

The AAD will provide updates on biologic therapy andindications for its uses. As the body of evidence sup-porting the efficacy of these new therapies for psoriasisand PsA grows, it is expected that a large number of der-matologists will accept these agents into their practices.

Sources

Krueger GG, Feldman SR, Camisa C, et al. Two considerationsfor patients with psoriasis and their clinicians: what definesmild, moderate, and severe psoriasis? What constitutes aclinically significant improvement when treating psoriasis?J Am Acad Dermatol. 2000;43:281–285.

Menter A (ed). Therapies of Psoriasis — 2003. J Am Acad Der-matol (suppl). 2003. In press.

David M. Pariser, MD: How would managed care professionals pre-fer that dermatologists document or evaluate psoriasis?

Humberto Guerra-Garcia, MD, MPH: Some managed care organi-zations maintain a separate injectables program, using evidence-based guidelines to ensure optimal utilization and to control highcost. Many times, specific guidelines are not available, making ac-curate information from the practitioner crucial. The expertassessment of a specialist, such as a dermatologist with experiencein treating psoriasis, may frequently be the only justificationneeded for prior authorization. At the population level, psoriasispatients who qualify for treatment with biologics may vary innumber; therefore, the impact on usage of these injectables maybe different across MCOs.

Pariser: In thinking about how biologics might become accepted,how do you decide, for example, whether it is appropriate to treatrheumatoid arthritis with the use of existing biologics? Do youhave algorithmic guidelines to help you make these decisions?

Guerra-Garcia: Most cases of rheumatoid arthritis are cleared forstep therapy based on current standards of practice; we have notseen many rheumatologists requesting biologics as first-line ther-apy. Most requests for biologics include an evaluation of treat-ments that have been used, as well as FDA indications. However,we research applications beyond FDA indications, and in certainindividual cases we may authorize use of any medication beyondan FDA indication if it is clinically appropriate and in collabora-tion with the prescriber.

Craig L.Leonardi,MD: In my experience, the majority of the patientswho enroll in clinical trials for biologics have become disconnectedfrom the health care system. We run a large clinical trial center.Sixty percent of those who come to us do so because they havebeen unable to find somebody who is interested in their disease

ROUNDTABLE DISCUSSION

PANELISTS

Michael J. Boskello, RPhSenior Clinical Manager, Pharmacy ServicesOxford Health Plans, New York

William H. Crown, PhDVice PresidentOutcomes Research and EconometricsThe Medstat Group, Ann Arbor, Mich.

Humberto Guerra-Garcia, MD, MPHSenior Medical Director, Quality and RiskKeystone Mercy Health Plan, Philadelphia

Adelaide A. Hebert, MDVice ChairmanDepartment of DermatologyProfessor of Pediatrics and Pediatric DentistryUniv. of Texas Research Center, Houston

Leon H. Kircik, MDDermatologistPhysicians Skin Care, Louisville, Ky.

Craig L. Leonardi, MDDermatologistCentral Dermatology, St. LouisAssociate Professor of DermatologySt. Louis University School of Medicine

Terry J. Sullivan, MD, MPHMedical DirectorAnthem Blue Cross Blue Shield of Colorado,Denver

Pamella D.Thomas, MD, MPHDirector of Wellness and Health PromotionLockheed Martin, Lithonia, Ga.


or who could offer them treatment or advice thatworks to improve their condition. It is encouraging tohave new choices for psoriatic patients. This is a groupof patients who have been neglected for a long time.

William H.Crown,PhD: Will the availability of new bio-logic treatments cause dermatologists to forgo the useof standard treatments, considering the safety andside-effect profiles and the quality-of-life issues asso-ciated with the older therapies?

Leonardi: In my opinion, the safety profiles of biologictherapy, even in a trial setting, are better than those ofcurrently available treatments.

Leon H. Kircik, MD: The cost of monitoring the side ef-fects of older therapies, such as performing liver biop-sies or monitoring renal toxicity, should beconsidered when talking about the overallcost of a treatment.

Adelaide H.Hebert,MD: I would concur. Thefollow-up that we must perform to moni-tor the safety of patients taking methotrex-ate for psoriasis is costly. I have seen casesof lung disease and bone marrow suppres-sion that have resulted from methotrexatetherapy. I have many patients who have notundergone therapy for their condition be-cause they found therapy either discourag-ing or messy. These patients will benefitfrom the use of biologics. They will get theresults they seek without the disadvantages.Dermatologists, too, will embrace the newbiologic agents, because they will be morecomfortable using them for patients with moderate tosevere psoriasis. The educational programs availableto educate dermatologists on the use of biologic agentsare excellent.

Terry J. Sullivan, MD, MPH: The bottom line is that bio-logics will evolve the same way that drugs for rheuma-toid arthritis have. They will become first-line therapy.I do not see cost as an issue with biologics; the systemwill absorb the extra cost and will accommodate bio-logics because these drugs are effective.

Kircik: There is a need for some kind of objective mea-sure to automatically qualify a patient for a biologicagent. Creating such a measure would save patients thetorture of having to go through step therapy withtopical steroids and other therapies when it is clearthey will not work.

Pariser: If there is some concern about the AAD con-sensus statement because it’s not an algorithmic guide-line, then you might consider the National PsoriasisFoundation, which does have a more formal guideline.

Sullivan: But I think you made the point earlier, whendiscussing PASI, that this does not lend itself to aguideline easily, because of the nature of the condition

and they way it is scored. As an evaluative tool, thePASI may not be the best clinical approach. Nor doesthe available research support a benefit to developingrigid measures of disease severity as might be done forsome other medical conditions.

Kircik: However, every time dermatologists ask man-aged care for preauthorization for a treatment, they areasked to present their notes proving that the patienthas gone through step therapy. Perhaps the AAD con-sensus statement will be enough to prevent this.

Crown: Do you think that biologics will be used in com-bination with older therapies to treat patients withmore severe cases?

Leonardi: The early adopters will be dermatologists whoare using the current systemic treatments. Iwould expect to see combinations of metho-trexate and alefacept being used, crossing pa-tients over into new therapy. I have difficultywith mixing and matching biologic therapiesbecause in some cases, combinations of pred-nisone, cyclosporine, and infliximab resultedin high-grade immunosuppression.Crown: I was not thinking so much in termsof the development of a new compound thatcombined various properties of drugs; I wasthinking more about how physicians wouldpractice now that they have broader choicesin treating patients.Leonardi: Because I chose dermatology asmy profession, I have always wanted to findways to bring relief to patients with bad skin

disease. I have been frustrated by not having the righttools to do this, so the availability of biologics to treatpsoriasis is exciting to me. Biologics are not subtle; theyhave a major impact on patients who are in desperateneed.

Pariser: It exciting for us as medical dermatologists to beable to provide care in a way that we have never before.Patients are picking up on this.

Hebert: I think dermatologists will begin to see more pa-tients with psoriasis simply because, for the first time,we have a good treatment to offer. This is a wonder-ful time to practice dermatology, because of our newcapacity to help these patients with biologics.

Guerra-Garcia: The development of these biologic agentswill provide managed care with an opportunity topartner with dermatologists to develop guidelines forappropriate treatment of plaque psoriasis. Workingclosely with physicians who treat patients with thiscondition will produce the best results.

Pariser: I’m pleased that we didn’t get tremendous re-sistance from our managed care colleagues about this,and I hope we can figure out a way to provide theseagents to the people who will benefit from them.

Leon H. Kircik, MD:“There is a need forsome kind of objectivemeasure to automati-cally qualify a patientfor a biologic agent. ”

6. Because cyclosporine is nephrotoxic, the FDA limits its use in treatment of psoriasis to:a. 6 months.b. 9 months.c. 1 year.d. 18 months.

7. The cost-effectiveness of personalized medi-cine and biologic drugs could potentially berealized if these therapies can reduce or elim-inate the expense of treating patients whoare unresponsive to treatment.a. Trueb. False

8. In the AAD consensus statement, four bio-logic agents have been listed as first-lineagents for patients requiring systemic treat-ment for plaque-type psoriasis based on:a. Long-term studies.b. Patient demand.c. Clinical experience.d. FDA indications.

9. Medstat found that cost-effectiveness depends, in part, on the:a. Cost of drugs currently under development

for a condition.b. Cumulative cost of prior therapy.c. Sensitivity and cost of the test used to identify

a condition.d. All of the above.

10. Many health plans are now changing thelevel of patients’ financial responsibility forhealth care services by:a. Adding deductibles to copayments.b. Reevaluating member responsibility per tier

yearly.c. Abandoning management of drug therapy.d. Answers “a”and “b.”e. Answers “b”and “c.”


1. Psoriasis affects more than 7 million Ameri-cans. According to the National PsoriasisFoundation, how many psoriatic patientsconsider their disease to be moderate to se-vere?a. 200,000b. 500,000c. 1 milliond. 2 million

2. Medstat estimated the total cost of psoriasis(as a primary diagnosis only) to the nationalhealth care system to be:a. $74.2 million per year.b. $649.2 million per year.c. $705.6 million per year.d. $3 billion per year.

3. Which of the following therapies is most com-monly used in the management of moderateto severe psoriasis?a. Phototherapy.b. Systemic therapy with methotrexate.c. Systemic therapy with cyclosporine.d. Systemic therapy with retinoids.e. Topical therapy with steroids.

4. According to the AAD, in choosing psoriasis therapy, physicians should consider the:a. Form of psoriasis, patients’ quality of life, and

comorbid conditions.b. Severity and locations of lesions and patient’s

state of health.c. Patient’s access to office for treatment.d. Answers “a”and “b.”e. All the above.

5. Contract language and a drug’s acquisitionprice:a. Help to shape a health plan’s unique system.b. Contribute toward uniform standards among

plans.c. Influence the placement of drugs in certain

tiers.d. Answers “a”and “c.”

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