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PSYCHIATRIC SERVICES

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T he cost of second-generationantipsychotics in the treat-ment of schizophrenia isabout $10 per day, more than tentimes the cost of generic first-gener-ation antipsychotics and three to fourtimes the cost of patented antide-pressants (1). Total sales of second-generation antipsychotics reached$11.5 billion in the United States in2006 (2), over $100 per household. Whether these expenditures are justi-

fied and what, if anything, might bedone to reduce them are issues of substantial public concern (3).

Cost-effectiveness analysisand consumer choiceCost-effectiveness analysis is a scien-tific method for determining whetherthe increased cost of new treatmentsis justified by their relative benefits.Most commercial goods are pur-chased on the basis of consumerchoice in private markets without aneed for scientific evaluation. An im-portant assumption about such mar-kets is that consumers have adequate

information on which to base theirchoices. Such information is far lessaccessible in health care markets. As a

result, patients largely rely on theirphysicians for guidance. Physicianopinion, however, is often shaped by industry-sponsored research (46)and marketing (7), especially whennew drugs are brought to market.Cost-effectiveness analysis conductedby independent researchers seeks toprovide data on relative health care value, or the cost of additional healthgains with new treatments compared with the best available alternatives.

Cost-effectiveness analysis, policy, and politicsBecause cost-effectiveness analysisconsiders costs and outcomes in a sin-gle analysis, it offers the most compre-

hensive empirical estimate of treat-ment valuecritical information forshaping policy. But cost-effectivenessresearch is only one of many inputs tochoice of health care policy. First, al-ternative policies representing diversecourses of action must be outlined.Such policies affect different sets of stakeholders: patients, family mem-bers, professional groups, insuranceand pharmaceutical companies, and,ultimately, taxpayers. Political deci-sion making, in turn, represents a

transition from scientific fact and pol-icy review to collective action and isshaped by interest group politics (8),regulatory law (9), and broad social valuesdomains in which emotionalsymbolism and narrow stakeholder in-terest carry increasing weight (10).

This commentary has three objec-tives: first, to summarize recent re-search on the cost-effectiveness of second-generation antipsychotics; sec-ond, to review the diverse policy op-

Second-Generation Antipsychotics:Cost-Effectiveness, Policy Options,and Political Decision MakingRobert A. Rosenheck, M.D.Douglas L. Leslie, Ph.D.

Jalpa A. Doshi, Ph.D.

Dr. Rosenheck is affiliated with the Department of Psychiatry, Yale Medical School, 950Campbell Ave., New Haven, CT 06516 (e-mail: [email protected]). Dr. Leslie is with the Department of Psychiatry, Medical University of South Carolina, Charleston.Dr. Doshi is with the Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia. This article is part of a special section on the Clinical Antipsy-chotic Trials of Intervention Effectiveness (CATIE) and its implications. Marvin S.Swartz, M.D., served as guest editor of the special section.

The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)and other recent research suggest that second-generation antipsychoticsother than clozapine may offer few, if any, advantages over first-genera-tion antipsychotics, especially agents of intermediate potency. Thus thenewer agents are not likely to generate sufficient benefit to justify their $11.5 billion annual cost. Policy approaches for containing drug costs areavailable and could improve cost-effectiveness by encouraging that sec-ond-generation antipsychotics be prescribed more selectively, such as only

when clearly indicated. However, restrictions on either drug availability or physician choice are vigorously opposed by professional and consumer ad-vocacy groups as well as by industry, and excessively restrictive approach-es could unintentionally reduce access to beneficial treatments. Interven-tions that directly reduce second-generation antipsychotic prices wouldincrease access for consumers but are inconsistent with broad oppositionto government price regulation in the United States. High expenditures onthese medications are thus likely to continue without concomitant gainsfor public health. ( Psychiatric Services 59:515520, 2008)

Special Section on Implications of CATIE


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tions available for drug cost-contain-ment; and third, to map the wider po-litical landscape in which antipsychot-ic policy is shaped. We thus seek tocontrast cost-effectiveness analysis(scientific data), with policy develop-ment (conceptualization of alterna-tive choices), and political action (theresponses of decision makers).

Cost-effectiveness of second-generation antipsychoticsTo put the $11.5 billion annual domes-tic expenditure on second-generationantipsychotics into perspective, it isnoteworthy that the additional cost of using these drugs rather than first-generation antipsychoticsabout $10billionis substantially greater thanthe $8.5 billion total annual income of all 47,000 U.S. psychiatrists (11,12).This amount could fund 150,000 casemanagersenough to provide inten-sive evidence-based treatments likeassertive community treatment or sup-ported employment to 1.5 million ad-ditional consumersor could supportthree times the total number of social workers currently employed in theUnited States (13).

Early researchEarly research on second-generationantipsychotics suggested that thesemedications are more effective than

their predecessors (14), pose less riskof neurological side effects (especial-ly tardive dyskinesia) (15), and saveenough in inpatient costs to pay forthemselves (16).

Effectiveness and tolerabilityCochrane reviews, however, do notsupport these conclusions (17), and in2003 a 12-month Department of Vet-erans Affairs (VA) cooperative study of 309 inpatients unexpectedly found nosignificant differences between olanza-

pine and haloperidol on measures of symptoms, quality of life, or most sideeffects (18). One explanation for theseunexpected findings was that haloperi-dol was given in the VA trial with pro-phylactic anticholinergics, whereasmost industry-sponsored trials hadused haloperidol without such medi-cines (19) and at higher doses than rec-ommended by the Food and Drug Ad-ministration (FDA) (20), which poseda high risk of neurological side effects

that could be mistaken for negativesymptoms of schizophrenia.

More recently a series of reportsfrom the 18-month Clinical Antipsy-chotic Trials of Intervention Effective-ness (CATIE) indicated that eventhough patients used olanzapine longerthan two other second-generation an-tipsychotics (21), none of four second-generation antipsychotics (olanzapine,risperidone, quetiapine, or ziprasidone)showed any statistically significant advantage over the first-generation an-tipsychotic perphenazine on measuresof symptoms, neurologic side effects,quality of life, employment, violent be-havior, or neuropsychological function-ing (2224). CATIE has been chal-lenged because follow-up rates werelower than in briefer studies, study du-ration was limited to 18 months, pa-tients had chronic schizophrenia, andthose with tardive dyskinesia were ex-cluded from assignment to the random-ization stratum that received per-phenazine. However, a detailed litera-ture review showed that the design andimplementation of CATIE was no moreflawed in these respects, and less flawedin some, than studies that showed sec-ond-generation antipsychotics to be su-perior to older drugs (25).

CATIE findings were reinforced by the Cost Utility of the Latest Antipsy-chotic Drugs in Schizophrenia Study

(CUtLASS 1), a government-fundedtrial in the United Kingdom, whichalso found no advantage of second-generation antipsychotics over first-generation drugs on symptoms, sideeffects, or quality of life (26). Most re-cently, a post-CATIE industry-spon-sored trial also found no meaningfuldifference between the latest second-generation antipsychotic, aripiprazole,and perphenazine (27,28).

Metabolic side effects

There has also been growing concernthat some second-generation antipsy-chotics (especially olanzapine andclozapine) increase the risk of weightgain, diabetes, and metabolic syn-drome (29), risks that may offset thebenefit of any reduced risk of tardivedyskinesia (30).

Tardive dyskinesiaReduced risk of tardive dyskinesia re-mains an area of potential benefit for

newer drugs. A 2004 review estimatedthat the annual risk of this syndrome with first-generation antipsychotics was 4.6% greater than with second-generation antipsychotics (5.4% versus.8%) (15) but noted that the resultscould have been biased because themajor trials all involved moderate tohigh dosages of haloperidol and may thus not be generalizable to other first-generation antipsychotics. These trials were not substantially longer thanCATIE, which found no benefits forthe newer drugs on similar measures(21). Recent epidemiologic studiesalso question whether second-genera-tion antipsychotics have any lower riskof tardive dyskinesia than first-genera-tion antipsychotics (3133), even inelderly populations (34).

Another recent analysis with prevail-ing estimates found that the cost of avoiding one case of tardive dyskinesiaby using second-generation antipsy-chotics ranged from $52,000 to$135,000 per year (15), or from$149,000 to $683,00 per quality-adjust-ed life year (35), which is three to 13times the ceiling of $50,000 per quality-adjusted life year used by many indus-trial countries to determine whether atreatment is cost-effective (36).

Cost-effectivenessThe VA trial found no reductions in

health service use with olanzapine, which was associated with increasedtotal health care costs (includingdrugs) of $3,000 to $10,000 per year(18). A comprehensive review of cost-effectiveness research before CATIEalso found no evidence of cost savingsor greater cost-effectiveness for sec-ond-generation antipsychotics (37).CATIE itself found second-genera-tion antipsychotics to have greatercosts (that is, $2,400$6,000 greaterper year) and no clinical advantages

over perphenazine (22). CUtLASSfound first-generation antipsychoticsto be more cost-effective than sec-ond-generation antipsychotics (38).

A naturalistic analysis of 19932001data from California Medicaid, fur-thermore, found that second-genera-tion antipsychotics did not pay forthemselves in that the sixfold greatercost of second-generation antipsy-chotics versus older medications didnot reduce other health care costs



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Medicare and transitioned fromMedicaid to private Medicare Part Dplans in 2006 may further increaseprices of antipsychotics. Persons withdual eligibility constituted a signifi-cant proportion of Medicaid benefici-aries receiving antipsychotics, andtheir exit reduces the bargaining pow-er of state Medicaid programs for theremaining beneficiaries (54). The dis-persed enrollment of the dually eligi-ble beneficiaries across severalMedicare Part D plans within eachstate also limits the bargaining powerof any single plan. The Part D re-quirement that all drugs in the sec-ond-generation antipsychotic class becovered by all plans substantially lim-its price negotiations.

Government regulationThe final set of policies primarily af-fects manufacturers and includes di-rect price regulation, mandated vol-ume rebates, accelerated conversionof patent drugs to generic status, di-rect-to-consumer advertising, and re-importation of less expensive medi-cines from other countries (43). Theseapproaches are far less disruptive forproviders or patients and are likely toenhance, rather than reduce, drug ac-cess. In regard to pricing policies,Medicaid rebates have lowered drugcosts but have been countered, as not-

ed above, by increased prices (53,55).By lowering corporate income suchregulations risk reducing investmentin the development of new drugs(56,57), with possible adverse effectsin the long run. Price regulation ap-pears to be most stringent in countriesthat lack a significant domestic drugmanufacturing sector, such as theNetherlands. France, Germany, andthe United Kingdom all regulate drugprices despite a strong industrial phar-maceutical presence (58). The possi-

bility that price controls could limit theneed for utilization managementstrategies and improve access deservesfurther study, but opposition to pricecontrols in the United States is strongand broad based.

Stakeholder interest and politicsAlthough many appropriate policy al-ternatives are thus available, a recentcross-national study showed a generalreluctance to use cost-effectiveness

analysis to influence policy in theUnited States compared with otherindustrial countries (36). Americansseem to distrust cost-effectivenessanalysis, perhaps fearing that it couldlead to harmful restrictions. Govern-ments in the United Kingdom, Cana-da, and Australia, in contrast, general-ly do not pay for treatments that costmore than U.S. $50,000 per quality-adjusted life year (36).

Responses to the CATIE trial vivid-ly reflect the differing perspectives of major competing stakeholders. Pressreleases from the American Psychi-atric Association and from leading pa-tient and family advocates have ex-pressed alarm that the results of CATIE would lead to restrictive for-mulary policies that would limit thefreedom of physicians to prescribe orthe right of consumers to have accessto all approved medications. None of these stakeholders would supportpreferential use of less expensive first-generation antipsychotics before moreexpensive drugs. Although none ar-gued against recent research showingthat second-generation antipsychoticsare no more cost-effective than first-generation antipsychotics, they takethe implicit position that rights of ac-cess should take priority over regula-tions promoting cost-effectiveness.

A New York Timeseditorial (59), in

contrast, concluded that CATIEshowed that the system for approv-ing and promoting drugs is badly outof whack and that the nation is wasting billions, and aWashingtonPost report concluded that physi-cians, patients and policymakers canbe blindsided by self-interested re-search by drugmakers (60). Butthese expressions of dismay were alsounaccompanied by calls for limits onuse of more expensive drugs.

Manufacturers of second-genera-

tion antipsychotics, in contrast, notedadvantages that CATIE showed fortheir specific products (61), and someCATIE results have been used, albeitselectively, in their advertising cam-paigns. At least one company has beenalleged to operate a program through which it offers to pay for quality man-agement data reviews for state mentalhealth agencies in exchange for a com-mitment that no formulary restrictionsare placed on its product (62).

State Medicaid agencies, which his-torically paid 70% of costs for second-generation antipsychotics, have beenlargely silent on recent research. Costsfor this class of drugs are clearly a con-cern for both Medicaid and forMedicare Part D, and prior authoriza-tion, copayments, and other restric-tions are increasingly used in theseprograms (63,64). In some cases ac-cess to individual second-generationantipsychotics has been restricted(65), but no policy has been imple-mented for systematically limiting useof the class as a whole. One state Med-icaid official described psychotropicdrugs as the third rail of formulary policy, uniting the interests of left-leaning patient advocates with those of pharmaceutical industry interests (66).This may explain why the Medicaid re-sponse to recent research on newerantipsychotics has been muted.

Some psychiatrists have expresseddismay that they were misled by in-dustry (67,68) or have expressed re-newed confidence in first-generationantipsychotics (69), but policy propos-als suggesting change to the status quofor antipsychotic formularies or drugpricing have been few (70). The TexasMedication Algorithm Project grouprecently decided that second-genera-tion antipsychotics should not neces-sarily be prescribed in preference to

first-generation drugs in chronic schiz-ophrenia (71). Some of the importantCATIE findings have only recently been published (2224) and may re-quire more time to influence policy.

The most compelling responses toCATIE have been anecdotal. Physi-cians, consumers, and family mem-bers have reported in various settingsthat regardless of research findings,the benefits of second-generation an-tipsychotics are clear to them, and theimposition of any limits on these

medications would cause grave harm.A powerful rhetoric of deprivation ar-gues that if all drugs are not available,some patients will suffer unduly. Theprobabilistic estimates of clinical tri-als pale beside the imagery of tragi-cally impaired lives. Successes of old-er drugs go unreported because suchstories are not considered news.

Attitudes of mental health groups to- ward medications (72), including sec-ond-generation antipsychotics, are po-



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larized, and it has been suggested thatconflicts between patient, family, andprovider groups are stronger in themental health community than else- where (73). A 1991 survey of U.S. con-gressional staff concerning the relativepolitical effectiveness of the mentalhealth and developmental disabilitiescommunities concluded that the devel-opmental disabilities community wasmore effective because it was less di- vided (74). Dry cost-effectiveness dataare not likely to attract the attention of parties contending over broader policy issues, such as whether medicationsshould be used at all.

One final policy option that mightlimit the dominance of industry re-search and foster studies like CATIEthat provide additional independentinformation to public policy discus-sions would establish a new federalagency or funding pool that wouldcarry out independent trials compar-ing different FDA-approved drugs with each other (75). Such an agency could be funded through taxes onprofits of blockbuster drugs, such asthose with sales of more than $1 bil-lion per year, without underminingcorporate incentives to innovate (76).

Despite offering the public, physi-cians, and policy makers better datafor judging price appropriateness,such studies would not, by them-

selves, improve the cost-effectivenessof practice. That will remain a matterof health system administration, poli-cy, and politics.

ConclusionsRecent independent research suggeststhat higher expenditures on second-generation antipsychotics are not justi-fied by their relative clinical benefits.Also, alternative policy options areavailable that would favor more selec-tive and more efficient antipsychotic

use; however, such policies are not like-ly to be implemented for want of polit-ical support. Expenditures on antipsy-chotic drugs are likely to remain high with limited health benefit.

Acknowledgments and disclosuresCATIE was supported by grant N01-MH-90001 from the National Institute of MentalHealth. A list of study locations and principalinvestigators can be found at www.catie.unc.edu/schizophrenia/locations.html.

Dr. Rosenheck has received research support

from Eli Lilly and Company, Janssen Pharma-ceutica, Astra-Zeneca, and Wyeth. He has beena consultant to GlaxoSmithKline, Bristol-My-ers Squibb, Organon, and Janssen Pharmaceu-tica. Dr. Doshi is on a Health Economics andOutcomes Research advisory board of Bristol-Myers Squibb. Dr. Leslie reports no competinginterests.

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AP Atipicos-costo Efectividad-opciones Politicas y Decisiones Politicas

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