CURRENT ISSU ES

A strategy for generating relevant economic data

Pharmaceutical companies need to develop a strategy for generating the most appropriate pharmacoeconomic data, claim UK-based investigators. TIley believe thai the importance of developing a strategy for pharmaco­economic evaluation early in the drug development process cannot be overemphasised.

Pros of combined studies ... Combining pharmacoeconomic and clinical analyses

encourages a closer integration of health economists and other hea1thcare researchers. 'Such a marriage . . . sub to creole a powerful 1001 for curoing lhe inappropriate use ofhealthcare resources', note the investigators.

Prospective pharmacoeconomic studies perfonned alongside clinical triaJs minimise the loss of economic data by pennitting the coUection of relevant cost and benefit data Also, there is a minimal incrementaJ cost associated with adding a pharmacoeconomic analysis to a clinical tria1.

Integrating economics with drug development

BridgIng afudIn: These IIudies. whidl can be concIt.Iaed ttvough phases I to IV, a~ to COf1'IbN data from pharmac:o­epidemjoIogy and cost-ol-ihss studies. ~ tedlnlquea: Data collected from numetOUI sources (e.g . ..,.,. trials, expert opinion, tna/1(eI

researdI) are !dlject m vamus models, partiw\aIty cIec:isIon MaIysis.~ __ "dala

coIaded In:m ~ WId oost-d .... studies. A drug COfTll8rlY can use Ihe results 01 pharmac:oec::oo modelling tedmiques to decide whether m persevere Mh a research and deoelopmenl progamme, and m eJfIIore various pricing achedules. These stud"Ies can be oonducted throogh phases I to IV. PIggytMck friIII: Pharmacoeconomi analyses are attachecl to uisOOg phase III or IV cinicaI trials; this is a oosI-efIec:tive approach to ~ drug CCftlIInies ~ 8COI1OIric data.. Piggy­back trials can also provide opportunities lor coIlectilg quality-of. life data. However, proIoaH!duced adMties in dinic:al trials are no( based on ~ cIncaI pracIice and can, Iherefore, reduce a sb.JtI$ 8ICI8maI vaiIity. And becauselhe ~ of econonic studies tend to Y8J}' more !han c&1ic:aI erq,oInts, phannaco­economic analyses may requM'e a larger 58lTlJIe sizto NfturIIiJtk triU: Serri<ontroled clinical economic trials that are most often performed in phase III and IV studies. Thete types allrials ha", good "'""'" _ u they _ ""'"' cIosety 10 clinical prac:tioe, have a relevant foIow.lJp period and _-",,_._,_"-0811 only be performed once phase III studies have 8SI8IIlId the

safely 01 ... drug. A Iatge """" ........ ~ "" nalU!abtic studies.

... and the cons However, concurrent economic and clinical mals are

conducted in an artificial study environment that is atypical of clinical practice, the investigators point OUl

Also. economic data collection may seriously over· burden study researchers and patients, and threaten the feasibility of conducting the trial . The difficulty associaled with designing, implementing and allocating

resources to such combined studies is an additional problem. they note.

TIle inability to generalise pharmacoeconomic data across countries is driven by inter-country differences in the availability and costs of healthcare resources. practice panerns and incentives to healtheare professionals. To overcome this problem. researchers must conduct combined clinical/economic studies in a number of countries or undertake economic modelling to modify the study from one area to another, according to the investigatOrS. They believe that various approaches can be used to integrate phannacoeconomic analyses with various stages of drug development [see boxed text). Lim MCT, VKani P. DnImmond MF. Economic analysis with dinicallrials. Applied C\inic:&I Trials.: 6C).66, Oct 1995 _ ..

Australia's experience with phannacoeconomic guidelines

"The Australian pharmaceutical industry realises that cost-effectiveness guidelines in that country are designed to make better. not perfect. choices about drug reimbursement. However. the industry continues to doubt that economic analyses will be applied with the same rigour to other areas of healthcare.

Insights and recommendations A number of insights and recommendations can be

drawn from the experience of the Australian phanna­ceutical industry with regard to pharmacoeconomic guidelines. • Using cost effectiveness as quasi-cost containment

may seriously limit Australia's access to new, inno­vative drugs developed in other parts of the world.

• Cost effectiveness is not an efficient method for containing costs, and it is only one of a number of ways 10 achieve more efficient allocation of healthcare resources.

• Decision-making that is based on cost-effectiveness criteria may not always reflect community concerns about equity and access.

• Economic evaluation must be transparent and open for dispute: evaluators and decision-makers should also be held publicly accountable for their actions.

• The increasing evolution of pharmacoeconomics, and the growing specificity and long lead times associated with drug development, mean that the processes and technical expectations of phannacoeconomic evaluation need to be adaptable and practical.

• The role and evaluation of cost effectiveness may change considerably as the focus shifts from the short tenn to the long tenn, and from drug management to disease management.

• Phannacoeconomic evaluations must be conducted from the societal perspective in order to avoid cost shifting.

• Drug companies cannot be expected to provide all 100 required data; governments must be conunitted to supplying the necessary resources to define health goals. establish health outcome measures and develop appropriate epidemiological databases.

• Government commitment must ensure that price nego­tiation will not negate or delay the reimbursement listing of drugs that have proven cost effective.

Gcriwn P. Co&t-elfoctivmess pidclincs: the expc:rience of AU$IJalian manuf~. 1'IwmacoEeonorn18: 369·373, NO"¥ 1995 _

PHAAMACOAESOUACES 2 Dec 11M

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