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PHARMACOECONOMIC ANALYSIS WORK SHEET

Product Information
Drug Product
(generic name/strength/dosage form)
Drug X Tablet USP
Generic C 5 mg Tablet
Name of Manufacturer ACME Ltd.
Please complete each of the following questions:
1. (a) What is the question being asked in the analysis
(b) What type of economic analysis was performed to answer the question
i !ost comparison
ii. !ost"consequence analysis
iii. !ost"effecti#eness analysis
i#. !ost"utility analysis
#. !ost"benefit analysis
(c) What is the $ustification for the approach taken
%. (a) &id the study in#ol#e a comparison of alternati#e treatments for patients with the
same clinical condition
(b) 're those alternati#es e(plicitly stated
(c) )s the analysis therefore an incremental analysis
*. (a) )s the #iewpoint or perspecti#e for the analysis stated clearly
(b) )s it a societal perspecti#e+ third"party payer perspecti#e+ patient perspecti#e
(c) )s the analysis presented in a disaggregated fashion showing these perspecti#es
separately
,. (a) Was the e#idence of the product-s efficacy established through randomi.ed trials
(b) Was this e#idence of efficacy supplemented by e#idence of effecti#eness
applicable to the patients co#ered by the /ntario &rug 0enefit program
(c) Was the latter e#idence deri#ed from studies documenting routine use in clinical
practice
1. (a) 're the methods and analysis displayed in a clear and transparent manner
(b) 're the components of the numerator (cost of each alternati#e) and denominator
(clinical outcomes of each alternati#e) displayed
(c) 're clinical outcomes e(pressed first in natural units and then translated into
alternati#e units such as benefits or utility (2ee 2ection *.,.d. of the Ontario
Guidelines or Economic Anal!sis o P"armaceutical Products for suggested
format).
3. 're all important and rele#ant costs and consequences (outcomes)+ including ad#erse
effects+ for each alternati#e identified
4. (a) 're costs and consequences modelled as in a decision tree with information
deri#ed from a #ariety of sources5 /6
(b) estimated directly from a #ariety of sources5 /6
(c) estimated directly from a specific patient population
7. (a) 're capital costs and o#erhead costs included as well as operating costs
(b) 8ow were they measured
9. 8ow were indirect costs identified and estimated
1:. 8ow was quality of life measured
11. (a) What equity assumptions were made in the analysis
(b) ;or e(ample+ are <'=>s gained by any indi#idual considered equal
1%. (a) )f some #ariables were difficult to measure+ how did the authors handle this
difficulty
(b) &id they slant the analysis all in fa#our of one inter#ention in order to bias the
analysis against the desired result
1*. (a) Were e(tensi#e sensiti#ity analyses performed
(b) What were the ranges of #alues for #ariables in the sensiti#ity analyses
1,. (a) )s quality of life an important component of an economic analysis of this question
(b) 8ow sensiti#e is the estimate of cost utility to #ariations in quality of life
11. (a) )s there an estimate of the aggregate incremental e(penditure required for the
pro#ince to pro#ide this product to patients co#ered by its programs
(b) What is the estimate of aggregate incremental costs
(c) &oes this estimate co#er all of the ma$or indications for use of the product
13. (a) 8as the incremental cost"effecti#eness ratio been estimated for a special clinical
indication that represents the ma$ority or all of its e(pected use by those co#ered
under the /ntario &rug 0enefit program
(b) &o these other indications in#ol#e a large amount of utili.ation for which the ratio
may be #ery different
14. (a) Who performed the analysis
(b) &id the authors of the report sign a letter indicating their agreement with the entire
document presented
(c) &oes the report indicate that the authors had independent control o#er the
methods and right to publish the analysis regardless of its results
17. What is the ?bottom line? result of the analysis in quantitati#e terms @he answer to
this question will be statements like the following:
@he cost per <'=>s gained for using this product compared to the alternati#e is
AB+ or ranges from A> to AC.
@he use of this product compared to the stated alternati#e will result in an
e(pected incremental e(penditure of AB per patient treated with a net reduction of
> ma$or ad#erse clinical e#ents (e.g.+ cardiac deaths) and C minor clinical e#ents
(e.g.+ side effects).

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