De Cock, E.

Payne, K.A.

Urspruch, A.

Elsevier - Publisher Connector 

PHP44
INTERNATIONAL COMPARISON OF PHARMACEUTICAL EXPENDITURE IN
MIDDLE INCOME COUNTRIES: METHODOLOGICAL QUESTIONS
Kalo Z1, Inotai A2, Merész G2
1Eötvös Loránd University, Budapest, Hungary, 2Syreon Research Institute, Budapest, Hungary
OBJECTIVES: Scarcity of public resources inmiddle-income countries, especially in
challenging economic times, draws attention to potential reduction of pharmaceu-
tical expenditure. Per capita pharmaceutical spending in purchasing power parity
(PPP) exchange rates, proportion of pharmaceutical spending compared to GDP and
total health care spending are frequently used indicators to justify potential sav-
ings. Our objectivewas to explore the influencing factors of pharmaceutical spend-
ing in European middle-income countries. METHODS: We conducted a literature
review to set up hypotheses for differences in pharmaceutical spending between
middle-income (below 30’000 USD GDP/capita) and high income countries (above
30,000 USD GDP/capita). Cross sectional survey based on OECD Health Data 2010
and cluster analysis was conducted to test those hypotheses by applying Mann-
Whitney-Wilcoxon test. RESULTS: Payers calculate international price references
in currency exchange rates, no adjustment is made to local purchasing power. Due
to manufacturers’ response to international price referencing and parallel trade
middle-income countries have to pay almost the same global price for innovative
drugs as high income countries. Therefore adjustment of pharmaceutical expen-
diture to GDP PPP may not be justifiable, application of currency exchange rates is
more appropriate for comparison of pharmaceutical spending. Our cluster analysis
indicates that expenditure is proportionally higher in middle-income countries
compared to high income countries (1.89 vs. 1.41% of GDP%, p0.039; 23.58% vs.
14.14% of total health expenditure, p0.001), as prices of pharmaceuticals are not
adjusted to local price levels, whilst costs of other health care services are lower
mainly due to lower salaries of health care professionals. CONCLUSIONS: It can be
misleading to compare the pharmaceutical expenditure of middle-income coun-
tries to the average of OECD countries. Cluster analyses of countries with similar
economic status and comparison of absolute spending based on currency ex-
change rate provide appropriate benchmarks to substantiate policy initiatives.
PHP45
BURDEN OF ILLNESS OF CHRONIC CONDITIONS (CC) AMONG HOSPITALIZED
PATIENTS: THE ARGENTINE-HEALTH CARE COST AND UTILIZATION PROJECT
(A-HCUP)
Insua JT1, Giunta D2, Ioli P3, Villalon R1
1Hospital Universitario Austral, Universidad Austral, Derqui, Argentina, 2Hospital Italiando de
Buenos Aires, Caba, Argentina, 3Hospital Privado de la Comunidad, Fundacion Medica de Mar del
Plata, Mar del Plata, Buenos Aires, Argentina
OBJECTIVES: Non-Communicable Diseases (NCDs), are difficult to measure, so we
used a Chronic Conditions (CC) table in a discharge registry to obtain them.
METHODS: In a 1 year output of 3 hospitals, a CC (MCRR, 2006; 63: 327 - 346) table was
used. A Pareto rank of first 10 CCSwith CC () in primary diagnosis (Dx1) and second-
ary diagnosis (Dx2) among 19 yrs old, costs, Clinical Classification Software-CCS
single level-SL groupers (2009) (#CCS [descriptive term]), average length of stay (ALOS),
total costs (CT$) mean and median per discharge cost ($), (25P-75P-percentiles), in
international dollars PPP, (1Arg$  1.608 I$ PPP, 2008) were obtained. CT$ of all CC
burden is reported. RESULTS: Among  19 years, 17169 Dx1 with CC () (37,76%),
had CT$: I$ 243 893 494 (39,36% of hospital cost) and ($): I$ 14 473,04. 15 102 dis-
charges had 1 ormore CC() in Dx2 (32,97%), with a CT:I$ PPP 216 158 768, (1,86% of
discharges not costed). The top 10 CCS with CC where 7489 discharges, a 16,35% of
total discharges 19 years old, CT$: I$ 109 896 918. The first 10 CCS of the pareto
ranking, mean age 42 years (SD 30,45 yrs), an ALOS was 3,54 (SD 5,07) days, with a ($):
I$ 10 560,92 (SD I$ 18 101,73), a median cost of I$ 4057,56 (25-75 percentiles I$ 1022,97-
8250,84). The CCS #45 [Maintenance chemotherapy; radiotherapy] of which 100%was
CC ()was ranked #1, followedbyCCS#149 [Biliary tract disease], ofwhich 19,34%was
CC(). In hospital mortality of CC () in Dx1 was 817 deaths (4,75%). CONCLUSIONS:
CC table obtained the Burden of CC in discharges at 38% of total costs. Behavior of
CC in CCS are compatible with each condition. Future studies should address gen-
eralizability of results, accuracy of Dx2 coding and co-morbidity.
PHP46
DESIGN AND OPERATIONAL CHALLENGES WITH TIME AND MOTION (T&M)
STUDIES RUN ALONGSIDE CLINICAL TRIALS
De Cock E1, Payne KA2, Urspruch A3
1United BioSource Corporation, Barcelona, Spain, 2United BioSource Corporation, Dorval, QC,
Canada, 3F. Hoffmann-La Roche, Basel, Switzerland
OBJECTIVES: T&M studies are designed to collect observational data to quantify effi-
ciency-relatedoutcomes,mainly staff-timeandconsumablesassociatedwithmedical
interventions. Our aim is to describe scientific and operational challenges that were
observed when implementation a T&M study alongside a clinical trial. METHODS:
T&M-method involves repeated observations of pre-identified tasks associated
with a process in order tomeasure task durations to estimate total process time. As
part of amulti-centre T&M study run as a sub-study to a clinical trial, we identified
key design parameters that drive robustness as well as process elements that are
critical factors to successful operational conduct. RESULTS: T&M-endpoints are to
be carefully selected to align with their final use as inputs in e.g. economicmodels.
As part of a trial that investigates time for a new route of administration (subcuta-
neous as alternative to intravenous), it is important to discuss with staff the appli-
cability of task descriptions, with local CRF adjustment justifiable if providingmore
accurate time measurements. Trial protocol determines number and timing of
observations, leading to sample size restriction and potentially extended study
period. In the absence of clear guidelines on T&M study classification, regulatory
processes are to be well understood, and absence of patient interaction clearly
stated. Initiation of T&M-sub-study togetherwith First-Patient-In is crucial to avoid
losing valuable observations. Sites prefer to be given options for selecting observ-
ers, but ideally observers are external to the care unit (within or outside the hos-
pital) and are competent and available during study period. As sites are inexperi-
enced with T&M-method, streamlined communication and focused training
proved crucial. CONCLUSIONS: T&M-methodology is associated with important
design and operational challenges that must be identified early on to guarantee a
scientifically robust design and operational feasibility, with the ultimate aim to
produce valid efficiency-related data in support of economic analyses.
PHP47
THE ECONOMIC IMPACT OF A COST-EFFECTIVENESS THRESHOLD ON THE
INNOVATIVE DRUG EXPENDITURE IN QATAR
Al-Badriyeh D1, Mohamed H1, Abunoora R1, Fahey M2
1Qatar University, Doha, Doha, Qatar, 2Hamad Medical Corporation, Doha, Doha, Qatar
OBJECTIVES: Hamad Medical Corporation (HMC), the main health provider in Qa-
tar, does not implement a cost-effectiveness threshold (CET) of acceptable cost-
per-effect for the innovative drugs when considered for formulary inclusion, i.e.
drug selection is based on the drugs’ safety and effectivenesswith no regard to cost.
This study sought to estimate the economic impact of implementing a CET on the
expenditure of innovative drugs in HMC.METHODS: This is a retrospective study,
in whichwe analyzed the HMC drug utilization data for the period 2008-2010. From
the Qatari perspective, a CET was calculated and used to screen innovative drugs
for formulary inclusion. This was based on cost-per-quality adjusted life years
(QALYs) values of innovative drugs, as analyzed from literature. Drugs that had
estimated negative costs (savings) and equal/moreQALYs comparedwith standard
treatment were not taken into the analyses. Threshold and scenario one-way sen-
sitivity analyses, and an uncertainty (Monte Carlo simulation) analysis were per-
formed to assess the robustness of the study conclusions. RESULTS: Thirty-four
innovative drugswere identified (12 in 2008, 11 in 2009, and 11 in 2010) and included
in the analysis. Based on an underestimation of the CET effect, a potential 22.2-
68.0% reduction in innovative drug expenditure was demonstrated. Based on the
uncertainty analysis, there is a 70% chance that a CET will result in the 68.0%
innovative drugs expenditure reduction. Thiswas equivalent toQAR16,429,260 and
to a 2.1% reduction in the overall HMC drug expenditure. Drugs were ranked as per
their influence on the CET effect, where the drug ‘Sitagliptin’ had the highest in-
fluence. According to sensitivity analyses, study results were robust against uncer-
tainties with inputs. CONCLUSIONS: Reduction in HMC innovative drug expendi-
ture maybe achieved with the application of a formal CET. For formulary drug
selection, HMC decisionmakers should consider the cost-effectiveness of drugs, in
addition to their effectiveness and safety.
PHP49
REFERENCE PRICINIG PROPOSAL BASED ON GROSS DOMESTIC PRODUCT PER
CAPITA
Kockaya G1, Wertheimer A2, Kılıc P3, Daylan Kockaya P4
1General Directorate of Pharmaceuticals and Pharmacy, Ankara, Turkey, 2Temple University
School of Pharmacy, Philadelphia, PA, USA, 3General Directorate of Pharmaceuticals and
Pharmacy, Ankara, Ankara, Turkey, 4Polatlý Duatepe Hospital, Ankara, Turkey
OBJECTIVES: Even though the lowest of the prices amongst reference countries are
taken into account during reference piricing, these price are still relativley high
according to our country’s purchasing power. The price of a certain medication is
considered normal in a developed country whereas that price for the same product
presents itself higher than the purchasing power of developing country.Develop-
ment of a new reference pricing system estimated in accordance with Turkey’s
GDPC is proposed. METHODS: The most essential requirement for reference pric-
ing is to reach a new reference price based on themolecule significance coefficient-
(MSC) - obtained through an assessment and GDPC no higher than the lowest
reference country price. A committe of 5 academicians convened from different
universities has evaluated bevacizumab, erlotinib and rituximab, using the assess-
ment formprepared on grounds of 5 questions for the calculation of the coefficient.
New public pricesof the products were calculated by the use of the MSC. The phar-
maceutical product pricing calculation is suggested as below: Product Price  

(Country GDPC/Ref. Country GDPC  Ref. Country Price)  Molecule Significance
Coefficient; Mol. Sig. Coeff.  Average Score/Total Score  3. RESULTS: The MSC
values for bevacizumab, erlotinib and rituximab were 1.09, 1.21 and 1.29, respec-
tively. The probable the new calculated public prices depending the formulas were
decreased from the public price, 37%, 40% and 21%, respectively. CONCLUSIONS:
GDPC-based reference pricing sample may provide a new perspective in phar-
maeutical pricing control in countries like Turkey. On the other hand, this can also
provide an opinion for countries with insufficient facilities for approaching MSC
and HTA, during reimbursement decision making. For instance, an MSC value
under 1 is not included in reimbursementwhereas one falling in between 2 and 3 is
suggested for reimbursement.This can be similarly used for determining the MSC
reimbursement levels independent from reference pricing.
PHP50
THE HEALTH AND ECONOMICS BULLETIN – AN ANALYSIS OF THREE YEARS OF
PUBLICATION
Lima SO, Calais GSP, Caldeira TR, Garcia GC, Gava CM, Pereira RF, Ronchini MAK,
Troncoso GCBCEC
Brazilian Health Surveillance Agency (Anvisa), Brasília, Brazil
OBJECTIVES: The Health and Economics Bulletin is an electronic periodic of The
Brazilian Health Surveillance Agency (ANVISA). It aims to provide information to
health care decision makers and patients when there is more than one pharma-
ceutical option to treat the same disease and there is no scientific evidence of
A21V A L U E I N H E A L T H 1 5 ( 2 0 1 2 ) A 1 – A 2 5 6


PHP46 Design and Operational Challenges With Time and Motion (T&M) Studies Run Alongside Clinical Trials 

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PHP46 Design and Operational Challenges With Time and Motion (T&M) Studies Run Alongside Clinical Trials

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