2001 an Economic Overview of Chronic Obstructive Pulmonary Disease

8/9/2019 2001 an Economic Overview of Chronic Obstructive Pulmonary Disease

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An Economic Overview of ChronicObstructive Pulmonary Disease Hirsch S. Ruchlin1 and Erik J. Dasbach2

1 Weill Medical College of Cornell University, New York, USA

2 Health Economics Statistics, Merck Research Laboratories, Blue Bell, Pennsylvania, USA

Contents

Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6231. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6242. Data Selection and Presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6243. Cost and Utilisation Patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 625

3.1 Overall Burden of Illness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6253.2 Cost of Care Relative to Other Illnesses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6253.3 Cost by Disease Severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6263.4 Utilisation Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6273.5 Correlates of Cost and Utilisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 627

4. Economic Evaluations of Clinical Interventions for Chronic Obstructive

Pulmonary Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6284.1 Pharmacotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6284.2 Oxygen Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6364.3 Home Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6364.4 Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6374.5 Exercise and Rehabilitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6374.6 Health Education . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 638

5. Discussion and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 638

Abstract Chronic obstructive pulmonary disease (COPD) is a major cause of mortalityand morbidity. Relatively few pharmacoeconomic studies have been conductedon this disease. This article reviews available information about the utilisation of healthcare resources and cost of care, and the cost or cost effectiveness of thera-peutic interventions reported for this disease.

Burden-of-illness data indicate that hospital care, medications and oxygentherapy were the major cost drivers in these studies. Mean annual Medicareexpenditures in the US were $US11 841 (2000 values) for patients with COPDcompared with $US4901 for all covered patients. Utilisation was skewed; themost expensive 10% of the Medicare beneficiaries accounted for nearly 50% of total expenditures for this disease. Costs are associated with health status, age,physician specialty, geographic location and type of insurance coverage.

Six types of interventions were assessed in the literature - pharmacotherapy,

oxygen therapy, home care, surgery, exercise and rehabilitation and health edu-cation. The studies used different analytic strategies (e.g. cost-minimisation andcost-effectiveness analyses) and even within the realm of cost-effectiveness anal-

REVIEW ARTICLE Pharmacoeconomics 2001; 19 (6): 623-6421170-7690/01/0006-0623/$22.00/0 © Adis International Limited. All rights reserved.


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yses, no uniformity existed as to how outcome was measured. Patient severity

was not always delineated, and the length of the follow-up period, while quite

short, varied. Only 11 of the 34 evaluations were based on randomised controlled

trials.

Cost-minimisation studies generally found no significant difference in the cost

of antimicrobial treatment for first-line, second-line and third-line agents. Studies

of bronchodilators indicated that ipratropium bromide alone or in combination

with salbutamol (albuterol) was the preferred medication.

The major area for achieving cost savings is by reducing hospital utilisation.

As the annual rate of hospitalisation is relatively low, large patient samples will

be required to demonstrate an economic advantage for a new therapy. The major

challenges will be financing such a study, and selecting an outcome measure that

satisfies both clinical and economic conventions.

1. Background

Chronic obstructive pulmonary disease (COPD)

is defined as a disease of the respiratory system char-

acterised by chronic bronchitis and/or emphysema.[1]

The prevalence of chronic bronchitis per 1000

persons in the US rose from 49.7 in 1985 to 54.0

in 1994. However, the prevalence of emphysema

per 1000 persons declined from 8.9 in 1985 to 7.8in 1994. Applying these rates to US 1996 census

data, Wilson et al.[2] estimated that there were 14.3

million cases of chronic bronchitis and 2.1 million

cases of emphysema in 1996, and an estimated

119 340 deaths (7.3 per 100 000 population) attrib-

utable to chronic bronchitis and emphysema – 2980

deaths from chronic bronchitis (1.1/1000 000) and

116 360 from emphysema (6.2/100 000). COPD is

the fourth leading cause of death in the US.[3]

Worldwide information generated by the GlobalBurden of Disease study[4] indicates that COPD

ranked sixth among the 30 leading causes of death,

accounting for 2 211 000 deaths. By 2020, it is pro-

jected to be the third leading cause of death.

Despite its prevalence and contribution to over-

all morbidity, National Institutes of Health (NIH)

research funding for COPD in the US in 1994 was

low. COPD-related research funding was 1.3%

of total funding, and ranked 21st among the 29

disease areas reported by Gross et al.[5] However, itranked 11th with regard to both incidence (670 000)

and prevalence (4 271 000) and fifth with regard to

mortality (96 000). Among the 29 illnesses, COPD

was the most underfunded disease relative to its

illness burden.[5]

A key to developing new interventions for treat-

ing COPD will be establishing that the therapy can

reduce the economic burden associated with the

disease. In particular, government and managed

care formulary decision makers are increasingly

limiting access to therapies that do not demonstrateeconomic benefits and/or cost effectiveness.[6]

This review highlights and assesses what is cur-

rently known about the cost of care and the eco-

nomic attributes of therapeutic interventions for

COPD. It also highlights future research needs.

2. Data Selection and Presentation

We searched the English language medical lit-

erature for 2 types of economic studies: those de-

scribing the prevalence and incidence of healthcare

resources utilised and the cost incurred by persons

with COPD, including cost-of-illness studies, and

economic evaluations of treatment interventions.

To locate these articles of interest, we reviewed

government publications, professional society pub-

lications and Medline and Embase. Both searches

were confined to the 1980 to 2000 period. The key

search terms used for the Medline search were

‘lung diseases, obstructive’ AND ‘cost and cost

analysis’, ‘patient care’, ‘inpatients’, ‘outpatients’,‘emergency service, hospital’, ‘economics, hospi-

tal’ and ‘economics, pharmaceutical’. For Embase

624 Ruchlin & Dasbach

© Adis International Limited. All rights reserved. Pharmacoeconomics 2001; 19 (6)


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we used ‘chronic obstructive lung disease’ AND

‘health economics’ and ‘healthcare utilisation’. We

also obtained studies noted in the reference sec-

tions of articles that we reviewed, thereby further

widening our search effort. Collectively, we iden-

tified over 350 articles dealing with the delineated

subject matter. Articles were excluded from the re-

view if they focused on any of the following: cost

savings created by adhering to guidelines or dis-

ease management programmes; screening costs;

costs reported for a single intervention without us-

ing any comparator (i.e. cost identification analy-

ses); and reports which co-mingled COPD withother illnesses. Fifty-eight articles qualified for in-

clusion.

The studies cover a broad time horizon. All data

are also presented in 2000 US costs, based on in-

flation using the medical services component of the

Consumer Price Index for all urban consumers.[7]

These values appear in parentheses after the actual

values. Annual average currency conversion rates

were used to translate costs reported in local cur-

rencies for other countries into US dollars.[8]

3. Cost and Utilisation Patterns

The material in this section reviews the various

cost-of-illness studies that have appeared in the lit-

erature and presents some estimates of utilisation

rates for the US. As no multivariate analyses were

found assessing the correlates of utilisation and

cost, individual bivariate relationships are noted.

This material can form the basis for subsequent

multivariate analyses and for hypothesising direc-tions of association in such analyses.

3.1 Overall Burden of Illness

Cost-of-illness data have been reported for the

US, UK, The Netherlands and Sweden and are

summarised in table I. Differences in data sources

per country account for the differences in the US

and UK estimates reported in the table. Tradition-

ally, COPD encompasses 4 International Classifi-

cation of Diseases, version 9 (ICD-9) codes: bron-chitis, not specifiedas acute or chronic (490); chronic

bronchitis (491); emphysema (492); and chronic

airways obstruction, not elsewhere classified (494

to 496). Not all of the studies include the 4 ICD-9

codes; 2 studies present information only for the

largest 2 codes: chronic bronchitis and emphysema.

Direct medical costs per patient ranged from

$US930 in Sweden to $US2208 in the US (2000

values). Inpatient care, medications and oxygen ther-

apy were the major cost drivers in each country.

Differences in medical treatment patterns unique

to each country undoubtedly account for much, if

not all, of the cost differences. In the 2 studies which

also included indirect costs, direct medical care

costs ranged from 39.3% of total cost in Sweden to61.5% of total cost in the US. The higher cost of

medical care in the US relative to worker earnings

probably accounts for this differential.

3.2 Cost of Care Relative to Other Illnesses

Grasso et al.[14] reported that 1992 Medicare per

capita expenditures for patients with COPD were

2.4 times that of all Medicare beneficiaries –

$US8482vs

$US3511 ($US11 841vs

$US4901; 2000values). Hospital expenditures, 64% of the total,

were 2.7 times higher: $US5409 vs $US2001;

($US7551 vs $US2793) while physician care was

2.2 times higher: $US2604 vs $US1198 ($US3365

vs $US1672). The overall utilisation of care was

not evenly distributed across all patients; the most

expensive 10% of Medicare beneficiaries ac-

counted for nearly half of total expenditures for

this population.

A larger differential was reported by Ireys et

al.[15] for children in Washington State in the fiscalyear (FY) 1993 on Medicaid; median payments for

children with chronic respiratory disease (detailed

data on COPD were not reported) were $US3353

($US4392; 2000 values) and chronic respiratory dis-

ease ranked second among the 8 conditions stud-

ied. The median payment for all children in that

year was $US290 ($US378), and $US891 ($US1167)

for children with at least 1 condition.

Using data from a health maintenance organisa-

tion (HMO), Mapel et al.[16] reported that patientswith COPD were 2.3 times more likely to be ad-

mitted to the hospital at least once during the year

Economics of COPD 625



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compared with age- and gender-matched patients

with other conditions, and those admitted had longeraverage lengths of stay (4.7 vs 3.9 days, p < 0.001).

Mean charges per patient in 1997 for inpatient care

were $US5093 vs $US2026 ($US5665 vs $US2453;

2000 values), $US5042 vs $US3050 ($US5607 vs

$US3392) for outpatient services and $US1545 vs

$US739 ($US1718 vs $US822) for outpatient phar-

macy services (all p < 0.001).

3.3 Cost by Disease Severity

Using the American Thoracic Society staging

system, Hilleman et al.[17] reported that treatment

costs were highly correlated with disease severity.

Annual median treatment costs (1993/1994) bystage were: stage I = $US1681, stage II = $US5037

and stage III = $US10 812 (p < 0.01) [$US2177,

$US6523 and $US14 002; 2000 values]. [Stage cri-

teria: stage I = forced expiratory volume in 1 sec-

ond (FEV1) ≥50% to ≤65% of predicted; stage II =

FEV1 ≥35% to 49% of predicted; stage III =


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3.4 Utilisation Rates

Adding prevalence data to the utilisation data

for the US reported by Wilson et al.[2] one can es-

timate annual (unadjusted) utilisation rates. These

rates are reported in table II for 1996. The overall

annual hospitalisation rate per patient with COPD

was 0.089, the physician office visit rate was 0.732,

the emergency department visit rate was 0.0009

and the rate of physician visits for inpatient care

was 0.4481. Patients with emphysema had higher

annual hospital utilisation rates (0.158 vs 0.080)

and physician inpatient care rates (0.7951 vs

0.4034) than those with chronic bronchitis, but pa-

tients with chronic bronchitis had higher physician

office visit rates (0.789 vs 0.283). Emergency de-

partment rates were practically equal, and quite

low for both conditions.

Analysing an age- and gender-matched sample

from the 1987 US National Medical Care Expen-

diture Survey, Strassels et al.[19] noted that patients

with COPD had higher rates of hospitalisation (0.7

vs 0.3) as well as longer hospital stays (4.6 vs 2.2days) and costlier stays ($US4430 vs $US2019)

[$US9802 vs $US4139; 2000 values] compared

with the non-COPD sample. They further noted

that patients with COPD utilised more office visits

to a generalist physician (4.2 vs 2.6), emergency

room visits (0.7 vs 0.2) and prescribed medications

(6.7 vs 3.0). By resource area, average expendi-

tures were: prescribed medications – $US509 vs

$US213 ($US1043 vs $US437; 2000 values), out-

patient hospital visits – $US782 vs $US270($US1603 vs $US554), physician office visits –

$US630 vs $US372 ($US1292 vs $US763) and

emergency department visits – $US118 vs $US43

($US242 vs $US88).

Patients with COPD are frequent users of care.

An analysis of utilisation patterns of an inception

cohort of Medicare patients conducted by Cydulka

et al.[20] noted that 14% of the patients hospitalised

in 1984 did not require a subsequent admission by

1991. 88% of those hospitalised were admitted 5

or more times during this period. A frequent re-

hospitalisation pattern was also noted by Connors

etal.

[21]

who followed a prospective cohort of 1016hospitalised patients for 6 months. They reported

that after discharge, 446 patients were readmitted

754 times.

3.5 Correlates of Cost and Utilisation

Articles appearing in the literature have identi-

fied patient health status, illness severity, age, phy-

sician specialty, geographic location and type of

insurance coverage as potential correlates of costand utilisation.

Strassels et al.[19] noted that poor health status

is associated with higher resource utilisation. The

mean number of inpatient admissions were 0.3 for

those reporting ‘excellent’ health, 0.5 for those re-

porting either ‘good’ or ‘fair’ health and 0.9 for

those reporting ‘poor’ health. Average cost per ad-

mission follows a similar pattern. They were

$US1512 ($US4100; 2000 values) for those in

‘excellent’ health, $US4514 ($US7000) for thosein ‘good’ health, $US2845 ($US5832) for those in

Table II. Resource utilisation in the US, 1996[1,2]

Condition Hospital dischargesa Physician office visits Physician ER visits Physician hospital or

nursing home visits

Prevalence Crude

annual ratebPrevalence Crude



annual rateb

COPD 1 464 000 0.089 12 002 000 0.732 15 500 0.0009 7 349 700 0.4481

Chronic bronchitis 1 168 000 0.080 11 473 000 0.789 13 600 0.0009 5 862 900 0.4034

Emphysema 296 000 0.158 529 000 0.283 1 900 0.0010 1 486 800 0.7951

a First listed discharge.

b Rate per patient diagnosed with condition.

COPD = chronic obstructive pulmonary disease; ER = emergency room.




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‘fair’ health and $US6141 ($US12 589) for those

in ‘poor’ health.

Crockett et al.,[22] in a study conducted in Aus-

tralia, also noted a positive relationship between

the number of comorbid conditions and hospital

stay. Mean length of stay for patients with


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©A d i s I nt er n at i on al L i mi t e d .Al l r i gh t s r e s er v e d .

P h ar m a c oE c on omi c s 2 0 0 0 : 1 9 ( 6 )

Table III. Summary of chronic obstructive pulmonary disease (COPD) cost studies

Author Studytype

Country Period Type of costanalysis

Perspective Samplesize

Diseaseseverity

Comparators Follow-upperiod

Finding

Pharmacotherapy

Alkins &O’Malley[28]

M,O US 1998 CE Third-partypayer

NR Severeemphysema(FEV1


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Table III. Contd

Author Studytype



Diseaseseverity


Findin

Friedman etal.[33]

RCT US 1998 CM, CE Provider 1067 Stable withmoderatelysevere airflowobstruction(FEV1 = 65%of predicted)

Salbutamol(albuterol) [n =347], ipratropiumbromide (n = 362),

salbutamol +ipratopium bromide

(n = 358)

85 days The mfollow-

alone (

+ salbusignific

($US2

and $U$US11ipratro

bromidsignificas cosarm warespec$US23statisti

Grossman etal.[34]

RCT, M Canada 1994 CE Societal 222 Acuteexacerbation ofchronic

bronchitis

Ciprofloxacin (n =115) vs usual care(any antibiotic

other than aquinolone, n = 107)

Lifetime Incremciproflodiffere

favoursignific$US16

Hay &Robin[35]

M, O US 1990 CE Societal NR CongenitalAAT-deficientpatients

AAT replacementtherapy

Lifetime At an esaved$US72depensmokinbecom700-$U

Jurban etal.[36]

O US 1988 CE Third-partypayer

600 NN Theophylline (n =311) vs ipratropium

bromide (n = 289)

1 year Ipratro($US4

effectivtherap

Orens etal.[37]

O, S US 1989 CM Provider Hospitalisedpatients notmanaged in anICU

MDI vs smallvolume nebulisers

Admission Institut$US42depen(20 00percentreatm$US23




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Rosell &Miravitlles[38]

O Spain 1997 CM Provider 2323 Acuteexacerbation

Cefixime (400mg/day, n = 1438)and 8 otherantibacterials (363receivedamoxicillin/clavulanicacid)

1 month Total cfailure)amoxicantibacand $Utotal co($US8rates wamoxicantibac

Sclar et al.[39] O US 1994 CM Provider 417 NN Ipratropiumbromide (n = 109),theophylline (n =116), corticosteroid(triamcinolone orbeclomethasone, n= 64), salbutamol(n = 128)

6 months Additiomonthsalbutatheophcorticobromid$US370.05

Summer etal.[40]

RCT US 1987c CM Provider 36 Patients with>10% increasein FEV1

Standardbronchodilatortherapy [15mg oforciprenaline

(metaproterenol)]administered byupdraftnebulisation (n =18, UDN) vs 0.5mgof bronchodilatorgiven by a MDI(terbutaline, n = 18,MDI)

Episode Equivawith M($US1statisti

Torrance etal.[41]

RCT, M Canada 1994/95 CE Societal 222 Type I or IIacuteexacerbation ofchronic

bronchitis

Ciprofloxacin (n =115) vs usual care(any antibacterialother than

ciprofoxacin orquinolone, n = 107)

RCT = 1year; M =lifetime

Incremciproflo($US1

Wool et al.[42] M Italy 1995 CE Third-partypayer

NR NN Ciprofloxacin,rufloxacin,clarithromycin andamoxicillin/clavulanicacid

Episode Cost ptreatm($US2L270 0clarithr($US2400/$U


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Table III. Contd

Author S t u d y

typeCountry Period Type of cost

analysisPerspective Sample

sizeDiseaseseverity


Finding

Oxygen therapy

Anon et al.[43] O Spain 1992-94 C/E Third partypayer

20 Acuterespiratoryfailure inpreviously

stable patients(exacerbationfree for 3months)

Mechanicalventilation in anICU

5 years Cost p($US3case s

Heaney etal.[44]

O, S UK 1996 CM Provider NR NN Oxygen therapy byconcentrator vs cylinder

2 years At 90 mof 2 L/£710.7

Keenan etal.[45]

O, S Canada 1996 CM Provider NR Severe acuteexacerbation

Addingnoninvasivepositive pressureventilation tostandard therapy

Hospitaladmission

Cost s($US2

Nava et al.[46] O Italy 1995-96 CM Provider 16 Acuterespiratoryfailure

Noninvasivemechanicalventilation (n = 10)vs invasiveventilation (n = 6)

48 hours Daily c

($US8

[$US9

Neri et al.[47] O Italy 1995-96 CM Societal 29 NN Oxygen saverdevice (Companion5 oxygen saver)

1 year Annua

($US2

Home care

Bergner et

al.[48]

RCT US 1981-82 CM Societal 301 FEV1 /FVC


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Haggerty etal.[49]

O US 1985-88 CM Provider 17 End-stagechronicpulmonarydisease

Multi-disciplinaryhome careprogramme vs standard home care

Approximately 1.5 years

Averag($US5($US5to the

Roselle &D’Amico[50]

O US 1978-80 CM Provider 553 NN Home careincludingrespiratory therapy

vs standard homecare

1 year Prevenafter thresulte

238) pthe yea

Shepperd etal.[51]

RCT UK 1994-95 CM Societal 32 NN Hospital (n = 17)vs home care (n =15)

3 months Hospitvs £12$US19

Surgery

Al et al.[52] M, O TheNetherlands

1992 CE Societal 125 Patients withend-stagepulmonarydisease with apredicted lifeexpectancy


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Table III. Contd

Author Studytype



Diseaseseverity


Finding

Guell et al.[56] RCT Spain NN CM Provider 60 Moderate tosevere illness(FEV1 /FVC


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approximately $US136. Ciprofloxacin, a third-line

agent, had the second best outcome – $US157 per

patient who received successful treatment, and

cefaclor, a second-line agent, had the highest cost –

$US208 per patient who received successful treat-

ment.

Grossman et al.[34] and Torrance et al.[41] used

data from the same Canadian randomised control-

led trial to model the cost per quality-adjusted life-

year (QALY) of ciprofloxacin compared with

usual care. Their modelling adopted a societal per-

spective and was based on a fairly large sample.

Cost per QALY was about $US16 700 ($US16 969

and $US16 330 in each study), a value below all

thresholds used in the literature to denote a worth-

while social investment of resources.

Wool et al.[42] calculated the cost per patient

who received successful treatment with rufloxacin,

compared with clarithromycin or amoxicillin/

clavulanic acid and ciprofloxacin. The degree of

COPD severity was not noted in this article. Costs

were all in the $US200 range, with the lowest cost

being for amoxicillin/clavulanic acid ($US206),followed by rufloxacin ($US212), ciprofloxacin

($US272) and clarithromycin ($US289). Although

tests of statistical significance were not reported,

the authors assert that rufloxacin was no more

costly than the other drugs which were more

widely used.

Four studies assessed the cost of bronchodilat-

ors.[33,36,37,40] Friedman et al.,[33] using data from a

randomised controlled trial, compared salbutamol,

ipratropium bromide and salbutamol plus ipratrop-ium bromide and concluded that ipratropium bro-

mide alone or in combination with salbutamol was

less expensive than salbutamol alone ($US168 and

$US212 compared with $US290). This saving re-

sulted from fewer exacerbations and hospital days.

Using data from an observational data set, Jurban

et al.[36] compared theophylline to ipratropium bro-

mide and reported an annual saving of $US848

favouring ipratropium bromide. These savings

were due to a reduced rate of unscheduled clinicvisits, emergency room visits and hospitalisations.

The Friedman et al. study[33] was based on a large

sample and focused on patients with moderately

severe airflow obstruction, while the Jurban et

al.[36] study used a smaller sample and did not spec-

ify the extent of disease severity. With regard to

cost effectiveness, the studies reached different

conclusions. Friedman et al.[33] concluded that all

3 options were equally cost effective in terms of

change in airflow outcomes, while Jurban et al.[36]

reported that ipratropium bromide produced a bet-

ter outcome (complication-free months) than theo-

phylline. As the 2 studies did not adopt a long term

perspective, a common outcome measure and did

not include similar patients, the cost-effectiveness

findings can not be compared. However, the results

seem to note that ipratropium bromide is less

costly.

Two studies, Orens et al.[37] and Summer et al.,[40]

compared 2 different methods of administering

bronchodilator therapy. Summer et al.,[40] using data

from a randomised controlled trial conducted on a

small number of patients reported equivalent bron-

chodilation with both methods, but the metered-

dose inhaler resulted in reduced charges of $US356per episode because of shorter hospitalisations. Or-

ens et al.[37] also reported cost savings from a sim-

ulation using observational data as a result of re-

duced labour costs.

Sclar et al.[39] compared the cost of 2 broncho-

dilator agents – salbutamol and theophylline – and

corticosteroids to a third bronchodilator – ipratrop-

ium bromide, over a 6-month period. Based on a

regression analysis, they reported a higher monthly

cost per patient for the other 3 drugs than for ipra-tropium bromide. The incremental costs for the 2

bronchodilators, based on a regression analysis,

were $US36.20 and $US63.99 for salbutamol and

theophylline. The incremental monthly cost for the

corticosteroids was close to that of the least expen-

sive bronchodilator, at $US37.45. The study did

not attribute the cost difference to any specific re-

source use difference. As these data were derived

from an observational cohort and could be associ-

ated with different case severity, a measure notincluded in the study, they must be used with cau-

tion.




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Two studies addressed the cost effectiveness of

α1-antitrypsin replacement.[28,35] Both were simu-

lations based on modelling using observational

(administrative) data. Although detailedcase severity

data were not provided in the Hay and Robin

study[35] (i.e. FEV1 levels) it appears that both stud-

ies focused on comparable patients requiring this

therapy. Alkins and O’Malley[28] reported a cost

per life-year saved of $US15 047. The incremental

cost per life-year saved values reported by Hay and

Robin[35] are higher; they range from $US45 752

to $US209 152. Part of the cost differential is ac-

counted for by the different perspectives and dis-count rates (7% and 5%, respectively). In both

studies, the reported findings are quite sensitive to

the assumed effectiveness of the therapy. Greater

effectiveness leads to lower cost per life-year

saved. Until more definitive data are available on

the effectiveness of this therapy, a clear statement

on the cost effectiveness of this intervention must

be held in abeyance. If information is nevertheless

required here, the newer clinical data used by Al-

kins and O’Malley[28]

suggest that more credencebe placed in their findings.

Two studies assessed immunoactive bacterial

extract OM-85 BV versus placebo as a preventive

strategy in patients with acute exacerbations of

chronic bronchitis.[30,31] Both studies used data

from randomised controlled trials, adopted a 6-

month time horizon and were based on large sam-

ples (n ≥ 300). The Collet et al. study[31] suggested

that this therapy may reduce the rate of hospitalisa-

tion (as the finding is statistically significant only

at a relaxed threshold of p < 0.10), and does re-

duce length of stay per hospital episode by almost

2 days. The net saving calculated by Bergemann et

al.[30] over the 6-month follow-up period was

$US39.47 per patient.

4.2 Oxygen Therapy

Five evaluations focused on the use of oxygen

therapy.[43-47] They are summarised under the sec-

ond subheading of table III. All are based on obser-vational studies, and the 3 that are not based on

simulations[43,46,47] are based on relatively small

samples. Only Neri et al.[47] adopted a societal per-

spective; the follow-up periods in the nonsimula-

tion studies ranged from 48 hours to 5 years.

Anon et al.[43] reported a cost per QALY for the

use of mechanical ventilation in an intensive care

unit ranging from $US34 562 to $US58 652 for pa-

tients with acute respiratory failure. Among the

cost-minimisation studies, Nava et al.[46] reported

comparable costs for noninvasive mechanical ver-

sus invasive ventilation, and Neri et al.[47] reported

annual cost savings of about $US3000 for the use

of an oxygen saver device which lowered the daily

consumption rate. Heaney et al.[44] reported a 2-year supply saving slightly in excess of $US1300

for the use of a concentrator delivery device versus

a cylinder, and Keenan et al.[45] reported a $US2723

savings per admission for adding noninvasive pos-

itive pressure ventilation to standard therapy due

to a reduced probability of developing ventilation-

associated pneumonia. As none of the studies were

based on randomised controlled trials or large sam-

ples, their findings should be regarded as sugges-

tive rather than definitive.

4.3 Home Care

Four studies addressed the cost of home care;

they are summarised under the third subheading of

table III. Two studies were based on randomised

controlled trials and 2 were observational studies.

Bergner et al.[48] compared 2 types of home care in

a randomised controlled trial, 1 delivered by nurses

with special training in respiratory care and the

other by regular nurses, to care received in a phy-sician’s office in older patients (average age of

65 years). The 2 home care programmes led to

significantly higher annual costs – $US32 954 and

$US27 188 vs $US17 042. Annual costs for the en-

tire sample were $US19 950. This finding is not at

all uncommon in an older population; most studies

evaluating home care costs in this population have

found that this benefit is not associated with cost-

offsets of equal magnitude.[62]

Shepperd et al.[51] compared the cost of homecare versus inpatient care in a randomised control-

led trial of a small sample of patients whose sever-




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ity of illness was not delineated. Not surprisingly,

they reported that inpatient care was more expen-

sive – $US2142 over a 3-month follow-up period.

The 2 observational studies reported cost sav-

ings from a multidisciplinary home care team (about

$US500/month)[49] and the addition of a respira-

tory therapist to standard home care ($US10 238/

year) using a pre-post study design.[50] In both

studies the savings were attributable to reduced

hospital use.

In assessing these studies it is important to rec-

ognise that the studies reporting savings did not

report the cost of the intervention; this informationis needed in assessing overall programme value.

Furthermore, 3 studies did not control for change in

illness severity over time, and in 1 case [49] the au-

thors did not identify the component of the pro-

gramme that produced the bulk of the savings. Fi-

nally, none addressed whether the savings continued

once the intervention was halted, and if they did,

for how long a period of time.

4.4 SurgeryThree studies addressed surgical techniques, 2

focused on lung transplantation and 1 on the rela-

tive cost of different surgical techniques. They are

summarised under the fourth subheading of table

III. Based on a convenience sample, Ramsey et al.[54]

estimated that the cost per QALY gained associated

with surgery was $US231 630. Al et al.[52] arrived

at a much higher figure – $US451 050 – in their

simulation. Both values would be judged as quite

high by any standard that has been used in thehealth services research literature. Ko and Wa-

ters[53] reported costs for the 2 surgical techniques

– sternotomy and thorascopy – that were not sig-

nificantly different. In discussing this finding they

noted that both procedures led to comparable sur-

gical outcomes.

4.5 Exercise and Rehabilitation

Six studies focused on this type of interven-

tion.[55-60] They are summarised under the fifthsubheading of table III. Since the actual interven-

tions used in each study differed in scope and con-

tent, one cannot comment on the merits of any sin-

gle approach. However, as a group they do provide

a basis for assessing this broad type of interven-

tion.

Guell et al.[56] and Wright et al.[60] only reported

data on hospital utilisation. As hospital care is a

major cost driver, these studies could be quite use-

ful for hypothesis generation. Unfortunately, their

findings are not consistent. Using patient random-

isation, Guell et al.[56] failed to find a significant

difference in hospitalisation over a 2-year period

in patients with moderate to severe illness. Wrightet al.,[60] however, found a large 1-year reduction

in hospitalisations in their observational cohort. As

they failed to document illness severity in their ar-

ticle, one does not know if they studied patients

with an illness profile comparable to those studied

by Guell et al.[56]

Goldstein et al.[55] and Toevs et al.[59] performed

cost-effectiveness evaluations; severity of illness

was not reported in the Goldstein et al.[55] article,

whereas the Toevs et al.[59]

sample had moderate tosevere illness. The studies adopted different ana-

lytic perspectives – societal and provider, respec-

tively; had different follow-up periods – 6 months

and 18 months; and used clinical measures of out-

come rather than QALYs. The reported costs in

these 2 studies were similar – $US28 767 (for 6

months) and $US69 639 (1 year). Both imply that

such interventions are of moderate cost relative to

outcome.

The study by Scherer and Schmeider[58]

re-ported the reduction in hospital utilisation in the 6

years after intervention compared with the year be-

fore intervention. Significant reductions were

noted for post-operative years 1, 2 and 4, and the

reduction in year 3 approached statistical signifi-

cance at conventional levels. As this study was ob-

servational in nature, sample size declined rapidly

the longer the follow-up period and the case sever-

ity of the studied patients was not delineated, one

must use their findings with extreme caution. Par-ker and Walker[57] also reported a saving of

$US1094 due to reduced hospital care in their pro-




16/20

gramme in the year after the intervention as com-

pared with the year before.

As was the case with the studies that assessed

home care, none of the studies isolated the most

important component of the intervention, or eval-

uated the long term duration of savings once the

actual programme was over. The absence of case

severity data in 4 of the studies precludes extrapo-

lating the reported results to other COPD patients.

4.6 Health Education

One study

[61]

assessed health education alone asan intervention. It is summarised under the last sub-

heading of table III. It should be noted that almost

all the exercise and rehabilitation studies had a

health education component in them. Using a pre-

post perspective for a randomised trial of ‘per-

sonalised’ health education versus standard prac-

tice in an inpatient population, Tougaard et al.[61]

reported an annual savings of $US4051 due pri-

marily to reduced hospital care for respiratory

treatments and reduced use of emergency services.

As the target population were hospitalised patientsrather than those receiving care in community set-

tings and the full extent of the personalised inter-

vention was not clearly delineated, the reported

findings cannot be used as a basis for making any

claims about the economic value of health educa-

tion among patients with COPD.

5. Discussion and Conclusions

The literature on the economic aspects of COPD

is not all that voluminous compared with that of

other chronic conditions. This is true both for the lit-

erature focusing on utilisation and cost studies as well

as economic analyses of various medically related

interventions to treat or facilitate the treatment of the

disease.

Burden-of-illness data indicate an annual cost

of approximately $US2000 per prevalent patient,

although such data were found for only 4 countries

– the US, the UK, the Netherlands and Sweden.

Hospital care, medications and oxygen therapywere the major cost drivers in these studies. Mean

annual Medicare expenditures in the US in 2000

dollars were $US11 841 compared with $US4901

for all covered patients. Patients with emphysema

utilised more institutional care while those with

chronic bronchitis used more ambulatory care.

Utilisation was skewed; the most expensive 10%

of the Medicare beneficiaries accounted for nearly

50% of total expenditures for this disease.

With regard to cost and utilisation studies, no

multivariate analyses were found that assessed the

correlates of cost. Univariate analyses suggest that

costs can be related to health status, age, physician

specialty, geographic location and type of insur-

ance coverage.

Six types of interventions were reviewed here –

pharmacotherapy, oxygen therapy, home care, sur-

gery, exercise and rehabilitation and health educa-

tion. The studies reported in the literature adopt

different analytic strategies (e.g. cost-minimisation

and cost-effectiveness analyses), and even within

the realm of cost-effectiveness analyses, no unifor-

mity existed as to how outcome was measured.

Outcomes varied from clinical (i.e. process) meas-

ures, to well-year, lives saved and QALYs. Patientseverity was not always delineated in the studies,

and where it was it was often quite broad. Two

other important elements of heterogeneity were the

length of the follow-up period and the study meth-

odology – randomised controlled trials or observa-

tional studies. The lack of an effective control

group in such studies is a major limitation. Finally,

many studies were based on very small samples.

Cost-minimisation studies generally found no

significant difference in the cost of antimicrobialtreatment for first-line, second-line and third-line

agents. Costs per exacerbation were in the $US700

to $US1000 range. A meta-analysis of randomised

controlled trials, conducted by Backhouse et al.,[29]

indicated that within a cost-effectiveness frame-

work (cost per patient who received successful

treatment), first-line agents such as amoxicillin had

a relatively low cost (about $US136) as did cipro-

floxacin (about $US157), a third-line agent. Second-

line agents, such as cefaclor, had a higher cost($US208). Two studies reported on the cost per

QALY associated with the use of ciprofloxacin –




17/20

about $US16 700 – a value that is well within the

range of affordable interventions. Studies of bron-

chodilators indicated that ipratropium bromide

alone, or in combination with salbutamol were the

preferred drugs.

Evaluations of the cost effectiveness of α1-

antitrypsin replacement indicated that the cost per

life-year saved was very sensitive to drug efficacy.

Cost-effectiveness ratios over most ranges were in

excess of $US50 000, indicating that such intervent-

ions were not as attractive as pharmacotherapy.

Similarly, the costs of surgical interventions werequite high; 1 study reported a cost per QALY for

lung transplantation in excess of $US450 000.

Comparisons of alternative surgical techniques for

lung reduction surgery indicated comparable costs

(about $US36 000) and outcomes.

Mechanical ventilation for patients with acute

respiratory failure had a cost per QALY below

$US60 000, a threshold usually considered ‘ac-

ceptable’ in the health economics literature. Home

care services did not produce concomitant cost-offsets in other resource use categories; this service

added approximately $US10 000 to $US15 000 in

cost per year. No studies were noted that assessed

the cost of home care relative to any measure of

benefit. Exercise and rehabilitation programmes

assessed cost relative to numerous outcome meas-

ures; one had a cost per well year below $US70 000,

a level that is comparable to mechanical ventilation.

Areas for future research follow directly from

the above summary. Studies are needed to clarifythe correlates of cost and utilisation. Two concerns

are associated with designing such studies. First,

budgetary considerations will probably favour the

use of administrative data sets, which may not be

able to adequately assess the impact of illness se-

verity. Second, it is widely held that COPD is fre-

quently unrecognised and untreated.[63] Thus avail-

able data sets will not permit easy extrapolation of

the cost of treating this disease to all who require

such care. It is reasonable to assume that the avail-able data is biased in that only the most severely ill

seek treatment.

The challenge with demonstrating cost effective-

ness using QALYs is measuring quality-adjusted

survival. Only 2 economic evaluations of a COPD

intervention in the literature related the cost of

treating the illness to quality-adjusted survival.[34,41]

In these studies, the Health Utility Index was used

to measure quality-adjusted survival. Other instru-

ments which could be used include the EuroQOL

instrument (EQ-5D), the time trade-off technique,

the Quality Well-Being scale and the 36-item Short

Form (SF-36). The latter would need to be trans-

formed to a utility scale using algorithms avail-

able in the literature in order to measure quality-

adjusted survival. In all cases, each measure has its

logistical trade-offs when used in clinical trials.

However the biggest challenge with these instru-

ments is their lack of sensitivity to measure small

changes in health-related quality-of-life. More-

over, presuming these instruments can detect small

changes, the required sample size given the inter-

individual variation can be fairly significant. As an

alternative to using the recommended economic

metrics, disease-specific measures of effectivenesshave been used to make a cost-effectiveness argu-

ment. In fact, a number of economic studies of

COPD interventions have used improved lung

function, for example FEV1, as a measure of effec-

tiveness. Unlike the QALY, the disadvantage of

this measurement approach is that there is no clear

economic methodology to value this gain. Al-

though some benchmarks may be available from

the asthma literature which confronts similar prob-

lems, this still limits the domain of diseases acrosswhich comparisons can be made.

Another challenge with demonstrating cost ef-

fectiveness is modelling the long term effects of

the intervention on quality-adjusted survival. No

existing models are available from the literature

and hence they would need to be developed. Even

if developed, selecting appropriate input data (e.g.

incidence data) from the literature to populate a

cost-effectiveness model may be difficult given

that the definition of COPD has changed over time,and many studies have not measured COPD sever-

ity. In the absence of ‘hard data’ from trials, one




18/20

would have to rely on expert opinion to populate

the cost-effectiveness model; however, the poten-

tial bias inherent in such information is a method-

ological concern. One advantage with a modelling

approach is that its application can serve as an al-

ternative to demonstrating the effect of treatment

on quality-adjusted survival in a clinical trial. In

particular, QALYs could be measured in a sample

of persons separate from the clinical trial and ap-

plied to the health states defined in the economic

model. The model would then be used to project

long term quality-adjusted survival.Demonstrating cost reductions is just 1 type of

economic objective. Another economic objective is

to demonstrate that the intervention reduces the use

of healthcare resources. With this objective a vari-

ety of other types of challenges exist. The first of

these is that a large sample size may be necessary

to demonstrate an effect on reducing healthcare

resource use. When resource savings were identi-

fied, they almost always resulted from a reduced

use of hospital care, However, we have roughlyestimated that the annual rate of resource use in

general is relatively low for the costly hospital-

isations (0.09 per year), although it is substantially

higher for the less costly outpatient visits (0.73 per

year). Reduced use of outpatient care produces

much smaller savings than reduced use of inpatient

care. These COPD use rates are very similar to the

rates of resource use in populations with asthma.

Like the rates for asthma populations, actual rates

will depend on the targeted population with higherrates being experienced in the more severely ill

populations. An additional challenge is that these

studies may need to be at least 1 year in length to

be credible for economic decision-makers. A final

challenge is the selection of a relevant comparator.

Given that there is wide variation in treatment pat-

terns, the selection of a single or combination com-

parator drug may be difficult. The evidence, how-

ever, appears to favour ipratropium bromide alone

or in combination with salbutamol.All the challenges noted here are not meant to

discourage further research in this important area.

Rather, they serve as guideposts for designing fu-

ture studies.

Acknowledgements

This research was supported by Merck Research Labora-tories.

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2001 an Economic Overview of Chronic Obstructive Pulmonary Disease

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