Question Details

(Solved) please try to go through the work below and make short precise


please try to go through the work below and make short precise relevant notes. 

make only 10 pages of summary.


Pharmacoeconomics:

 

basic terms

 

applications

 

Gitau SC

 


 

Outline

 


 


 

What is it and what is it good for?

 


 


 


 

How much is the disease?

 


 


 


 

What is the value of drug?

 


 


 


 

What is the role of pharmacoeconomics in

 

process of costing & (reimbursement)?

 


 

Costs

 


 

Possibilities and limits of financing

 

from the state budget: ?health gap?

 

Technologies

 

development

 


 

?health gap?

 


 

Available sources

 


 

Time

 


 

Increases in expenditures between

 

1998?2003

 


 

OECD Health Data, June 2005

 


 

Prescription Drug

 

Expenditures

 


 


 

Is this is a good thing?

 


 

16%

 

14%

 

12%

 


 

% Change in

 

Rx Spending

 


 

10%

 

8%

 


 

Drugs as % of

 

Total Health

 

Spending

 


 

6%

 

4%

 

2%

 

0%

 

1965

 


 

1970

 


 

1980

 


 

1990

 


 

2000

 


 

Reasons of increasing health

 

expenditures

 

Demographic

 


 

situation = ageing of the

 


 

population

 

New technologies/innovations

 

Better public information

 

Unhealthy life-style

 

Growing demands on quality of life

 

Better availability of health care

 


 


 

an offer potentiates demand

 

Podle G. Kobelt 2002

 


 

VALUES in health care system

 


 

VALUE

 


 

=

 


 

COST

 

BENEFIT

 


 

COSTS

 

price of drug, price of its administration

 


 

price of hospitalization, outpatient treatment

 

price of transportation

 

price of ADRs

 


 

OUTCOMES

 

Lifetime prolongation

 

Improved quality of life

 

Remission-free interval

 

etter compliance, simplified therapeutic regime

 


 

1. PHARMACOECONOMICS

 

= complex evaluation of the

 

impact of drug use on the

 

health-care system from the

 

perspective:

 

clinical

 

economic

 

humanistic (quality of life)

 


 

Perspectives

 

Patient

 

-Clinical Cure

 

-Quality of life

 

-Out-of-pocket Cost

 

-Satisfaction with

 

treatment process

 


 

3rd-Party Payer

 

-Clinical Cure

 

-Cost

 

-Customer

 

perception of value

 


 

Hospital / Physician

 

-Clinical Cure

 

-Profit from treatment

 


 

Employer / Society

 

-Clinical Cure

 

-Cost

 

-Productivity

 


 

2. Definitions

 

Pharmacoeconomics is the application of

 

economic analysis to the use of pharmaceutical

 

products, services and programs, which

 

frequently focuses on the costs (inputs) and

 

consequences (outcomes) of that use.

 

Outcomes research refers to broader

 

consideration of the measurement of the efficacy

 

or effectiveness of treatment.

 


 


 

Outcomes Research

 

The assessment of technology (drugs, devices, etc)

 

Clinical

 


 

Economic

 


 

Humanistic

 


 

? Efficacy

 

? Safety

 

? Impact of therapy

 

on ?natural history?

 

of the disease

 


 

? Cost Analysis

 

? Cost-of-Illness

 

? Cost-Minimization

 

? Cost-Benefit

 

? Cost-Effectiveness

 

? Cost-Utility

 


 

? Health Related

 

Quality of Life

 

? Patient Satisfaction

 

? Caregiver Impact

 

? Patient Preferences

 

? Functional Status

 


 

Health Services Research

 

?Policy Research

 


 

?Access

 


 

?Structure of Care

 


 

Application of Pharmacoeconomics

 

Pharmacoeconomic Studies

 


 

Research and

 

Development

 

Strategy

 


 

Phase II

 


 

Pricing and

 

Reimbursement

 

Strategy

 


 

Phase III

 


 

Regulatory

 

Phase

 


 

Communication to

 

Physicians and

 

Patients

 


 

Marketing

 

Phase

 


 

Pharmacoeconomics:

 

depends on the corner of:

 

Patient

 

- healthy feeling

 


 

Payer (NHIF,

 

INSURANCE)

 


 

- QoL

 

- complicity

 

- satisfaction

 


 

- success of the

 

therapy

 

- costs /prices

 


 

Physicians/Hospitals

 

- success of the therapy

 

- profitability

 


 

Employer/

 

society

 

- success of the

 

therapy

 

- time of working

 

immobility

 

- productivity

 


 

Relation between price and outcome

 

Nothing to solve:

 

Refuse

 


 

Analyze, place for

 

PhE analyses

 

(ICER)

 


 

higher

 

price

 

A

 


 

B

 


 

lower

 

effect

 


 

0

 

WTP

 


 

Can be

 

analyzed but

 

who wants such

 

a drug?

 


 

Nothing to solve:

 

Accept

 

lower

 

price

 

0?baseline

 


 

Willingness to Pay (WTP)

 


 

higher

 

effect

 


 

Why Pharmacoeconomics - Internal

 

New Drug

 

Approval NDA

 


 

Investigational

 

New Drug - IND

 


 

Basic Research

 


 

Time (months) 42.6

 

Direct Cost ($mil.) 65.5

 

113.6

 

Capitalized Cost

 

155.6

 


 

230.8

 


 

Phase I

 


 

15.5

 


 

Phase II

 


 

24.3

 


 

Phase III

 


 

36.0

 


 

9.3

 


 

18.6

 


 

= 119.4

 

20.2 =

 


 

17.8

 


 

30.3

 


 

27.1

 


 

=

 


 

Why Pharmacoeconomics - External

 


 

Evidence

 


 

Efficacy

 


 

Safety

 


 

Efficiency

 

Market

 


 

Quality

 

Registration

 


 

Price/Reimbursement

 


 

Pricing Tool

 

2

 


 

1

 


 

3

 


 

Drug D

 


 

Drug C

 

Drug B

 


 

Drug A

 

Effectiveness

 

1. Break-even Price

 

2. Efficiency Price

 

3. Premium Price

 

Total Cost of Treatment

 


 

Patient Outcomes

 

Assessment Sources and

 

Examples

 

Clinician Reported

 


 

Global

 

impressions

 

Observation

 

& tests

 

of function

 


 

Physiological

 


 

FEV1

 

HbA1c

 

Tumor size

 


 

Caregiver Reported

 


 

Patient Reported

 


 

Dependency

 

Functional

 

status

 


 

Functional status

 

Symptoms

 

HRQL

 

Treatment

 

Satisfaction

 

Productivity

 


 

Value: Ratio Acceptability

 

Conclusion

 


 

II

 


 

III

 


 

Adopt

 


 

Evaluate

 


 

Effectiveness /

 

Outcomes

 


 

# : New Drug

 

C

 

I

 


 

Evaluate

 


 

C : Control

 

IV

 


 

Reject

 


 

Treatment Cost

 


 

Regulation and Acceptance of PE

 

AUS

 


 

2000

 

Level of Regulation

 


 

NL

 

CDN

 


 

F

 

FRG

 


 

UK

 


 

USA

 


 

B

 

I

 

SW

 

ESP

 


 

Level of Acceptance

 


 

Cost-effectiveness analysis must

 

have an comparator

 

There is no absolute cost effectivity!

 


 

How to measure ?outcomes?

 

Illness

 


 

Indicator

 


 

Clinical

 

outcome

 


 

BP

 


 

Ren. failure

 

stroke

 

MI

 

CVS death

 


 

Dyslipidaemia

 


 

LDL

 


 

MI

 

stroke

 

CVS death

 


 

Diabetes

 


 

HbA1C

 

Fg

 

PPg

 


 

Osteoporosis

 


 

BMD

 


 

Hypertension

 


 

Asthma

 


 

FEV, PEF

 


 

Humanistic

 

outcome

 


 

Economic

 

outcome

 


 

QoL

 


 

price/ mmHg BP

 

price/event

 

avoidance

 

/life saved

 


 

QoL

 


 

price/ decrease of

 

LDL

 

price/avoidance of MI

 


 

Micro+Macro

 

vascul.

 

complications,

 

Death

 


 

QoL

 


 

Cost/decrease of

 

HbA1C

 

Cost/event avoidance

 


 

OP fracture

 


 

QoL

 


 

Exacerbation

 

Death

 


 

QoL

 


 

Price/OP fracture

 

avoidance

 


 

Cost/day without

 

symptoms

 


 

Types of PhE analyses

 

Type of analysis

 


 

Results

 


 

Cost of illness

 


 

Cost of treatment (i.e. per patient, per

 

year etc.)

 


 

CCA ? cost-consequence analysis

 


 

Simple and separated evaluation of

 

costs and well defined benefits

 


 

CMA ? cost-minimization analysis

 


 

Same efficacy of different approaches,

 

comparison of costs

 


 

CBA ? cost-benefit analysis

 


 

Both imputs and outputs are

 

expressed in monetary units

 


 

CEA ? cost-effectivenes analysis

 


 

Price per life saved/clinical outcome

 


 

CUA ? cost-utility analysis

 


 

Price per QALY/LYG etc.

 


 

BIA ? budget impact analysis

 


 

Change in total costs after

 

implementation of new therapy in

 

comparison to current standard

 


 

What types of costs? ?

 


 

COSTS

 

Indirect

 


 

Direct

 

? Medicinal

 


 

Intangible

 


 

?drugs, material

 


 

?hospitalisation

 

?outpatient care

 


 

? working immobility

 

? hardly to be expressed

 


 

? pain, deprivation

 


 

? loss of productivity

 

? disability

 


 

?wages

 


 

? preterm death

 


 

?complicity

 


 

? draw down from

 

social-care system

 


 

?Non-medicinal

 

?transporation

 

??hotel services?

 


 

Estimated costs of chosen diagnoses in

 

U.S. (USD)

 

Tumors

 

Alzheimer disease

 

Diabetes

 

Coronary artery disease

 

Depression

 

Osteoarthrosis

 

Stroke

 

Hypertension

 

Schizophrenia

 


 

107 bil.

 

100 bil.

 

98.2 bil.

 

95.6 bil.

 

83.1 bil.

 

54.6 bil.

 

43.3 bil.

 


 

31.7 bil.

 

23 bil.

 

source: PhRMA 2000

 


 

Example

 

suboptimally controlled asthma

 

(SCA)

 


 

Sources drawing during 1 year

 

Type of source

 


 

Per SCA

 


 

Other diseases

 


 

TOTAL

 


 

Hospitalisation at

 

standard dpt.

 

(days/year)

 


 

10.4

 


 

1.4

 


 

11.8

 


 

Hospitalisation at ICU

 

(days/year)

 


 

2.3

 


 

0.3

 


 

2.6

 


 

Visits of emergency

 

(-times/year)

 


 

7.8

 


 

0.3

 


 

8.1

 


 

Visits of a lungspecialists

 

(-times/year)

 


 

15.6

 


 

Visits of other specialists

 

(-times/year)

 

spa (days/year)

 


 

6.2

 


 

15.6

 


 

4.8

 


 

4.8

 


 

0

 


 

6.2

 


 

Structure of indirect costs in

 

patients with SCA per 1 year

 

Social benefits + health

 

inssurance

 


 

82 881

 


 

Sickness benefits

 


 

19 767

 


 

Loss of productivity

 


 

97 050

 


 

TOTAL

 


 

199 698

 


 

Value of a drug

 

?

 

price of a drug

 


 

Structure of costs in the same

 

Dg. but different therapeutic

 

approach per 1 patient

 


 

Jirásková, Dole?al ? ISPOR 2006, Koda?

 


 

How to decide thanks to

 

pharmacoeconomics?

 


 

5 levels of perspective

 


 


 

Ministry of health/state ? pricing, categorisation

 


 


 


 

Payers ? health insurances

 


 


 


 

Health institutions ? hospitals ? positive drug lists,

 

comissions for effective pharmacoterapy,mass drug

 

purchase etc.

 


 


 


 

Physician ? optimalisation of his budget

 


 


 


 

Patient ? choice of a drug, i.e. preference of the

 

cheapest alternative

 


 

Hurdles for a new drug to reach the

 

market

 


 

AFFORDABILITY

 

COST

 

SAFETY

 

EFFICACY

 

QUALITY

 


 

EFFECTIVITY

 


 

Countries evaluating cost-efficacy (4th hurdle)

 

in the process of reimbursement

 

Australiy

 


 

Compulsory for new drugs since 1993

 


 

New Zealand

 


 

Compulsory for new drugs since 1993

 


 

Canada

 


 

Compulsory for new drugs since 1995/6

 


 

Denmark

 


 

Can be asked since 1997 or optionally

 


 

France

 


 

Can be asked since 1997

 


 

Finland

 


 

Compulsory for new drugs since 1998

 


 

UK

 


 

Can be asked since 1999

 


 

Italy

 


 

Can be asked since 1998

 


 

Sweden

 


 

Compulsory for new drugs since 2002 ? perspective of

 

society

 


 

Norway

 


 

Compulsory for new drugs since 2002

 


 

Holand

 


 

Compulsory for new drugs since 2003

 


 

Germany

 


 

Compulsory cost-benefit analysis since 1.4.2007

 


 

Process of reimbursement ?

 

main factors

 

Economic suitability ? cost/LYG, QALY

 

Budget impact

 

Urgency of a disease ?

 

prevalence/incidence/morbidity/mortality

 

Availability of alternative treatment

 


 

Quality of life, prognosis, health status

 

Patients organisations, media

 

Manufacturers/organizations/interest groups lobbing

 

Principle of equality and solidarity; political decissions, phase of

 

electoral cycle

 


 

How to measure quality

 

of life?

 


 

?thermometer of quality of life ?

 


 

Maximal possible health

 


 

100

 

90

 

80

 


 

choice of patient

 


 

e.g. 0.65

 


 

70

 

60

 

50

 

40

 


 

30

 

20

 

10

 


 

Death

 


 

VAS -

 


 

Standard Gamble (SG)

 


 

0

 


 

- Time Trade-off (TTO)

 


 

Two approaches with distinct lifespan

 

expectancy and quality of life

 

Quality of life

 


 

Which one approache should be

 

prefered?

 


 

Absolute

 

health = 1

 


 

- green: better lifespan expectancy?

 

- red: better quality of life?

 


 

0.5

 


 

Death = 0

 


 

1

 


 

5

 


 

10

 


 

Time (years)

 


 

Ilavská, Tomek 2006: Farmakoekonomické posouzení lé?by diabetologii

 


 

QALYs ? green curve

 

Quality of life

 


 

Area under curve showing lifespan

 

prolongation

 


 

Absolute

 

health = 1

 


 

0.5

 


 

7.75 QALY

 


 

Death = 0

 


 

1

 


 

5

 


 

10

 


 

Time (years)

 


 

Ilavská, Tomek 2006: Farmakoekonomické posouzení lé?by diabetologii

 


 

QALYs ? red curve

 

Quality of life

 


 

Absolute

 

health = 1

 


 

0.5

 


 

6.75 QALY

 


 

Death = 0

 


 

1

 


 

5

 


 

10

 


 

Time (years)

 


 

Ilavská, Tomek 2006: Farmakoekonomické posouzení lé?by diabetologii

 


 

Comparison of previous two

 

approaches

 


 


 

In this case green option is more suitable

 

because lifespan prolongations means higher

 

value of QALY than in red option:

 


 

7.75 QALY > 6.75 QALY

 

Crux: Is this compatible with

 

patients´attitude? ?e.g. diabetic patient has

 

to comply with dietary restrictions etc?

 

Ilavská, Tomek 2006: Farmakoekonomické posouzení lé?by diabetologii

 


 

QALYs in diabetic patients

 

Absolute

 

health

 


 

QALY

 

1.0

 

0.814

 


 

Visual disturbances

 


 

Diabetic patient

 

without

 

complications

 


 

0.734

 

0.68

 

0.49

 


 

Low amputation of LE

 


 

Haemodialysis

 


 

0.0

 


 

Death

 


 

Clarke P et al (2002) Med Decision Making, 22 (4) (UKDPS 62), Teng TO et al (2000) Med Care, 38 (6)

 


 

QALY in patients with OP fracture

 

50?64 years

 


 

65?74 years

 


 

75+ years

 


 

No fracture

 


 

0.90

 


 

0.79

 


 

0.63

 


 

Femoral

 

fracture

 


 

0.70

 


 

0.59

 


 

0.43

 


 

Vertebral

 

Fracture

 


 

0.81

 


 

0.71

 


 

0.57

 


 

Wrist fracture

 


 

0.86

 


 

0.75

 


 

0.60

 


 

After femoral

 

fracture

 


 

0.80

 


 

0.69

 


 

0.53

 


 

Jonsson 1996

 


 

?Chart of QALY?

 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 

Cholesterol measurement

 

220 GBP/QALY

 

Neurosurgery after cranial injuries

 

240

 

Recommendation

 

to stop smoking by GP

 

270

 

WTP:

 

Antihypertensives for stroke prevention

 

940

 

Arthroplasty

 

of hip joint

 

1.180

 

USA???????.

 

80.000 USD/QALY

 

CABG in CAD

 

2.090

 

Kidney

 

transplantation

 

4.710

 

NICE???????

 

30.000 GBP /QALY

 

Pharmacotherapy of dyslipidaemia (second. prev.)

 

5.000

 

Screening for breast cancer

 

5.780

 

Australia?????..

 

51.000

 

USD/QALY

 

Heart transplantation

 

7.840

 

Home-performed dialysis

 

17.260

 

Canada??????

 

83.900

 

USD/QALY

 

Pharmacotherapy of dyslipidaemiea (primar. prev.)

 

20.000

 

Hospital haemodialysis

 

21.970

 

Poland........................17.500

 

USD/QALY

 

EPO

 

for anaemia due to dialysis

 

54.380

 

Neurosurgery (malignant intracran. tumors)

 

107.780

 


 

Estimation of WTP/QALY

 

according to GDP

 


 

CZ:....33.900 USD/DALY

 


 

Eichler...ViH 2004

 


 

Is there a will/valour to exclude

 

some ther. approaches insted of

 

some others?

 


 

Maynard 2004

 


 

Orphan drugs

 


 


 

expansive drugs for rare diseases

 


 


 


 


 


 


 


 


 


 


 


 


 

i.e. up to 5.000 diagnoses!

 

mostly non-specific treatment only

 

costly development x small target group/low profit

 

monopolist position of the manufacturer/atyp. market

 

big political topic

 


 

no PhE analyses previously

 

? number ......... ? need of economic evaluations

 

? costs - sources for other diagnoses?

 

?opportunity cost?

 


 

Prevalence and costst per ODs

 


 

Orphan drugs ? examples

 

from UK

 

Therapy

 


 

Disease

 


 

Costs

 

/patient

 

/year

 


 

Price/

 

QALY

 


 

Number

 

of

 

patients

 


 

imiglucerase Gaucher

 


 

90.000

 

GBP

 


 

400.000

 


 

250

 


 

agalsidase

 


 

Fabry

 


 

119.000

 

GBP

 


 

252.000

 


 

150

 


 

laronidase

 


 

Mucopoly- 450.000

 

sacharid. GBP

 


 

?

 

100

 

>450.000

 

Burls ... BMJ 2005

 


 

Neglected tropical diseases

 

(NTD) in sub-Saharan Africa

 

Thera Disease

 

py

 


 

Costs

 

/patient

 

/year

 


 

Price/

 

QALY

 


 

Number

 

of

 

patients

 


 

Hookworm

 

infections

 


 

500

 

million

 


 

leishmaniasis

 


 

100,000

 


 

trachoma

 


 

30 million

 


 

Overall burden of Africa's NTDs may be severely

 

underestimated

 


 

a

 


 

b

 


 

Hookworm

 


 

198 million

 


 

29%

 


 

34%

 


 

Schistosomiasis

 


 

192 million

 


 

25%

 


 

93%

 


 

Ascariasis

 


 

173 million

 


 

25%a

 


 

21%

 


 

Trichuriasis

 


 

162 million

 


 

24%

 


 

a

 


 

27%

 


 

2b

 

b

 


 

Lymphatic filariasis 46?51 million

 


 

6%?9%

 


 

37%?44%

 


 

Onchocerciasis

 


 

37 million

 


 

5%

 


 

>99%

 


 

Active trachoma

 


 

30 million

 


 

3%

 


 

48%

 


 

Loiasis

 


 

?13 million

 


 

1%?2%

 


 

100%

 


 

Yellow fever

 


 

180,000

 


 

0.02%

 


 

90%

 


 

Human African

 

trypanosomiasis

 


 

50,000?70,000

 

<0.01%

 

(17,000 new cases

 

annually)

 


 

100%

 


 

Leprosy

 


 

30,055 (registered

 

prevalence);

 

21,037 new cases

 

in 2007

 


 

<0.01%

 


 

14%

 


 

Leishmaniasis

 

(visceral)

 


 

19,000?24,000

 

new cases

 

annually in Sudan

 

and Ethiopia

 


 

<0.01

 


 

ND

 


 

c

 


 

Conflict between cost-effectivity

 

and social value

 


 

Drummond 2007

 


 

Position of PhE in the Czech

 

Republic

 


 


 

cost of illness studies in the CZ

 


 


 


 

epidemiologic characteristics of various

 

diseases

 


 


 


 

modelling...Markov, decision trees

 


 

Costs of new technologies must be

 

assessed as an invenstment

 

We accept an expansive drug

 

without positive impact

 

on system

 


 

We refuse a new drug

 

with positive impact

 

on system

 


 

Cost effectiveness evaluation

 


 

HTA

 


 

Conclusions

 

"Not

 


 

everything that can be counted

 

counts, and not everything that counts can

 

be counted."

 

- Albert Einstein (1879-1955)

 


 

Questions

 


 

 


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