phamacoeconomic guideline for malaysia

7/30/2019 Phamacoeconomic Guideline for Malaysia

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PHARMACOECONOMIC GUIDELINE FOR MALAYSIA


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FOREWORD

The rising cost o healthcare delivery systems is a major concern to

all patients, healthcare proessionals, and the government. As the

aordability o new medical technologies continues to be the subject

o heated debate, attention is also increasingly ocused on providing

quality, cost-eective healthcare.

In this era o cost-conscious healthcare delivery, pharmacoeconomic

research has evolved as a signicant and important eld o research.Pharmacoeconomic evaluation identies measures and compares the

costs and consequences o pharmaceutical products and services.

The numerous stakeholders in the healthcare arena must understand

the basics o pharmacoeconomic principles and how these may be

applied to make rational therapeutic choices.

In an attempt to standardise the conduct o pharmacoeconomic

studies in Malaysia or the purpose o preparing supporting economic

documents, this guideline has been conceived and developed by an

expert committee. I wish to congratulate all members o this committee

or their hard work in developing this guideline. This document will

serve as an invaluable tool or all stakeholders and researchers to

produce relevant high quality pharmacoeconomic evaluations which

will meet the needs o the clinicians and decision makers.

Dato Sri Dr. Hasan Abdul Rahman

Director General o Health

Ministry o Health, Malaysia


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PREFACE

Economic evaluat ion o pharmaceutical products, or

pharmacoeconomics, is a rapidly growing area o research.

Pharmacoeconomic evaluation is important in helping clinicians

and decision makers to make choices about new pharmaceutical

products and in helping patients obtain access to new medicines.

Over the last ew years, the scientic rigor o this eld has increased

greatly.

However, in Malaysia there is lack o local research done in the eld

o pharmacoeconomics. I we wish to make rational therapeutic

choices, it is essential that all parties involved in healthcare proession

know the basics o pharmacoeconomic principles as well as the

need or pharmacoeconomic evaluations. Thereore, to address

these shortalls, the Pharmacoeconomic Guideline or Malaysia has

been developed.

This guideline is intended to be used as a reerence or the conduct

o pharmacoeconomic studies in Malaysia. The development o

this guideline is aimed to urther promote relevant stakeholders

and researchers so that more pharmacoeconomic studies are

undertaken at various levels in healthcare settings to acilitate decision

making. I hope this guideline will be utilised by relevant target groups.

Finally, I would like to express my gratitude to everyone involved in

the development o this guideline especially the Technical Working

Committee or their immense support and contribution towards

making this guideline a reality.

Dato Eisah A.Rahman

Senior Director

Pharmaceutical Services Division

Ministry o Health, Malaysia


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ACKNOWLEDGEMENT

We thank the Director General o Health, Malaysia, or permission to

publish this guideline. The Pharmaceutical Services Division, Ministry

o Health is grateul to the members o the Pharmacoeconomics

Technical Working Committee and the advisors who have devoted

substantial time, expertise and commitment in the development o

this guideline. We are deeply indebted, particularly to the council

members o Malaysian Society or Pharmacoeconomicsand Outcome Research (MySPOR) and Malaysian Pharmaceutical

Society (MPS) or their continuing support that has ensured the

completion o this guideline. We are also grateul or the considerable

contributions o the external reviewers: Pharmaceutical Association

o Malaysia (PhAMA)and Association o Private Hospitals o Malaysia

(APHM) or their valuable inputs and comments during the completiono this guideline.


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TECHNICAL WORKING COMMITTEE MEMBERS

Pro. Kenneth K. C. Lee

Proessor o Pharmacy & Head o Pharmacy

Jerey Cheah School o Medicine & Health Sciences

Monash University Sunway Campus (MUSC)

Dr. Salmah Bahri

Director

Pharmacy Practice & Development

Pharmaceutical Services Division, MOH

Mdm. Anis Talib

Deputy Director

Formulary & Pharmacoeconomic Branch


Dr. Jameela Zainuddin

Deputy Director

Malaysian National Health Account, MOH

Pro. Dato Dr. Syed Mohamed Aljunid

Proessor o Health Economics

Senior Research Fellow

United Nations University-International Institute or Global Health (UNU-IIGH)

Pro. Madya Dr. Saperi Sulong

Head o Department

Health Inormation Department

Universiti Kebangsaan Malaysia Medical Centre (UKMMC)

Pro. Dr. Samsinah Hussain

Proessor o Pharmacy &

Head o Student Empowerment and Research Unit

University o Malaya (UM)

Pro. Madya Dr. Maznah Dahlui

Head

Department o Social & Preventive Medicine

Faculty o Medicine

University o Malaya (UM)


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Dr. Asrul Akmal Shafe

Senior Lecturer

School o Pharmaceutical Sciences

Universiti Sains Malaysia (USM)

Pro. Dr. Mohamed Mansor Manan

Pro. o Clinical Pharmacy & Pharmacy Practice

Faculty o Pharmacy

Puncak Alam Campus

Universiti Teknologi MARA (UiTM)

Dr. Ramli Zainal

Head o Health Financing & Economic Research Division

Institute or Health Systems Research, MOH

Dr. Faridah Aryani Md. Yuso

Senior Principal Assistant Director

Formulary & Pharmacoeconomic Branch


Mdm. Noormah Mohd. Darus


Health Technology Assessment Section (MaHTAS)

Medical Development Division, MOH

Mdm. Saimah Mat Noor


Drug Pricing Branch


Mdm. Zaiton Kamarruddin

Head o Pharmacy Department

Kajang Hospital, MOH

Mdm. Rosminah Mohd. Din

Head o Pharmacy Department

Selayang Hospital, MOH

TECHNICAL WORKING COMMITTEE MEMBERS (cont.)


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Dr. Nur Akmar Taha

LecturerFaculty o Pharmacy

Universiti Kebangsaan Malaysia (UKM)

Mdm. Azuana Ramli

PhD student

United Nations University-International Institute or Global Health (UNU-IIGH)

Mr. Abd. Aziz Dan

Malaysian Pharmaceutical Society (MPS)

Mr. Adrian Goh

Azmi Burhani Consulting Sdn. Bhd.

Ms. Kathleen Yeoh

Bayer Health Care Pharma, Malaysia

TECHNICAL WORKING COMMITTEE MEMBERS (cont.)


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ABBREVIATIONS

ACER Average Cost-Eectiveness Ratio

ATC Anatomical Therapeutic Chemical

BIA Budget Impact Analysis

CBA Cost-Benet Analysis

CEA Cost-Eectiveness Analysis

CEAC Cost-Eectiveness Acceptability Curve

CMA Cost-Minimisation Analysis

CUA Cost-Utility Analysis

DALY Disability Adjusted Lie Year

DCA Drug Control Authority

DRG Diagnosis-Related Group

EQ-5D EuroQol 5D

HRQoL Health-Related Quality o Lie

HUI3 Health Utility Index 3

ICER Incremental Cost-Eectiveness Ratio

MDC Malaysia Drug Code

PSA Probabilistic Sensitivity AnalysisQALY Quality Adjusted Lie Year

RCT Randomised Controlled Trial

SF-6D Short-Form 6D


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TABLE OF CONTENTS

FOREWORD i

PREFACE ii

ACKNOWLEDGEMENT iii

TECHNICAL WORKING COMMITTEE MEMBERS iv

SECRETARIAT vii

EXTERNAL REVIEWERS vii

ABBREVIATIONS viii

1. BACKGROUND AND PURPOSE 1

2. OVERVIEW OF PHARMACOECONOMIC ANALYSIS 2

A. Types o Pharmacoeconomic Analysis 2

B. Types o Costs in Pharmacoeconomic Analysis 3

C. Measurements o Outcomes in Pharmacoeconomic Analysis 4

D. Decision Analytic Model 5

E. Discounting 5

F. Sensitivity Analysis 5

G. Average Cost-Eectiveness Ratio (ACER)and Incremental Cost-Eectiveness Ratio (ICER) 6

H. Budget Impact Analysis (BIA) 6

3. THE METHODOLOGICAL GUIDELINE 7

A. Scope o the Analysis and Perspective o Study 7

i) Problem Statement 7

ii) Description o Drug/Intervention and Its Use 7

iii) Target Population 7

iv) Perspective o the Study 8


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B. Evaluation Technique 8

C. Selection o Comparator(s) 9

D. Source and Retrieval o Evidence 9

E. Measuring Cost 10

i) Cost Perspective 10

ii) Cost Data Sources 10

F. Measuring Health Outcome 10

G. Decision Analytic Model 11

H. Time Horizon 12

I. Discounting 12

J. Sensitivity Analysis 13

K. Presentation o Results and Discussion 13

L. Budget Impact Analysis 14

M. Report Format or a Standard Pharmacoeconomic Analysis 14

N. Ethical Code o Practice While Conducting andPublishing Results o Pharmacoeconomic Analysis 15

O. Format or Reerences 16

4. LIST OF REFERENCES 17

5. LIST OF KEY FEATURES 18


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1. BACKGROUND AND PURPOSE

Pharmacoeconomics is a eld within the broader health economics

eld that ocuses mainly on the costs and benets o pharmaceuticals.

Pharmacoeconomic analysis concerns not only the ecacy and

eectiveness o new health technologies but with the costs o these

technologies weighed against their benets.

Pharmacoeconomic analysis helps the decision makers o

healthcare institution to optimise the limited resources in health.

Healthcare providers and administrators must balance the needs

o individual patients with the larger societal needs, recognising that

limited resources cannot meet all needs and wishes. Thereore,

pharmacoeconomic analysis is needed to assess both costs and

benets in order to bring the eciency o the medical advances in an

evidence-based manner.

This guideline shall serve as a standard to conduct pharmacoeconomic

studies in Malaysia or the purpose o preparing economic supporting

documents. This guideline will ensure the quality and standardisation o

pharmacoeconomic analyses to enable more meaningul comparisons

between similar health interventions. It will also encourage the generation

o primary local data.

The guideline will also allow users o the pharmacoeconomic

evaluation reports to assess the methodology o analyses and the

report ndings thus providing greater transparency and validity o

analysis conducted, allowing replication o analysis i necessary.

The pharmacoeconomic reports shall be used as scientic tools to

help decision makers in making inormed and rational choices in

striving to maximise total health benets within the budget limitations.


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2. OVERVIEW OF PHARMACOECONOMIC ANALYSIS

A. Types o Pharmacoeconomic Analysis

There are our main types o pharmacoeconomic evaluations:

Cost-Minimisation Analysis (CMA)

Cost-Eectiveness Analysis (CEA)

Cost-Utility Analysis (CUA)

Cost-Benet Analysis (CBA)

Full economic evaluation has 2 major components costs and

outcomes o the compared alternatives. The cost component is

always measured in monetary unit, while outcome component can

be measured in various ways such as lie years saved, case treated

and utility terms.

CMA compares treatment alternatives that yield similar healthconsequences. Once the health consequences are established to

be the same, a CMA would compare all cost between treatments to

determine the option with the least cost.

CEA compares the relative dierence o costs and consequences

o dierent treatment strategies. In CEA, costs are measured in

monetary terms and health consequences are measured in naturalor physical units.

CUA has the same principle as a CEA, but includes measures o the

impact on the quality o lie. CUA is oten used when quantity and

quality o lie are both important.

CBA compares treatment alternatives where both costs and benetsare expressed in monetary terms.


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The dierence between the types o pharmacoeconomic analysis is

summarised in the ollowing table.

Table 1: Dierence Between Types o Pharmacoeconomic Analysis

Type of Analysis Measurement of Costs Measurement of Outcomes

Cost-Minimisation MonetaryNone (health consequences are

assumed to be similar)

Cost-Eectiveness MonetaryNatural/physical units (fnal,

intermediate or surrogate outcomes)

Cost-Utility Monetary Multidimensional (DALY/QALY)

Cost-Beneft Monetary Monetary

B. Types o Costs in Pharmacoeconomic Analysis

Costs in health economic analyses are divided into three main groups:

Direct cost

Indirect cost

Intangible cost

Direct cost mainly covers cost o resources used related to the illness

and it consists o medical cost and non-medical cost. Direct medical

cost is related to resources that are directly used in treating the

patient such as the cost o medication, diagnostic, treatment, ollow

up, rehabilitation and hospital admission. It also includes the costs o

treating side eects. Direct non-medical cost cover personal acilities,

travel, ood, lodging, paid personal care, etc.


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Indirect cost reers to resources lostas a result o the treatment andillness that involve morbidity and mortality. This includes both paid and

unpaid productivity loss such as temporary sickness absenteeism,

permanent unctional impairment, premature death, etc. Indirect costcan be measured by approaches such as the Human Capital or

Frictional Methods.

Intangible cost represents costs as a consequence o the treatment

not measurable in monetary terms. These costs can be pain, grie,

and suering. When intangible costs are quantied, this can be done

using approved outcome-measurement techniques.

C. Measurements o Outcomes in Pharmacoeconomic Analysis

Health outcomes are consequences o a treatment/intervention

or programme which results in changes o quantity and quality o

lie. Health consequences can be nal, intermediate or surrogate

outcomes.

Final outcomes are usually measured as lie years or quality adjusted

lie years (QALYs). Intermediate outcomes are usually measured by

clinical parameters that have evidence-based correlation with the nal

outcome. A surrogate outcome is an end point that substitutes and

can be predictive o a nal outcome.

Final outcomes are measured over a natural course o the disease

whilst intermediate outcomes are measured over a short time horizon.

Changes in quality o lie can be valued directly by several methods

such as rating scale or time trade-o. It can also be valued indirectly

by employing instruments such as EQ-5D, HUI3, or SF-6D.


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D. Decision Analytic Model

Modelling is necessary in health economic analysis in order to inorm

decision-making. It consists o a series o health states, representingthe expected health consequences o dierent treatments. Modelling

provides an important ramework or synthesising available evidence

and generating estimates o clinical and cost-eectiveness. Modelling

can be used to extrapolate short-term outcome data or surrogate

measures to long-term outcomes using modelling techniques. It may

also be used to generate data rom clinical trial settings to routine

practice and to estimate the relative eectiveness o the technologies

where these have not been directly compared.

E. Discounting

The reason or the need to discount in an economic evaluation istime preerence which reers to the desire to enjoy benets in the

present while deerring any negative eects o doing so. Future costs

are discounted to account or the time value o money, and uture

health benets are discounted to account or the delay in satisaction

rom these outcomes. The eect o discounting is to give uture costs

and health benets less weight in an economic analysis.

F. Sensitivity Analysis

Uncertainty could arise in pharmacoeconomic studies rom the natural

variation in populations and also the heterogeneous external data

source used. Sensitivity analysis is perormed or all key parametersin an analysis, in order to test the validity and robustness o the

conclusion.


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G. Average Cost-Eectiveness Ratio (ACER) and IncrementalCost-Eectiveness Ratio (ICER)

ACER is the ratio o the cost to benet o an intervention without

reerence to a comparator. It deals with a single intervention and

evaluates that intervention. ACER is calculated by dividing the net

cost o the intervention by the total number o health consequences

prevented by the intervention. It is generally described as cost per

unit o outcome.

ICER compares the dierence between the costs and healthconsequences o two alternative interventions that compete or the

same resources. It is generally described as the additional cost per

additional health consequence.

H. Budget Impact Analysis (BIA)

BIA estimates the nancial consequences o adopting a new health

technology in a clearly specied setting. BIA complements the

pharmacoeconomic evaluations by providing additional inormation

or decision making as it addresses the issue o aordability and

sustainability. BIA provides inormation on the overall impact o a new

health technology to a budget.


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3. THE METHODOLOGICAL GUIDELINE

This methodological guideline shall be used when conducting anypharmacoeconomic studies in Malaysia or the purpose o preparing

economic supporting documents. The key eatures o this guideline

are summarised in section 5.

A. Scope o the Analysis and Perspective o Study

i) Problem Statement

The problem statement that brought about thepharmacoeconomic analysis or study should be clearlystated. This includes inormation on the disease such asepidemiology, cost o illness and standard treatment options

used in the applied setting.

ii) Description o Drug/Intervention and Its Use

The drug/intervention under study should be ullydescribed. I the study involves drugs, it should includename o drug, Anatomical Therapeutic Chemical (ATC)classication or Malaysia Drug Code (MDC), strength,

dosage orm, indication(s) and drug registration number inMalaysia (i available).

iii) Target Population

The target population should be clearly described. It may bedened by describing type o patient in terms o age, gender,

socioeconomic status with a specic disease, with or withoutother comorbidities or risk actors.

Subgroup analysis can be perormed i there is evidenceto support better results in a particular patient subgroup.


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iv) Perspective o the Study

The study should be conducted rom the perspective o the

provider or under in the applied setting. Patient and societalperspectives are encouraged. The perspective should be

consistent or both cost and outcome components.

B. Evaluation Technique

The type o economic analysis selected should be indicated and the

choice should be justied. The ollowing types o evaluation can be

carried out:

i) CMA should be applied when two interventions have similar

health consequences at dierent costs. In this case, only the

costs o treatment are compared.

ii) CEA should be used to compare dierential costs and

dierential outcomes o the alternatives. It should be chosen

when clinical outcome parameter or improvement in lie

expectancy is the main objective o the treatments. Final

outcome is preerred. When using intermediate or surrogate

outcome, it should be justied.

iii) CUA should be used i the quality o lie orms an important

eect o the intervention assessed. It should also be used

when the treatment assessed has multiple patient-related

outcome parameters reported in dierent units.

iv) I it is easible and acceptable to interpret the outcomes

studied into monetary terms, CBA can be undertaken.


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C. Selection o Comparator(s)

The health technologies to be assessed should be compared against

the most relevant alternative(s) or the proposed indication in theapplied setting.

The most relevant alternative should be the standard intervention

based on the National Clinical Practice Guidelines and Standard

Treatment Guidelines, i available. I standard treatment guideline

does not exist, usual treatment can be used upon prior consultation

with subject matter experts.

Comparator(s) should not be a placebo but non-drug therapy can

be used. Multiple comparators can be included in the analysis.

In case o add-on intervention, the current treatment without the

added intervention can be used as comparator. In the case where

replacement o intervention is necessary, the intervention most likely

to be replaced can be used as the comparator.

The choice o comparator(s) should always be justied.

D. Source and Retrieval o Evidence

Data rom local setting should be given precedence. In the absenceo evidence rom local setting, the pharmacoeconomic analysis shall

be based on evidence o clinical eects and adverse reactions o

treatment obtained via a comprehensive and systematic literature

review. All available evidence should be sought and considered as

part o the review process.

The most common source o clinical data or pharmacoeconomicstudies are randomised controlled trials (RCTs). Whenever available,

data rom meta-analyses or systematic reviews o RCTs should be

used.


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In the absence o valid RCTs, evidence rom the highest available level

o study design should be considered with reerence to the limitationso the study design. The methods used to analyse or combine datashould be clearly outlined and justied.

E. Measuring Cost

i) Cost Perspective

Fundamentally, all costs relevant to the chosen perspective

must be determined and included in the analysis and inthis case the perspective o the provider or under in theapplied setting. The dierent costs should be reported inboth disaggregated and aggregated orms.

I it is easible, societal cost is preerred in any analysis.

ii) Cost Data Sources

Local cost data should be used i available in the appliedsetting. The source o cost data must be identied. Thesesources may include cost rom observational studies,databases, Diagnosis-Related Group (DRG) list, patientrecords or local literatures. Where the local costs cannotbe obtained, other sources such as expenses and charges

can be used as substitute, but the reasons or this mustbe justied.

F. Measuring Health Outcome

The choice o outcome parameters will depend on indication o the

drug, the research question(s) and also the type o pharmacoeconomicanalysis selected. The outcome parameters selected should be madein advance and justied. Health consequences in natural orm, andmeasured as intermediate or nal outcome can be analysed usingCEA. However, only nal outcome valued by utility can be analysedusing CUA whilst outcomes that are valued as monetary term can

only be analysed using CBA.


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The nal outcome is usually measured as survival, and/or QALYs.

QALYs is preerable or the ollowing conditions: 1

Whenhealth-relatedqualityoflife(HRQoL)isthe/animportant

outcome.

Whentheinterventionaffectsbothmorbidity&mortalityandcommon unit o outcome is needed.

When the interventions compared have a wide range ofoutcomes and a common unit o output is needed orcomparison.

Whenaninterventioniscomparedtoothersthathavealreadybeen evaluated using CUA.

When dealingwith a limitedbudget situation such that thedecision maker must determine which programmes/servicesto reduce or eliminate to ree up unding or new programme.

Whentheobjectiveistoallocatelimitedresourcesoptimallyby

considering all alternatives and using constrained optimisationto maximise the health gain achieved.

Outcomes should be measured using validated tools or instruments.

As utilities may be infuenced by local cultural actors, preerences

obtained directly rom the target and local population is preerred.

Where local preerences are not available, preerences rom

populations with greatest similarity to the local population should be

employed.2-3

Beside valuation by preerence, changes in health state can also be

valued in monetary term using human capital approach, contingent

valuation, revealed preerence or discrete choice experiment.

G. Decision Analytic Model

Modelling can be used or the pharmacoeconomic evaluation in

certain situations, or example to extend the time horizon to longer

time span due to the nature o the disease or to model comparators

which have become more relevant to practice.


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When modelling is used, it is recommended to present the structure,

rationale behind chosen model and as well as to present it in a graphical

way (simple decision tree or Markov model).When choosing relevant

clinical trials or a model, it is important to ensure that the trials are assimilar as possible with respect to patients population, inclusion and

exclusion criteria, the problem presented in the trial, and the duration

o the treatment. This is to ensure that mutual consistency is achieved.

Models should be as transparent as possible with all assumptions

explicitly stated. The simplest model type should be chosen providing

it captures the essential eatures o the disease and interventions,and all relevant data are incorporated and reerenced.

Non-Malaysian model analyses may be used, but they should

principally be adjusted to Malaysian conditions regarding clinical

practice, costs and possibly health consequences. Justication must

be given or any adjustments made. In the absence o adjustments,

the consequences which the lack o adjustment may have on the

results must be stated.

H. Time Horizon

Time horizon chosen should be long enough to include or capture allchanges in cost and outcomes o the intervention being analysed.

The choice o time horizon depends on the natural history o the

disease and should be justied clearly.

I. Discounting

In a study longer than a year,annual discount rate o 3% should be

adopted or both costs and outcomes. Sensitivity analysis with higher

and lower discount rates (or example 0% and 5%) should be used to

veriy the robustness o the results o the analysis.


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J. Sensitivity Analysis

In the sensitivity analysis, critical component(s) in the calculation

should be varied through a relevant range rom worst case to best

case, and the results recalculated. These ranges and the omission o

any model input rom the sensitivity analysis must be justied.

Although univariate sensitivity analysis is acceptable, a multivariate

analysis is preerred where appropriate. A probabilistic sensitivity

analysis (PSA) with presentation o cost-eectiveness acceptability

curve (CEAC) can be used.

K. Presentation o Results and Discussion

Data and results o the analysis should be presented in the most

transparent and clear way so that the quality, validity and relevance o

the ndings to local settings can be easily assessed.

The total costs and total health consequences o all alternatives being

considered should be reported separately to provide clear view on

economic and health consequences o the alternatives. Base case

results can be presented as a table o costs (itemised by the dierent

types o cost) and outcomes o all the alternatives considered.

Aggregate and disaggregate results on costs, outcomes and cost-eectiveness ratio should be presented to provide inormation about

the new drug or intervention at individual and population level.

ACER and ICER or the CEA and CUA can be presented i deemed

appropriate.

The ICER refects the additional (incremental) cost per additional unit o

outcome achieved. No ormal cost-eectiveness threshold is adopted

in this guideline. Graphical presentations such as in the orm o cost-

eectiveness planes can be used when it is deemed benecial.


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Justications must be made on the transerability o trial results to the

local clinical practice (ecacy vs. eectiveness). Sources o secondary

data used and assumptions made in the analysis should be clearly

stated and properly reerenced to the reerences list. Limitations othe analysis should also be discussed in the discussion section.

Comparison o ndings with other pharmacoeconomic analysis

should be discussed.

L. Budget Impact Analysis

BIA shall take the budget holder perspective i.e. o the healthcare

provider or under. The design o the BIA model must be clear and

justied, incorporating real population data in Malaysia or specic

local setting. It must consider the population, market share, growth

rate and costs in two scenarios i.e. scenario with the new treatment

and scenario without the new treatment. The reerence scenario shallcomprise o the current treatment mix o the healthcare setting being

analysed.

M. Report Format or a Standard Pharmacoeconomic Analysis

Summary

Denitionofissue

Epidemiological/Prevalencedata(Malaysia)

Reviewofliterature

Analysisobjectives

Targetaudience

Studyperspective


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Timehorizon

Comparator(s)

Studymethodology

Descriptionofmodel

Costs(unitsofusedresources,unitarycosts,sourceofdata)

Outcome(s)

Discounting

Sensitivityanalysis

Presentationofresults(e.g.ACER,ICER,etc.)

BudgetImpactAnalysis

Discussion

References

Appendices(samplesofquestionnaires,qualityoflifemeasurementtools or instruments, source o data i.e. meta-analysis, RCTs)

Declaration o a potential confict o interest

N. Ethical Code o Practice While Conducting and Publishing

Results o Pharmacoeconomic Analysis

Pharmacoeconomic analysis should be conducted in accordance to

this guideline. Any nancial support or the study should be revealed.The author(s) should also declare any relationship with the unders

o the study or any other confict o interest. Publication o the local

pharmacoeconomic studies is encouraged.


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O. Format or Reerences

All reerences should be written according to Vancouver Style as

shown in examples below.

1. Journal article, personal author(s):

Rose ME, Huerbin MB, Melick J, et al. Regulation o

interstitial excitatory amino acid concentrations ater

cortical contusion injury. Brain Res. 2002; 935(1-2):40-46.

2. Journal article, organisation as author:

Diabetes Prevention Program Research Group. Hypertension,

insulin and proinsulin in participants with impaired glucose

tolerance. Hypertension. 2002; 40(5):679-686.


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4. LIST OF REFERENCES

1. Drummond MF, Sculpher MJ, Torrance GW, et al. Methods

or the economic evaluation o health care programmes.

[Oxord medical publications].3rd ed. New York: Oxord

University Press; 1997.

2. Dolan P. Modeling valuations or EuroQol health states.

Med Care. 1997; 35(11):1095-1108.

3. Faridah AMY, Goh A, Soraya A. Estimating an EQ-5D value

set or Malaysia using Time Trade-O and Visual Analogue

Scale Methods. Value in Health. 2012; 15:S85-S90.


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5. LIST OF KEY FEATURES

List o Key Features o Pharmacoeconomic Guideline or Malaysia

Key Features

til nd o h docmnPharmacoeconomic Guideline For

Malaysia 2012

afliion o mmbPSD, MOH, MaHTAS, MySPOR,MPS,MUSC,UM,UKM,UKMMC,

USM, UNU-IIGH, UiTM

Ppo o h docmn

A methodological guide to conduct

pharmacoeconomic analysis in

Malaysia.

sndd poing om

inclddYes

Diclo Yes

tg dinc o nding/

ho in

Both public and private payers,

healthcare industries, clinicians, and

research communities, accordingly.

PpcivProvider or under. Patient and

societal perspective are encouraged.

IndicionIndication(s) must be approved by

DCA/reerence country.


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Key Features

tg poplion Must be clearly stated.

sbgop nli Yes, can be included when appropriate.

Choic o compo

To be compared against the most

relevant alternatives or the proposed

indication in the applied setting.

Comparator(s) should not be a

placebo but non-drug therapy can

be used. The choice o comparator(s)

should always be justied.

tim hoizon

Should be long enough to capture all

changes in cost(s) and outcome(s)

o the intervention.

ampion qid Yes. Should be clearly stated.

Pd nlicl chniqCEA and CUA.Technique chosen

should be justied clearly.

Co o b incldd

All costs relevant to the chosen

perspective (provider/under). Societal

cost is preerred in any analysis.


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Key Features

soc o coLocal cost data in the applied setting.

The source o cost data must be

identied.

Modlling

Yes. Clearly detailed with maximum

transparency. All assumptions shouldbe explicitly stated.

smic viw o vidnc Yes. Meta-analysis is encouraged.

Pnc o civn

ov fccN/A

Pd ocom m Should justiy the selection.

Pd mhod o div

iliShould justiy the selection.


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Key Features

eqi i d N/A

Diconing co 3% (Sensitivity Analysis, 0 and 5%)

Diconing ocom 3% (Sensitivity Analysis, 0 and 5%)

sniivi nli-pm

nd ng

All key uncertain parameters. Best

and worst case scenario presented.

sniivi nli-mhodOne-way, multivariate analysis as

deemed appropriate.

Pning lAggregated and disaggregated orm

or cost(s) and outcome(s).


33/33


Key Features

Incmnl nli Yes

tol C/e Yes

Pobili o l

(Gnlibili)N/A

Bdg impc nli Yes

Mndo o commndd o

voln

Voluntary or 2 years upon launch

o the pharmacoeconomic guideline

and mandatory thereater.

phamacoeconomic guideline for malaysia

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