2002 guidelines for the pharmaceutical industry€¦ · web vieweffect sizes (with confidence...

STATE OF ISRAELMINISTRY OF HEALTH

Guidelines for the submission of Cost Utility Analyses of candidate

interventions for the National List of Health Services

Prepared by:Gary Ginsberg PhD, MSc(Econ)Dept of Medical Technology AssessmentMinistry of [email protected] 624 2122

mailto:[email protected]

CUA Guidelines Version 1Ministry of Health

Table of Contents Page

A: Why cost-utility analysis?............................................................................................4

B: What to Submit?...........................................................................................................7

C: Content of the Document...........................................................................................10

D. Who should prepare the study?.................................................................................20

E: When and Where to Submit?....................................................................................21

F. Bibliography................................................................................................................22

Appendix 1........................................................................................................................25

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Abbreviations:

Average Cost-effectiveness RatioACERיחס עלות-יעילות ממוצעת

Central Bureau of StatisticsCBSהלשכה המרכזית לסטטיסטיקה

Cost-Effectiveness AnalysisCEAניתוח עלות-יעילות

Cost-Utility AnalysisCUAניתוח עלות-מועילות

Disability WeightDWמשקל אי-תפקודי

European Quality of Life 5 DimensionsEQ-5D

Healthy Adjusted Life ExpectancyHALEתוחלת חיים מתוקננת לבריאות

Health Technology AssessmentHTAהערכת טכנולוגיה רפואית

Israeli Center for Disease ControlICDCהמרכז הישראלי לבקרת מחלות

Incremental cost-effectiveness ratioICERתוספת יחס עלות-יעילות

Intensive Care UnitICUיחידת טיפול נמרץ

Ministry of HealthMOHמשרד הבריאות

MedicalTechnology AssessmentMTAהערכת טכנולוגיה רפואית

New Israeli ShekelNISשקל חדש )₪(

National list of Health ServicesNLHSסל שירותי הבריאות

Pharmaco-Economic EvaluationPEEהערכות כלכליות

Purchasing Power ParityPPPשוויון כח קניה

Quality Adjusted Life YearQALYשנת חיים מתוקננת לאיכות

Short Form 6 DimensionsSF-6D

World Health OrganizationWHOארגון הבריאות העולמי

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Guidelines for the submission of Cost Utility Analyses of candidate interventions for the National List of Health

Services (NLHS)

A: Why cost-utility analysis?

Each year the Department of Medical Technology Assessment (MTA) of the Ministry of

Health (MOH) collates information on new potential interventions for possible inclusion

into the basket of health services. For brevity these guidelines will refer to all

interventions as being “pharmaceuticals or drugs”, though it is acknowledged that they

could also be in the form of medical devices, palliative care, screening programs or health

promotion interventions.

A committee, consisting of representatives of institutions and the public meets annually

to decide which interventions should be included in the “basket of health services”. Due

to the complex nature of the issue, the decision making process is lengthy and is often

complicated by political, patient, health service provider and pharmaceutical pressure

groups pushing their own vested interests.

In order to counteract these influences, we need to utilize a more objective means of

prioritizing potential interventions. Evidence on effectiveness alone is not a sufficient

basis to make recommendations for resource allocation to clinical care.

Cost-utility analysis (CUA) utilizes the disciplines of epidemiology, medicine and

economics to rank projects according to the Cost per QALY (quality adjusted life years)

saved. CUA is now used by many countries throughout the world as a necessary (but not

sufficient) tool in deciding health service priorities.

These guidelines have been drawn up to enable the Pharmaceutical Industry, Medical

Device Industry and other Health Service Providers to submit comparable, evidence-

based CUAs of the interventions they are putting forward as candidates for funding from

the basket of health services.

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The overall objective of the CUA is to provide reliable systematic and transparent

information so that investment opportunities in different areas of health care can be

compared. This aids the decision making and prioritization process so as to achieve

greater efficiency in the allocation of resources.

Essentially the epidemiological-economic analysis (or CUA) has four components:

establishing effectiveness, estimating quality of life, estimating costs of intervention and

averted treatment costs.

The CUA will help prioritize a new drug for inclusion into the basket of health services

if:

I. It is needed for the prevention or treatment of significant medical conditions not

already covered, or inadequately covered, by drugs in the existing basket AND is

of acceptable cost-effectiveness;

II. It is more effective, less toxic (or both) than a drug already listed for the same

indications AND is of acceptable cost-effectiveness; or

III. It is at least as effective and safe as a drug already listed for the same indications

AND is of similar or better cost-effectiveness.

Conversely, a drug should be considered for removal from the list under the following

circumstances:-

I. A more effective or equally effective but less toxic drug becomes available;

II. Evidence becomes available that the effectiveness of the drug is unsatisfactory;

III. Evidence becomes available that the toxicity or abuse potential of the drug

outweighs its therapeutic value;

IV. The drug has fallen into disuse or is no longer available; or

V. Treatment with a drug is no longer deemed cost-effective compared with other

therapies.

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According to the WHO Commission on MacroEconomics and Health an intervention is

considered to be:-

Cost-Saving: if treatment costs averted exceed intervention costs.

Very Cost-Effective: if Costs per QALY saved < per capita GNP (around $27,000 in

Israel in 2008).

Cost-Effective: If per capita GNP < Costs per QALY < 3 x per capita GNP ($81,000 in

Israel in 2008).

Not Cost-Effective: If Costs per QALY > 3 x per capita GNP.

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B: What to Submit?

This document provides guidelines for the formatting of CUA evidence in order that the

intervention be considered for inclusion in the health basket. These guidelines are

designed to help identify and format the basic information needed for such an

epidemiological-economic evaluation. They should be adhered to wherever possible.

Deviations, which may be necessary for some drugs, are permitted if accompanied by a

justification. Submitters should not assume that justifications will be accepted, so

consultation with the Department of MTA is advised in such circumstances.

In situations where the efficacy is identical to a drug already in the basket, but the costs

are lower, one could argue that only a cost-minimization analysis is required. However, it

is requested that a full CUA is submitted to aid comparability with drug treatments for

different conditions. Note: This may lead to the withdrawal of the more costly alternative

from the health basket in favour of the newer more cost-effective drug.

A submission should be as succinct and informative as possible. Documentation should

be provided of the sources of all the major variables. The MTA and the public committee

will be more likely to be influenced by arguments based on scientifically rigorous data

rather than opinions. Try as far as possible to follow the guidelines.

Executive Summary

Prepare a one page executive summary of the CUA including references to the following

terms:

Name of Drug (generic and brand)

Name of manufacturer, submitting company, and contact person (including

position, phone number and e-mail)

Drug indication addressed in the pharmaco-economic evaluation (PEE)

Action of drug

Main comparator used in the PEE, and whether it is included in the NLHS

Perspective used in the PEE

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http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-pbs-general-pubs-pharmpac-glossary-glossary.htm#evidence


Discount percentage used in the PEE

The benefit (in QALYs) of the intervention and the comparator

Number of persons expected to take drug

Gross cost of intervention and comparator (direct and indirect – not including

non-medical costs) in New Israeli Shekel (NIS)

Incremental cost per QALY ratio

Incremental Gross and Net cost of intervention over the next three years,

based on take-up rate of new drug

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Checklist of material to be provided for a major submission:

Use the following checklist as a final check before lodging a submission.

Two hard copies of PEE with executive summary

Articles and other materials used in the PEE

Electronic version of the PEE

Excel worksheet with short basic user guide

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C: Content of the Document

The CUA document should contain the following sections:

1. Description of the generic name, brand name and principal pharmacological action of

the drug.

2. The formulation(s), strength(s), pack size(s), maximum quantity(ies), dispensed

price(s).

3. Indication of drug.

4. The recommended course of treatment.

5. Description of the main comparator(s) used in the report

5.1. Highest preference is given to comparisons with alternatives within the NLHS

which comprise the standard of care.

5.2. A second comparison should be made with the lowest cost comparator (if

available) that is more effective than placebo.

5.3. A third comparison may be made with the no-treatment or do-nothing alternative.

6. A systematic review of the effectiveness of the intervention, with level of evidence

and sources.

6.1. The submitter should provide details of the thorough search strategy of the

systematic review used to identify relevant meta-analyses, trials and studies (see

The Cochrane Collaboration http://www.cochrane.org/reviews for additional

guidance). If important trials have been excluded details as to why should be

provided.

6.2. Effect sizes (with confidence intervals) should be provided for the relevant major

outcomes (e.g. decreases in incidence, case-fatality rates, increases in life

expectancy, and decreases in complications), for both intervention and

comparator.

6.3. Level of evidence should be described according to the proposed hierarchy of

evidence of efficacy as follows:

Ia Randomized controlled clinical trials comparing drug to comparator

Ib Two sets of randomized trials involving a common comparator (e.g.

placebo or other active therapy).

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http://www.cochrane.org/reviews


II-1a Controlled trial with pseudo-randomisation

II-1b Controlled trial without randomization

II-2a Prospective cohort study with parallel control

II-2b Prospective cohort study with historical control

II-2c Retrospective cohort studies with parallel control

II-3a Case-control studies

III Studies of the “before and after” type

IV Expert Opinion

6.4. The use of meta-analyses (if available), where several comparative trials can be

reviewed, is encouraged.

6.5. Use of modeling techniques to estimate effectiveness is a permitted substitute,

especially when the disease progression course is lengthy (eg: polyps developing

into colorectal cancer) and where surrogate health variables (eg: HDL/LDL

ratio) are used to predict final health outcomes (eg: mortality).

6.6. Considerations should be given to the difference between efficacy (evidence that

demonstrates the drugs value when used under the optimal circumstances of

randomized trials) and effectiveness of using the product in normal routine

circumstances.

7. Calculation of the Burden of Disease(s) for which the drug is aimed at by aggregating

QALY losses due to morbidity and mortality.

7.1. Morbidity burden:

I. Provide recent data on the age (preferably from 0-100 years) and gender

specific incidence and prevalence (in the case of chronic diseases) of the

disease(s). Ideally based on the last five years available data (obtained from

the CBS, ICDC, Sick Funds or the MOH for cancers and infectious diseases),

adjusted up to 2009 using population estimates based on projected data from

the CBS Annual Abstract of Statistics

(http://www1.cbs.gov.il/reader/shanatonenew.htm ) and/or CBS Monthly

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http://www1.cbs.gov.il/reader/shanatonenew.htm


Bulletin of Statistics (http://www1.cbs.gov.il/reader/yarhon/

yarmenu_e_new.html).

II. Include burden data based on the incidence of any chronic sequelae

attributable to the disease, based on evidence from the medical literature.

III. Documentation of the following (including source of data) should be provided

for:

The expected duration of the state of disability caused by the illness

(by stage in the case of cancers) used in the calculation.

The age-specific Disability Weights used to describe the illness (by

stage in the case of cancers and some chronic illnesses).

The expected duration of the state of disability for chronic sequelae

caused by the illness.

The age-specific Disability Weights of any chronic sequelae caused by

the illness.

IV. Where more than one source of data is available for the disability weights

(i.e.: utilities) or disease duration, all should be listed and rationale given for

the chosen value. If possible, try and use WHO based weights

(http://www.who.int/healthinfo/bodreferencedisabilityweights.xls) and

duration data (Murray CJL, Lopez AD. Global Health Statistics, Cambridge,

Harvard University Press) for comparability. However, other weights using

visual analogue scale, time trade off or standard gamble techniques or

instruments like the EQ-5D, Health utilities index, SF-36, McMaster health

utilities index, or other Quality of Life health questionnaires are also

acceptable.

7.2. Mortality Burden

I. Provide recent data on the age (preferably from 0-100 years), gender and

religion specific mortality rates from the disease(s). Ideally based on the last 5

years available mortality data (from the MOH or CBS), adjusted up to 2009

using population estimates based on projected data from the CBS Annual

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http://www.who.int/healthinfo/bodreferencedisabilityweights.xls

http://www1.cbs.gov.il/reader/yarhon/%20yarmenu_e_new.html



Abstract of Statistics (http://www1.cbs.gov.il/reader/ shanatonenew.htm)

and/or CBS Monthly Bulletin of Statistics

(http://www1.cbs.gov.il/reader/yarhon/yarmenu_e_new.html).

II. Calculate the HALE lost by the disease by multiplying the mortality by the

age-gender specific life expectancy adjusted by the age-specific values

(provided in APPENDIX A) that take into account decreased functionality

(quality of life) due to the aging process.

7.3. Include a detailed description of the assumptions underlying the model used for

the calculation of the effect of the intervention and comparator on the burden of

disease, integrating data on efficacy (section 6) and burden of disease (section 7)

with data on the expected percentage of target population who have potential

access to the drug and compliance.

8. Calculation of the expected QALY gain from both mortality and morbidity decreases

from using the drug.

8.1. Utilities should be based on visual analogue scale, time trade off or standard

gamble techniques or multiattribute utility scales like the EQ-5D, Health utilities

index, SF-6D, etc. Utilities should be appropriate to the Israeli population.

Source of utility should be specified, and attach, if possible.

8.2. Include a detailed description of the assumptions underlying the model used for

this calculation, integrating the effects of the intervention and the comparator on

duration of health states and the quality of life (utilities) of the disease.

8.3. Take into account any QALYs lost (or gained) due to the different side effects

experienced by the drug and its comparator.

8.4. Do not include age or equity-weightings for QALYs.

9. Calculation of the expected gross cost of the drug, direct and indirect costs, including

costs of side effects, not including non-medical costs.

9.1. Cost of the drug should represent its current market price in Israel or the

proposed price for its use in Israel.

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http://www1.cbs.gov.il/reader/yarhon/yarmenu_e_new.html

http://www1.cbs.gov.il/reader/%20shanatonenew.htm


9.2. Fixed costs (e.g. hospital administration overhead), unaffected by the level of

implementation of the intervention, should generally be excluded.

9.3. Population estimates should be based on data from the CBS Annual Abstract of

Statistics (http://www1.cbs.gov.il/reader/shanatonenew.htm) and/or CBS

Monthly Bulletin of Statistics (http://www1.cbs.gov.il/reader/yarhon/

yarmenu_e_new.html).

9.4. Both the quantities or volume of services that are utilized and unit prices should

be listed separately with source references for each resource used in the

intervention (e.g. drug, hospitalization, out-patient visits, staff labour, surgery,

equipment implanted in body, fixed equipment, disposable equipment,

maintenance, administrative overheads, media advertising, marketing, staff and

patient training costs). Basic cost data (e.g. hospitalization costs, laboratory

costs) can be obtained from the MOH website

http://www.health.gov.il/pages/default.asp?maincat=1&catId=111&PageId=827

9.5. Methods for the estimation of both quantities and prices (unit costs) should be

given. This must include a description of the underlying epidemiological model

used and economic cost sources.

9.6. Direct costs falling outside the health sector such as transport costs and special

diet costs, may be presented but should not be included in the calculation.

9.7. Do not include costs specifically relevant only to clinical trials

9.8. Present all drug costs exclusive of Value Added Tax (VAT), as this merely

constitutes a transfer payment.

9.9. A similar list of quantities and prices should be provided for the treatment of

adverse effects associated with the drug (e.g. doctors visits, Intensive Care Unit

(ICU) use, hospitalization and other costs).

9.10. Documentation should be provided as to the probability of a person taking

the drug having each type of side effect listed.

Note: Similar data on the cost of the comparator (i.e. competing therapeutic strategy)

and its side effects should also be provided.

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http://www.health.gov.il/pages/default.asp?maincat=1&catId=111&PageId=827



http://www1.cbs.gov.il/reader/shanatonenew.htm


10. Calculation of the expected treatment costs averted due to a decrease in morbidity and

or mortality (including costs of long term sequelae)

10.1. The probability of occurrence (in the case of chronic sequelae),

quantities/volumes (e.g. hours, tasks, nursing days, doses etc.) and unit prices

with source references (at January 2009 price levels) should be listed for each

individual element used to deliver treatment for the disease(s) that are being

impacted by the drug (eg: general practitioner visits, specialists, out-patient

visits, emergency room, day hospitalization, psychiatric day care,

complementary medical practitioners, imaging, laboratory tests, as well as

pharmaceutical, hospitalization, institutional care, home care and special

education costs).

10.2. Direct costs falling outside the health sector such as care giver costs,

transport costs and special diet costs, may be presented but should not be

included in the calculation.

10.3. This data should then be combined with data on efficacy (section 6),

coverage and compliancy to calculate the expected treatment costs averted by use

of the drug.

10.4. Records of the major sick funds are a valuable source of information for

both quantity (e.g. hospital utilization) and cost data.

10.5. Basic cost data (e.g. hospitalization costs, laboratory costs) can be

obtained from the MOH website (http://www.health.gov.il/pages/ default.asp?

maincat=1&catId=111&PageId=827). However, use of more accurate and

specific marginal costs is encouraged (along with supporting evidence) e.g. use

departmental or disease specific hospital costs instead of the general per-diem

costs provided by the MOH.

10.6. Costs of unrelated diseases (e.g. broken leg in an evaluation of an anti-

schizophrenia drug) and non-health care costs resulting from the patient living

longer due to an intervention should be excluded.

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http://www.health.gov.il/pages/%20default.asp?maincat=1&catId=111&PageId=827

http://www.health.gov.il/pages/%20default.asp?maincat=1&catId=111&PageId=827


10.7. Medical costs arising during life-years that have been saved, should only

be included if they are directly related to the intervention.

10.8. Costs based on international data should be adjusted to January 2009

levels taking into account the differentiation in the costs of non-traded (e.g.

labour costs) and traded goods (e.g. equipment, drugs) using the relative

Purchasing Power Parities (PPP) of the quoted country and Israel.

10.9. Care should also be taken to adjust for any differences in treatment

patterns (care protocols) that may exist between the international country and

Israel (e.g. Eastern European countries hospitalizing all hepatitis A and syphilis

instead of treating them mainly in an ambulatory care setting as in Israel).

10.10. Costs of lost time of family or friends who are caregivers should not be

included.

10.11. Do not include transfer payments such as sickness benefits, unemployment

insurance and income supplements.

Note: Similar data on the treatment costs (including costs of long term sequelae)

using the comparator effects should also be provided.

11. Calculation of the incremental and average cost-effectiveness ratios (ICER and

ACER), based on comparing the drug with the suitable comparators and no-treatment

option. These should be made from a societal perspective, which means all costs and

all health benefits resulting from the intervention should be taken into consideration,

irrespective of who benefits and who pays (e.g. government, sick-fund or individual)

from the intervention.

11.1. The costs and health effects of the drug used should be compared with the

appropriate comparator, using the basic formulae:

Net intervention cost of intervention = (Cost of drug – Treatment costs averted)

Net intervention cost of comparator = (Cost of comparator – Treatment costs averted)

Giving the ICER as,

_(Net intervention cost of intervention – Net cost of comparator)_(QALYs gained using intervention) – (QALYs gained using comparator)

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Specifically:

11.2. Present all prices in NIS at January 1st 2009 price levels.

11.3. Discount both costs and QALY outcomes at a 3% per annum rate.

11.4. Use a time horizon long enough to capture all the interventions effects on

health outcomes and resource use, taking into account the limitations of the

supporting evidence. This could vary considerably depending on the disease in

question (e.g. 20 days for urinary tract infection, or several decades for hepatitis

B and its sequellae). If modeled data are necessary to meet this requirement, then

the model’s structure and basis need to be described.

11.5. For the sake of simplification and due to their trivial size, there is no need

to value work productivity losses and out-of pocket expenses (e.g. transport) due

to the intervention. Similarly do not take into account extra premature burial

costs.

11.6. Do not value work productivity losses due to the disease(s) impact and

treatment, as it can been argued that these are implicitly included in the disability

weights of the disease(s).

11.7. Out-of pocket expenses related to the disease(s) and their treatment should

be included in the cost analysis. Take care not to double count items such as

participation in drug costs, which are included under direct drug costs.

11.8. Similarly intangible costs and benefits (eg: pain reduction) should not be

valued in monetary terms as their effects are included in the QALYs.

11.9. Explicit and clear details should be given of any modeling used, eg:

decision tree model, epidemiology model, Markov process, Monte Carlo

simulation (see Appendix M). Using a ready packaged template like the WHO

CHOICE POPMOD tool (http://www.who.int/choice/toolkit/pop_mod/en/

index.html ) is also acceptable.

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http://www.who.int/choice/toolkit/pop_mod/en/%20index.html

http://www.who.int/choice/toolkit/pop_mod/en/%20index.html


11.10. If disability weight or utility data is unavailable then results may be

presented in the form of a cost-effectiveness ratio of the cost per life year saved

(i.e. unadjusted for quality of life).

11.11. Conduct a number of sensitivity analyses on the ICER

I. By substituting the upper and lower 95% confidence limits of the

effectiveness difference in outcomes achieved.

II. By only discounting costs at a 3% rate.

III. By discounting costs and outcomes using a 5% rate.

IV. By applying a maximum time horizon of 30 years.

V. By varying in one, two way or analyses, on the major variables that drive and

present uncertainty in the calculation of the Cost per QALY ratio.

by conducting multivariate Monte Carlo simulation analyses (including

reference to pertinent software programs)

VI. By presenting a “best case” analysis, where costs are minimized and benefits

maximized.

VII. By presenting a “worst case” analysis, where costs are maximized and

benefits minimized.

11.12. Present the incremental cost of achieving each additional unit of outcome

with the proposed drug when substituted for the main comparators (ICER) and

the no-treatment option (ACER).

11.13. If deemed necessary for the intervention in question, the cost-effectiveness

ratios may be presented for identifiable sub-groups of the population at high-risk

for the disease.

11.14. Provide your search strategy along with copies of any published and

unpublished CUAs carried out in other countries. Estimate the main Cost-per

QALY result for Israel from these papers, by adjusting for cost, care protocol,

incidence and case fatality rate differences.

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http://www.health.gov.au/internet/wcms/publishing.nsf/Content/health-pbs-general-pubs-pharmpac-glossary-glossary.htm#sensitivityanalysis


12. Calculation of the estimated gross financial and incremental gross cost of the drug

and its comparators in each of the next five years.

12.1. The CUA results will assist the MTA to provide information to the

committee on the basket of health services about prioritizing what drugs should

be included or subsidized. The decision is based on a comparison of health

benefits and net costs from the perspective of society as a whole. However, the

Ministry of Health will need to make provision for the necessary funds required

by a successful submission using the perspective of health system costs as

calculated in this section and section 12 below.

12.2. Basically this is a based on the product of the expected utilization of the

drug and their unit costs. Speed of adoption (market penetration) of the

intervention should be taken into account.

12.3. Similar data on the gross financial cost of the comparator(s) in providing

the levels of utilization used in Section 12.2 should also be provided.

12.4. Calculate the gross incremental cost, by subtracting the gross financial

cost of comparator (see Section 12.3) from gross financial cost of drug (Section

11.2).

12.5. Include VAT in the calculations of costs.

13. Calculation of the net financial cost of the drug (and comparators) for each the next

five years.

13.1. Net Financial cost is defined as the gross financial cost of drug (see

Section 12) plus the cost of side effects less the savings in averted treatment

costs.

13.2. Similar data on the cost of the comparator and its side effects should also

be provided.

13.3. Calculate the net incremental cost, by subtracting net financial cost of

comparator (see Section 13.2) from Net financial cost of drug (Section 13.1).

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D. Who should prepare the study?

It is expected that most pharmaceutical companies will have access to the services of an

in- house health economist who will be trained in the complexities of epidemiological-

economic analyses like CUA.

A second option would be to hire a university based or freelance health economist to

undertake the task of preparing the specific CUA.

A final option is for the company to commission the CUA analysis (for a fee) from the

MOH.

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E: When and Where to Submit?

Cost-Utility Analysis submissions should be made for pharmaceutical candidates for

inclusion in the NLHS discussions starting in October/November.

The cut-off date for the initial major cost-utility submission for a new pharmaceutical to

the Department of Medical Technology Assessment (MTA) of the Ministry of Health will

be on July 31st 2009 and on July 31st of each subsequent year. Ministry staff, trained in

health economics and epidemiology will then verify the accuracy of the submissions. If

necessary, the MTA staff will contact the designated liaison person of the institution that

made the submission in order to clear up any questions.

Submission should include two hard copies:

Dr. Gary Ginsberg, Department of Technology and Infrastructure, MOH, Ben-

Tabai St Jerusalem 93591, POB 1176, Tel: 02 565 7730

Dr. Ifat Abadi-Korek, ICHTAC, the Gertner Institute, Sheba Medical Center,

52621, Tel: 03 737 1526

Each hard copy must be suitably bound, have a clear and adequate index, and have

consistent pagination throughout.

Attach copies of any original articles and other data sources used in the PEE.

The language of the submissions may be in Hebrew and/or English.

Extra copy of the entire submission (including accompanying articles) in electronic

format (with any word processed document compatible with WORD 2003) should be sent

to: [email protected]

In addition, include one copy of the spreadsheet model underlying the CUA (in any

format compatible with Microsoft Excel). If WHO POPMOD has been used, submit the

whole structure of data, templates, costs and results files. Finally, submit a short basic

user guide to the spreadsheet model in WORD format.

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mailto:[email protected]


F. Bibliography

References reviewed in preparing these guidelines:

Note: This reference has particularly detailed appendices that might be of use to

submitters.

Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the

Pharmaceutical Benefits Advisory Committee: including major submissions involving

economic analyses. Commonwealth Department of Health and Aging. Canberra,

Australia. September 2002. Available in http://www.ispor.org/PEguidelines/

On line references:

1. Hay J, Jackson J, Luce B, Avorn J, Ashraf T (co-chairs). Methodological Issues in

conducting pharmacoeconomic evaluation – Modelllng. http://www.ispor.org/

workpaper/ adpanel/mims-.asp

2. Langley P. Preparing Health Technology Submissions for Pharmaceutical products

(Executive Summary). URCH publishing Ltd. April, 2006.

http://www.urchpublishing.com/publications/pricing/health_technology.html

3. Ontario Guidelines for Economic Analysis of Pharmaceutical products. Ministry of

Health and Long-Term Care. Ontario, Canada. http://www.health.gov.on.ca/

english/providers/pub/drugs/economic/

4. ISPOR International Society for Pharmacoeconomics and outcomes research.

Pharmacoeconomic Guidelines Around the World.

http://www.ispor.org/PEguidelines/

Containing the following guidelines:

4.1. Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the

Pharmaceutical Benefits Advisory Committee: including major submissions

involving economic analyses. Commonwealth Department of Health and Aging.

Canberra, Australia. September 2002.

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http://www.health.gov.on.ca/

http://www.ispor.org/



4.2. Baltic Guideline for Economic Evaluation of Pharmaceuticals

(Pharmacoeconomic Analysis) Common Drug Review Submission Guidelines

for Manufacturers. Canadian Agency for Drugs and Technologies in Health

(CADTH). May 2006.

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Appendix 1

Values for converting life expectancy to Healthy Adjusted Life Expectancy (HALE). לתוחלת תוחלת חייםערכים להמרת

חיים מתוקננת לבריאות

HALE HALEAdjustors Adjustors

Males Females

זכריםנקבו

ת0 0.893 0 0.8761-4 0.887 1-4 0.8695-9 0.875 5-9 0.856

10-14 0.86110-14 0.841

15-19 0.84815-19 0.827

20-24 0.83720-24 0.814

25-29 0.82525-29 0.800

30-34 0.81230-34 0.786

35-39 0.80035-39 0.772

40-44 0.78740-44 0.758

45-49 0.77445-49 0.744

50-54 0.76250-54 0.731

55-59 0.74955-59 0.716

60-64 0.73760-64 0.703

65-69 0.72465-69 0.689

70-74 0.71270-74 0.675

75-79 0.70075-79 0.661

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80-84 0.68780-84 0.648

85+ 0.671 85+ 0.627

Source: Interpolations and Extrapolations of data in World Health Report 2002, WHO.

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2002 guidelines for the pharmaceutical industry€¦ · web vieweffect sizes (with confidence...

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