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
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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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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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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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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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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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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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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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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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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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
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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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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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.
4.3. National Institute for Health and Clinical excellence (NICE). Single Technology
Appraisal (STA). Specification for Manufacturers/Sponsor Submission of
Evidence. 17 May 2006. London. England.
4.4. A Prescription for Pharmacoeconomic Analysis, Pharmac, Pharmaceutical
Management agency Ltd. New Zealand. September 2004.
4.5. Orlewska E, Mierejewski P.Polish Guidelines for Conducting
Pharmacoeconomic Evaluations (project). Warsaw, Poland.
4.6. Guidance to assist manufacturers in the submission of a case to the Scottish
Medicines Consortium (URL).
4.7. General guidelins for economic evaluations from the Pharmaceutical benefits
Board, LFNAR 2003:2. Sweden.
4.8. Weinstein MC, O’Brien B, Hornberger J et al. Principles of good practice for
decision analytic modeling in health care evaluation: Report of the ISPOR Task
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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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