USING ECONOMIC EVALUATIONS IN DRUG REIMBURSEMENT DECISIONS

USING ECONOMIC USING ECONOMIC EVALUATIONS IN DRUG EVALUATIONS IN DRUG

REIMBURSEMENT DECISIONSREIMBURSEMENT DECISIONS‘NICE’ experiences from overseas‘NICE’ experiences from overseas

Michael DrummondMichael Drummond

Centre for Health EconomicsCentre for Health Economics

University of YorkUniversity of York

United KingdomUnited Kingdom

OUTLINE OUTLINE OF PRESENTATIONOF PRESENTATION

Some background.Some background. International guidelines for economic International guidelines for economic

evaluation.evaluation. Procedures in different countries.Procedures in different countries. Lessons from the use of economic Lessons from the use of economic

evaluation in drug reimbursement evaluation in drug reimbursement decisions.decisions.

Issues for countries considering introducing Issues for countries considering introducing economic evaluation requirements.economic evaluation requirements.

SOME BACKGROUNDSOME BACKGROUND Several jurisdictions have imposed a ‘Fourth Hurdle’ Several jurisdictions have imposed a ‘Fourth Hurdle’

or requirement for economic data as part of or requirement for economic data as part of pricing/reimbursement decisions for drugs.pricing/reimbursement decisions for drugs.

The new requirements are usually accompanied by a The new requirements are usually accompanied by a set of guidelines for company submissions.set of guidelines for company submissions.

Pricing decisions may or may not be linked with Pricing decisions may or may not be linked with reimbursement decisions.reimbursement decisions.

Australia was the first jurisdiction to implement such a Australia was the first jurisdiction to implement such a requirement. England and Wales (through the requirement. England and Wales (through the National Institute for Clinical Excellence) provides a National Institute for Clinical Excellence) provides a recent example.recent example.

CLASSIFICATION OF EXISTING GUIDELINESCLASSIFICATION OF EXISTING GUIDELINESPURPOSEPURPOSESOURCESOURCE

Government Government or or PayersPayers

AcademiaAcademia

IIndustryndustry

Reimbursement Reimbursement or Listingor Listing

Australia Australia Belgium Belgium Finland Finland The Netherlands The Netherlands Norway Norway Ontario Ontario Portugal Portugal Sweden Sweden United KingdomUnited Kingdom

Langley Langley et al et al (USA) (USA) Alban Alban et al et al (DK)(DK)

Methodological Methodological StandardsStandards

CCOHTA (Canada) CCOHTA (Canada) PHS Panel PHS Panel (USA) AMCP (USA)(USA) AMCP (USA)

LDI Task Force (USA) LDI Task Force (USA) Rovira Rovira et alet al (Spain) (Spain) Hannover (Germany) Hannover (Germany) BESPE (Belgium) BESPE (Belgium) BMJ Working Party (UK) BMJ Working Party (UK) Garattini Garattini et alet al (Italy) (Italy) College of Economists (France)College of Economists (France)

PHrMA (USA)PHrMA (USA)

Ethics and ConductEthics and Conduct

LDI Task Force (USA)LDI Task Force (USA)

IN GENERAL, WHAT’S IN GENERAL, WHAT’S COVERED BY GUIDELINES?COVERED BY GUIDELINES?

Viewpoint for analysis.Viewpoint for analysis. Choice of comparator.Choice of comparator. Form(s) of economic analysis.Form(s) of economic analysis. Measurement and valuation of costs and benefits.Measurement and valuation of costs and benefits. Discounting.Discounting. Allowing for uncertainty.Allowing for uncertainty. Presentation of results.Presentation of results.

THE MAIN SIMILARITIES THE MAIN SIMILARITIES AMONG GUIDELINESAMONG GUIDELINES

Choice of comparator.Choice of comparator. Importance of good data on Importance of good data on

clinical effectiveness.clinical effectiveness. Discounting of future costs and Discounting of future costs and

benefits.benefits. Incremental comparisons.Incremental comparisons. Allowing for uncertainty.Allowing for uncertainty.

MAJOR AREAS FOR MAJOR AREAS FOR METHODOLOGICAL DEBATEMETHODOLOGICAL DEBATE

Viewpoint for the analysis.Viewpoint for the analysis. Relevance of Phase III trials and the role of Relevance of Phase III trials and the role of

modelling. modelling. Measurement and valuation of health Measurement and valuation of health

outcomes (e.g. QALYs, WTP).outcomes (e.g. QALYs, WTP). Handling uncertainty.Handling uncertainty. Budget impact analysis.Budget impact analysis.

PRICING AND REIMBURSEMENT PRICING AND REIMBURSEMENT OF DRUGS IN AUSTRALIAOF DRUGS IN AUSTRALIA

Submissions for inclusion on the Pharmaceutical Submissions for inclusion on the Pharmaceutical Benefits Schedule are made to the Pharmaceutical Benefits Schedule are made to the Pharmaceutical Benefits Advisory Committee (PBAC).Benefits Advisory Committee (PBAC).

Submissions are required for all new drugs Submissions are required for all new drugs (including additional indications and new (including additional indications and new formulations) to be used outside of public hospitals.formulations) to be used outside of public hospitals.

The PBAC issues recommendations to the Minister.The PBAC issues recommendations to the Minister. Although a price is assumed in the submission, Although a price is assumed in the submission,

pricing decisions are made by a separate pricing decisions are made by a separate committee.committee.

SUBMISSION AND REVIEW PROCESS UNDER THE AUSTRALIAN GUIDELINESSUBMISSION AND REVIEW PROCESS UNDER THE AUSTRALIAN GUIDELINES(Glasziou and Mitchell, 1996)(Glasziou and Mitchell, 1996)

PRICING AND REIMBURSEMENT OF PRICING AND REIMBURSEMENT OF DRUGS IN ENGLAND AND WALESDRUGS IN ENGLAND AND WALES Most drugs are reimbursed under the NHS at Most drugs are reimbursed under the NHS at

the manufacturer’s chosen price.the manufacturer’s chosen price. Several drugs with a ‘major impact on the NHS’ Several drugs with a ‘major impact on the NHS’

are selected by NICE for detailed appraisal.are selected by NICE for detailed appraisal. On the basis of its appraisal, NICE issues On the basis of its appraisal, NICE issues

guidance on the use of health technologies to guidance on the use of health technologies to the NHS.the NHS.

Since December 2001 the guidance has been Since December 2001 the guidance has been mandatory.mandatory.

NATIONAL NATIONAL INSTITUTE INSTITUTE

FOR CLINICAL FOR CLINICAL EXCELLENCE EXCELLENCE

(NICE) (NICE) APPRAISAL APPRAISAL

PROCESSPROCESS

Appraisal Process Diagrammatic Timeline

DH = Department of Health NAW = National Assembly of Wales NHS = National Health Service Source: National Institute for Clinical Excellence. Guide to the technology appraisal process. 1: Introduction and background to the appraisal process. London, NICE, 2001.

NICE TECHNOLOGY APPRAISALS NICE TECHNOLOGY APPRAISALS ISSUED BY 2001ISSUED BY 2001

Cardiovascular diseaseCardiovascular diseaseCoronary artery stents in the treatment of IHD (May 2000).Coronary artery stents in the treatment of IHD (May 2000).Implantable cardioverter defibrillators for arrhythmias (September 2000)Implantable cardioverter defibrillators for arrhythmias (September 2000)

Endocrine diseasesEndocrine diseasesPioglitazone for type 2 diabetes mellitus (March 2001).Pioglitazone for type 2 diabetes mellitus (March 2001).Rosiglitazone for type 2 diabetes mellitus (August 2000).Rosiglitazone for type 2 diabetes mellitus (August 2000).

ENTENTHearing aid technology (July 2000).Hearing aid technology (July 2000).

Gastrointestinal diseaseGastrointestinal diseaseLaparoscopic surgery for inguinal hernia (January 2001).Laparoscopic surgery for inguinal hernia (January 2001).Proton pump inhibitors for dyspepsia (July 2000).Proton pump inhibitors for dyspepsia (July 2000).

Infections/infectious diseasesInfections/infectious diseasesInterferon alpha and ribavirin for hepatitis C (October 2000).Interferon alpha and ribavirin for hepatitis C (October 2000).Zanamivir for the treatment of influenza (November 2000).Zanamivir for the treatment of influenza (November 2000).

Malignant disease and immunosuppressionMalignant disease and immunosuppressionTaxanes for breast cancer (June 2000 and September 2001).Taxanes for breast cancer (June 2000 and September 2001).Fludarabine for chronic b-cell lymphocytic leukaemia (September 2001).Fludarabine for chronic b-cell lymphocytic leukaemia (September 2001).Topotecan for advanced ovarian cancer (August 2001).Topotecan for advanced ovarian cancer (August 2001).Docetaxel, paclitaxel, gemcitabine and vinorelbine for non-small cell cancer (June Docetaxel, paclitaxel, gemcitabine and vinorelbine for non-small cell cancer (June 2001).2001).Gemcitabine for the treatment of pancreatic cancer (May 2001).Gemcitabine for the treatment of pancreatic cancer (May 2001).Temozolomide for malignant glioma (April 2001).Temozolomide for malignant glioma (April 2001).Laparoscopic surgery for colorectal cancer (December 2000).Laparoscopic surgery for colorectal cancer (December 2000).Liquid based cytology for cervical screening (June 2000).Liquid based cytology for cervical screening (June 2000).Taxanes for ovarian cancer (May 2000).Taxanes for ovarian cancer (May 2000).

NICE TECHNOLOGY APPRAISALS NICE TECHNOLOGY APPRAISALS ISSUED BY 2001ISSUED BY 2001

Mental health/central nervous systemMental health/central nervous systemDonepezil, rivastigmine and galantamine for Alzheimer’s disease (January 2001).Donepezil, rivastigmine and galantamine for Alzheimer’s disease (January 2001).Methylphenidate for attention deficit hyperactivity disorder (October 2000).Methylphenidate for attention deficit hyperactivity disorder (October 2000).Orlistat for the treatment of obesity in adults (March 2001).Orlistat for the treatment of obesity in adults (March 2001).Riluzole for motor neurone disease (January 2001).Riluzole for motor neurone disease (January 2001).Sibutramine for obesity in adults (October 2001).Sibutramine for obesity in adults (October 2001).

Musculo skeletal and jointMusculo skeletal and jointCOX II selective inhibitors for osteoarthritis and rheumatoid arthritis (July 2001).COX II selective inhibitors for osteoarthritis and rheumatoid arthritis (July 2001).Hip prostheses for primary hip replacement (April 2000).Hip prostheses for primary hip replacement (April 2000).Autologous cartilage transplantation for full thickness cartilage defects in knee joints Autologous cartilage transplantation for full thickness cartilage defects in knee joints (December 2000).(December 2000).

NICE TECHNOLOGY APPRAISALS NICE TECHNOLOGY APPRAISALS ISSUED BY 2001ISSUED BY 2001

Oral and maxillofacialOral and maxillofacial

Wisdom teeth – appropriate removal (March 2000).Wisdom teeth – appropriate removal (March 2000).

Respiratory systemsRespiratory systems

Inhaler systems for under-5s (August 2000).Inhaler systems for under-5s (August 2000).

Skin/woundsSkin/wounds

Debriding agents and specialist wound care clinics for difficult to heal Debriding agents and specialist wound care clinics for difficult to heal surgical wounds (April 2001).surgical wounds (April 2001).

NICE TECHNOLOGY APPRAISALS NICE TECHNOLOGY APPRAISALS ISSUED BY 2001ISSUED BY 2001

MOST RECENT MOST RECENT GUIDANCE FROM NICEGUIDANCE FROM NICE

New topics are not dissimilar from those studied this far:New topics are not dissimilar from those studied this far:– glycoprotein 11b/111a inhibitors revision;glycoprotein 11b/111a inhibitors revision;– surgery to aid weight reduction;surgery to aid weight reduction;– pegylated liposomal doxorubicin hydrochloride for advanced pegylated liposomal doxorubicin hydrochloride for advanced

ovarian cancer;ovarian cancer;– metal hip resurfacing arthoplasty;metal hip resurfacing arthoplasty;– human growth hormone in children with growth failure;human growth hormone in children with growth failure;– routine antenatal anti-D prophylaxis for RhD-negative women;routine antenatal anti-D prophylaxis for RhD-negative women;– infliximab for Crolin’s disease.infliximab for Crolin’s disease.

Now that NICE also issues clinical practice guidelines there is Now that NICE also issues clinical practice guidelines there is a growing debate about the relationship between technology a growing debate about the relationship between technology appraisals and practice guidelines.appraisals and practice guidelines.

MAIN LESSONS FROM THE USE MAIN LESSONS FROM THE USE OF ECONOMIC EVALUATION OF ECONOMIC EVALUATION AT THE CENTRAL LEVEL (1)AT THE CENTRAL LEVEL (1)

Demonstration of clinically-important benefits Demonstration of clinically-important benefits is still paramount.is still paramount.

Economic data are more important when Economic data are more important when there is substantial budgetary impact.there is substantial budgetary impact.

Devices and procedures are generally harder Devices and procedures are generally harder to appraise than drugs.to appraise than drugs.

MAIN LESSONS FROM THE USE MAIN LESSONS FROM THE USE OF ECONOMIC EVALUATION OF ECONOMIC EVALUATION AT THE CENTRAL LEVEL (2)AT THE CENTRAL LEVEL (2) Difficulties arise owing to the lack of Difficulties arise owing to the lack of

transferability of economic data.transferability of economic data. Political will is sometimes tested (e.g. Political will is sometimes tested (e.g.

Beta-interferon).Beta-interferon). In reimbursement decisions, total In reimbursement decisions, total

refusal is rare; limitations or restrictions refusal is rare; limitations or restrictions in use are much more common.in use are much more common.

NICE GUIDANCE ON THE USE OF NICE GUIDANCE ON THE USE OF COX II SELECTIVE INHIBITORS COX II SELECTIVE INHIBITORS

(CELCOXIB, ROFECOXIB, MELOXICAM (CELCOXIB, ROFECOXIB, MELOXICAM AND ETODOLAC) FOR OSTEOARTHRITIS AND ETODOLAC) FOR OSTEOARTHRITIS

AND RHEUMATOID ARTHRITISAND RHEUMATOID ARTHRITISCox II selective inhibitors are not recommended Cox II selective inhibitors are not recommended for routine use in patients with rheumatoid for routine use in patients with rheumatoid arthritis (RA) or osteoarthritis (OA). They should arthritis (RA) or osteoarthritis (OA). They should be used in preference to standard NSAIDs, be used in preference to standard NSAIDs, when clearly indicated as part of the when clearly indicated as part of the management of RA or OA, only in patients who management of RA or OA, only in patients who may be at ‘high risk’ of developing serious may be at ‘high risk’ of developing serious gastrointestinal adverse effects.gastrointestinal adverse effects.

MAIN LESSONS FROM THE USE MAIN LESSONS FROM THE USE OF ECONOMIC EVALUATION AT OF ECONOMIC EVALUATION AT

THE CENTRAL LEVEL (3)THE CENTRAL LEVEL (3) Cost-effectiveness of a technology may change over Cost-effectiveness of a technology may change over

time and decisions may have to be reviewed.time and decisions may have to be reviewed. Application of economic evaluation in decision making Application of economic evaluation in decision making

has revealed weaknesses in Phase III drug studies.has revealed weaknesses in Phase III drug studies. Litigation is increasingly being used by Litigation is increasingly being used by

manufacturers.manufacturers. Decisions do reflect a ‘cost-effectiveness logic’ Decisions do reflect a ‘cost-effectiveness logic’

although other factors clearly come into play.although other factors clearly come into play.

INCREMENTAL COST PER ADDITIONAL INCREMENTAL COST PER ADDITIONAL LIFE-YEAR GAINED LEAGUE TABLELIFE-YEAR GAINED LEAGUE TABLE

Number

Incremental cost per additional life-year

gained at 1998/1999 prices ($AU)

PBAC decision

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

5517 8374 8740 17387 18762 18983 19807 22255 26800 38237 39821 42697 43550 43550 43550 56175 57901 63703 71582 75286 85385 88865 98323 229064 231650 256950

Recommend at price Recommend at price Recommend at price Recommend at price Recommend at price Recommend at price Recommend at lower price Recommend at price Recommend at price Recommend at price Recommend at price Reject Reject Defer Recommend at price Reject Recommend at price Reject Recommend at price Recommend at price Recommend at lower price Reject Reject Recommend at lower price Reject Reject

$AU = Australian dollars. The average interbank exchange rate to US dollars for 1998/1999 was 0.63772 (range 0.68760 to 0.54850). PBAC = Pharmaceutical Benefits Advisory Committee.

Source: George et al. PharmacoEconomics 2001; 19(11): 1103-1109.

PROBLEMS WITH A SINGLE PROBLEMS WITH A SINGLE COST-EFFECTIVENESS THRESHOLDCOST-EFFECTIVENESS THRESHOLD Cost-effectiveness of health technologies varies by Cost-effectiveness of health technologies varies by

country.country. Societal willingness-to-pay for health technologies Societal willingness-to-pay for health technologies

may vary by country.may vary by country. Without the overall budgetary impact, the cost-Without the overall budgetary impact, the cost-

effectiveness ratio cannot tell us the opportunity cost effectiveness ratio cannot tell us the opportunity cost of adopting the new technology.of adopting the new technology.

Other factors (e.g. equity) enter into decision-Other factors (e.g. equity) enter into decision-making.making.

FACTORS FREQUENTLY FACTORS FREQUENTLY CONSIDERED ALONGSIDE CONSIDERED ALONGSIDE

COST-EFFECTIVENESSCOST-EFFECTIVENESS Seriousness of the health condition.Seriousness of the health condition. Availability of alternative therapies.Availability of alternative therapies. Number of patients, and hence budgetary Number of patients, and hence budgetary

impact.impact. Daily cost to patients if drug not listed.Daily cost to patients if drug not listed. Whether the drug is a ‘lifestyle drug’.Whether the drug is a ‘lifestyle drug’.

HOW ARE REIMBURSEMENT RULES HOW ARE REIMBURSEMENT RULES OR GUIDANCE IMPLEMENTED?OR GUIDANCE IMPLEMENTED?

Depends on the jurisdiction and clinical setting.Depends on the jurisdiction and clinical setting. Use of hospital-based drugs can be influenced by Use of hospital-based drugs can be influenced by

budgetary controls and formulary listing.budgetary controls and formulary listing. Use of drugs in primary care can be influenced by Use of drugs in primary care can be influenced by

clinical guidelines (e.g. approval ‘on authority’), clinical guidelines (e.g. approval ‘on authority’), financial incentives and formulary restrictions.financial incentives and formulary restrictions.

In the UK, the Department of Health is conducting In the UK, the Department of Health is conducting a study of the implementation of NICE guidance.a study of the implementation of NICE guidance.

ISSUES FOR COUNTRIES ISSUES FOR COUNTRIES INTRODUCING THE INTRODUCING THE ‘FOURTH HURDLE’‘FOURTH HURDLE’

Do we request evidence for all new drugs, or Do we request evidence for all new drugs, or just some?just some?

How do we prioritize drugs for assessment?How do we prioritize drugs for assessment? Does it make sense to assess several drugs Does it make sense to assess several drugs

in the same class together?in the same class together? How prescriptive, or flexible, should we be in How prescriptive, or flexible, should we be in

specifying the data requirements?specifying the data requirements?

ISSUES FOR COUNTRIES ISSUES FOR COUNTRIES INTRODUCING THE INTRODUCING THE ‘FOURTH HURDLE’ ‘FOURTH HURDLE’

(Continued)(Continued) Should we be willing to accept data from other Should we be willing to accept data from other

countries? If so, which?countries? If so, which? Should we be willing to accept commercial-in-Should we be willing to accept commercial-in-

confidence data submitted by companies?confidence data submitted by companies? Should the reasons for reimbursement Should the reasons for reimbursement

decisions be made public?decisions be made public? Should there be an appeals process? If so, Should there be an appeals process? If so,

what should this consist of?what should this consist of?

ISSUES FOR COUNTRIES ISSUES FOR COUNTRIES INTRODUCING THE INTRODUCING THE ‘FOURTH HURDLE’ ‘FOURTH HURDLE’

(Continued)(Continued)

Should we consider a two-stage Should we consider a two-stage appraisal process?appraisal process?

Should we consider risk-sharing Should we consider risk-sharing deals with companies?deals with companies?

ACCEPTING DATA FROM ACCEPTING DATA FROM OTHER COUNTRIES OTHER COUNTRIES

An important issue for countries with limited An important issue for countries with limited resources to undertake or assess economic resources to undertake or assess economic evaluations.evaluations.

The key issue is whether economic studies The key issue is whether economic studies are generalizable from one setting to are generalizable from one setting to another.another.

FACTORS LIKELY TO FACTORS LIKELY TO LIMIT GENERALIZABILITY LIMIT GENERALIZABILITY

OF ECONOMIC STUDIES OF ECONOMIC STUDIES Demography and epidemiology of disease.Demography and epidemiology of disease. Clinical practice patterns.Clinical practice patterns. Relative price differences.Relative price differences. Incentives to health professionals or Incentives to health professionals or

institutions.institutions. Community valuations of health and health Community valuations of health and health

care.care.

THE GENERALIZABILITY OF THE GENERALIZABILITY OF ECONOMIC EVALUATIONS ECONOMIC EVALUATIONS

OF DRUGS IN EUROPEOF DRUGS IN EUROPE What are the main causes of variation in study What are the main causes of variation in study

results from place to place?results from place to place? Does the extent of variation differ among different Does the extent of variation differ among different

health economic study types? (e.g. modelling health economic study types? (e.g. modelling studies, trial-based studies).studies, trial-based studies).

Are there systematic differences in study results Are there systematic differences in study results between particular countries?between particular countries?

Is the extent of variation in study results between Is the extent of variation in study results between countries important for decision-making?countries important for decision-making?

Barbieri Barbieri et alet al, , 2003.2003.

QUANTITY OF STUDIES QUANTITY OF STUDIES AND RANGE OF COVERAGEAND RANGE OF COVERAGE

2400 references retrieved.2400 references retrieved. 46 intercountry comparisons:46 intercountry comparisons:

– 29 comparisons in multicountry studies;29 comparisons in multicountry studies;– 17 comparisons in methodologically-17 comparisons in methodologically-

equivalent single-country studies.equivalent single-country studies.

MAJOR CAUSES OF VARIATION MAJOR CAUSES OF VARIATION IN STUDY RESULTS FROM IN STUDY RESULTS FROM

PLACE TO PLACEPLACE TO PLACE Depends on type of study.Depends on type of study. When only unit costs are allowed to vary, When only unit costs are allowed to vary,

drug costs and hospitalization costs are drug costs and hospitalization costs are the most important causes.the most important causes.

When all factors are allowed to vary, When all factors are allowed to vary, differences in resource use and cost are differences in resource use and cost are the most important causes.the most important causes.

GENERALIZABILITY OF GENERALIZABILITY OF STUDIES BY METHODOLOGYSTUDIES BY METHODOLOGY

0

810

0

11

7 6

2

108

17

9

11

15 15

2

27

17

0

5

10

15

20

25

30

TB/V TB/NV M/V M/NV TB M RV RN T

G or PG

LG or NG

RELATIVE COMPARISON OF COST-RELATIVE COMPARISON OF COST-EFFECTIVENESS AMONG COUNTRIESEFFECTIVENESS AMONG COUNTRIES

France France more CE more CE thanthan

Germany Germany more CE more CE thanthan

Italy more Italy more CE thanCE than

Spain more Spain more CE thanCE than

UK more UK more CE thanCE than

TOTALTOTAL

France less France less CE thanCE than

-- 2 (20%)2 (20%) 2 (22%)2 (22%) 4 (45%)4 (45%) 0 (0%)0 (0%) 8 (22%)8 (22%)

Germany Germany less CE thanless CE than

8 (80%)8 (80%) -- 6 (55%)6 (55%) 6 (75%)6 (75%) 4 (40%)4 (40%) 24 (61%)24 (61%)

Italy less Italy less

CE thanCE than

7 (78%)7 (78%) 5 (45%)5 (45%) -- 3 (60%)3 (60%) 4 (36%)4 (36%) 21 (55%)21 (55%)

Spain less Spain less CE thanCE than

5 (55%)5 (55%) 2 (25%)2 (25%) 2 (40%)2 (40%) - - 3 (50%)3 (50%) 12 (43%)12 (43%)

UK less UK less

CE thanCE than

8 (100%)8 (100%) 6 (60%)6 (60%) 7 (64%)7 (64%) 3 (50%)3 (50%) -- 24 (68%)24 (68%)

TOTALTOTAL 28 (78%)28 (78%) 15 (39%)15 (39%) 17 (45%)17 (45%) 16 (57%)16 (57%) 11 (32%)11 (32%)

IMPORTANCE OF VARIATION IMPORTANCE OF VARIATION IN STUDY RESULTS FOR IN STUDY RESULTS FOR

DECISION-MAKINGDECISION-MAKING

Depends on the threshold cost-effectiveness Depends on the threshold cost-effectiveness ratio.ratio.

With a willingness-to-pay for a QALY of With a willingness-to-pay for a QALY of $50,000 we would only reach a different $50,000 we would only reach a different decision (comparing countries) in 3 out of 28 decision (comparing countries) in 3 out of 28 cases.cases.

CONCLUSIONS CONCLUSIONS Several jurisdictions now request cost-Several jurisdictions now request cost-

effectiveness data in respect of drug pricing effectiveness data in respect of drug pricing or reimbursement decisions.or reimbursement decisions.

These decision-making processes have These decision-making processes have proved workable, although many problems/ proved workable, although many problems/ issues have emerged.issues have emerged.

Other countries introducing the ‘Fourth Other countries introducing the ‘Fourth Hurdle’ can learn from others’ experiences.Hurdle’ can learn from others’ experiences.